A pilot randomized controlled trial of delayed versus immediate oxytocin infusion after amniotomy for induction of labour.

Completed

Conditions: augmentation of labour
Induction
10010273

Registration Number: NL-OMON45440

Lead Sponsor: Onze Lieve Vrouwe Gasthuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 180

Inclusion Criteria

- Due for induction of labour for the following maternal or fetal indications:
o prolonged pregnancy (>41wks of pregnancy)
o mild hypertensive disorders
o diabetes
o expected macrosomia
o maternal request.
- Term pregnancy (37-42 weeks of pregnancy)
- Singleton pregnancy
- Cephalic presentation of the fetus
- Viable fetus
- Favourable cervix (bishop score >5) and intact membranes
- >= 18 years old
- Sufficient command of the Dutch or English language

Exclusion Criteria

- Previous caesarean section
- Fetal distress prior to induction
- Maternal fever prior to induction
- Contra-indication for oxytocin

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Amniotomy to delivery interval.<br /><br>Patient satisfaction.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Process of delivery:<br /><br>- Amniotomy-to-oxytocin interval<br /><br>- Meconium stained fluid<br /><br>- Use of pain relief<br /><br>- Intrapartum fever<br /><br>- CTG FIGO-classification<br /><br>- Micro-blood-examination<br /><br>- Uterine hyperstimulation<br /><br><br /><br>Outcome of delivery:<br /><br>- Total oxytocin augmentation time<br /><br>- Total oxytocin dose<br /><br>- Highest oxytocin dose<br /><br>- Mode of delivery<br /><br>- Haemorrhagia post partum<br /><br>- Apgarscore <7 at 5 minutes<br /><br>- Neonatal infection<br /><br><br /><br>Pilot evaluation<br /><br>- The enrolment rate<br /><br>- Rate and reason of violation of study protocol</p><br>