DOI: 10.1111/1471-0528.

13589 Intrapartum care

www.bjog.org

Continuation versus discontinuation of oxytocin

infusion during the active phase of labour: a
randomised controlled trial
P Bor, S Ledertoug, S Boie, NO Knoblauch, I Stornes
Department of Obstetrics and Gynaecology, Regional Hospital of Randers, Randers, Denmark
Correspondence: P Bor, Department of Obstetrics and Gynaecology, Skovlyvej 1, 8930 Randers, Denmark. Email isipinbo@rm.dk

Accepted 6 July 2015. Published Online 26 August 2015.

Objective To investigate whether discontinuation of oxytocin
infusion increases the duration of the active phase of labour and
reduces maternal and neonatal complications.
Design Randomised controlled trial.
Setting Department of Obstetrics and Gynaecology, Regional
Hospital of Randers, Denmark.
Population Women with singleton pregnancy in the vertex
position undergoing labour induction or augmentation.
Methods Two hundred women were randomised when cervical
dilation was ≤4 cm to either continue or discontinue oxytocin
infusion when cervical dilation reached 5 cm.
Main outcome measures The primary outcome was duration of
the active phase of labour, defined as the time period from 5 cm
of cervical dilation until delivery. Secondary outcomes were mode
of delivery, uterine tachysystole, hyperstimulation, abnormalities
in fetal heart rate, postpartum haemorrhage rate, perineal tears,
and neonatal outcomes.
Results The active phase of labour was longer by 41 minutes
(95% confidence interval 11–75 minutes) in the discontinued
group (median 125 minutes in 85 women who had reached the
active phase and delivered vaginally) versus the continued group
(median 88 minutes in 78 women). The incidence of fetal heart
rate abnormalities (51 versus 20%) and uterine hyperstimulation
(12 versus 2%) was significantly greater in the continued than the
discontinued oxytocin group. The incidence of tachysystole,
caesarean deliveries, postpartum haemorrhage, third degree
perineal tears and adverse neonatal outcomes was higher in the
continued group, but did not reach significance.
Conclusions Discontinuation of oxytocin infusion in the active
phase of labour may improve some labour outcomes but has the
disadvantage of increasing the duration of the active phase of
labour.
Keywords Active phase of labour, caesarean delivery,
discontinuation of oxytocin, fetal heart rate abnormalities,
hyperstimulation.
Tweetable abstract Stopping oxytocin in the active phase seems
to make labour less complicated but lengthens duration.

Please cite this paper as: Bor P, Ledertoug S, Boie S, Knoblauch NO, Stornes I. Continuation versus discontinuation of oxytocin infusion during the active
phase of labour: a randomised controlled trial. BJOG 2016;123:129–135.

Although various oxytocin regimens for the induction or

Introduction
Since oxytocin was first synthesised in 1953, it has become
one of the most widely used medications in obstetrics to
induce and augment labour. In many delivery units, oxy-
tocin is used in more than 50% of deliveries.1–3 In Den-
mark, up to 45% of nulliparous women are stimulated with
oxytocin for either induction or augmentation of labour.4
Clinical trial number: EudraCT2006-006956-36
https://www.clinicaltrialsregister.eu/ctr-search/trial/2006-006956-36/DK.
augmentation of labour have been described,5–9 relatively
few studies have focused on the duration of oxytocin
administration in labour.10–15
The use of oxytocin during labour may result in a num-
ber of maternal adverse effects including hypotension,
tachycardia, arrhythmias, nausea, vomiting, headache and
flushing.16 Rarely, large doses of oxytocin may cause water
retention, hyponatraemia, myocardial ischaemia, seizures
and coma.17 Furthermore, a long duration of labour induc-
tion or augmentation due to use of oxytocin decreases the

