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

Sponsor
Ain Shams Maternity Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03320187
Collaborator
Dr. Ahmed S. Abd El-Hameed (Other), Prof. Abdel-Megeeed I. Abdel- Megeeed (Other)
100
Enrollment
1
Location
2
Arms
9.7
Duration (Months)
10.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
NITROGLYCERINE SKIN PATCH VS PLACEBO PATCH FOR ENHANCING CERVICAL RIPENING IN LABOR INDUCTION: A RANDOMIZED CONTROLLED TRIAL
Study Start Date :
Dec 1, 2016
Actual Primary Completion Date :
Sep 1, 2017
Actual Study Completion Date :
Sep 21, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group A

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
Transdermal nitroglycerin 5mg skin patch
Other Names:
  • Nitroglycerin transdermal patch

    • Drug: Dinoprostone
    Dinoprostone 3gm vaginal tablet will be used as the study method of labor induction
    Other Names:
  • Prostaglandin E2 Analogue

    		•
    Placebo Comparator: Group B

    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
    Dinoprostone 3gm vaginal tablet will be used as the study method of labor induction
    Other Names:
  • Prostaglandin E2 Analogue

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Changes in the cervical Bishop's score [6,12,18 and 24 hours after administration]

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

    Secondary Outcome Measures

    1. Development of any fetal or maternal side effects [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 [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    17 Years to 35 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 AinShams University Maternity Hospital Cairo Egypt

    Sponsors and Collaborators

    • Ain Shams Maternity Hospital
    • Dr. Ahmed S. Abd El-Hameed
    • Prof. Abdel-Megeeed I. Abdel- Megeeed

    Investigators

    • Study Chair: Prof. Abdel-Megeeed I. Abdel-Megeeed, Doctorate, Ain Shams University Maternity Hospital
    • Study Director: Ahmed S. Abd El-Hamid, Doctorate, Ain Shams University Maternity Hospital

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Peter Nagy Aziz Hanna, Resident Physician, Ain Shams Maternity Hospital
    ClinicalTrials.gov Identifier:
    NCT03320187
    Other Study ID Numbers:
    • OG MS27042017
    First Posted:
    Oct 25, 2017
    Last Update Posted:
    Oct 25, 2017
    Last Verified:
    Oct 1, 2017
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Nitroglycerin
    Dinoprostone

    Study Results

    No Results Posted as of Oct 25, 2017