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CompletedNCT03320187Updated Oct 25, 2017

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

A Phase 2/3 interventional study of Nitroderm TTS and Dinoprostone in Induction of Labor Affected Fetus / Newborn, sponsored by Ain Shams Maternity Hospital. Completed at 1 site in Egypt. Open to female participants aged 17 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-10-25.

Sponsored by Ain Shams Maternity Hospital · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
17 Years to 35 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Induction of Labor Affected Fetus / Newborn
03

Who can participate

Ages eligible
17 Years to 35 Years
Sexes eligible
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

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
04

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
100 participants (actual)

Study arms

  • 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 · Drug: Dinoprostone

  • 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

Interventions

  • DrugNitroderm TTS

    Transdermal nitroglycerin 5mg skin patch

    Also known as: Nitroglycerin transdermal patch

  • DrugDinoprostone

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

    Also known as: Prostaglandin E2 Analogue

05

What researchers measure

Primary outcomes

  1. Changes in the cervical Bishop's score

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

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

Secondary outcomes

  1. Development of any fetal or maternal side effects

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

    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

  2. Need of Oxytocin to initiate uterine contractions

    Whether the case managed to initiate uterine contractions without the need to induce them with oxytocin

    Time frame: from time of patch administration up to 24 hours

06

Study locations

1 site
  • AinShams University Maternity Hospital
    Cairo, Egypt
07

References and documents

Publications

  • 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. PubMed 15916656 ↗
  • 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. PubMed 16580291 ↗
  • 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. PubMed 28599068 ↗
  • 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. PubMed 21678363 ↗

Study documents

  • Study protocol · Apr 27, 2017
  • Informed consent form · Apr 27, 2017

Documents are hosted by the registry — open the source record to download them.

08

Registry details

Key details

Study ID
NCT03320187
Lead sponsor
Ain Shams Maternity Hospital
Collaborators
Dr. Ahmed S. Abd El-Hameed, Prof. Abdel-Megeeed I. Abdel- Megeeed
Responsible party
Peter Nagy Aziz Hanna (Resident Physician, Ain Shams Maternity Hospital) — Principal investigator
First posted
Oct 25, 2017
Start date
Dec 2016
Primary completion
Sep 2017
Completion
Sep 21, 2017
Last update
Oct 25, 2017

Study contacts

Prof. Abdel-Megeeed I. Abdel-Megeeed, Doctorate
study chair · Ain Shams University Maternity Hospital
Ahmed S. Abd El-Hamid, Doctorate
study director · Ain Shams University Maternity Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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