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

Phase 2

Completed

• Conditions: Induction of Labor Affected Fetus / Newborn
• Interventions: Drug: Nitroderm TTS; Drug: Dinoprostone

• Registration Number: NCT03320187
• Lead Sponsor: Ain Shams Maternity Hospital

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 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.

Study Timeline

• Study Start: 2016-12
• Primary Completion: 2017-09
• Study Completion: 2017-09-21
• Study First Submitted: 2017-09-22
• Status Verified: 2017-10
• Study First Submitted QC: 2017-10-20
• Last Update Submitted: 2017-10-20
• Study First Posted: 2017-10-25
• Last Update Posted: 2017-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

1. Singleton living full-term fetus.
2. Cephalic presentation,
3. Bishop score less than 5,
4. Assuring fetal monitoring,
5. The mother does not have PROM,

Exclusion Criteria

1. Expected fetal anomaly (eg. by ultrasound),
2. Abnormal presentation,
3. Multiple pregnancy,
4. Non assuring fetal CTG,
5. Fetus more than 90th percentile of expected weight,
6. Previous maternal obstructed labor or previous cesarean section,
7. Maternal obstetric or medical complication,
8. Structural anomaly of the uterus

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Nitroderm TTS	Nitroglycerin as Nitroderm TTSⓇ skin patch is applied on the upper chest alongside with regular induction of labor protocol ( 3gm/ 8 hours DinoprostoneⓇ vaginal tablet in the posterior vaginal fornix)
Group A	Dinoprostone	Nitroglycerin as Nitroderm TTSⓇ skin patch is applied on the upper chest alongside with regular induction of labor protocol ( 3gm/ 8 hours DinoprostoneⓇ vaginal tablet in the posterior vaginal fornix)
Group B	Dinoprostone	Placebo patch is applied on the upper chest alongside with regular induction of labour protocol ( 3gm/ 8 hours DinoprostoneⓇ vaginal tablet in the posterior vaginal fornix)

Primary Outcome Measures

Name	Time	Method
Changes in the cervical Bishop's score	6,12,18 and 24 hours after administration	progression of Bishop's score recorded twice during the induction of labor

Secondary Outcome Measures

Name	Time	Method
Development of any fetal or maternal side effects	From the time of administration of medication, cases will be assessed every 6 hours till 24 hours after delivery at time of discharge	associated headache and nausea (for instance) are well-recognized side effects during the induction of labor
Need of Oxytocin to initiate uterine contractions	from time of patch administration up to 24 hours	Whether the case managed to initiate uterine contractions without the need to induce them with oxytocin

Trial Locations

Locations (1)

AinShams University Maternity Hospital; 🇪🇬 Cairo, Egypt