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Titrated Oral Misoprostol Compared to Vaginal Dinoprostone for Induction of Labor

Information source: Ain Shams University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Medical Induction of Labor Affecting Fetus

Intervention: Misotac® Sigma Pharmaceutical Industries (Drug); Dinoprostone 3 mg (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Ain Shams University

Official(s) and/or principal investigator(s):
Amr H Yehia, MD, MRCOG, Study Director, Affiliation: Ain Shams University

Summary

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Induction delivery interval i.e. Time from start of medication till delivery

Secondary outcome:

Patients delivered vaginally within the first 24 hours

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

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

Maternal complications

Mode of delivery

Neonatal outcome

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.

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Female.

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.

Locations and Contacts

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

Starting date: September 2013
Last updated: February 17, 2014

Page last updated: August 23, 2015

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