Impact of Early Versus Late Amniotomy on Labour Induction in Nulliparous Women After Vaginal Misoprostol

Not Applicable

Completed

• Conditions: Labour Induction
• Interventions: Drug: Misoprostol

• Registration Number: NCT04514770
• Lead Sponsor: Menoufia University

Brief Summary

Investigation the effect of timing of amniotomy (early versus delayed) after vaginal misoprostol in induced labor.

Condition: induction of labour intervention: eary versus late amniotomy on labour induction after vaginal misoprostol Phase: Not applicable

Detailed Description

study type: randomized clinical trial actual enrollment: 140 allocation: Random intervention model: two groups assignment masking: open lebal primary purpose: induction of labour actual study start: May 3, 2019 Primary Completion: January 10, 2020 actual study completion date: March 20, 2020

Study Timeline

• Study Start: 2019-05-03
• Primary Completion: 2020-01-10
• Study Completion: 2020-03-20
• Study First Submitted: 2020-07-28
• Status Verified: 2020-08
• Study First Submitted QC: 2020-08-12
• Last Update Submitted: 2020-08-12
• Study First Posted: 2020-08-17
• Last Update Posted: 2020-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 140

Inclusion Criteria

1. Pregnant women at 36 weeks gestation or more
2. Nullipara
3. singleton fetus
4. cephalic presentation with common medical causes for labour induction e.g. intrauterine fetal growth restriction, post term pregnancy and preeclampsia.

Exclusion Criteria

1. Macrocosmic babies with estimated fetal weight of more than 4000 gram
2. Previous uterine scars
3. Pre labor premature rupture of fetal membranes
4. Polyhydramnios.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
early amniotomy	Misoprostol	Group A: 1. Pregnant women had taken misoprostol (vagiprost vaginal tablet; Adwia Pharmaceutical Company) vaginally as 25 micro gram of misoprostol. It was repeated every 6 hours until three or more uterine contractions of 40 second duration occur over 10 minutes, or when reaching four doses maximum (i.e. 100 micro gram) is reached. 2. Early amniotomy was performed for the participant of the first group at 3 cementer cervical dilatation with Kocher's forceps provided the head is well fitted to the cervix.
Late amniotomy	Misoprostol	Group B: 1. Pregnant women had taken misoprostol (vagiprost vaginal tablet; Adwia Pharmaceutical Company) vaginally as 25 micro gram of misoprostol. It was repeated every 6 hours until three or more uterine contractions of 40 second duration occur over 10 minutes, or when reaching four doses maximum (i.e. 100 micro gram) is reached. 2. late amniotomy was performed for the participant of the second group at 7 cementer cervical dilatation.

Primary Outcome Measures

Name	Time	Method
successful induction	immediately after intervention	definition of successful induction is occurrence of vaginal delivery within 24 hours from the beginning of induction
induction-delivery interval	immediately after intervention	duration of labor and amniotomy delivery interval

Secondary Outcome Measures

Name	Time	Method
Apgar score	during the intervention	Apgar score less than 7 at 1 and 5 minutes
misoprostol doses administered	during the intervention	number of misoprostol doses administered
the need for augmentation of labor	during the intervention	the need for augmentation of labor by oxytocin and perinatal outcomes included cord prolapse and abnormal FHR changes during labor
intrapartum meconium	during the intervention	intrapartum meconium passage
newborn admission in the neonatal intensive care unit	immediately after intervention	newborn admission in the neonatal intensive care unit (NICU).

Trial Locations

Locations (1)

Menoufia University hospital; 🇪🇬 Shibīn Al Kawm, Menoufia, Egypt