ª 2015 Royal College of Obstetricians and Gynaecologists 129

 Bor et al.
efficacy of labour induction and increases complication
rates.3,18 Thus, there is growing concern about the use of
non-standardised oxytocin infusion for labour augmenta-
tion or induction. The U.S. Food and Drug Administration
describes oxytocin as a drug that carries a heightened risk
of causing significant patient harm.19 These problems are
most commonly due to incorrect administration of oxy-
tocin infusion and lack of timely recognition and appropri-
ate treatment of excessive uterine activity. To reduce rates
of maternal and fetal adverse events due to inappropriate,
excessive or unnecessary oxytocin administration, a
standard and specific protocol is needed.
The aim of this randomised study was to investigate
whether discontinuation of oxytocin infusion could affect
the duration of the active phase of labour compared with
continuation of oxytocin until delivery, and to compare
maternal and neonatal complications.
Methods
This randomised controlled trial was undertaken at the
Regional Hospital of Randers, Denmark, between May
2009 and May 2012. Pregnant women who underwent
either labour induction or augmentation with oxytocin
were included.
The exclusion criteria were age <18 years, unable to give
written informed consent, cervical dilation more than
4 cm, multiple pregnancies, more than one prior caesarean
section, non-vertex presentation, persistent pathological
cardiotocography (CTG) before oxytocin infusion, and a
clinically estimated fetal weight of more than 4250 g. Cer-
vical ripening with either misoprostol or intracervical bal-
loon catheter before initiation of oxytocin infusion was
accepted in the study protocol.
Vaginal examination was performed by midwives as an
initial assessment when women in labour entered the deliv-
ery unit. Only women with cervical dilation ≤4 cm were
included and randomised. After randomisation, vaginal
examination was performed by midwives each hour during
the labour according to the study protocol in order to
assess the degree of opening of the cervix, as well as cervi-
cal effacement, rotation and descent of the fetal head to
evaluate the progress in labour. Furthermore, midwives or
a physician performed a vaginal exploration when needed
to gain a clear understanding of the progress when compli-
cations occurred. To reduce inter-observer variability as far
as possible, women were observed and examined by the
same midwife during labour.
The women were randomised using a computer-gener-
ated randomisation program with stratification on parity
(nulliparous versus multiparous) to either continued or
discontinued oxytocin infusion. All women initially
received oxytocin infusion administered according to the
130
Danish Society of Obstetrics and Gynaecology (DSOG)
guidelines.20 Briefly, intravenous oxytocin infusion [5 IU
oxytocin, (Syntocinon; Novartis, Copenhagen, Denmark)
diluted in 500 ml of isotonic saline] was initiated at
3.3 mIU/minute and increased every 20 minutes by
3.3 mIU/minute until regular contractions (three to five
contractions every 10 minutes) were achieved. The maxi-
mal dose of oxytocin infusion was 30 mU/minute. In the
continued group, oxytocin infusion was continued until
delivery of both child and placenta, unless complications
occurred. In the discontinued group, oxytocin infusion was
discontinued when cervical dilation reached 5 cm. If arrest
of labour occurred, defined as no cervical dilation in
2 hours, oxytocin infusion was re-started in the discontin-
ued group after 2 hours.
All women were monitored with CTG during labour,
with continuous CTG if an abnormal fetal heart pattern
has been observed. After oxytocin was discontinued, fetal
monitoring was assessed by Doppler every 15–20 minutes
and intermittent CTG.
The main outcome measure was duration of the active
phase of labour, defined as the period of labour from 5 cm
of cervical dilation to vaginal delivery. The secondary out-
comes were mode of delivery, uterine tachysystole (more
than five contractions in 10 minutes in at least two consec-
utive intervals or averaged in a 30-minute window), abnor-
malities in fetal heart rate (FHR, defined as fetal tachycardia
or bradycardia, minimal to absent baseline variability,
recurrent variable or late decelerations), hyperstimulation
(tachystole with abnormal fetal heart rate changes), postpar-
tum haemorrhage, perineal tears, and neonatal outcomes;
Apgar score at 5 minutes, umbilical artery pH, and admis-
sion to the neonatal intensive care unit.
Statistics
The necessary sample size was calculated based on the
duration of the active phase of labour. We chose the rele-
vant difference between groups to be 60 minutes in the
active phase of labour with a common standard deviation
of 120 minutes, a two-sided test, a significance level of 5%
and a test power of 90%. According to these criteria, 86
individuals should be included in each group.
The data were analysed according to the intention-to-
treat principle using SPSS version 19.0 (SPSS for Windows,
Chicago, IL, USA) and STATA software (version 11.0 IC;
StataCorp, College Station, TX, USA). Categorical variables
were analysed using the Pearson chi-square test. None of
the continuous variables was normally distributed, except
age, which had a near-normal distribution. Therefore a
non-parametric approach was applied, and continuous
variables were tested using the Mann–Whitney test. Differ-
ences in proportions for outcome variables were analysed
by computing relative risks (RR) with 95% confidence
ª 2015 Royal College of Obstetricians and Gynaecologists

