ST.

PAUL’S HOSPITAL MILLENNIUM MEDICAL COLLEGE

PREGNANCY-RELATED VENOUS THROMBOEMBOLISM:

ASSESSMENT OF PREVALENT PERIOD, ASSOCIATED
FACTORS AND ITS OUTCOME IN ST. PAUL'S HOSPITAL
MILLENNIUM MEDICAL COLLEGE

RESEARCHER: AMANUEL WELDEGEBRIEL, INTERNAL MEDICINE RESIDENT

SEPTEMBER 2021
ADDIS ABABA, ETHIOPIA
 ST. PAUL’S HOSPITAL MILLENNIUM MEDICAL COLLEGE

PREGNANCY-RELATED VENOUS THROMBOEMBOLISM:

ASSESSMENT OF PREVALENT PERIOD, ASSOCIATED
FACTORS, AND ITS OUTCOME IN ST. PAUL'S HOSPITAL
MILLENNIUM MEDICAL COLLEGE

RESEARCHER: AMANUEL WELDEGEBRIEL, INTERNAL MEDICINE RESIDENT

ADVISORS:
AFEWORK HAGOS (MD, ASSISTANT PROFESSOR, INTERNIST, HEMATOLOGIST)
ANDAMLAK GIZAW (MPH)

A THESIS PAPER SUBMITTED TO THE DEPARTMENT OF INTERNAL

MEDICINE, ST. PAUL’S HOSPITAL MILLENNIUM MEDICAL COLLEGE IN
PARTIAL FULFILLMENT OF THE REQUIREMENTS FOR CERTIFICATE OF
SPECIALITY IN INTERNAL MEDICINE

SEPTEMBER 2021
ADDIS ABABA, ETHIOPIA
List of acronyms and Abbreviations

APS - Antiphospholipid syndrome

CTPA - Computed tomographic pulmonary angiography
CUS - Compression ultrasonography
CVD - Cardiovascular disease
CVT - Cerebral venous sinus thrombosis
DVT - Deep venous thrombosis
INR - International normalized ratio
HIT - Heparin-induced thrombocytopenia
HIV/AIDS - Human Immunodeficiency Virus
LMWH - Low molecular weight heparin
PTE - Pulmonary embolism
RCOG - Royal College of Obstetricians and Gynecologists
RVI - Retroviral infection
VTE - Venous thromboembolism
UFH - Unfractionated heparin
SLE - Systemic lupus erythematosus
SPHMMC - St. Paul’s Hospital Millennium Medical College

I
List of tables and figures
List of tables
Table 1: Sociodemographic characteristics of patients, SPHMMC, Addis Ababa, 2021……………........12

Table 2: Medical history of Patient with VTE, SPHMMC, Addis Ababa, 2021………………………….13

Table 3: Other risk factors of VTE identified among patients, SPHMMC, Addis Ababa, 2021….............13

Table 4: Pregnancy information Gravida in number, SPHMMC, Addis Ababa, 2021……….…………..14

Table 5: Pregnancy information Abortion in number, SPHMMC, Addis Ababa, 2021………………......15

Table 6: Pregnancy information Stillbirth (dead fetus >28 weeks) in number, SPHMMC, Addis Ababa,
2021……………………………………………………………………………………………………......15

Table 7: Trimester of pregnancy (from LNMP or Obstetric U/S) and VTE diagnosis, SPHMMC, Addis
Ababa,
2021……………………………………………………………………………………………………......17

Table 8: Post-partum who delivered within 6 weeks and VTE diagnosis, SPHMMC, Addis Ababa,
2021……………………………………………………………………………………………………......18

Table 9: Characteristic of DVT in pregnant and post-partum who delivered within 6 weeks, SPHMMC,
Addis Ababa, 2021……………….………………………………………………………………………..19

Table 10: Characteristic of PTE in pregnant and post-partum who delivered within 6 weeks, SPHMMC,
Addis Ababa,
2021………………………………………………………………………………………………………..20

Table 11: CVT diagnosed tool in pregnant and post-partum who delivered within 6 weeks, SPHMMC,
Addis Ababa, 2021………………………………………………………………………………………...20

Table 12: Management of VTE in pregnancy and the postpartum period, SPHMMC, Addis Ababa,
2021..............................................................................................................................................................21

Table 13: Management with an oral anticoagulant in pregnancy and the postpartum period, SPHMMC,
Addis Ababa,
2021……………………………………………………………………………………………………..…21

Table 14: Management with parenteral anticoagulant in pregnancy and the postpartum period, SPHMMC,
Addis Ababa,
2021………………………………………………………………………………………………………..21

Table 15: Duration of treatment in pregnancy and the postpartum period, SPHMMC, Addis Ababa,
2021……………………………………………………………………………………………………......22

Table 16: Complication of VTE and management in pregnancy and the postpartum period, SPHMMC,
Addis Ababa, 2021……………………………………………………………………………….………..23

Table 17: Recurrent VTE in pregnancy and the postpartum period, SPHMMC, Addis Ababa, 2021……23

II
List of figures

Figure 1: Diagnosis of VTE in pregnancy and the postpartum period, SPHMMC, Addis Ababa, 2021…16

Figure 2: Type of VTE in pregnancy and the postpartum period, SPHMMC, Addis Ababa,
2021……………………………………………………………………………………………………….16

Figure 3: Diagnosis of VTE & Trimester of pregnancy, SPHMMC, Addis Ababa, 2021……………….17
Figure 4: Diagnosis of VTE & Post-partum period (delivered within 6 weeks), SPHMMC, Addis Ababa,
2021………………………………………………………………………………………………………18

Figure 5: Post-partum who delivered within 6 weeks diagnosed with VTE and stay day after delivery,
SPHMMC, Addis Ababa, 2021…………………………………………………………………………..19

III
List of Appendices

Appendix 1 Questionnaire ..................................................................................................................... 31

IV
Acknowledgments

I would like to express my deepest gratitude to my advisors Dr. Afework and Mr. Andamlak for
their tireless efforts in assisting me to prepare this paper. I am grateful to the internal medicine
department and research office for providing me with this opportunity.

