Oxytocin in Multiparous Women
ConditionPregnancy Related
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorRambam Health Care Campus
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Age 18 and under.
High order gestation.
Women with contraindication for vaginal delivery.
Previous cesarean delivery.
Trial design
Design model
Parallel
Treatments tested in this trial
Pitocin Injectable Product
DrugThe primary dose of oxytocin is 1.0 mU/min, with an incremental increase by 2.5 mU/min every 30 minutes, until 20.0 mU/min, tittered to a target of 3-5 contractions in a 10-minute period, or active labor (dilatation \> 6 cm).
Treatment groups
166 Participants
are divided into 2 treatment groupsGroup A: continuous oxytocin infusionExperimental treatment 1 intervention
Group B: intermittent oxytocin infusionActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
The rate of women delivering within 24 hours.
number of women (among those who received continues Oxytocin) who manage to deliver within 24 hours from the beginning of the induction.
Time frame
During admission for delivery (assessed up to 5 days since admission to delivery room)Secondary outcomes
1
Length of latent and active phases of labor.
Time interval from admission to delivery room to delivery of fetus
Time frame
During admission for delivery2
The rate of instrumental and caesarean deliveries.
Cesarean section and operative vaginal delivery including vacuum assisted vaginal delivery
Time frame
During admission for delivery3
chorioamnionitis
Chorioamnionitis diagnosed at discretion of primary provider during the second stage of labor
Time frame
During admission for delivery4
obstetric anal sphincter injuries (OASIS)
3rd or 4th degree perineal lacerations
Time frame
During admission for deliveryLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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