Midwifery 30 (2014) 975–982

Contents lists available at ScienceDirect

Midwifery
journal homepage: www.elsevier.com/midw

Outcome measures in studies on the use of oxytocin for the treatment

of delay in labour: A systematic review
Cecily M. Begley, RM, MSc, PhD, FTCD (Professor of Nursing and Midwifery)a,n,
Mechthild M. Gross, PD, Dr, RM, RN (Head of Midwifery Research and Education Unit)b,
Anna Dencker, RN, RM, PhD (Research Fellow)c,d, Carina Benstoem, RM, BSc,
MSc (Research Fellow)b, Marie Berg, RN, RM, MSc, PhD (Professor in Health Care Sciences
Specialising Reproductive and Perinatal Health)c,d, Declan Devane, RM, MSc, PhD,
PGDip (Professor of Midwifery)e
a
School of Nursing and Midwifery, Trinity College Dublin, 24 D'Olier St, Dublin 2, Ireland
b
Midwifery Research and Education Unit, Department of Obstetrics, Gynaecology and Reproductive Medicine, Hannover Medical School, Hannover, Germany
c
Gothenburg Centre for Person-Centred Care (GPCC), Institute of Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
d
Institute of Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
e
School of Nursing and Midwifery, National University of Ireland Galway, Ireland

art ic l e i nf o a b s t r a c t

Article history: Objectives: to identify primary and secondary outcome measures in randomised trials, and systematic
Received 21 February 2014 reviews of randomised trials, measuring effectiveness of oxytocin for treatment of delay in the first and
Received in revised form second stages of labour, and to identify any positive health-focussed outcomes used.
31 May 2014
Design: eight relevant citation databases were searched up to January 2013 for all randomised trials, and
Accepted 16 June 2014
systematic reviews of randomised trials, measuring effectiveness of oxytocin for treatment of delay in
labour. Trials of active management of labour or partogram action lines were excluded. 1918 citations
Keywords: were identified. Two reviewers reviewed all citations and extracted data. Twenty-six individual trials and
Oxytocin five systematic reviews were included. Primary and secondary outcome measures were documented and
Delay in labour
analysed using frequency distributions.
Core outcomes
Findings: most frequent primary outcomes were caesarean section (n ¼15, 46%), length of labour (n ¼14,
Health focus
Salutogenesis 42%), measurements of uterine activity (n ¼13, 39%) and mode of vaginal birth (n ¼9, 27%). Maternal
Systematic review satisfaction was identified a priori by one review and included as a secondary outcome by three papers.
No further positive health-focussed outcomes were identified.
Key conclusions: outcomes used to measure the effectiveness of oxytocin for treatment of delay in labour
are heterogeneous and tend to focus on adverse events.
Implications for practice: it is recommended that, in future randomised trials of oxytocin use for delay in
labour, some women-centred and health-focussed outcome measures should be used, which may instil a
more salutogenic culture in childbirth.
& 2014 The Authors. Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND
license (http://creativecommons.org/licenses/by-nc-nd/3.0/).

Contents

Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 976
Methods. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 976
Eligibility criteria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 977
Data collection and analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 977
Findings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 977
Description of included original studies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 977

n
Corresponding author.
E-mail address: [email protected] (C.M. Begley).

http://dx.doi.org/10.1016/j.midw.2014.06.005
0266-6138/& 2014 The Authors. Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/3.0/).
976 C.M. Begley et al. / Midwifery 30 (2014) 975–982

Demographic characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 977

Outcome measures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 980
Primary outcome measures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 980
Secondary outcome measures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 980
Summative view on outcome measures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 980
Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 980
Strengths and limitations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 980
Main findings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 980
Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 981
Conflict of interest. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 981
Authors' contributions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 981
Details of ethics approval . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 981
Funding . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 981
Acknowledgements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 981
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 981