V
Contents
Chapter 1: Introduction ............................................................................................................................. 1
1.1. Background ................................................................................................................................... 1
1.2. Statement of the problem .............................................................................................................. 2
1.3. Significance of the study .................................................................................................................... 3
Chapter 2: Literature review ..................................................................................................................... 4
Chapter 3: Objectives ................................................................................................................................. 7
3.1. General objectives .............................................................................................................................. 7
3.2. Specific objectives ............................................................................................................................. 7
Chapter 4: Methods .................................................................................................................................... 8
4.1. Study area and study period ............................................................................................................... 8
4.2. Study design ....................................................................................................................................... 8
4.3. Source population .............................................................................................................................. 8
4.4. Study population ................................................................................................................................ 8
4.4.1 Inclusion criteria ............................................................................................................................ 8
4.4.2. Exclusion criteria .......................................................................................................................... 9
4.5. Sample size and sampling method ...................................................................................................... 9
4.6. Study variables ................................................................................................................................... 9
4.7. Data collection method and tool ........................................................................................................ 9
4.8. Operational definitions..................................................................................................................... 10
4.9. Data quality control.......................................................................................................................... 11
4.10. Method of statistical analysis ......................................................................................................... 11
4.11. Ethical consideration ...................................................................................................................... 11
4.12. Dissemination of results ................................................................................................................. 11
Chapter 5: Results and Discussion .......................................................................................................... 12
5.1. Results .............................................................................................................................................. 12
5.2. Discussion ........................................................................................................................................ 24
Chapter 6: Conclusions and recommendations...................................................................................... 26
References .................................................................................................................................................. 27
Annex .......................................................................................................................................................... 30
Abstract
Background: Pregnancy and the puerperium are well-established risk factors for deep vein
thrombosis (DVT) and pulmonary embolism (PE), which are collectively referred to as venous
thromboembolic disease (VTE). The need for thromboprophylaxis should be assessed antepartum,
postpartum, and at any time the patient transitions from the outpatient to the inpatient setting. The
clinical features of DVT in pregnancy overlap with many of the features of normal pregnancy. A
high index of clinical suspicion and a low threshold for the use of objective confirmatory testing
are required to accurately diagnose DVT during pregnancy.

Method: A hospital-based descriptive cross-sectional study was conducted at SPHMMC from

September 2017 to February 2021 by using a retrospective chart review of eligible pregnant and
postpartum women with VTE having follow-up at the Hematology referral clinic. 84 pregnant and
post-partum VTE patients were included, assessment of the prevalent period of VTE, associated
factors, and its outcome was done.

Results: The highest prevalent period for VTE was the post-partum period with 51 (60.7%)
patients of which 27 (52.9%) modes of delivery were spontaneous vaginal delivery (SVD) and 24
(47.1%) were cesarean sections (C/S), with the day of stay after delivery 3-7 days 38 (74.5%). The
most common VTE diagnosed was DVT alone 59 (70.2%), PTE alone 14 (16.7%) then CVT 6
(7.1%) and last is DVT with PTE 5 (6%). All the 64 DVT diagnoses are lower extremity 58
(90.6%) are left extremities while 6 are right extremities. From the 19 PTE diagnoses, 13(68.4%)
are mild PTE. The most frequently identified medical history that the patient with VTE had is a
history of hypertension 15 (83.3%). Other risk factor for VTE besides pregnancy the most
frequently identified risk is preeclampsia 12 (66.7%). Out of 84 patients with VTE 67 (79.7%)
completed their management with no complication related to the disease or management.

Conclusions: From this study, the post-partum period which is within 6 weeks after delivery is the
high likely prevalent time for VTE to occur and needs careful follow-up. And preeclampsia
patients have a high chance to develop VTE as compare to other comorbid conditions. The
outcome of VTE in pregnancy from this study is good with appropriate management using
anticoagulants for a specific period.

VI
Chapter 1: Introduction
1.1. Background
The risk of venous thromboembolism increases significantly during pregnancy, peaks during the
postpartum period, and is one of the leading causes of maternal mortality in developed countries.
VTE is the third most common cause of CVD globally [1–4] Recommendations for
thromboprophylaxis among a large proportion of postpartum women with only one or more "low
to moderate" risk factors (such as obesity, cesarean section, and postpartum hemorrhage) are
inconsistent across countries[1].
Venous thromboembolism, including deep vein thrombosis and pulmonary embolism, remains an
important cause of maternal mortality and severe maternal morbidity, despite recent advances in
thromboprophylaxis. Pulmonary embolism continues to be one of the most common causes of
maternal death following childbirth in developed countries [2].
In addition to the mortality and short-term morbidity, women who have experienced venous
thromboembolism during pregnancy may develop long-term sequelae that are associated with a
post-thrombotic syndrome, ranging from edema and skin changes to recurrent thromboses and
ulceration [1,2].
Pregnant women, in general, are four to five times more likely to develop venous
thromboembolism than women who are not pregnant. This predisposition of pregnant women is
attributed to the hypercoagulable state of pregnancy that protects women from hemorrhage during
miscarriage and delivery [2,3]. Venous thromboembolism is both more common and more complex
to diagnose in patients who are pregnant than in those who are not pregnant [3].
Better quantification of risk factors can help target women who are most likely to benefit from
postpartum thromboprophylaxis with heparin [1,2,5].
Venous thromboembolism also complicates low-risk pregnancies in the postpartum period, with
the risk of VTE being 2.2-fold higher after planned Caesarean section than after planned vaginal
delivery [2].
The prevalence of deep vein thrombosis (DVT) in Africa varied between 2.4% and 9.6% in
postoperative patients and between 380 and 448 per 100 000 births per year in pregnant and
postpartum women. The prevalence of VTE and associated mortality are high following surgery,
and in pregnant and postpartum women in Africa [4].
Two-thirds of cases of deep-vein thrombosis occurred in the antepartum period and were
distributed relatively equally among all three trimesters. In contrast, 43 to 60% of pregnancy-
related episodes of pulmonary embolism appear to occur in the puerperium [3,4]. Delayed diagnosis,
delayed or inadequate treatment, and inadequate thromboprophylaxis account for many of the
deaths due to venous thromboembolism [3–5].

1
1.2. Statement of the problem

Pregnancy is classically thought to be a hypercoagulable state. Fibrin generation is increased,

fibrinolytic activity is decreased, levels of coagulation factors II, VII, VIII, and X are all increased,
free protein S levels are decreased, and acquired resistance to activated protein C is common [3].
Uncomplicated pregnancy is accompanied by substantial hemostatic activation as indicated by
increased markers of coagulation activation, such as prothrombin fragment F1+2 and d-dimer.
Also, a reduction in venous flow velocity of approximately 50% occurs in the legs by 25 to 29
weeks of gestation and lasts until approximately 6 weeks after delivery, at which time it returns to
normal nonpregnancy flow-velocity rates. In addition, the presence of inherited thrombophilia and
the antiphospholipid syndrome, as well as a previous history of thrombosis, increase the risk for
venous thromboembolism during pregnancy and the postpartum period [1,3,4,6,7].
Additional risk factors include black race, heart disease, sickle cell disease, diabetes, lupus,
smoking, multiple pregnancies, age greater than 35 years, obesity, and cesarean delivery [2,3,5]
There is a striking predisposition for deep-vein thrombosis to occur in the left leg (approximately
70 to 90% of cases), possibly because of exacerbation of the compressive effects on the left iliac
vein due to its being crossed by the right iliac artery.
The incidence of isolated deep-vein thrombosis in the iliac vein is thought to be higher in pregnant
women than in nonpregnant women. This complicates the diagnosis of deep-vein thrombosis in
symptomatic pregnant women because compression ultrasonography does not reliably detect iliac
deep-vein thrombosis.
Isolated iliac-vein thrombosis may present with abdominal pain, back pain, and swelling of the
entire leg; however, patients may also be asymptomatic and have no findings on physical
examination [3,4]
Clinical suspicion is critical for the diagnosis of venous thromboembolism. However, many of the
classic signs and symptoms of deep-vein thrombosis and pulmonary embolism, including leg
swelling, tachycardia, tachypnea, and dyspnea, may be associated with a normal pregnancy.
Treatment with low-molecular-weight heparin or unfractionated heparin is recommended until the
diagnosis is ruled out by objective testing unless treatment is strongly contraindicated.
So far, in our country, despite knowledge related to VTE and its risk factors, poorly known
regarding VTE disease related to pregnancy. In light of the paucity of literature, this study will
serve as a starting point by filling knowledge gab on pregnancy related VTE.

