Skip to main content
OpenTrials
Completed

NCT Number: NCT03320187

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Induction of Labor Affected Fetus / Newborn

Age range

17 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

AinShams University Maternity Hospital

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nitroderm TTS

Drug

Transdermal nitroglycerin 5mg skin patch

Other names: Nitroglycerin transdermal patch

Dinoprostone

Drug

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

Other names: Prostaglandin E2 Analogue

Primary outcomes

  1. Changes in the cervical Bishop's score

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

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

Secondary outcomes

  1. Development of any fetal or maternal side effects

    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

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

  2. Need of Oxytocin to initiate uterine contractions

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Ain Shams Maternity Hospital

Other

Collaborators

  • Dr. Ahmed S. Abd El-Hameed
  • Prof. Abdel-Megeeed I. Abdel- Megeeed

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 25, 2017
Registry last updated
Oct 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.