intervals. The Hodges–Lehmann method was used to esti-
mate the difference between medians for the main outcome
variable.
Results
In all, 266 women assessed for eligibility were invited to
participate in the study. Of these, 66 women (25%)
declined to participate. Thus 200 women were included in
the study and randomised to the intervention (n = 100) or
to the control group (n = 100) (Figure 1).
The maternal characteristics of the two study groups are
presented in Table 1.
The two main indications for oxytocin infusion in both
groups were rupture of the membranes and post-term
pregnancy. The outcome of labour in both groups is pre-
sented in Table 2.
The median duration of the active phase for the women
with a vaginal delivery was longer in the discontinued than
the continued oxytocin group (median, 88 versus 125 min-
utes, P = 0.007).
There was a significant difference in the duration of oxy-
tocin infusion (median, 274 minutes in the continued
group versus 226 minutes in the discontinued group,
P = 0.04), but not in the maximum dose of oxytocin used.
The incidence of FHR abnormalities was significantly
Number of women invited to participate in the study
n = 266
Number of women randomised
n = 200
Oxytocin continued
n = 100
Protocol adherence
3 oxytocin discontinued >30 minutes
Unable to reach primary outcome
11 delivered by caesarean section before active
phase
Duration of active phase recorded and analysed
(vaginal delivery only)
n = 78
Figure 1. CONSORT flow diagram.
ª 2015 Royal College of Obstetricians and Gynaecologists
Oxytocin during the active phase of labour
greater in the continued (51%) than the discontinued oxy-
tocin group (20%) (RR 2.63; 95% CI 1.67–4.14;
P < 0.001). The rate of uterine hyperstimulation was 12%
in the continued group but 2% in the discontinued group,
which was statistically significant (RR 5.62; 95% CI 1.28–
24.65; P < 0.008). The rates of caesarean deliveries, uterine
tachysystole, postpartum haemorrhage, and third degree
perineal tears were greater in the continued group than the
discontinued group; however, these differences were not
significant.
Seven patients in the discontinued oxytocin group and
11 patients in continued oxytocin group were delivered by
caesarean section when cervical dilation was <5 cm. The
indications for caesarean delivery in both groups are pre-
sented in Table 2.
In the discontinued group, the care of 11 women did
not adhere completely to the discontinuation protocol (Fig-
ure 1). Oxytocin was re-started in 36 of 100 women in the
discontinued group due to arrest of labour after discontin-
uing oxytocin for 2 hours; 26 of these women were nulli-
parous (72%). The mean cervical dilation was 6.4 cm at
re-starting oxytocin infusion. Twenty-two of these women
(22/36, 61%) had a normal vaginal delivery, and six deliv-
ered by vacuum extraction after oxytocin was restarted.
The remainder (n = 8) had caesarean delivery, seven of
them were nulliparous.
Declined to participate n = 66
Oxytocin discontinued
n = 100
Protocol adherence
6 oxytocin continued
2 oxytocin discontinued <2 hours
36 oxytocin restarted >2 hours
2 oxytocin discontinued when cervical dilatation
was 4cm
1 received oxytocin only a few minutes due to
fast labour
Unable to reach primary outcome
7 delivered by caesarean section before active
phase
Duration of active phase recorded and analysed
(vaginal delivery only)
n = 85
131
 Bor et al.

