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

Phase 3CompletedNCT03320187

Ain Shams Maternity Hospital100 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

100

Conditions

Induction of Labor Affected Fetus / Newborn

Interventions

Nitroderm TTSDRUG

Transdermal nitroglycerin 5mg skin patch

DinoprostoneDRUG

Dinoprostone 3gm vaginal tablet will be used as the study method of labor induction

Eligibility

Sex: FEMALEMin age: 17 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

AinShams University Maternity Hospital

Cairo, Egypt

Outcomes

Primary Outcomes

Changes in the cervical Bishop's score

progression of Bishop's score recorded twice during the induction of labor

Time frame: 6,12,18 and 24 hours after administration

Secondary Outcomes

Development of any fetal or maternal side effects

associated headache and nausea (for instance) are well-recognized side effects during the induction of labor

Time frame: From the time of administration of medication, cases will be assessed every 6 hours till 24 hours after delivery at time of discharge

Need of Oxytocin to initiate uterine contractions

Whether the case managed to initiate uterine contractions without the need to induce them with oxytocin

Time frame: from time of patch administration up to 24 hours

Data from ClinicalTrials.gov

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