2
1.3. Significance of the study

Knowing the characteristic of VTE in pregnancy is an important tool in the early diagnosis and
management of the scenario. The diagnosis and management of VTE in pregnancy are challenging,
and many diagnostic tests are less accurate in pregnant than non-pregnant patients, and the
available options are suboptimal.

Developed countries have promulgated guidelines for risk assessment and prevention of maternal
VTE, and standardized management has led to a significant reduction in maternal mortality.
However, there is a paucity of relevant research related to pregnancy and puerperal VTE in
Ethiopia even at wide-angle in developing countries. This research tries to bump some ideas on
the characteristic of pregnancy-related venous thromboembolism.

This study will help in identifying which pregnancy time is highly influenced to have VTE and
compare the pregnancy time to the post-partum aspect and tries to see the outcome regarding the
management and complication of the disease.

3
Chapter 2: Literature review
VENOUS THROMBOEMBOLISM AND PREGNANCY

A population-based cohort study, using 30-year data, detected an overall incidence of VTE of 200
per 100,000 women per year. Venous thromboembolism was 5 times more likely in the postpartum
period than during the pregnancy, and DVT was 3 times more common than pulmonary embolism
[1]
.

Venous thromboembolism, including deep vein thrombosis and pulmonary embolism, remains an
important cause of maternal mortality and severe maternal morbidity, despite recent advances in
thromboprophylaxis. Pulmonary embolism continues to be one of the most common causes of
maternal death following childbirth in developed countries [1,2]. Pulmonary embolism is 15 times
more likely to occur in the postpartum period than during pregnancy. Lower extremities deep
venous thrombosis (DVT) during pregnancy occurs at a rate of 0.13-0.61 per thousand
pregnancies. The risk of DVT is approximately twice as high after cesarean delivery than vaginal
birth [2,4,8].

A population-based cohort study (N = 3,852,569) done in Canada. All women with pregnancy-
related hospitalizations in Canada were identified. DVT and PE rates were calculated using the
number of hospital deliveries as the denominator for the antepartum and peripartum (labour and
delivery) hospitalizations and for postpartum readmissions. Risk factors for DVT/PE were
identified using logistic regression. The strongest risk factors for DVT occurrence during the
peripartum period were thrombophilia (95% CI 10.8–22.0), a past history of circulatory disease,
and major puerperal infection, whereas those for PE were previous DVT (CI 40.9–79.1), heart
disease (CI 35.0–53.9), antiphospholipid syndrome, past history of circulatory disease and major
puerperal infection [2]

Pregnant and puerperal women face a higher risk for venous thromboembolism (VTE) than that of
non-pregnant women due to their specialized physiologic changes, including hypercoagulation,
venous stasis, and vascular endothelial injury [2,3].

Venous stasis of the lower extremities occurs during pregnancy because of two factors: pregnancy-
associated changes in venous capacitance and compression of large veins by the gravid uterus. The
lower extremity veins of pregnant patients appear to be subject to increased stasis even before the

4
uterus has enlarged substantially. Although blood volume and total venous return are supernormal
in pregnancy, the linear flow velocity in the lower extremity veins is decreased due to hormonally
induced dilation of capacitance veins, leading to venous pooling and valvular incompetence [3,9,10].

Delivery is associated with vascular injury and changes at the uteroplacental surface, which
probably contribute to the increased risk of VTE in the immediate postpartum period. Forceps,
vacuum extraction, or surgical delivery can exaggerate vascular intimal injury and amplify this
phenomenon as well [11,12].

Pregnancy is a hypercoagulable state associated with progressive increases in several coagulation

[11,12]
factors, including factors I, II, VII, VIII, IX, and X, along with a decrease in protein S .A
progressive increase in resistance to activated protein C is normally observed in the second and
third trimesters, and high resistance to activated protein C was shown in one study to be associated
with an increased risk for pregnancy-related venous thrombosis. The activity of the fibrinolytic
inhibitors PAI-1 and PAI-2 is increased during pregnancy, although total fibrinolytic activity may
not be impaired patients [9,11,12].

Compression ultrasonography is a noninvasive test with a sensitivity of 97% and a specificity of

94% for the diagnosis of symptomatic, proximal deep-vein thrombosis in the general population.
This test is without risk and is the test of choice in pregnant patients with suspected venous
thromboembolism Compression ultrasonography is less accurate for isolated calf- and iliac-vein
thrombosis [3,4].

Patients with suspected pulmonary embolism and normal findings on compression

ultrasonography require additional diagnostic imaging. A chest radiograph should be obtained to
rule out alternative diagnoses and to guide further diagnostic testing. Ventilation-perfusion lung
scanning or computed tomographic pulmonary angiography (CTPA) should be performed [3].

Management of VTE in pregnancy and postpartum period

Current guidelines from the Royal College of Obstetricians and Gynecologists (RCOG)
recommend that antenatal pharmacological thromboprophylaxis should be considered in pregnant
women during admissions to hospital for stays of three or more days if they also have two or more
risk factors [13].

5
The options for prophylaxis include mechanical methods (e.g. mobilization, compression
stockings, calf stimulation, or intermittent pneumatic compression) or pharmacologic agents (low
molecular weight heparin [LMWH] and unfractionated heparin [UFH]). Mechanical methods are
suitable for women who are at low risk or for those in whom pharmacologic prophylaxis is
contraindicated (e.g. acute hemorrhage or impending surgery). Low molecular weight heparin is
used in preference to UFH for pharmacologic prophylaxis, and measurement of anti-Xa levels is
not required. In the absence of compelling evidence, it seems premature to recommend an
increased dose of LMWH for thromboprophylaxis in pregnancy for all women weighing more than
90 kg, but a reasonable threshold for considering higher doses is not clear [7,14,15].

The preferred agents for anticoagulation in pregnancy are heparin compounds. Neither heparin nor
LMWH crosses the placenta, and both are considered safe in pregnancy. Unique aspects of
anticoagulation in pregnancy include an increase in maternal blood volume of 40% to 50% and an
increase in the volume of distribution. An increase in glomerular filtration results in increased
renal excretion of heparin compounds, which are eliminated by this route[14–16].

