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Completed

NCT Number: NCT06560515

Dinoprostone Versus Vaginal Misoprostol for Induction of Labour

This randomized controlled study was carried out on 370 pregnant women with gestational age ≥ 40 weeks of different ages and parities at El-Shatby Maternity University Hospital after approval of ethical committee of Alexandria Faculty of Medicine. After assessment for eligibility & enrollment in the study, women were randomly assigned into one of the two study groups, Group (I) received 3 mg vaginal Dinoprostone of maximum 2 doses 6 hours apart and Group (II) received 50 μg of vaginal misoprostol of maximum 2 doses 6 hours apart.

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Key information

Conditions

Induced Vaginal Delivery

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

ElShatby University Maternal Hospital

Alexandria, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • pregnant women at 40 weeks or beyond
  • singleton pregnancy
  • Bishop score 4 or more
  • fetus in a cephalic presentation
  • Adequate fetal biophysical profile

Exclusion criteria

  • Any signs of labour (Prelabor rupture of membranes)
  • Grand Multiparous women (parity of 4 or more)
  • IUFD
  • fetal weight > 4 kg
  • BMI > 35

Treatment and study plan

Vaginal Dinoprostone

Drug

induction of labour in women with postdate pregnancy with vaginal dinoprostone vs. vaginal misoprostol

Primary outcomes

  1. Sucess of induction

    Time frame: number of women who delivered vaginally after induction

    percentage of women with a successful vaginal delivery

  2. Induction to delivery time

    Time frame: time from start of induction till delivery of the fetus

    time lapse from receiving first dose of induction till delivery of the fetus

Secondary outcomes

  1. Postpartum hemorrhage

    Time frame: after delivery of the placenta

    quantification of amount of postpartum bleeding

  2. neonatal outcomes

    Time frame: at 1 and 5 minutes of delivery

    Apgar Score at 1 and 5 minutes

Sponsors and collaborators

Lead sponsor

University of Alexandria

Other

Registry information

Official study title

Vaginal Dinoprostone Versus Vaginal Misoprostol for Induction of Labour in Post-dated Pregnancy; a Randomized Controlled Study.

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 19, 2024
Registry last updated
Aug 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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