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

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.

Study Overview

• Status: Unknown
• Conditions: Normal Vaginal Delivery
• Intervention / Treatment: Drug: Misoprostol

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Ainshams university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: oral; patients undergoing induction of labour using misoprostol oral solution	Drug: Misoprostol; induction of labor
Experimental: vaginal; patients undergoing induction of labour using vaginal misoprostol	Drug: Misoprostol; induction of labor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
•Induction-delivery time	2 hours

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2018
• Primary Completion (Actual): November 29, 2018
• Study Completion (Anticipated): March 15, 2019

Study Registration Dates

• First Submitted: February 18, 2019
• First Submitted That Met QC Criteria: March 2, 2019
• First Posted (Actual): March 5, 2019

Study Record Updates

• Last Update Posted (Actual): March 5, 2019
• Last Update Submitted That Met QC Criteria: March 2, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Gastrointestinal Agents; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Misoprostol
• Other Study ID Numbers: test123

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No