Introduction
each labour and birth. However, comparisons between studies are
Labour duration has shown a wide variation in different challenging due to inconsistencies in choice, and definitions, of
women (Albers, 1999; Vahratian et al., 2006; Neal et al., 2010), outcome variables, which indicates the need to develop a core set
and slow labour progress is common in nulliparous women. It is of outcomes (Devane et al., 2007). It remains unclear how, or if, the
associated with childbirth complications, concerns for fetal well- outcomes identified by Devane et al. (2007) (including maternal
being, and negative birth experiences (Waldenström et al., 2004), mortality, caesarean section rates, length of labour, analgesia,
and is one of the main indications for unplanned caesarean section mode of vaginal birth, post partum haemorrhage, blood transfu-
in labour (Bugg et al., 2006; Florica et al., 2006). sion, Apgar scores, admission to SCBU, perinatal mortality or
Some evidence indicates that early oxytocin administration is morbidity), and other more positive health-focussed outcomes,
associated with an increase in spontaneous vaginal birth (Wei have been picked up in the light of the ongoing research on
et al., 2009) but others conclude that oxytocin does not affect oxytocin during delay in labour.
delivery mode (Bugg et al., 2013). Likewise, there is no consensus This systematic review aims to identify primary and secondary
regarding doses of oxytocin (Xenakis et al., 1995; Oscarsson et al., outcome measures in randomised trials, and systematic reviews of
2006; Hayes and Weinstein, 2008). Systematic reviews of high randomised trials, measuring effectiveness of oxytocin for treat-
versus low dose oxytocin for augmentation of delayed labour ment of delay in the first and second stages of labour. The review
report shorter labour duration and an increase in spontaneous will also identify any positive health-focussed outcome measures
vaginal birth associated with high doses (Wei et al., 2010; Mori used in this field.
et al., 2011) but there are few studies and, overall, the evidence is
scarce (Mori et al., 2011). This would appear to indicate that
further research should be conducted, and therefore the outcome Methods
measures chosen should receive some attention.
Healthy outcomes and positive experiences are core issues for Two of the authors performed a systematic search in March
women in childbirth, yet the majority of outcome measures used in 2011, which was updated in January 2013, using the following
research are focussed on physical aspects only and refer to adverse databases:
outcomes (for example, pain requiring analgesia, admission to Special
Care Baby Unit (SCBU), mortality). There is a need for inclusion of  Maternity and Infant Care (MIDIRS).
positive health-focussed outcome measures using a salutogenic  Cochrane Database of Systematic Reviews (CDSR).
approach. Salutogenesis concentrates on health and how it can be  Cochrane Central Register of Controlled Trials (CENTRAL).
promoted, rather than focussing on illness and how it can be cured  Medical Literature Analysis and Retrieval System Online
(Day-Stirk and Palmer, 2003), which is in congruence with the (MEDLINE).
philosophy of childbirth that views pregnancy as a normal physiolo-  The Cumulative Index to Nursing and Allied Health Literature
gical event, not an illness. Smith et al. (2014), in a systematic review of (CINAHL).
102 systematic reviews of maternity care, identified 16 categories of  Exerpta Medica Database (EMBASE).
outcomes that could be called ‘salutogenic’; these included mobility  Database of Abstracts of Reviews of Effects (DARES).
during labour, comfort, spontaneous rupture of membranes, intact  Health Technology Assessment Database.
perineum, well-being, and positive relationship with infant. Focussing
on such outcomes may encourage clinicians to try to increase their A detailed search strategy was developed and tested for each
incidence, thus improving care for mothers and infants. database, restricted to English language publications. Appropriate
Some positive outcomes are expected from oxytocin (e.g. keywords were combined with the Boolean operands ‘and’ and ‘or’
shorter labour duration, spontaneous vaginal birth), but it is as appropriate; for example, for a search in MEDLINE, ‘delay OR
acknowledged as not only a powerful and effective drug (Clark delayed OR progressn OR augmentn OR dystocn OR slow OR
et al., 2009; Rooks, 2009) but also one that is associated with arrested OR latent OR prolonged OR protracted OR active manage-
adverse neonatal outcome and operative delivery (Bugg et al., ment OR partogram OR timing.’ We also hand-searched the
2006; Oscarsson et al., 2006). There is little evidence on the reference lists of all eligible studies for references to other possibly
general impact of oxytocin during delay of labour, except that it relevant studies. A flow diagram was produced (Fig. 1) to represent
shortens labour (Wei et al., 2009; Bugg et al., 2013; Mori et al., our search technique and results in accordance with the PRISMA
2011). A good maternal and fetal outcome is the overall aim for statement (Liberati et al., 2009).
 C.M. Begley et al. / Midwifery 30 (2014) 975–982 977

