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 hoursTime 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
|