A Phase 4 interventional study of discontinuation of oxytocin administration and continuation of oxytocin administration in Neonatal Morbidity, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-05.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 4, Interventional, and Treatment
The purpose of this study is to measure the impact of a discontinuous administration of oxytocin during the active phase of the 1st stage of labor on the neonatal morbidity rate.
The investigators hypothesize that discontinuation of oxytocin in the active phase of labor (from 6 cm) in women who received oxytocin in the latent phase or for an induction (before 4 cm of dilation) could reduce neonatal morbidity.
Oxytocin is effective in increasing frequency and intensity of uterine contractions and therefore in reducing the duration of labor. Nevertheless, its administration is potentially associated with fetal and maternal short-and long- term complications, such as neonatal acidosis and post-partum hemorrhage and its effectiveness in decreasing caesarean section rate has not been clearly demonstrated.
The most important side effect of oxytocin infusion is uterine hyper-stimulation, which has been shown to occur in more than 30% of women induced with oxytocin. By causing uterine hyper-stimulation, oxytocin infusion may lead to or aggravate abnormal fetal heart rate, contributing to neonatal acidosis. Acidosis is a major part of neonatal morbidity due to related complications such as hospitalization in neonatal intensive care units, but also neonatal death or cerebral palsy in the most severe cases.
The first stage of labor is divided into two phases, a latent phase where cervical dilation is relatively slow until 5-6 cm and an active phase until full dilatation, where cervical dilation accelerates. Currently in France, when oxytocin administration has been initiated during the latent phase, the standard care is to continue it during the whole duration of labor. One assumption is that, once women requiring oxytocin during the latent phase enter the active phase, natural oxytocin takes over from synthetic oxytocin. Thus, in the active phase, oxytocin could be discontinued, reducing exposure duration and therefore reducing the risk of complications, in particular neonatal complications, without compromising the chances of vaginal delivery.
It can therefore be hypothesized that discontinuation of oxytocin in the active phase of labor (from 6 cm) in women who received oxytocin in the latent phase or for an induction (before 4 cm of dilation) could reduce neonatal morbidity.
Several small trials attempting to evaluate this practice have been published, but their design and small population did not allow evaluating the impact of discontinuation of oxytocin on neonatal morbidity. Thus, the investigators propose to conduct a large randomized controlled trial, STOPOXY, aiming to reduce oxytocin exposure and its adverse effects.
The investigators expect an improvement of child health at birth, with less severe neonatal morbidity that may cause neurologic damages and less moderate neonatal morbidity that may be associated with the need of resuscitation and hospitalization.
The investigators plan to conduct a multicenter, randomized, open-label, controlled trial comparing neonatal and maternal outcomes among term singleton neonates after discontinuation or continuation of oxytocin infusion during the active phase of the 1st stage of labor.
Two arms:
The open-label design was chosen for several reasons. The main reason is that in case of a blinded trial, the need for un-blinding would be too frequent as the investigators estimate it from the previous published trials at 30 to 40%. The second reason is feasibility. Indeed, in case of non-reassuring fetal heart rate, it is important for the obstetrician to be able to stop the oxytocin infusion to reduce the uterine contractility.
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Exclusion Criteria:
Discontinuation of oxytocin administration at the beginning of the active phase of the 1st stage of labor, i.e. oxytocin infusion will be stopped beyond a cervical dilatation of 6cm
Drug: discontinuation of oxytocin administration
Standard care in France, i.e. when oxytocin is started during the latent phase of the 1st stage, administration of oxytocin is continued during the active 1st stage and during the 2nd stage if the fetal heart rate is reassuring.
Drug: continuation of oxytocin administration
Discontinuation of oxytocin administration at the beginning of the active phase of the 1st stage of labor, i.e. oxytocin infusion will be stopped beyond a cervical dilatation of 6cm. In the experimental group, oxytocin can be re-started, if necessary, after 2 hours of arrest of labor.
continuation of oxytocin administration
neonatal morbidity composite measure
Neonatal morbidity will be assessed using a composite variable defined by: an umbilical arterial pH at birth \<7.10 and/or a base excess \>10mmol/L and/or umbilical arterial lactates\>7 mmol/L and/or a 5 minutes Apgar score \<7 and/or admission in neonatal intensive care unit (NICU). This composite outcome is based on pertinent and previously published thresholds to assess neonatal acidosis\[16\]
Time frame: At birth
umbilical cord pH<7.20
umbilical arterial cord pH at birth less than 7.20
Time frame: At birth
umbilical cord pH<7.10
umbilical arterial cord pH at birth less than 7.10
Time frame: At birth
umbilical cord pH<7.00
umbilical arterial cord pH at birth less than 7.00
Time frame: At birth
Need for hypothermia
need for hypothermia
Time frame: At birth
other neonatal complications:
need of resuscitation at birth
Time frame: 2 hours postpartum
neonatal admission
transfer to neonatal care unit
Time frame: 2 hours postpartum
length of the newborn's hospital stay
length of hospital stay
Time frame: 0-1 month
mode of delivery
cesarean rate
Time frame: 0-48hours
mode of delivery
cesarean rate for abnormal fetal heart rate
Time frame: 0-48hours
mode of delivery
instrumental vaginal delivery
Time frame: 0-48hours
mode of delivery
instrumental delivery for abnormal fetal heart rate
Time frame: 0-48hours
labor duration
labor duration (active 1st stage, passive and active 2nd stage)
Time frame: 0-48hours
uterine hyper-stimulation
uterine hyper-stimulation, defined by periods with more than 5 uterine contractions in 10 minutes during labor
Time frame: 0-48hours
fetal scalp blood testing
need for fetal scalp blood testing during labor
Time frame: 0-48hours
fetal occipito-posterior position
fetal occipito-posterior position
Time frame: 0-48hours
maternal hyperthermia
maternal fever during labor, defined by maternal temperature \>38°C
Time frame: 0-48hours
postpartum hemorrhage
post-partum hemorrhage, defined by an estimated blood loss \>500mL
Time frame: 0-48hours
The post-partum women's satisfaction
women's satisfaction is recorded using the "labor agentry scale". Scores on the Labor Agentry Scale range from 29 to 203, with higher scores indicating greater perceived control during childbirth.
Time frame: 0 5 day
The post-partum women's satisfaction: labor agentry scale
women's satisfaction is recorded using the "labor agentry scale"\[18\]
Time frame: at 2 months postpartum in a survey
The post-partum women's satisfaction
Edinburgh Postnatal Depression Scale. Scores on the Edinburgh Postnatal Depression Scale rabge from 0 to 30, with higher score indicating mental health issues.
Time frame: at 2 months postpartum in a survey
The post-partum women's satisfaction
Satisfactiuon of labor and childbirth with Labor Agentry Scale
Time frame: at 2 months postpartum in a survey
The post-partum women's satisfaction
Birth experience and well being with EPDS at 2 months
Time frame: at 2 months postpartum in a survey
The post-partum women's satisfaction
Breastfeeding at 2 months
Time frame: at 2 months postpartum in a survey
Plan to share: No
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Assistance Publique - Hôpitaux de Paris