Records identified Additional records pattern defined as a frequency of less than three contractions
through database identified through lasting 40 seconds each in a 10-minute time period’ (p. 1175),
searching other sources
(n=2747) (n=0) which could have indicated delay, or perhaps just the latent phase
of labour. As ‘the early aggressive management protocol’ was
instituted ‘within 30 minutes of admission to the labour ward’ it
seemed to be more like AML than waiting and eventually diagnos-
ing delay in labour, therefore it was thought reasonable to judge
this study as outside the scope of the review.
Records after duplicates removed We finally included 28 papers, on 26 studies, for which data
(n=1918)
were extracted (Fig. 1). All papers except Sharami et al. (2012)
were available as full text papers, and all provided an abstract.
More recent papers had structured abstracts but this was less the
case if the papers were published earlier. Two papers reported on
different aspects of the same study (Bidgood and Steer, 1987a,
Records screened Records 1987b) and one paper (Bergqvist et al., 2012) reported on a sub-
by title and abstract excluded
(n=1918) (n=1851) sample of the study reported by Dencker et al. (2009). All included
original studies (n¼ 26) were randomised controlled trials where
at least one of the groups received oxytocin for augmentation for
delay in spontaneous labour (Table 1).
Five systematic reviews of randomised trials were also
Full-text articles
excluded
included. In the five reviews there was a total of 45 included trials
Full-text articles but several of these were already included in our review as
(n=34)
assessed for
eligibility individual studies, and many were included several times as they
Oxytocin was not the
(n=67) occurred in more than one review. The reviews included both
primary focus, or not
a randomised trial or randomised (and quasi randomised) trials, and both published and
systematic review
unpublished studies (Table 2). No quality assessment was made of
selected papers and reviews, as only outcomes were to be counted,
not results. Similarly, results are not included in the tables, as the
focus is on outcomes measured.
Studies included in
analysis Data were collected into a pre-prepared form by three authors
(n=33) and checked by three others. We counted all maternal and fetal
(28 papers and 5 outcomes used in the RCTs or specified a priori as outcomes in the
systematic reviews) reviews, and presented them as frequencies. Not all studies
distinguished between primary and secondary outcomes. For the
Fig. 1. Flow diagram of systematic review search.
purposes of this review, outcomes were deemed to be ‘primary’
when the study authors presented them as such, or used a small
Eligibility criteria number of outcomes in the power computation for sample size
calculations. Other outcomes were then deemed to be ‘secondary’
We included randomised controlled trials (RCTs), and systematic (Table 3). When a study presented a large number of outcomes
reviews of RCTs. All studies used oxytocin for the treatment of delay without distinguishing between primary and secondary, they were
in the first and second stage of labour as defined by the trial authors all deemed to be secondary outcomes. Positive health focussed-
(e.g. delay of labour, slow progress for labour, prolonged labour, outcomes, defined as outcomes tending toward the health, rather
prolonged latent labour, late timing, diagnosis of arrested labour, no than pathological, end of the health continuum (e.g. spontaneous
cervical change for two hours, no descent of the head). We excluded birth, intact perineum, breast feeding), and women-centred out-
studies that compared the use of different partogram action lines, as comes such as maternal satisfaction, were also noted.
the main focus was not on oxytocin. Studies that evaluated the use
of active management of labour were also excluded, because these
studies applied a package of care, which would have influenced the Findings
outcomes chosen.
Description of included original studies
Data collection and analysis
Demographic characteristics
Our search identified 1918 citations after removal of duplicates, Most of the trials (25 out of 26) included nulliparous women
of which 1885 were excluded. Each identified citation was with a single cephalic pregnancy (Table 1). Eleven of these trials
reviewed independently by all review authors, working in pairs, included both nulliparous and multiparous women. Only one
and filtered through three screening levels i.e., (i) title screening study also included women with multiple pregnancies (Merrill
(ii) title and abstract screening and (iii) full-text screening. and Zlatnik, 1999). One study differed from the others and
Disagreement at any level was resolved through discussion included only women with previous caesareans and ‘unknown’
between two reviewers with recourse to a third reviewer if scars (Grubb et al., 1996). Women were most often randomised in
required. the first stage of active labour but sometimes in early labour or in
There were a number of papers where it was difficult to reach a the second stage. Two studies (Saunders et al., 1989; Shennan
decision as to whether the study looked at Active Management of et al., 1995) included only women using epidural analgesia.
Labour (AML), which was to be excluded, or oxytocin used for All trials included women at term and some studies also included
treatment of delay, which should be included. For example, Cohen women at an earlier gestational age (Table 1).
et al.'s paper (1987) was eventually excluded, after much discus- Various exclusion criteria were defined. Several studies stated
sion. The authors said ‘all subjects demonstrated an inadequate fetal related exclusion criteria as signs of ‘fetal distress’, estimated
 978
Table 1
Characteristics and inclusion criteria of included RCTs.