During pregnancy, both UFH and LMWH have shorter half-lives and lower peak plasma
concentrations, usually necessitating higher doses and more frequent administration [7,8,17].

Disadvantages of UFH include the necessity of parenteral administration, risk of major bleeding,
risk of reduced bone density, risk of vertebral fracture, and risk of heparin-induced
thrombocytopenia (HIT). Although the risk of HIT is low in pregnancy and may be lower than in
nonpregnant patients the actual risk is unknown [17].

Cutaneous allergic reactions to low-molecular-weight heparin are rare and include pruritus,
[18]
urticarial rashes, erythematous plaques, and very rarely, skin necrosis . These reactions are
reported to be more common during long-term use in pregnant women than during short-term use
in nonpregnant persons [17–19].

Warfarin is known to cross the placenta. Warfarin embryopathy is characterized by midface

hypoplasia, stippled chondral calcification, scoliosis, short proximal limbs, and short phalanges; it
affects 5% of fetuses that are exposed to the drug between 6 and 9 weeks of gestation. The use of
warfarin in the second trimester and early in the third trimester is associated with fetal intracranial
hemorrhage and schizencephaly [20].

6
Chapter 3: Objectives
3.1. General objectives
To describe the characteristics of pregnancy-related venous thromboembolism and its outcome in
the hematology unit of the internal medicine department at St. Paul’s Hospital Millennium Medical
College from September 1/2017 to February 28/2021

3.2. Specific objectives

▪ To determine the prevalent period for VTE in pregnancy at the hematology unit of the
internal medicine department in SPHMMC from September 1/2017 to February 28/2021

▪ To describe the associated factors for VTE in pregnancy at the hematology unit of the
internal medicine department in SPHMMC from September 1/2017 to February 28/2021

▪ To assess the complications related to VTE in pregnancy at the hematology unit of the
internal medicine department in SPHMMC from September 1/2017 to February 28/2021

▪ To measure the outcome of VTE management in pregnancy and postpartum period at the
hematology unit of the internal medicine department in SPHMMC from September 1/2017
to February 28/2021

7
Chapter 4: Methods
4.1. Study area and study period
The study was conducted in St. Paul’s Hospital Millennium Medical College (SPHMMC) located
in Addis Ababa, Ethiopia. SPHMMC is a referral and teaching hospital established in 2007 after a
medical college was opened in a Hospital built by Emperor Haile Selassie I in 1969 with the help
of the German Evangelical Church aiming to serve the poor. It has a catchment population of more
than 5 million.

The department of internal medicine has 7 subspecialty clinics. The hematology unit is one of
them. Under the hematology unit around 5500 patients per year are seen at the OPD level.

The pregnant and postpartum women who have been seen in hematology unit OPD clinic between
September 2017 to February 2021 with a diagnosis of venous thromboembolism (VTE)

4.2. Study design

A descriptive cross-sectional study was conducted.

4.3. Source population

The source population were pregnant women who had VTE during pregnancy and the postpartum
period within 6 weeks having a follow up at the hematology unit of internal medicine from
September 2017 to February 2021 in the past 3 years and 6 months.

4.4. Study population

The study population were all pregnant women who had VTE during pregnancy and the
postpartum period within 6 weeks, aged ≥18 years having a follow up at the hematology unit of
internal medicine.

4.4.1 Inclusion criteria

The inclusion criteria included
• all aged 18 years and above
• who are diagnosed with VTE (DVT, PTE, or CVT) during pregnancy or within 6 weeks
post-partum period and who started treatment and stayed on follow up until the date of
accomplishment at the hematology unit.

8
4.4.2. Exclusion criteria
• Patients with incomplete records and
• patients who lost on follow-up from hematology unit were excluded.

4.5. Sample size and sampling method

The study included all pregnant women who had VTE during pregnancy and the postpartum period
within 6 weeks having a follow up at the hematology unit of internal medicine during the study
period

4.6. Study variables

VTE include DVT, PE, or CVT in a pregnant woman or postpartum woman who give birth within
6 weeks, sociodemographic variables including (age, gender, race, and marital status), diabetes,
obesity, family history of the same disease, smoking, renal disease, mode of delivery, number of
parities, number of abortions, preeclampsia, Hyperemesis gravidarum, post-partum hemorrhage,
and serology status to HIV/AIDS

4.7. Data collection method and tool

Data gathered was secondary data obtained by using a structured data extraction checklist from
the chart review of VTE patients at the hematology unit. The data collection format includes
different sections these are socio-demographic characteristics, behavioral assessment, medical
history assessment, pregnancy information, trimester of pregnancy (from LNMP or Obstetric U/S),
mode of delivery (if post-partum delivered within 6 weeks), stay days after delivery, diagnosis of
VTE, other causes of VTE, management of VTE and complication of management

9
4.8. Operational definitions

The following operational definitions were used in the study.

Proximal deep venous thrombosis (DVT): is located in the popliteal, femoral, or iliac veins.

Isolated distal DVT: is located below the knee, and is confined to the calf veins (peroneal,
posterior, anterior tibial, and muscular veins)

Sub massive (or intermediate-risk) PE: refers to those patients with acute PE without systemic
hypotension but with evidence of either right ventricle (RV) dysfunction or myocardial necrosis.

Massive (or high-risk) PE: is a term used to designate patients with sustained hypotension,
pulselessness, or persistent profound bradycardia.

CVT: Cerebral venous sinus thrombosis is the presence of a blood clot in the dural venous sinuses,
which drain blood from the brain.

HIT: Heparin-induced thrombocytopenia (HIT) is a life-threatening complication of exposure to

heparin (i.e., unfractionated heparin or low molecular weight heparin/ LMWH)

Targeted INR (Therapeutic INR): an INR ranges from 2.0 to 3.0 for a patient taking warfarin
for disorders of blood clots in the body.

Recurrent VTE: DVT or PE occurring after successful acute treatment.

Post-thrombotic syndrome: refers to symptoms and signs of chronic venous insufficiency that
develop following deep vein thrombosis (DVT)

10
4.9. Data quality control

Data was collected by the researcher and data collectors. The data collectors were trained about
the contents of the questionnaires and to collect the data compassionately and accurately manner.
Immediately after the administration of the questionnaires, each paper was checked for
completeness. It was checked again during and after the feeding of data.

4.10. Method of statistical analysis

Different statistical analysis methods were used ranging from frequency count of each variable to
estimation of relative frequency, cross-tabulation between variables and descriptive statistical tests
including estimation of mean and percentage. Paragraphs, tables, graphs, charts were used to
illustrate findings using the statistical package for social sciences (SPSS) software version 25.

4.11. Ethical consideration

Before conducting the research, ethical clearance was obtained from the Institutional Review
Board of St. Paul’s Hospital Millennium Medical College, and then permission was sought from
the school administration through the academic provost of the school to carry out the study. Each
data was collected using a structured checklist. The collected data was only use for this particular
study and was kept confidential.

