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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-03

Study Completion Date

2020-03-20

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

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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

Conditions

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Labour Induction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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early amniotomy

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.

Group Type ACTIVE_COMPARATOR

Misoprostol

Intervention Type DRUG

rupture of membrane early and late

Late amniotomy

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.

Group Type ACTIVE_COMPARATOR

Misoprostol

Intervention Type DRUG

rupture of membrane early and late

Interventions

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Misoprostol

rupture of membrane early and late

Intervention Type DRUG

Other Intervention Names

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Amniotomy

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes