Titrated Oral Misoprostol Compared to Vaginal Dinoprostone for Induction of Labor

Titrated Oral Misoprostol Compared to Vaginal Dinoprostone for Induction of Labor: a Randomized Control Trial

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

Study Overview

• Status: Unknown
• Conditions: Medical Induction of Labor Affecting Fetus
• Intervention / Treatment: Drug: Misotac® Sigma Pharmaceutical Industries; Drug: Dinoprostone 3 mg

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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11666
    • Recruiting
    • New Maternity Hospital - Ain Shams university
    • Contact: Amr H Yehia, MD,MRCOG; Phone Number: 002 01227900014; Email: am_helmy77@hotmail.com
    • Principal Investigator: Sherif E Daoud, MB.Bch. Msc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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.; Other Names: Misotac (Misoprostol)
Active Comparator: 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.	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.; Other Names: Dinoglandin®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Induction delivery interval i.e. Time from start of medication till delivery	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	uterine hyperstimulation, postpartum hemorrhage, uterine rupture, sepsis, shivering, headache, nausea, vomiting, and retained placenta.	24 hours
Mode of delivery	Vaginal , instrumental or Cesarean section	24 hours
Neonatal outcome	Apgar score at 1 and 5 minutes and Neonatal Intensive Care Unit admission	24 hours

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Director: Amr H Yehia, MD, MRCOG, Ain shams university

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Anticipated): September 1, 2014
• Study Completion (Anticipated): September 1, 2015

Study Registration Dates

• First Submitted: January 13, 2014
• First Submitted That Met QC Criteria: January 13, 2014
• First Posted (Estimate): January 15, 2014

Study Record Updates

• Last Update Posted (Estimate): February 19, 2014
• Last Update Submitted That Met QC Criteria: February 17, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: Misoprostol; Induction of Labor
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Gastrointestinal Agents; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Misoprostol; Dinoprostone
• Other Study ID Numbers: elkont1984