Status:
COMPLETED
Nitroglycerin Skin Patches for Facilitating Cervical Ripening: A Randomized Controlled Trial
Lead Sponsor:
Ain Shams Maternity Hospital
Collaborating Sponsors:
Dr. Ahmed S. Abd El-Hameed
Prof. Abdel-Megeeed I. Abdel- Megeeed
Conditions:
Induction of Labor Affected Fetus / Newborn
Eligibility:
FEMALE
17-35 years
Phase:
PHASE2
PHASE3
Brief Summary
This study aims to establish the efficacy of transdermal glyceryl trinitrate as a nitric oxide donor in addition to dinoprostone for induction of cervical ripening in the third trimester through progr...
Detailed Description
Objectives: The primary outcome of the study is to compare the changes occurring to the cervix through the progression in the Bishop's score between NO donor (nitroglycerine patch) vs placebo; in comb...
Eligibility Criteria
Inclusion
- Singleton living full-term fetus.
- Cephalic presentation,
- Bishop score less than 5,
- Assuring fetal monitoring,
- The mother does not have PROM,
Exclusion
- Expected fetal anomaly (eg. by ultrasound),
- Abnormal presentation,
- Multiple pregnancy,
- Non assuring fetal CTG,
- Fetus more than 90th percentile of expected weight,
- Previous maternal obstructed labor or previous cesarean section,
- Maternal obstetric or medical complication,
- Structural anomaly of the uterus
Key Trial Info
Start Date :
December 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 21 2017
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03320187
Start Date
December 1 2016
End Date
September 21 2017
Last Update
October 25 2017
Active Locations (1)
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1
AinShams University Maternity Hospital
Cairo, Egypt