Oral Misoprostol Solution in Comparison to Vaginal Misoprostol in Induction of Labor

Not Applicable

• Conditions: Normal Vaginal Delivery
• Interventions: Drug: Misoprostol

• Registration Number: NCT03863392
• Lead Sponsor: Ain Shams University

Brief Summary

Induction of labour at term is a common obstetric intervention. Induction of labour is the artificial initiation of labour before its spontaneous onset for the purpose of delivery of the fetoplacental unit using mechanical or pharmacological methods.

To determine the effects of oral misoprostol solution compared to vaginal misoprostol in induction of labour.

Detailed Description

Patients recruited in the study will be primigravida at term with obstetric or medical indication for labour induction. These patients will be either booked attending antenatal clinic referred for induction of labour or emergency admissions in labour room.

A total of 100 women will be randomly selected for the study. I. Women will be given 20 ml (20 µg) of misoprostol solution orally every 2 hourly until adequate uterine contractions occurred (3 contractions per 10 min lasting 30-40 s).

II. The induction regimen included application of Vagiprost 25 µg tablet in the posterior fornix of the vagina every 4 h (up to 6 doses) after determination of the Bishop score.

Study Timeline

• Study Start: 2018-06-15
• Primary Completion: 2018-11-29
• Study First Submitted: 2019-02-18
• Status Verified: 2019-03
• Study First Submitted QC: 2019-03-02
• Last Update Submitted: 2019-03-02
• Study First Posted: 2019-03-05
• Last Update Posted: 2019-03-05
• Study Completion: 2019-03-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Primigravida or Primipara
• Pregnancy between 36 and 42 weeks of gestation.
• A live singleton fetus in cephalic presentation.
• No history of uterine surgery.
• Clinically adequate pelvis.
• Modified Bishop's score <5.
• Reactive Non stress test (NST) .

Exclusion Criteria

• •Known hypersensitivity or contraindications to oral misoprostol (uterine surgery).

  • Any antenatal medical complications.
  • A situation requiring LSCS (Maternal or Fetal) e.g:fetal distress
  • Non-reactive NST.
  • Patient's refusal to give consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
oral	Misoprostol	patients undergoing induction of labour using misoprostol oral solution
vaginal	Misoprostol	patients undergoing induction of labour using vaginal misoprostol

Primary Outcome Measures

Name	Time	Method
•Induction-delivery time	2 hours

Trial Locations

Locations (1)

Ainshams University; 🇪🇬 Cairo, Egypt