4.12. Dissemination of results

At the end of the research, the findings will be distributed to the health care providers, hospital
quality control bodies, administrators, policymakers directly affected by the results by publishing
the results in a journal and making presentations on a research symposium.

11
Chapter 5: Results and Discussion
5.1. Results

Out of the 86 questionnaires filled 2 lacks complete records and patients were lost on follow-up
from the hematology unit. And therefore, not included in the study. From the questionnaires, all
included patients were married and were Ethiopians by nationality. The youngest age was 19,
oldest was 38 with a mean age of 28.29 with 46.4% belonging to the 26-30 years age group. 67.9%
have attained primary school and 69% were unemployed and 75% live in an urban area as shown
in Table 1 below.

Table 1:
Sociodemographic characteristics of patients, SPHMMC, Addis Ababa, 2021
Characteristics Number Percent
Age Group
18-20 3 3.6
21-25 23 27.4
26-30 39 46.4
31-35 9 10.7
36-40 10 11.9
Marital status
Married 84 100.0
Total 84 100.0
Education level
Illiterate 7 8.3
Primary (1-8th Grade) 57 67.9
Secondary (9-12th Grade) 15 17.9
Higher education 5 6.0
Total 84 100.0
Occupation
Employed 5 6.0
Unemployed 58 69.0
Private business 21 25.0
Total 84 100.0
Residence
Urban 63 75.0
Rural 21 25.0
Total 84 100.0

12
Associated factors for VTE in pregnancy

The most frequently identified medical history that the patient with VTE had is a history of
hypertension 15 (83.3%), followed by connective tissue diseases such as SLE 2 (11.1%) and
Diabetes 1 (5.6%). There was no medical history of obesity with BMI > 30 Kg per m 2 and there
was no identified behavioral risk factors history of smoking and alcohol consumption. From other
risk factors of VTE besides pregnancy the most frequently identified risk factor is preeclampsia
12 (66.7%) followed by RVI 4 (22.2%) and history of Hyperemesis gravidarum and history of
renal disease (i.e., Nephrotic syndrome) each 1 (5.6%) respectively. None of the patients have a
family history of VTE.

Table 2: Medical history of Patient with VTE, SPHMMC, Addis Ababa, 2021

Diagnosis Frequency Percent

Diabetes 1 5.6
Hypertension 15 83.3
Connective tissue disease 2 11.1
(i.e., SLE)
Obesity (BMI > 30 Kg per m2) 0 0
Total 18 100

Table 3: Other risk factors of VTE identified among patients, SPHMMC, Addis Ababa, 2021

Other risk factors of VTE Frequency Percent

Air travel history > 8 hr. 0 0
Preeclampsia history 12 66.7
Hyperemesis gravidarum history 1 5.9
Renal disease 1 5.9
(i.e., Nephrotic syndrome)
GI disease (i.e., Crohn’s disease) 0 0
RVI serostatus Reactive (+) 4 23.5
Family history of VTE 0 0
Total 18 100

13
The prevalent period for VTE in pregnancy

The maximum number of gravidas a patient had was 7 (3%) while the minimum was 1 (24.2%)
also the maximum number of abortions a patient had was 5 (1.2%). There was only 1 (8.3%)
stillbirth record in 7 patients.
The highest prevalent period for VTE was the post-partum period with 51 (60.7%) patients with
27 (52.9%) modes of delivery spontaneous vaginal delivery (SVD) and 24 (47.1%) cesarean
sections (C/S) with the day of stay after delivery 3-7 days 38 (74.5%) followed by >7 days 9
(17.6%) and < 3 days 4 (7.8%)
The next most prevalent period was the third trimester of pregnancy 28 weeks to 42 weeks with
15 (17.9%) followed by the second trimester 16 weeks to 28 weeks 12 (14.3%) next is the first
trimester <16 weeks 4 (4.8%) and last is post-term >42 weeks 2 (2.4%)
The most common VTE diagnosed was DVT alone 59 (70.2%) PTE alone 14 (16.7%) then CVT
6 (7.1%) and last is DVT with PTE 5 (6%). All the 64 DVT diagnoses are lower extremities and
58 (90.6%) are left extremities while 6 (9.4%) are right extremities. 61 (95.3%) are proximal DVT
2 (3.1%) are both proximal and distal DVT and 1 (1.6%) is distal DVT.
All the 19 PTE were diagnosed with either signs and symptoms, ECG or CT-Scan of the chest.
From the 19 PTE diagnoses, 13(68.4%) are mild PTE, 4 (21.1%) are submassive PTE and 2
(10.5%) are massive PTE.
Among the 6 CVT diagnoses, 4 (66.7%) were diagnosed using MRI of the brain and 2 (33.3%)
were diagnosed using a CT-Scan of the brain. From the 6 CVT patients 5 were diagnosed during
post-partum period whom all delivered with C/S and 1 was during third trimester of pregnancy.

Table 4: Pregnancy information Gravida in number, SPHMMC, Addis Ababa, 2021

Gravida in number Frequency Percent

1 8 24.2
2 10 30.3
3 6 18.2
4 4 12.1
5 3 9.1
6 1 3.0

7 1 3.0

Total 33 100

14
Table 5: Pregnancy information Abortion in number, SPHMMC, Addis Ababa, 2021

Abortion in number Frequency Percent

0 64 76.2

1 12 14.3
2 5 6.0
3 1 1.2
4 1 1.2
5 1 1.2

Total 84 100

Table 6: Pregnancy information Stillbirth (dead fetus >28 weeks) in number, SPHMMC, Addis
Ababa, 2021

Stillbirth (dead fetus >28 weeks) in number Frequency Percent

0 77 91.7

1 7 8.3

Total 84 100

15
 DIAGNOSIS OF VTE (DVT, PTE OR CVT)

Pregnancy time

Post-partum < 6 weeks

Figure 1: Diagnosis of VTE in pregnancy and postpartum period, SPHMMC, Addis Ababa, 2021

Diagnosis of VTE
70

59
60

50
Frequency

40

30

20
14

10 6 5

0
DVT PE CVT DVT & PE

Figure 2: Types of VTE in pregnancy and postpartum period, SPHMMC, Addis Ababa, 2021

16
 Table 7: Trimester of pregnancy (from LNMP or Obstetric U/S) and VTE diagnosis, SPHMMC,
Addis Ababa, 2021

Diagnosis of VTE

DVT PE CVT DVT & PE TOTAL

Trimester of pregnancy Less than 16 weeks 3 1 0 0 4

(From LNMP or Obstetric U/S)
16 to 28 weeks 10 2 0 0 12
28 to 42 weeks 8 4 1 2 15

>42 weeks 0 2 0 0 2
Total 21 9 1 2 33

Diagnosis of VTE (DVT, PTE or CVT) in Pregnancy

50
45%
45

40 36%
35

30
Percent

25

20

15 12%
10
6%
5

0
Less than 16 weeks 16 weeks to 28 weeks 28 weeks to 42 weeks >42 weeks

Trimester of pregnancy (from LNMP or Obstetric U/S)

