- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02036437
Titrated Oral Misoprostol Compared to Vaginal Dinoprostone for Induction of Labor
February 17, 2014 updated by: Sherif Essam, Ain Shams University
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
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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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
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Principal Investigator:
- Sherif E Daoud, MB.Bch. Msc
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
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.
|
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:
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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.
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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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Induction delivery interval i.e. Time from start of medication till delivery
Time Frame: 24 hours
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patients delivered vaginally within the first 24 hours
Time Frame: 24 hours
|
24 hours
|
|
Time from start of labor augmentation by either misoprostol or Syntocinon (oxytocin) to active phase of labor
Time Frame: 12 hours
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12 hours
|
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Duration of 1st,2nd and 3rd stages of labor
Time Frame: 24 hours
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24 hours
|
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Maternal complications
Time Frame: 24 hours
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uterine hyperstimulation, postpartum hemorrhage, uterine rupture, sepsis, shivering, headache, nausea, vomiting, and retained placenta.
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24 hours
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Mode of delivery
Time Frame: 24 hours
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Vaginal , instrumental or Cesarean section
|
24 hours
|
Neonatal outcome
Time Frame: 24 hours
|
Apgar score at 1 and 5 minutes and Neonatal Intensive Care Unit admission
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Amr H Yehia, MD, MRCOG, Ain Shams University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- elkont1984
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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