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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Induction of Labor Affected Fetus / Newborn

Intervention / Treatment
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* Drug: Nitroderm TTS
* Drug: Dinoprostone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Singleton living full-term fetus. Cephalic presentation, Bishop score less than 5, Assuring fetal monitoring, The mother does not have PROM, Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>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) | Drug: Nitroderm TTS<br>* Transdermal nitroglycerin 5mg skin patch<br>* Other names: Nitroglycerin transdermal patch;Drug: Dinoprostone<br>* Dinoprostone 3gm vaginal tablet will be used as the study method of labor induction<br>* Other names: Prostaglandin E2 Analogue;|
| Placebo Comparator: Group B<br>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) | Drug: Dinoprostone<br>* Dinoprostone 3gm vaginal tablet will be used as the study method of labor induction<br>* Other names: Prostaglandin E2 Analogue;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the cervical Bishop's score | progression of Bishop's score recorded twice during the induction of labor | 6,12,18 and 24 hours after administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of any fetal or maternal side effects | associated headache and nausea (for instance) are well-recognized side effects during the induction of labor | 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 | from time of patch administration up to 24 hours |