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

M

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

  • 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.

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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