Reference Country Total number of participants Oxytocin group Comparison group Nulli-parous Multiparous Stage when Comment
randomised women women randomised

Arulkumaran et al. Singapore 68 (34/34) Oxytocin until target uterine Oxytocin until target uterine frequency was Y Active labour
(1989) activity was achieved achieved
Bergqvist et al. Sweden 536 (284/252) (sub-sample of Oxytocin within 20 minutes Expectancy three hours Y 4–9 cm
(2012) Dencker et al. (2009))
Bidgood and Steer United 60 (21/19/20) (three arms) Oxytocin low dose/high dose Expectancy eight hours Y First stage
(1987a, 1987b) Kingdom active labour
Blanch et al. (2005) United 60 (21/20/19) (three arms) ARMþ oxytocin immediately/ Expectancy Y Y Active labour
Kingdom ARM only
Bleich et al. (2011) USA 350 (174/176) Oxytocin Misoprostol Y 4–8 cm
Cluett et al. (2001) United 12 (4/4/4) Oxytocin Water birth pool or conservative management Y 43 cm
Kingdom
Cluett et al. (2004) United 99 (50/49) ARMþ oxytocin Water immersion Y 43 cm
Kingdom
Cummiskey et al. USA 94 (48/46) Continuous oxytocin Pulsatile oxytocin Y Y First or second
(1989) stage
o5 cm

C.M. Begley et al. / Midwifery 30 (2014) 975–982

Curtis et al. (1999) USA 79 (30/49) Oxytocin Breast stimulation, delayed oxytocin Y Y From 34 weeks
Dencker et al. (2009) Sweden 630 (314/316) Oxytocin within 20 minutes Expectancy three hours Y 4–9 cm
Grubb et al. (1996) USA 197 (96/101) Oxytocinfna;� Out-patient managementfna;n Previous CS o4 cm Latent phase
Hemminki et al. Finland 57 (27/30) Oxytocin Ambulation Y Y First or second
(1985) stage
Hinshaw et al. United 412 (208/204) Oxytocin Expectancy eight hours Y 3–8 cm
(2008) Kingdom
Ho et al. (2010) Taiwan 231 (113/118) Oxytocin Misoprostol Y Y 3–9 cm
Jamal and Kalantari Iran 200 (100/100) High dose oxytocin Low dose oxytocin Y 43 cm
(2004)
Lazor et al. (1993) USA 467 (224/243)fnb;† Oxytocin 15-min interval dose Oxytocin with 40-minute intervals Y Y 43 cm
Majoko (2001) Zimbabwe 258 (125/133) High dose oxytocin Low dose oxytocin Y First stage From 36 weeks
Merrill and Zlatnik USA 491 (249/242) High dose oxytocin Low dose oxytocin Y Y 43 cm From 24 weeks
(1999)
Nachum et al. (2010) Israel 213 (72/71/70) (three arms) Oxytocin/ARM þ oxytocin ARM only Y Y 2–4 cm
Palomäki et al. Finland 107 (55/52) Propranolol þ oxytocin Placebo þ oxytocin Y First stage
(2006)
Read et al. (1981) USA 14 (6/8) Oxytocin Ambulation Y Y Not specified
Rouse et al. (1994) USA 118 (60/58) ARMþ oxytocin Oxytocin without ARM Y 44 cm From 36 weeks
Saunders et al. United 226 (108/118) Oxytocin Placebo Y Second stage Epidural analgesia
(1989) Kingdom
Sharami et al. (2012) Iran 118 (‘divided randomly’) Oxytocin with propranolol Oxytocin with Placebo Y ‘Active’ phase of
labour
Shennan et al. (1995) United 93 (46/47) Oxytocin Placebo Y o7 cm From 36 weeks
Kingdom Epidural analgesia
Stein et al. (1990) USA 65 (30/35) Oxytocin Nipple stimulation with breast Y Y Unclear
pumpfnc;‡ þExternal control group n¼17
Tribe et al. (2012) United 502 (250/252) Continuous infusion of oxytocin Pulsatile infusion of oxytocin Y Y First stage
Kingdom

