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

Ain Shams Maternity Hospital

Status and phase: Completed; Phase 3; Phase 2

Conditions: Induction of Labor Affected Fetus / Newborn

Treatments: Drug: Dinoprostone; Drug: Nitroderm TTS

Study type: Interventional

Funder types: Other

Identifiers

NCT03320187

OG MS27042017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: Female

Ages: 17 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups, including a placebo group

Group A

Experimental group

Description:

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)

Treatment:

Drug: Nitroderm TTS

Drug: Dinoprostone

Group B

Placebo Comparator group

Description:

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)

Treatment:

Drug: Dinoprostone