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

Study Overview
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Brief Summary
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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
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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

Official Title
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Early Versus Late Amniotomy on Labour Induction in Nulliparous Women

Conditions
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Labour Induction

Intervention / Treatment
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* Drug: Misoprostol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant women at 36 weeks gestation or more Nullipara singleton fetus cephalic presentation with common medical causes for labour induction e.g. intrauterine fetal growth restriction, post term pregnancy and preeclampsia. Exclusion Criteria: Macrocosmic babies with estimated fetal weight of more than 4000 gram Previous uterine scars Pre labor premature rupture of fetal membranes Polyhydramnios.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Group A: Early amniotomy was performed for the participant of the first group at 3 cm cervical dilatation with Kocher's forceps provided the head is well fitted to the cervix. Group B: late amniotomy was performed for the participant of the second group at 7 cm cervical dilatation.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: early amniotomy<br>Group A: 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. 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. | Drug: Misoprostol<br>* rupture of membrane early and late<br>* Other names: Amniotomy;|
| Active Comparator: Late amniotomy<br>Group B: 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. late amniotomy was performed for the participant of the second group at 7 cementer cervical dilatation. | Drug: Misoprostol<br>* rupture of membrane early and late<br>* Other names: Amniotomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| successful induction | definition of successful induction is occurrence of vaginal delivery within 24 hours from the beginning of induction | immediately after intervention | 
| induction-delivery interval | duration of labor and amniotomy delivery interval | immediately after intervention | 

Secondary Outcome Measures

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