Titrated Oral Misoprostol Compared to Vaginal Dinoprostone for Induction of Labor

NCT02036437 | Unknown Phase 3 DMC

• 1 other identifier: elkont1984
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

To test the safety and efficacy of titrated oral misoprostol compared to vaginal dinoprostone for labor induction.

Conditions

Medical Induction of Labor Affecting Fetus

Keywords

Induction of Labor; Misoprostol

Outcome Measures

Primary Outcomes (1)

• Induction delivery interval i.e. Time from start of medication till delivery

  24 hours

Secondary Outcomes (6)

• Patients delivered vaginally within the first 24 hours

  24 hours

• Time from start of labor augmentation by either misoprostol or Syntocinon (oxytocin) to active phase of labor

  12 hours

• Duration of 1st,2nd and 3rd stages of labor

  24 hours

• Maternal complications

  24 hours

• Mode of delivery

  24 hours

Study Arms (2)

Cases

EXPERIMENTAL

A dose of 20ug is required obtained by dissolving the 200ug tablet (Misotac® Sigma Pharmaceutical Industries) in 200 ml water (1ug per ml), the solution is shaked well before each administration. The solution will be orally administrated every two hours (max. 12 hrs) until adequate uterine contractions obtained (3 per 10 minutes each lasting 40-60 seconds) and then stopped. The initial dose will be increased to 40 ml (40ug) after two doses if there are no contractions. The timing and strength of contractions will be assessed by abdominal palpation. If the contractions are inadequate, augmentation of the active phase of labor will be attempted by hourly-titrated oral misoprostol (20 ml) +/- amniotomy.

Drug: Misotac® Sigma Pharmaceutical Industries

Control

ACTIVE COMPARATOR

Dinoprostone 3 mg (Dinoglandin® Alexandria Co. for Pharmaceuticals) will be inserted in the posterior vaginal fornix and repeated after six hours if contractions are inadequate (i.e. two doses maximum). If the contractions become inadequate, augmentation of the active phase of labor will be attempted by Syntocinon (oxytocin) infusion +/- amniotomy.

Drug: Dinoprostone 3 mg

Interventions

Misotac® Sigma Pharmaceutical Industries DRUG

The solution will be orally administrated every two hours (maximum 12 hours) until adequate uterine contractions obtained (3 per 10 minutes each lasting 40-60 seconds) and then stopped. The initial dose of 20 ml (20 ug) will be increased to 40 ml (40ug) after two doses if there are no contractions. The timing and strength of contractions will be assessed by abdominal palpation. If the contractions are inadequate, augmentation of the active phase of labor will be attempted by hourly-titrated oral misoprostol (20 ml) +/- amniotomy. If the uterine contractions are judged to be adequate, the next dose of misoprostol will be omitted.

Also known as: Misotac (Misoprostol)

Cases

Dinoprostone 3 mg DRUG

Dinoprostone 3 mg (Dinoglandin® Alexandria Co. for Pharmaceuticals) will be inserted in the posterior vaginal fornix and repeated after six hours if contractions are inadequate (i.e. two doses maximum). If the contractions become inadequate, augmentation of the active phase of labor will be attempted by Syntocinon (oxytocin) infusion +/- amniotomy.

Also known as: Dinoglandin®

Control

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Single vertex presentation.
• Gestational age \> 37 weeks calculated from last menstrual period or U/S scanning.
• Bishop score \<8 .
• Not in labor.
• Reassuring fetal heart rate (CTG for 20 min on the day of induction).
• Valid indication for Induction of labor.

You may not qualify if:

• Gestational age \<37 weeks.
• Patients with rupture of membranes.
• Previous uterine scar.
• Fetal malpresentation.
• Multiple pregnancy.
• Significant antepartum hemorrhage
• Uncontrolled DM.
• Severe Pre-eclampsia or Eclampsia
• If there are contraindications to receive the drugs, e.g. allergy, history of severe asthma,…..etc.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

New Maternity Hospital - Ain Shams university

Cairo, Cairo Governorate, 11666, Egypt

RECRUITING

MeSH Terms

Interventions

Misoprostol; Dinoprostone

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Prostaglandins E

Study Officials

• Amr H Yehia, MD, MRCOG

  Ain Shams University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer

Study Record Dates

• First Submitted: January 13, 2014
• First Posted: January 15, 2014
• Study Start: September 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2015
• Last Updated: February 19, 2014

Record last verified: 2014-02

Locations

EG (1)