unit, not an experimental setting with different exclusion

Table 1. Baseline maternal characteristics
criteria during the study process, as has been described in
Continued Discontinued previous studies.12,14,15 Furthermore, most of the previous
n = 100 n = 100 studies focused on the duration of the active phase of
labour and rate of caesarean delivery when oxytocin was
Parity, n discontinued. Only two previous studies considered the
Nulliparous 45 46 association between postpartum haemorrhage10,13 or vac-
Multiparous 55 54
uum extraction11,13 and discontinued oxytocin. None of
Maternal age (years) 31.0 (27–35) 29 (26–33)
median (IQR)
the previous studies investigated, as did we, the rate of
Gestational age, n third degree perineal tears when oxytocin was discontinued
<37 weeks 4 4 during the active phase.
37–40 weeks 53 61 In our study, oxytocin infusion was restarted in 36
>40 weeks 43 35 women, of whom only 13 women exactly fulfilled our def-
BMI (kg/m2) median (IQR) 25 (22–32) 26 (23–30) inition of arrested labour. Eight of these 13 women were
Missing data 1 0
delivered by caesarean section, which suggests that re-start-
Previous caesarean section, n 13 12
Indication for oxytocin infusion, n
ing oxytocin appears to be associated with an increased
Postdate pregnancy 21 21 risk of caesarean delivery (8/13, 62%). Without any clear
Ruptured membranes 49 46 explanation, many women (n = 23, 64%) in our study
Oligohydramnios 2 1 were restarted on oxytocin even when there was a progres-
Hypertension 8 8 sion of labour. The reason for this may be the lack of a
Gestational diabetes 1 4 clear definition of arrested labour, which was only based
Intrauterine growth 2 1
on cervical dilation and did not include descent of the
restriction
Augmentation of labour 7 5
fetal head and maternal contractions. Another explanation
Other* 10 14 for this bias could be explained by discontinuation of oxy-
Cervical ripening, n tocin for 2 hours, which was probably too short a time to
Misoprostol 31 26 define arrested labour. Furthermore, discontinuation of
Cervical ripening catheter 5 3 oxytocin and a vaginal examination performed every hour
were not part of the normal management in our setting.
*Other indications included conditions such as maternal anxiety,
maternal discomfort, recurrent reduced fetal movements, maternal Unblinded care providers might be tempted to restart the
age, history of fetal death or intrahepatic cholestasis of pregnancy. oxytocin infusion if the woman or her partner become
impatient or concerned about the progression of labour,
due to our study setting, and this could be one of the
There were no significant differences in birthweight or explanations for any unnecessary oxytocin re-start.
fetal distress (defined as a 5-minute Apgar score <7, or an Another limitation of our study could be that the care
umbilical artery pH < 7.10), or need for neonatal intensive providers’ decision to proceed to caesarean or vacuum
care unit admission between the groups. delivery might be affected due to the unblinded design of
the study.
Discussion
Interpretation
Main finding Despite a huge interest in oxytocin, relatively few studies
In this study, we found that the duration of the active have been published concerning the duration of oxytocin
phase of labour was prolonged by 41 minutes when oxy- infusion, and the results are conflicting10–15 (Table S1). In
tocin infusion was discontinued after 5 cm of cervical dila- contrast to our results, a shorter11 or no prolongation of
tion. However, the discontinuation of oxytocin during the the active phase of labour12,14 was found in some previous
active phase may improve labour outcomes. studies. However, our study supports the finding in three
previous studies that the active phase is prolonged when
Strengths and limitations oxytocin is discontinued during the active phase of
The strength of our study is that we used a computer-gen- labour.10,13,15 Girard et al.13 found that the active phase
erated randomisation program with stratification on parity, was around 2 hours longer when oxytocin was discontin-
which has been used in only one of the previous studies.10 ued, whereas Ozturk et al.15 found only 30 minutes’ pro-
We did an intention-to treat analysis, and no women were longation. It could be argued that a shorter duration is
excluded from the study after randomisation. Our study not necessarily always beneficial. Most women may proba-
setting reflects a daily obstetrical practice at a busy delivery bly tolerate, or even prefer, a longer phase of labour if

132 ª 2015 Royal College of Obstetricians and Gynaecologists

 Oxytocin during the active phase of labour

Table 2. Outcome of labour

Continued Discontinued Effect size* P-value

n = 100 n = 100 (95% CI)

