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

Induction of Labor Affected Fetus / Newborn Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03320187
• Other study ID #: OG MS27042017
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 22, 2017
• Last updated: October 20, 2017
• Start date: December 2016
• Est. completion date: September 21, 2017

Study information

• Verified date: October 2017
• Source: Ain Shams Maternity Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 21, 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 17 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Induction of Labor Affected Fetus / Newborn

Intervention

Drug:
• Nitroderm TTS
Transdermal nitroglycerin 5mg skin patch
• Dinoprostone
Dinoprostone 3gm vaginal tablet will be used as the study method of labor induction

Locations

Country	Name	City	State
Egypt	AinShams University Maternity Hospital	Cairo

Sponsors (3)

Lead Sponsor	Collaborator
Ain Shams Maternity Hospital	Dr. Ahmed S. Abd El-Hameed, Prof. Abdel-Megeeed I. Abdel- Megeeed

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

Kelly AJ, Munson C, Minden L. Nitric oxide donors for cervical ripening and induction of labour. Cochrane Database Syst Rev. 2011 Jun 15;(6):CD006901. doi: 10.1002/14651858.CD006901.pub2. Review. Update in: Cochrane Database Syst Rev. 2016 Dec 05;12 :CD00 — View Citation

Nunes FP, Campos AP, Pedroso SR, Leite CF, Avillez TP, Rodrigues RD, Meirinho M. Intravaginal glyceryl trinitrate and dinoprostone for cervical ripening and induction of labor. Am J Obstet Gynecol. 2006 Apr;194(4):1022-6. — View Citation

Sharma Y, Kumar S, Mittal S, Misra R, Dadhwal V. Evaluation of glyceryl trinitrate, misoprostol, and prostaglandin E2 gel for preinduction cervical ripening in term pregnancy. J Obstet Gynaecol Res. 2005 Jun;31(3):210-5. — View Citation

West HM, Jozwiak M, Dodd JM. Methods of term labour induction for women with a previous caesarean section. Cochrane Database Syst Rev. 2017 Jun 9;6:CD009792. doi: 10.1002/14651858.CD009792.pub3. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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