NCT03320187

Nitroglycerin Skin Patches for Facilitating Cervical Ripening: A Randomized Controlled Trial

NITROGLYCERINE SKIN PATCH VS PLACEBO PATCH FOR ENHANCING CERVICAL RIPENING IN LABOR INDUCTION: A RANDOMIZED CONTROLLED TRIAL

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Ain Shams Maternity Hospital · Academic / Other
• Sex: Female
• Age: 17 Years – 35 Years
• Healthy volunteers: Accepted

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 progression in the Bishop's score during 24 hour period.

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 combination with a well-established method of induction (Dinoprostone). The secondary objective of the study is to observe and report possible fetal and maternal side effects that may be associated. This will establish the safety and tolerability of NO donors. Research Question: Does the usage of Nitroglycerine skin patch enhance cervical ripening and facilitate induction of labor by Dinoprostone? Null hypothesis: Nitroglycerine skin patch does not cause advantage for ripening of the cervix nor facilitate the process of labor induction. Alternative hypothesis : Nitroglycerine skin patch has favorable effect in enhancing cervical ripening and the outcome of induction of labor.

Conditions

• Induction of Labor Affected Fetus / Newborn

Interventions

Type	Name	Description
DRUG	Nitroderm TTS	Transdermal nitroglycerin 5mg skin patch
DRUG	Dinoprostone	Dinoprostone 3gm vaginal tablet will be used as the study method of labor induction

Timeline

• Start date: 2016-12-01
• Primary completion: 2017-09-01
• Completion: 2017-09-21
• First posted: 2017-10-25
• Last updated: 2017-10-25

Locations

1 site across 1 country: Egypt