Vaginal deliveries, n n = 78 n = 85
Active phase of labour (minute),a median (IQR) 88 (54–151) 125 (65–290) 41 (11–75) 0.007
Missing data 6 2
Mode of delivery, n (%) n = 100 n = 100
Spontaneous vaginal delivery 70 (70) 74 (74) =1.0 0.39
Vacuum extraction 8 (8) 11 (11) 0.79 (0.34–1.87)
Caesarean section 22 (22) 15 (15) 1.42 (0.79–2.55)
Indications for caesarean section, n n = 22 n = 15
Non-reassuring fetal heart tracing 3 2
Dystocia 15 12
Suspicion of uterus rupture 2 0
Suspicion of placental abruption 2 0
Chorioamnionitis 0 1
n = 89 n = 93
Tachysystole,b n (%) 16 (18) 8 (9) 2 (0.90–4.43) 0.07
Missing data 0 4
n = 89 n = 93
Abnormal fetal heart rate,b n (%) 45 (51) 19 (20) 2.63 (1.67–4.14) 0.001
Missing data 0 0
n = 89 n = 93
Hyperstimulation,b n (%) 11 (12) 2 (2) 5.62 (1.28–24.65) 0.008
Missing data 0 2
n = 100 n = 100
Maximum dose of oxytocin infusion (ml), median (IQR) 120 (90–180) 90 (60–180) 0.12
Missing data 5 5
n = 100 n = 100
Total duration of oxytocin infusion (minute), median (IQR) 274 (186–405) 226 (123–360) 0.04
Missing data 1 0
n = 100 n = 100
Epidural analgesia, n (%) 41 (41) 51 (51) 0.16
n = 100 n = 100 1.38 (0.77–2.46) 0.28
Postpartum haemorrhage (>500 ml), n (%) 22 (22) 16 (16)
n = 78 n = 85
Perineal tears,a n (%) 59 (76) 56 (67) 0.17
Grade 1 24 32
Grade 2 31 23
Grade 3 4 1
Missing data 0 1
n = 100 n = 100 0.37
Fetal birthweight (g), median (IQR) 3600 (3212–4055) 3705 (3347–4000)
n = 100 n = 100
Apgar score (<7 at 5 minutes), n 0 0
Missing data 2 3
n = 100 n = 100
pH < 7.10, n (%) 4 (6) 3 (3) 0.73
Missing data 7 10
n = 100 n = 100 1.25 (0.35–4.52) 0.73
Neonatal care, n (%) 5 (5) 4 (4)

*For categorical variable; Relative Risk (RR); for continuous variable,; estimated difference between medians (Hodges-Lehmann method)
a The duration of the active phase and the rate of perineal tears were calculated for the women with a vaginal delivery only.
b The data were calculated for the women who reached the active phase of labour.

