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

NCT04514770 | Completed DMC

• 1 other identifier: 11/2019 OBSGN 27
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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

Conditions

Labour Induction

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• misoprostol doses administered

  during the intervention

• the need for augmentation of labor

  during the intervention

• intrapartum meconium

  during the intervention

• Apgar score

  during the intervention

• newborn admission in the neonatal intensive care unit

  immediately after intervention

Study Arms (2)

early amniotomy

ACTIVE COMPARATOR

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.

Drug: Misoprostol

Late amniotomy

ACTIVE COMPARATOR

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.

Drug: Misoprostol

Interventions

Misoprostol DRUG

rupture of membrane early and late

Also known as: Amniotomy

Late amniotomy; early amniotomy

Eligibility Criteria

• Age: 20 Years - 40 Years
• Gender Eligibility Details: Nulliparous Women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Menoufia University: lead

Study Sites (1)

Menoufia University hospital

Shibīn al Kawm, Menoufia, 11111, Egypt

Location

MeSH Terms

Interventions

Misoprostol; Amniotomy

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Labor, Induced; Delivery, Obstetric; Obstetric Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of obstetrics and gynecology

Model Details: 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.

Study Record Dates

• First Submitted: July 28, 2020
• First Posted: August 17, 2020
• Study Start: May 3, 2019
• Primary Completion: January 10, 2020
• Study Completion: March 20, 2020
• Last Updated: August 17, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)