n
If no cervical change after four hours.
†
Induction cases excluded.
‡
18/35 in Nipple stimulation group were switched to oxytocin.
 C.M. Begley et al. / Midwifery 30 (2014) 975–982 979

Table 2
Characteristics and inclusion criteria of included systematic reviews.

Reference Total number of Type of Comparison group Inclusion criteria

participants intervention
randomised

Fraser 1178 (705/473) ARMþ early Conservative/usual Randomised and quasi-randomised trials with:
et al. (10 trials) oxytocin care/amniotomy only Low-risk pregnant women without previous caesarean section with slow progress in
(1998) the first stage of spontaneous labour at term (37–42 weeks) and a single, cephalic
presentation (nulli- and multiparas)
Bugg et al. 1338 (eight trials) Oxytocin (low or Placebo or no Randomised trials with:
(2013) high dose) treatment/delayed Comparison of early amniotomy and oxytocin with conservative management in
treatment nulliparous women (nulliparas only, published and unpublished studies), excluded
studies where data were not reported by parity
Mori et al. 660 (four trials) High-dose Low-dose oxytocin Randomised and quasi-randomised trials with:
(2011) oxytocin Comparison of high and low dose oxytocin augmentation for delay in labour (nulli- and
multiparas)
Wei et al. 1983 (nine trials) Early oxytocin Conservative Randomised trials with:
(2009) augmentation approach Comparison of early oxytocin augmentation with a more conservative approach and
membrane management similar in comparison groups (nulli- and multiparas)
Wei et al. 8033 (14 trials) Early oxytocin and Expectant Randomised and quasi-randomised trials with:
(2012) early amniotomy management 1. Unselected pregnant women in spontaneous labour; 2. pregnant women in
spontaneous labour where there is delay in the first stage (nulli- and multiparas)
Excluding: studies where women in both treatment groups underwent amniotomy

Table 3
Primary and secondary outcomes.

Outcome Number of papers including this outcome (n¼ 33)

As a primary outcome As a secondary outcome Total

n % n % n %

Caesarean section (CS) 15 45.5 2 6.0 17 51.5

Length of labour (first, second and/or third stages) 14 42.4 7 21.2 21 63.6
Uterine activity, tachysystole, contractions measured by Montevideo units, hypertonus, 13 39.4 6 18.2 19 57.6
uterine hyperstimulation, uterine atony
Mode of birth (forceps/vacuum/SVD), spontaneous vaginal delivery (SVD) 9 27.3 10 30.3 19 57.6
within 12/24 hours, vaginal birth after CS
Umbilical artery pH, acidosis 6 18.2 6 18.2 12 36.4
Failure to progress, labour augmentation, labour progress, cervical dilatation 6 18.2 1 3.0 7 21.2
Apgar score, need for resuscitation 5 15.2 17 51.5 22 66.7
Admission to Special Care Baby Unit, or neonatal complications 5 15.2 13 39.4 18 54.6
Post partum haemorrhage, blood transfusion 5 15.2 11 33.3 16 48.5
Effect of oxytocin in various doses, mean oxytocin dose, length of time on oxytocin 5 15.2 10 30.3 15 45.5
Neonatal/perinatal mortality, or serious perinatal morbidity (e.g. seizures, birth asphyxia 5 15.2 10 30.3 15 45.5
defined by trialists, neonatal encephalopathy, disability in childhood)
Maternal mortality or serious morbidity (e.g. uterine rupture, admission to 5 15.2 8 xx 13 39.4
intensive care unit, septicaemia, placental abruption, chorioamnionitis, antibiotic use)
Birth weight 5 15.2 5 15.2 10 30.3
Epidural, analgesia used 4 12.2 11 33.3 15 45.5
Fetal distress, non-reassuring fetal heart rate, meconium, 3 9.1 5 15.2 8 24.3
need for fetal blood sampling
Episiotomy, vaginal tears 3 9.1 4 12.2 7 21.2
Maternal satisfaction 1 3.2 4 12.2 5 15.2
Indication for caesarean section (CS) 0 11 33.3 11 33.3
Hyperbilirubinaemia/jaundice requiring phototherapy 0 4 12.2 4 12.2
Discontinued or reduced oxytocin 0 2 6.1 2 6.1
Mean duration hospital stay 0 2 6.1 2 6.1
Time from intervention to birth 0 2 6.1 2 6.1
Placental abruption 0 2 6.1 2 6.1

