Titrated Oral Misoprostol Compared to Vaginal Dinoprostone for Induction of Labor

NCT ID: NCT02036437

Last Updated: 2014-02-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2015-09-30

Brief Summary

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

Detailed Description

• There are many indications for induction of labor in the obstetric practice, of which prolonged gestational age stands as the most common indication. It is well recognized that with an unripe cervix, induction may be difficult and often unsuccessful. The use of an agent to ripen the cervix prior to induction is acceptable in the modern practice.
• Misoprostol, a prostaglandin E1 analogue, is the most interesting alternative to Dinoprostone because of its effectiveness, low cost, and temperature stability. It ripens the cervix by inducing regular uterine contractions. However, it is associated with several adverse effects especially uterine hyperstimulation, which is painful and may result in fetal compromise.
• Testing the efficacy and safety of titrated oral misoprostol versus vaginal dinoprostone may develop a new safe and effective method for labor induction.

Conditions

Medical Induction of Labor Affecting Fetus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cases

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.

Group Type: EXPERIMENTAL

Misotac® Sigma Pharmaceutical Industries

Intervention Type: 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.

Control

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.

Group Type: ACTIVE_COMPARATOR

Dinoprostone 3 mg

Intervention Type: 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.

Interventions

Misotac® Sigma Pharmaceutical Industries

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.

Intervention Type: DRUG

Dinoprostone 3 mg

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.

Intervention Type: DRUG

Other Intervention Names

Misotac (Misoprostol); Dinoglandin®

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Sherif Essam

assistant lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amr H Yehia, MD, MRCOG

Role: STUDY_DIRECTOR

Ain Shams University

Locations

New Maternity Hospital - Ain Shams university

Cairo, Cairo Governorate, Egypt

Site Status: RECRUITING

Countries

Egypt

Facility Contacts

Amr H Yehia, MD,MRCOG

Role: primary

am_helmy77@hotmail.com

01227900014 ext. 002

Other Identifiers

elkont1984

Identifier Type: -

Identifier Source: org_study_id