Continuous Versus Intermittent Oxytocin Infusion for Induction of Labor in Multiparous Pregnant Women
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Rambam Health Care Campus
- Enrollment
- 166
- Primary Endpoint
- The rate of women delivering within 24 hours.
Study Overview
Brief Summary
This is a randomized controlled trial investigating whether continuous oxytocin infusion in multiparous women shortens time to delivery, without altering maternal or neonatal outcomes, in augmented deliveries, compared to intermittent infusion.
Detailed Description
Induction of labor (IOL) is defined as an artificial initiation of uterine contractions before the spontaneous onset of labor. It is indicated when maternal or fetal risks associated with continuation of pregnancy outweigh the risks associated with early delivery. Augmentation of labor refers to the stimulation of spontaneous but inadequate contractions. In high-income countries, up to 25% of all deliveries at term involve IOL.
Bishop score is a scoring system which measures changes in the cervix. It is based on several characteristics such as cervical effacement, dilatation, consistency, position and fetus head station. A Bishop score < 6 is often referred to as an unripe cervix (unfavorable), whereas ≥ 6 is referred to as a rip cervix (favorable).
Oxytocin is a commonly used drug for IOL, especially in a favorable cervix. It is a mammalian neuro-hypophyseal hormone and is used to generate regular coordinated contractions originating from the fundus towards the cervix. It is administered intravenously (IV) as an increasing infusion, titrated to the strength and frequency of uterine contractions.
There is voluminous experience with oxytocin, and it is considered as a safe drug. Although, there are several case reports reporting rare serious side effects such as: iatrogenic hyponatremia, grand mal seizure and coma, and maternal death. In a prospective observational study of 287 women at term, demonstrated that hyponatremia was correlated significantly with fluid infusion during labor, and not to oxytocin administration.
There is conflicting evidence whether oxytocin infusion should be continued during the active phase of labor or not. Prolonged administration of oxytocin may increase the risk of tachysystole and uterine rupture, which may result in fetal non-reassuring heart rate and caesarian deliveries. Conversely, discontinuing oxytocin infusion after a few hours may have an effect on time to delivery interval, duration of rupture of membrane (ROM) and chorioamnionitis.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •multiparous women (women who have given birth one or more times in the past) with a singleton pregnancy that are admitted for induction of labor.
- •Women at gestational age of 370/7 or more.
- •Vertex presentation.
Exclusion Criteria
- •Age 18 and under.
- •High order gestation.
- •Women with contraindication for vaginal delivery.
- •Previous cesarean delivery.
- •Active labor.
- •Documented fetal anomalies.
Arms & Interventions
continuous oxytocin infusion
continuous oxytocin infusion - women will continue to receive a continuous oxytocin infusion from start of labor augmentation until delivery.
Intervention: Pitocin Injectable Product (Drug)
intermittent oxytocin infusion
intermittent oxytocin infusion - oxytocin transfusion will be discontinued after 8 hours if the woman does not go into active labor, or does not deliver in that period of time.
The second course of oxytocin will be renewed after 6 hours if the woman hasn't progressed into labor or hasn't given birth yet.
Intervention: Pitocin Injectable Product (Drug)
Outcomes
Primary Outcomes
The rate of women delivering within 24 hours.
Time Frame: During admission for delivery (assessed up to 5 days since admission to delivery room)
number of women (among those who received continues Oxytocin) who manage to deliver within 24 hours from the beginning of the induction.
Secondary Outcomes
- Length of latent and active phases of labor.(During admission for delivery)
- neonatal outcome - 1 and 5-minute Apgar score(1 and 5 minutes after delivery)
- hyponatremia(During admission for delivery)
- umbilical artery pH(During admission for delivery)
- The rate of instrumental and caesarean deliveries.(During admission for delivery)
- chorioamnionitis(During admission for delivery)
- obstetric anal sphincter injuries (OASIS)(During admission for delivery)
- post-partum hemorrhage (PPH)(During admission for delivery)
- NICU admission(During admission for delivery)
- Women's satisfaction.(up to 5 days after delivery)
Investigators
Hiba Abu Rass MD
Resident in OB-GYN, Principal Investigator
Rambam Health Care Campus