Miscellaneous primary outcomes: Feasibility of full scale RCT, Length of time to rupture of membranes, Number of vaginal exams, Level of presenting part at onset of the
second stage, Time necessary to correct labour abnormality after augmentation, Efficacy and safety of a pulsatile regimen.
Miscellaneous secondary outcomes: At least one neonatal discharge diagnosis, Neonatal problems, Retained placenta, Anaemia, Birth injuries, Cephalhaematoma,
Meconium aspiration, Labour pain, Adverse fetal events, unspecified, Adverse uterine events, ‘Other outcomes,’ Augmentation, Induction, Amniotomy, Outcomes measured
on the Edinburgh Postnatal Depression Scale, Labour Agentry Scale, Attitudes Towards the Pregnancy and the Baby Scale, Narcaine given, Treatment side effects, Secondary
arrest, Number of vaginal examinations, Use of fetal scalp electrode or uterine pressure catheter, Neonatal vital signs, Maternal and cord plasma levels of propranolol,
Neonatal infection, Vaginal birth not achieved within 24 hours, Clinicians' views, Women's perceptions of childbirth one month post partum.

fetal macrosomia and known fetal anomalies. Other exclusion The five reviews included both randomised and quasi-
criteria included maternal fever/infection, abnormal bony pelvis, randomised trials, and both published and unpublished studies.
serious maternal disease, prolonged latent phase, high parity and Four reviews included studies with both nulliparous and multi-
contraindications for trial of labour. parous women. Fraser et al. (1998) included studies of nulliparous
980 C.M. Begley et al. / Midwifery 30 (2014) 975–982

women only (Table 2). Two reviews (Fraser et al., 1998; Wei et al., Maternal satisfaction was included as a secondary outcome by
2012) included both studies of management of delay in labour and three papers (Blanch et al., 2005; Cluett et al., 2004; Nachum et al.,
studies of AML (Table 2). 2010) and was identified a priori by one review (Wei et al., 2009).
All included trials used oxytocin alone or in combination with One study measured women's perceptions of childbirth one
artificial rupture of membranes as an intervention. There was a month post partum (Bergqvist et al., 2012). The review by Bugg
variation of study designs. Some studies compared high or low et al. (2013) identified ‘woman not satisfied’ and ‘care-giver not
dose (Bidgood and Steer, 1987a, 1987b; Merrill and Zlatnik, 1999; satisfied’ as secondary outcomes, but these are negatively-
Majoko, 2001; Jamal and Kalantari, 2004) different increment phrased. One study measured rates of breast feeding on discharge
intervals (Lazor et al., 1993), different measures of (optimal) (Hemminki et al., 1985). No further women-centred, or positive
uterine contractions (Arulkumaran, 1989), continuous versus pul- health-focussed outcomes were identified.
satile administration (Cummiskey et al., 1989; Tribe et al., 2012),
oxytocin versus other active drugs (Ho et al., 2010; Bleich et al., Summative view on outcome measures
2011) or in different combinations with placebo (Saunders et al., When all outcomes are combined, the findings demonstrate
1989; Shennan et al., 1995; Palomäki et al., 2006; Sharami et al., that more than half of all studies (n ¼ 22–17, 67–52%) assessed
2012) with or without artificial rupture of membranes (Rouse caesarean section rates, length of labour, Apgar score, uterine
et al., 1994; Blanch et al., 2005; Nachum et al., 2010) or compared activity, admission to SCBU, and mode of vaginal birth (Table 3).
to expectancy (Bidgood and Steer, 1987a; Blanch et al., 2005; Nearly half measured post partum haemorrhage/blood transfu-
Hinshaw et al., 2008; Dencker et al., 2009). Not all papers clearly sion, neonatal/perinatal mortality or morbidity, epidural/analgesia
defined the alternative treatment. Some of the studies did use an used and the timing and effect of oxytocin (n¼ 16–15, 49–46%).
alternative treatment such as bath (Cluett et al., 2001, 2004), At least one third (n ¼11–13, 33–39%) assessed umbilical artery
ambulation (Read et al., 1981; Hemminki et al., 1985) and breast or pH, indication for caesarean section and serious maternal morbid-
nipple stimulation (Curtis et al., 1999). One study (Lazor et al., ity or death. Only five studies (15%) sought women's views on their
1993) had an intervention also for women with induction of experiences. A number of miscellaneous outcomes that were
labour and here we only analysed the outcomes of the interven- included in only one study each was also noted (Table 3).
tion for women receiving augmentation of labour. One study
(Grubb et al., 1996) had an intervention with women in early
labour (latent phase) and the intervention was that women with Discussion
no contractions during four hours were sent home, whilst the
other group stayed at hospital and were given oxytocin. Strengths and limitations