ª 2015 Royal College of Obstetricians and Gynaecologists 133

 Bor et al.
contractions are less painful or if there are other potential
benefits.
The conflicting results in the previous studies can be
explained mainly by differences in the inclusion and exclu-
sion criteria. Most of these studies included full-term sin-
gleton pregnancies but excluded women with a history of
prior caesarean section.10,12,14,15 However, we did not
exclude women with previous caesarean section or those
who had a preterm delivery. In our study, 13% of the
labouring women had one prior caesarean section, which
reflects the normal proportion of births by caesarean sec-
tion in Denmark, around 20%.21 According to the Danish
Birth Registry, in 2010 around 55% of women with previ-
ous caesarean section tried vaginal delivery and approxi-
mately 65% of these delivered vaginally.21 In our study,
more women with previous caesarean section in the dis-
continued oxytocin group delivered vaginally (75%) com-
pared with the continued group (61%). However, the small
study population does not allow us to draw any firm
conclusions.
It is important to note that factors such as parity, history
of prior caesarean section, and administration of epidural
anaesthesia, which can also affect the duration of labour,
were not consistently described in all previous studies
(Table S1). In our study, 41% of women in the continued
oxytocin group had epidural anaesthesia compared with
51% in the discontinued group. The use of epidural anaes-
thesia was only mentioned in the three of the previous
studies,10,11,13 with a large variation (56–96%), which can
partly explain the different results with regard to maternal
outcomes.
While preparing this article, a meta-analysis concerning
the effect of oxytocin discontinuation in the active phase of
labour was published, which concluded that there were sig-
nificantly decreased rates of caesarean sections, uterine
hyperstimulation, and non-reassuring FHR patterns when
oxytocin was discontinued during the active phase of
labour.22
In our study, the active phase of labour was defined as
the period of labour from 5 cm cervical dilation to deliv-
ery, which is similar to the previous studies, except for two
studies in which it was defined from ≥4 cm of cervical dila-
tion.10,14 However, a recent retrospective observational
study, covering a total of 228 668 deliveries, suggests that
6 cm cervical dilation may be more appropriate for the
start of the active phase of labour.23 Therefore, the labour
process needs to be re-evaluated, and the definitions of
‘normal’, ‘abnormal labour’, and ‘active phase of labour’
should probably be re-examined.
We found fewer caesarean deliveries (15 versus 22%)
when oxytocin infusion was discontinued during the active
phase. However, analysis of the results showed no signifi-
cant differences, as likely the study was not powered to
134
evaluate this outcome. In the previous studies the rate of
caesarean sections showed large variations and was also
greater when oxytocin was continued during the active
phase,10–13,15 which is similar to our result.
The main risk of induction or augmentation with oxy-
tocin is excessive uterine activity, termed uterine tachysys-
tole, which may lead to decreased fetal intracerebral oxygen
saturation and to an increased risk of FHR changes,
hypoxia and acidosis. It has been shown that oxytocin dou-
bled the likelihood of tachysystole with FHR changes and
that there is a dose–response correlation between oxytocin
and tachysystole.24
Patient injury due to drug therapy is the most common
type of adverse event occurring in hospitals, and results in
a significant economic burden on the healthcare system.
Approximately half of all paid obstetric litigation claims
involve improper use of oxytocin infusion.25 We believe
that oxytocin administration-related errors and patient
harm can be prevented by the use of an evidence-based
consensus concerning the duration of necessary oxytocin
infusion during labour. This will probably reduce rates of
maternal–fetal adverse events resulting from inappropriate,
excessive or unnecessary oxytocin administration. Recently,
some studies have pointed out the long-term effects of oxy-
tocin such as hyperactivity in infants whose mothers
received oxytocin for induction of labour.26
Conclusion
Discontinuation of oxytocin during the active phase of
labour may improve labour outcomes but has the disad-
vantage of increasing the duration of the active phase of
labour. The findings in our study suggest that continuing
oxytocin during the active phase should be considered
carefully. Some women are probably treated unnecessarily
with continuous oxytocin during the active phase of
labour, and this may increase the risk of caesarean delivery
and make labour more complicated. Further studies with
larger sample sizes, stratified by parity, previous caesarean
section and epidural anaesthesia, are needed to identify
both the ideal doses and the timing of oxytocin infusion in
the different phases of labour.
Disclosure of interests
None declared. Completed disclosure of interests form
available to view online as supporting information.
Contribution to authorship
PB conceived the study. PB, SL, IS and NK contributed to
its design, conducted the analyses and performed the study.
PB drafted the original manuscript, and PB, SL, IS, SB, and
NK reviewed and revised the manuscript. All authors
approved the final manuscript as submitted.
ª 2015 Royal College of Obstetricians and Gynaecologists

Details of ethics approval
The study was approved by The Central Denmark Region
Committees on Health Research Ethics (no. 20060069,
10.08.2006) and The Danish Data Protection Agency (no.
2006-41-6866, 13.07.2006) and carried out in accordance
with the Helsinki Declaration. The trial was registered at
Clinical Trials.gov (2006-006956-36).
Funding
The Central Denmark Region Committees on Health
Research Foundation.
Acknowledgements
We thank Dr Julie Glavind for her valuable comments and
Dr Edwin Spencer for proofreading.
Supporting Information
Additional Supporting Information may be found in the
online version of this article:
Table S1. Previous studies concerning the duration of
oxytocin infusion in the active phase of labour. &
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