Figure 3: Diagnosis of VTE & Trimester of pregnancy, SPHMMC, Addis Ababa, 2021

17
 Table 8: Post-partum who delivered within 6 weeks and VTE diagnosis, SPHMMC, Addis
Ababa, 2021

Diagnosis of VTE

DVT PE CVT DVT & PE TOTAL

Mode of delivery Spontaneous vaginal 24 1 0 2 27

(If post-partum delivered delivery (SVD)
within 6 weeks) Cesarean section (C/S) 14 4 5 1 24

Total 38 5 5 3 51

Figure 4: Diagnosis of VTE & Post-partum period (delivered within 6 weeks), SPHMMC, Addis
Ababa, 2021

18
 Diagnosis of VTE in Post- partum

40 38

35

30

25
Count

20

15
9
10
4
5

0
< 3 days 3 to 7 days > 7 days
Stay days after delivery

Figure 5: Post-partum who delivered within 6 weeks diagnosed with VTE and stay day after
delivery, SPHMMC, Addis Ababa, 2021

Table 9: Characteristic of DVT in pregnant and post-partum who delivered within 6 weeks,
SPHMMC, Addis Ababa, 2021

DVT proximal or distal area

DVT upper or lower extremity Proximal Distal Proximal & Distal Total
Lower extremity DVT left or right Left extremity 55 1 2 58
extremity
Right extremity 6 0 0 6

Total 61 1 2 64

19
Table 10: Characteristic of PTE in pregnant and post-partum who delivered within 6 weeks,
SPHMMC, Addis Ababa, 2021

Type of PTE Frequency Percent

Mild PTE 13 68.4

Sub massive PTE 4 21.1

Massive PTE 2 10.5

Total 19 100.0

Table 11: CVT diagnosed tool in pregnant and post-partum who delivered within 6 weeks,
SPHMMC, Addis Ababa, 2021

CVT diagnosed by Frequency Percent

CT-Scan of the brain 2 33.3

MRI of the brain 4 66.7

Total 6 100.0

20
The outcome of VTE management in pregnancy and postpartum period

Of 84 VTE patients 81 (96.4%) were managed using oral anticoagulant where 79 took warfarin
and 2 take new oral anticoagulant which is rivaroxaban. From 84 patients 73 (86.9%) were
managed using parenteral anticoagulant 62 took unfractionated heparin (UFH) and 11 took low
molecular weighted heparin (LMWH)

Table 12: Management of VTE in pregnancy and the postpartum period, SPHMMC, Addis Ababa, 2021

VTE management Frequency Percent

Management with Oral anticoagulant 81 96.4
(i.e., Warfarin or NOAC)
Management with a parenteral anticoagulant 73 86.9
(i.e., UFH or LMWH)

Table 13: Management with an oral anticoagulant in pregnancy and the postpartum period, SPHMMC,
Addis Ababa, 2021

Management with oral anticoagulant Frequency Percent

Warfarin 79 97.5
New oral anticoagulant 2 2.5
(Rivaroxaban, Apixaban, Edoxaban, etc.)
Total 81 100.0

Table 14: Management with parenteral anticoagulant in pregnancy and the postpartum period,
SPHMMC, Addis Ababa, 2021

Management with a parenteral anticoagulant Frequency Percent

Unfractionated heparin (UFH) 62 84.9

Low molecular weight heparin 11 15.1

(i.e., Enoxaparin)
Total 73 100.0

21
The most frequent duration of management was 6 months 26 (31%) followed by 7months 20
(23.8%). The maximum duration of treatment is 4 years 4 (4.8%) and the minimum duration of
treatment is 4 months 1 (1.2%)

Table 15: Duration of treatment in pregnancy and the postpartum period, SPHMMC, Addis Ababa, 2021

Duration of treatment Frequency Percent

4 months 1 1.2
5 months 1 1.2
6 months 26 31
7 months 20 23.8
8 months 8 9.5
9 months 4 4.8
1 year 6 7.1
1 year & 2 months 2 2.4
1 year & 3 months 2 2.4
1 year & 6 months 1 1.2
2 years 2 2.4
2 year & 6 months 1 1.2
3 years 6 7.1
4 years 4 4.8
Total 84 100.0

Out of 84 patients with VTE 67 completed their management with no complications related to
the disease or management.

Complications related to VTE in pregnancy and post-partum period

The frequent complication is a recurrence of VTE 12 patients in number and specifically, 8 were
DVT diagnosed, 3 were PTE patients and 1 was both DVT and PTE diagnosed. The other
complication found was post-thrombotic syndrome (PTS) in 5 patients in which all the patients
presented with skin ulceration. There was no complication of heparin-induced thrombocytopenia
(HIT) related to management with a parenteral anticoagulant.

22
Table 16: Complication of VTE and management in pregnancy and postpartum period,
SPHMMC, Addis Ababa, 2021

The complication of VTE and management Frequency Percentage

Heparin-induced thrombocytopenia (HIT)
Yes 0 0
No 84 100.0
Post-thrombotic syndrome (PTS)
i.e., skin ulceration
Yes 5 6.0
No 79 94.0
Recurrent VTE (DVT, PTE, CVT)
Yes 12 14.3
No 72 85.7

Table 17: Recurrent VTE in pregnancy and the postpartum period, SPHMMC, Addis Ababa,
2021

Recurrent VTE (DVT, PTE, CVT)

Yes No Total
DVT 8 51 59
Diagnosis of VTE PE 3 11 14
CVT 0 6 6
DVT & PE 1 4 5
Total 12 72 84

23
5.2. Discussion

The highest occurrence of post-partum VTE in this study 51 (60.7%) is consistent with other
studies which suggest the risk of VTE in pregnancy time reaches its peak in the post-partal period
[1–4,11,12]
. In this study, the number of patients who delivered by spontaneous vaginal delivery
(SVD) 27 (52.9%) and cesarean section (C/S) 24 (47.1%) was nearly comparable, unlike other
studies that show more prevalence of VTE is seen in those who undergo C/S[2,4,8]. The day of stay
after delivery in most cases was 3-7 days both for SVD and C/S 38 patients and this could be the
high likely factor for VTE as support from other studies that bedridden for more than 3 days
predispose to VTE [13] The prevalence of VTE during the time of pregnancy in this study is
comparable in third trimester and second trimester 15 (17.9%) and 12 (14.3%) respectively. This
study also shows VTE during first trimester 4 (4.8%) and also post-term period 2 (2.4%) similar
to other studies that prevalence of VTE is evenly distributed in all trimesters that it could happen
in any trimester of pregnancy [3,4].

