NCT03320187

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2016

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 21, 2017

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 22, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 25, 2017

Completed
Last Updated

October 25, 2017

Status Verified

October 1, 2017

Enrollment Period

9 months

First QC Date

September 22, 2017

Last Update Submit

October 20, 2017

Conditions

Induction of Labor Affected Fetus / Newborn

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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

  • Need of Oxytocin to initiate uterine contractions

    from time of patch administration up to 24 hours

Study Arms (2)

Group A

EXPERIMENTAL

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 TTSDrug: Dinoprostone

Group B

PLACEBO COMPARATOR

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

Nitroderm TTSDRUG

Transdermal nitroglycerin 5mg skin patch

Also known as: Nitroglycerin transdermal patch
Group A
DinoprostoneDRUG

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

Also known as: Prostaglandin E2 Analogue
Group AGroup B

Eligibility Criteria

Age17 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Singleton living full-term fetus.
  • Cephalic presentation,
  • Bishop score less than 5,
  • Assuring fetal monitoring,
  • The mother does not have PROM,

You may not qualify if:

  • Expected fetal anomaly (eg. by ultrasound),
  • Abnormal presentation,
  • Multiple pregnancy,
  • Non assuring fetal CTG,
  • Fetus more than 90th percentile of expected weight,
  • Previous maternal obstructed labor or previous cesarean section,
  • Maternal obstetric or medical complication,
  • Structural anomaly of the uterus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AinShams University Maternity Hospital

Cairo, Egypt

Location

Related Publications (4)

  • 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.

    PMID: 15916656RESULT

  • 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.

    PMID: 16580291RESULT

  • 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.

    PMID: 28599068RESULT

  • 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.

    PMID: 21678363RESULT

MeSH Terms

Interventions

NitroglycerinDinoprostone

Intervention Hierarchy (Ancestors)

Nitro CompoundsOrganic ChemicalsProstaglandins EProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Prof. Abdel-Megeeed I. Abdel-Megeeed, Doctorate

    Ain Shams University Maternity Hospital

    STUDY CHAIR

  • Ahmed S. Abd El-Hamid, Doctorate

    Ain Shams University Maternity Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Physician

Study Record Dates

First Submitted

September 22, 2017

First Posted

October 25, 2017

Study Start

December 1, 2016

Primary Completion

September 1, 2017

Study Completion

September 21, 2017

Last Updated

October 25, 2017

Record last verified: 2017-10

Locations

EG(1)