This review has analysed outcome measures used in rando-

Outcome measures mised trials, which will enable clinicians to identify gaps in the
A total of 23 outcome measures that were used in two or more published research and what outcomes should be included in
studies or reviews were identified. future research. Complete retrieval of identified papers was
achieved. No quality assessment was conducted as results of trials
were not being analysed.
Primary outcome measures
The most frequently measured primary outcome was caesarean
section, occurring in 15 of the 33 publications studied (46%). The Main findings
length of labour was the next most frequently used (n ¼14, 42%),
followed by measurements of uterine activity (e.g., hypertonus, This systematic review demonstrated that the majority of
uterine hyperstimulation) (n ¼13, 39%) and mode of vaginal birth studies or reviews on using oxytocin to treat delayed progress in
(n ¼9, 27%). Umbilical artery pH and the progress of labour were labour focus, understandably, on maternal and fetal birth out-
assessed in six studies each (18%). Apgar score, admission to comes including caesarean section rates, length of labour, Apgar
special care baby unit (SCBU), post partum haemorrhage (PPH), scores, mode of vaginal birth, uterine activity, admission to SCBU,
the timing and effect of oxytocin, neonatal/perinatal mortality or post partum haemorrhage/blood transfusion, perinatal mortality
morbidity, birth weight and maternal mortality or serious mor- or morbidity, epidural/analgesia used and the timing and effect of
bidity were assessed as primary outcomes in only five (15%) oxytocin. These outcomes are well established and focus mostly on
(Table 3). adverse facets. Even the systematic review that did include
In relation to women-centred or positive health-focussed out- maternal satisfaction as an outcome, phrased it negatively (Mori
comes, maternal satisfaction was identified a priori by one review et al., 2011). Maternal satisfaction, although very important to
(Mori et al., 2011), but was not included as a primary outcome in include in all maternity care studies, is difficult to ascertain
any individual study included in the review. Spontaneous birth accurately as, even when mothers are not happy with the birth
was included only as part of the measurement of mode of birth. No they experienced, they often report ‘satisfaction’ once a positive
further positive health-focussed outcomes could be identified. outcome has been achieved (Hodnett, 2002). Despite these diffi-
culties, an attempt at measuring maternal satisfaction should be
made in all studies of interventions in childbirth.
Secondary outcome measures Devane et al.'s Delphi study of 218 key stakeholders in
Neonatal outcomes were more commonly assessed as second- maternity care (including maternity service users, paediatricians,
ary outcomes, with Apgar score/need for resuscitation used in 17 obstetricians, midwives, general practitioners and policymakers),
studies (52%) and admission to Special Care Baby Unit (SCBU) in 13 across 28 countries, outlined a core set of 48 key outcomes that
(39%). Post partum haemorrhage/blood transfusion, epidural/ they believed maternity care researchers should assess in future
analgesia used and the indication for caesarean section were studies evaluating models of maternity care (Devane et al., 2007).
measured in 11 studies (33%). Neonatal/perinatal mortality or The majority of the top 10 outcomes given above were all found in
morbidity, mode of vaginal birth, and the timing and effect of the Delphi study; exceptions were outcomes particular to the type
oxytocin were assessed as secondary outcomes in 10 studies (30%) of study (uterine activity, tachysystole, timing and effect of
(Table 3). oxytocin in various doses). However, seven arguably appropriate
 C.M. Begley et al. / Midwifery 30 (2014) 975–982 981