The most frequent VTE was DVT 59 (70.2%) which is highly prevalent in both pregnancy and
post-partum time, unlike other studies in which PTE is most prevalent during the post-partum
period. And the left lower proximal extremity 55 was the most common area to occur which is
similar compared to other studies [3,4]

All PTE are diagnosed using either sign & symptoms, ECG or CT-Scan of the chest of which the
most frequent one is mild PTE 13 (68.4%) compare to studies done in developed countries most
common PTE during pregnancy and post-partum period which result increase maternal mortality
is massive PTE [1,2]

In this study CVT was also seen in 6 (7.1%) of the VTE in which 5 were post-partum who delivered
with C/S and 1 was third trimester pregnant similar to other studies in which CVT is rare but seen
in the third trimester of pregnancy and puerperium. In this study, C/S was found to be a risk factor.

Multiple risk factors often co-exist in women who develop VTE in pregnancy in this study most
frequent associated medical history was hypertension 15 (83.3%), connective tissue disease which
is SLE 2 (11.1%), and diabetes 1 (5.6%) and another frequent factor was preeclampsia 12 (66.7%),
RVI seropositive 4 (23.5%), hyperemesis gravidarum 1 (5.9%) and renal disease which is
nephrotic syndrome 1 (5.9%). As compared to other studies obesity with BMI >30 Kg per m2 was
not found to be a risk factor since all of the patients in this study had no documentation of obesity
with BMI >30 Kg per m2 [2,3,5] In this study 20 patients with VTE had a history of abortion 1 or
more times but were no documented workup for a possible cause such as antiphospholipid
syndrome (APS) this may underestimate the possible risk factors in these patients.
In this study, most patients were managed with either oral anticoagulant or parenteral anticoagulant
or both and the most frequent duration of time of anticoagulation was 6 months 26 (31%) which
is recommended in most studies but some patients were given for prolonged time than the
recommendation from other studies.

24
Among 84 VTE patients in this study 12 had a complication which is a recurrence of VTE
specifically 8 were DVT diagnosed, 3 were PTE patients and 1 was both DVT and PTE diagnosed.
And 5 had post-thrombotic syndrome (PTS) were presented with skin ulceration. This is similar to
other studies that recurrence is the most common complication of VTE in pregnancy [3,4]. Unlike
other studies which show complications related to parenteral anticoagulants such as heparin-
induced thrombocytopenia (HIT) in this study no single patient was found to have this
complication [7,8,17]

Strengths

As to the investigator’s knowledge, there are no studies done on the subject particularly in internal
medicine in general at a country level. It serves as a very important starting point for other
institutions and other departments to take initiatives on this important issue.

Limitations

A small number of patients were included in the study and it may not show the general population
condition. Wider studies at other hospitals should be done to properly know the magnitude of the
problem. A critical limitation of this study was the absence of a control group to compare and
contrast the risk factors found in VTE patients. Another risk factor that is common in VTE is
inherited thrombophilia such as Factor V Leiden mutation, Antithrombin deficiency, Protein C
deficiency, and Protein S deficiency these factors were not assessed in this study.

25
Chapter 6: Conclusions and recommendations
Conclusions

From this study, the post-partum period which is within 6 weeks after delivery is the high likely
prevalent time for VTE to occur and needs careful follow-up. The day of stay after delivery is the
other attributing factor in which more than 3 days of stay was seen in the most post-partum period
who delivered either SVD or C/S. Another attributing factor was preeclampsia those patients have
a high chance to develop VTE as compare to other comorbid conditions.
The outcome of VTE in pregnancy from this study is good with appropriate management using
anticoagulants for a specific period. Though there was no standard duration of time used for
anticoagulation most patients were given anticoagulants for 6 months. The most common
complication in this study was a recurrence of VTE.

Recommendations

▪ Awareness should be created to physicians and pregnant woman’s that there is a risk of
developing VTE more during the post-partal period as to this study especially with a day
of stay after delivery more than 3 days and those vulnerable groups should have a means
of prevention with either mechanical method (e.g., early mobilization, compression
stockings, calf stimulation, or intermittent pneumatic compression) or pharmacologic
agents (low molecular weight heparin [LMWH] and unfractionated heparin [UFH]) should
be given as thromboprophylaxis.
▪ There should be enhanced risk assessment and documentation on history and workup of
possible causes for VTE in pregnancy such as thrombophilia including antiphospholipid
syndrome (APS) in selected cases.
▪ There should be a standard guideline on the management of VTE in pregnancy and the
post-partum period. A 6 month of anticoagulation is an appropriate time. This should be
the responsibility of healthcare institutions, hospital administrators, quality assurance
offices, healthcare consultants, and major regulators like the Ministry of health.

26
References

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Piercy C and Ludvigsson J 2016 Development and validation of risk prediction model for
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i6253

[2] Liu S, Rouleau J, Joseph K S, Sauve R, Liston R M, Young D and Kramer M S 2009
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[3] Hayes M, Bourjeily G and Rosene-Montella K 2009 Venous thromboembolic disease and
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Epidemiology of venous thromboembolism in Africa: a systematic review J. Thromb.
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[5] Morris J M, Algert C S and Roberts C L 2010 Incidence and risk factors for pulmonary
embolism in the postpartum period J. Thromb. Haemost. 8 998–1003

[6] Function P 2019 Clinical Management Guidelines for Obstetrician – Gynecologists

Thrombocytopenia in Pregnancy 133 181–93

[7] James A H 2009 Venous Thromboembolism : Mechanisms , Treatment , and Public

Awareness Venous Thromboembolism in Pregnancy 326–31

[8] Greer I A and Nelson-Piercy C 2005 Low-molecular-weight heparins for

thromboprophylaxis and treatment of venous thromboembolism in pregnancy: A
systematic review of safety and efficacy Blood 106 401–7

[9] Al-Gahtani F H 2009 Pregnancy-associated venous thromboembolism: Part I - Deep vein

thrombus diagnosis and treatment Saudi Med. J. 30 13–23

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[10] Taylor J, Hicks C W and Heller J A 2018 The hemodynamic effects of pregnancy on the
lower extremity venous system J. Vasc. Surg. Venous Lymphat. Disord. 6 246–55

[11] Bremme K, Ostlund E, Almqvist I, Heinonen K and Blombäck M 1992 Enhanced

thrombin generation and fibrinolytic activity in normal pregnancy and the puerperium
Obstet. Gynecol. 80 132—137

[12] Comp P C, Thurnau G R, Welsh J and Esmon C T 1986 Functional and immunologic
protein S levels are decreased during pregnancy Blood 68 881—885

[13] Sultan A A, West J, Tata L J, Fleming K M, Nelson-Piercy C and Grainge M J 2013 Risk
of first venous thromboembolism in pregnant women in hospital: Population based cohort
study from England BMJ 347 1–11

[14] Duhl A, Paidas M, Ural S, Branch W, Casele H, Cox-Gill J, Hamersley S, Hyers T, Katz
V, Kuhlmann R, Nutescu E, Thorp J and Zehnder J 2007 Antithrombotic Therapy and
Pregnancy: Consensus Report and Recommendations for Prevention and Treatment of
Venous Thromboembolism and Adverse Pregnancy Outcomes Am. J. Obstet. Gynecol.
197 457.e1-21

[15] RCOG 2015 Royal College of Obstetricians and Gynaecologists. Thromboembolic

Disease in Pregnancy and the Puerperium: Acute Management (Green-top Guideline No.
37b)

[16] Bates S M and Ginsberg J S 2002 How we manage venous thromboembolism during
pregnancy Blood 100 3470–8

[17] Bates S M, Rajasekhar A, Middeldorp S, McLintock C, Rodger M A, James A H,

Vazquez S R, Greer I A, Riva J J, Bhatt M, Schwab N, Barrett D, LaHaye A and
Rochwerg B 2018 American Society of Hematology 2018 guidelines for management of
venous thromboembolism: venous thromboembolism in the context of pregnancy Blood
Adv. 2 3317–59

[18] Goecke T, Voigt F and Rath W 2018 Thromboprophylaxis following cesarean section–a
nation-wide survey from Germany J. Matern. Neonatal Med.

