Clinical trial NCT03320187: Nitroglycerin Skin Patches for Facilitating Cervical Ripening: A Randomized Controlled Trial
Official title: NITROGLYCERINE SKIN PATCH VS PLACEBO PATCH FOR ENHANCING CERVICAL RIPENING IN LABOR INDUCTION: A RANDOMIZED CONTROLLED TRIAL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Induction of Labor Affected Fetus / Newborn
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
Collaborators: name: Dr. Ahmed S. Abd El-Hameed
name: Prof. Abdel-Megeeed I. Abdel- Megeeed
First posted: 2017-10-25
Enrollment: 100
Sex: FEMALE
Minimum age (years): 17
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in the cervical Bishop's score
timeFrame: 6,12,18 and 24 hours after administration
Secondary outcomes:
measure: Development of any fetal or maternal side effects
timeFrame: From the time of administration of medication, cases will be assessed every 6 hours till 24 hours after delivery at time of discharge
measure: Need of Oxytocin to initiate uterine contractions
timeFrame: from time of patch administration up to 24 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: AinShams University Maternity Hospital
Study officials:
affiliation: Ain Shams University Maternity Hospital
name: Prof. Abdel-Megeeed I. Abdel-Megeeed, Doctorate
role: STUDY_CHAIR
affiliation: Ain Shams University Maternity Hospital
name: Ahmed S. Abd El-Hamid, Doctorate
role: STUDY_DIRECTOR
References:
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. doi: 10.1111/j.1447-0756.2005.00271.x.
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. doi: 10.1016/j.ajog.2005.10.814.
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(6):CD009792. doi: 10.1002/14651858.CD009792.pub3.
citation: 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.