outcomes of the 48 derived from the Delphi study (birth injury to core data set developed by Devane et al. (2007) are measured to
infant, anal sphincter damage, faecal incontinence, postnatal read- provide a more complete outcome picture for both mother and
mission of mother or neonate, postnatal depression, puerperal psy- infant, in the short and long-term. In addition, including more
chosis) (Devane et al., 2007) were used in none, or at the most, one, of women-centred and positive health-focussed outcomes may instil
the studies on using oxytocin to treat delay of progress in labour. a more salutogenic culture in childbirth, with the potential to
All studies in this review were randomised trials and the increase women's resilience and sense of coherence as they
reviews were based on, or included, randomised trials. Results of progress through childbirth.
other non-randomised studies regarding possible links between
oxytocin use and these outcomes are conflicting, or non-existent.
Clavicle damage (Lurie et al., 2011) and brachial plexus injury Conflict of interest
(Tandon and Tandon, 2005) are, for example, said to be associated
with oxytocin use, but the confounding variables of fetal macro- None of the authors have any financial, personal, political,
somia and prolonged labour cloud this issue. Although some intellectual or religious interests that would compete with this
studies appear to show that oxytocin infusion can lead to anal work. Two of the authors are also authors of two papers included
sphincter damage (Jandér and Lyrenäs, 2001; Nakai et al., 2006) in the review (Dencker et al. (2009) and Bergqvist et al. (2012)),
and/or faecal incontinence (Casey et al., 2005), other large cohort which were reviewed and included by two of the other reviewers.
studies disagree (Christianson et al., 2003; Jangö et al., 2012).
Postnatal readmission of mother or neonate is an outcome studied
in relation to care pathways rather than individual intrapartum Authors' contributions
interventions, so this variable is not present in cohort studies on
oxytocin use. No direct association has been shown between All authors have made substantial contributions to all of the
oxytocin use and postnatal depression, but postnatal depression following: (1) conception and design of the study, or acquisition of
is linked with postnatal readmission of the mother (Sword et al., data and analysis and interpretation of data, (2) drafting the article
2011). Given these tentative associations, or lack of evidence, these or revising it critically for important intellectual content, (3) final
seven variables would thus be suitable outcomes to consider approval of the version submitted.
measuring in future randomised trials of oxytocin use.
Authors of the Delphi study noted that most items in the data
set were phrased as adverse outcomes (Devane et al., 2007). This is Details of ethics approval
understandable, as the main purpose of most randomised trials is
to test an intervention which sets out, first, to cause no injury and As this review was based on data from published literature,
second, to improve birth outcomes for mother and infant. Simi- ethical approval was not required.
larly, almost none of the studies or systematic reviews included in
this review refer to women-centred outcomes (e.g., maternal
experience of pain, women's views of length of labour) or to Funding
positive health-focused outcomes (e.g., intact perineum, maternal
self-esteem). Walsh has drawn attention to how women, when Funding to pay for open access publication was received from
discussing their choice of place of birth, did not focus on doctors, the COST Action IS0907.
provision of epidurals, or facilities for ventouse or caesarean
births, so outcomes phrased in this way may have no great
meaning for them. Instead, they spoke of the environment (how Acknowledgements
calm it was, or homely), the social aspect (near home, for visiting,
or that family or friends had birthed there), and personal factors This paper is part of the work of EU COST Action IS0907:
(friendliness of staff) (Walsh, 2007). Understanding the impor- ‘Childbirth Cultures, Concerns, and Consequences: Creating a
tance of such factors may help clinicians to be more positive and dynamic EU framework for optimal maternity care’ and was
mindful in their choice of language when talking with women, supported by the European Commission under EU COST Action
concentrating more on environmental, social and personal aspects IS0907.
than on adverse outcomes. Women-centred and positive-focussed
outcomes are thus important to measure, in addition to those of
interest to clinicians, so that we have results that are pertinent References
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