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

Menoufia University

Status: Completed

Conditions: Labour Induction

Treatments: Drug: Misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT04514770

11/2019 OBSGN 27

Details and patient eligibility

About

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

Full 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

Enrollment: 140 patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

140 participants in 2 patient groups

early amniotomy

Active Comparator group

Description:

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.

Treatment:

Drug: Misoprostol

Late amniotomy

Active Comparator group

Description:

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.

Treatment:

Drug: Misoprostol