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[19] Leonhardt G, Gaul C, Nietsch H H, Buerke M and Schleussner E 2006 Thrombolytic
therapy in pregnancy J. Thromb. Thrombolysis 21 271–6

[20] Lee H C, Cho S Y, Lee H J, Kim C J, Park J S and Chi J G 2003 Warfarin-associated
Fetal Intracranial Hemorrhage: A Case Report J. Korean Med. Sci. 18 764–7

29
Annex

Annex 1: The written consent form

How do you do? My name is _______________________________. I am a medical resident.
This questionnaire is designed for research work on the characteristics of pregnancy-related
venous thromboembolism and its outcome. I want to inform you that you have been selected
conveniently for the purpose of the study and you have the right to withdraw from participation
at any time during the interview. The information you give will be kept confidential and your
name will not be used in the analysis. The fact that you have participated in the study will not
interfere with the service you are going to receive here. If you wish to participate in the study,
please affirm it with your signature on the area provided below

I place my signature as a sign of agreeing to participate______________________________

Thank you for your participation and cooperation!

የጥናቱ መግለጫ

ጤና ይስጥልኝ፡፡ ይህ መጠይቅ የተዘጋጀው በቅዱስ ጳዉሎሰ ሚሊኒየም ሜዲካል ኮሌጅ በዉስጥ ደዌ የትምህርት
ክፍል ለድህረ ምረቃ ዲግሪ መመረቂያ የደም መርጋት በሽታ ባህሪና አይነት በነፍሠጡር እናቶች እንዲሁም
በወላድ እናቶች (የወሊድ ጊዚያቸው ከ6 ሳምንት በታች የሆነ) ላይ ለሚደረግ ጥናት ነው፡፡ እነዚህን ሁኔታዎች
ማወቃችን ችግሩን ለመቀነስ ምን መደረግ እንዳለበት አመላካች ይሆናል፡፡ክቡር መላሻችን ለጥናቱ የሚረዱ የተለያዩ
ጥያቄዎች ይጠየቃሉ፡፡

በዚህ ጥናት ላይ ተሳታፊ እንዲሆኑ የተደረገው የደም መርጋት በሽታ ህመምተኛ በመሆኖ ሲሆን ጥናቱ ላይ
የሚሳተፉት ፈቃደኛ ከሆኑ ብቻ ነው፡፡ ይህን ቃለ መጠይቅ ሲሞሉ ስምዎን እንዲጽፉ አይፈለግም፡፡በመሆኑም
ለሚያደርጉልን ቀና ትብብር በቅድሚያ ከልብ እናመሰግናለን፡፡

የፈቃደኝነት መግለጫ

እኔ የጥናቱ ተሳታፊ የጥናቱን አላማ እና ጥቅም እንዲሁም ከእኔ የሚጠበቁትን ነገሮች ተረድቼአለሁ፡፡ ስሜ እና
የምሰጣቸው መረጃዎች ለሶስተኛ ወገን ተላልፈው እንደማይሰጡም ተረድቼአለሁ፡፡ ስለዚህም በጥናቱ ላይ
ለመሳተፍ ፈቃደኛ ነኝ፡

የተሳታፊው ፊርማ ________________ ቀን _______________

የመረጃ ሰብሳቢው ስም ____________________ፊርማ __________ ቀን _____________

30
Appendix 1 Questionnaire

Section I: Socio-demographic characteristics

Card no.__________________ Age ______________________ Nationality _____________

1. Sex: Male Female

2. Marital status: Single Married divorced widower

3. Educational level:
Illiterate Primary (1-8th grade) Secondary (9-12th grade) Higher education

4. Employment status: Employed Unemployed Private business

Retired
5. Area of residence: Urban Rural

II. behavioral assessment

1. History of smoking Yes No
2. If yes, number of packs per year _______________
3. History of alcohol consumption Yes No
4. If yes, amount of drink per week _______________

III. Medical history assessment

1. History of Diabetes (DM) Yes No

2. History of Hypertension (HTN) Yes No
3. History of Connective tissue disease (i.e. SLE) Yes No
4. History of Obesity (BMI > 30 Kg per m2) Yes No

31
IV. Chart review

1. Pregnancy information (each questionaries’ in number)

a. Gravida ______________
b. Para _________________
c. Abortion _____________
d. Still birth (dead fetus >28 weeks) _____________

2. Trimester of pregnancy (from LNMP or Obstetric U/S)

a. Less than 16 weeks
b. 16 weeks to 28 weeks
c. 28 weeks to 42 weeks
d. > 42 weeks

3. Mode of delivery (if post-partum delivered within 6 weeks)

A. Spontaneous vaginal delivery (SVD)
B. Cesarean section (C/S)
C. Assisted Delivery (forceps or vacuum)

4. Stay days after delivery < 3 days 3 to 7 days > 7 days

5. Diagnosis of VTE (can select more than one)

DVT PE CVT Other ______________

6. If DVT
A. Upper extremity Lower extremity
B. Left Right
C. Proximal Distal
7. If PTE
A. Diagnosed by CT-Scan of chest ECG CXR
Sign and Symptom Other______________
B. Type of PTE
Mild Submassive Massive

8. CVT Diagnosed by CT Scan of the brain MRI of the brain Other_____

32
9. Other causes of VTE
A. Air travel history > 8 hr. Yes No
B. Preeclampsia history Yes No
C. Hyperemesis gravidarum history Yes No
D. Renal disease (i.e. Nephrotic syndrome) Yes No
E. GI disease (i.e. Chrons disease) Yes No
F. RVI serostatus Reactive (+) Non-reactive (-)
G. Family history of VTE Yes No

10. Management
a. Oral anticoagulant
Warfarin
New oral anticoagulant (Rivaroxaban, Apixaban, Edoxaban, etc.)
b. Heparin
Low molecular weight heparin (i.e. Enoxaparin)
Unfractionated Heparin (UFH)

c. Duration of treatment _______________________

11. Complication of management

A. Heparin-induced thrombocytopenia (HIT) Yes No

B. Skin ulceration or necrosis Yes No
C. Recurrent VTE (DVT or PE or CVT) Yes No

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