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Status unknownNCT03854383Updated Mar 12, 2019

Using Isosorbide Mononitrate in Reducing Time in Induction of Labor in Post Date Women

A Phase 2 interventional study of Isosorbide mononitrate and Misoprostol in Induction of Labor, sponsored by Abdelrahman Ali Fadel Youssef Mohamed. Status unknown at 1 site in Egypt. Open to female participants aged 20 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-12.

Sponsored by Abdelrahman Ali Fadel Youssef Mohamed · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
20 Years to 35 Years
Sex
Female
01

Study summary

We will compare between using isosorbide mononitrate together with misoprostol versus the misoprostol alone in induction of labor in postdate women

02

Conditions studied

  • Induction of Labor
03

In context

Lead sponsor

This is the only study on the registry with Abdelrahman Ali Fadel Youssef Mohamed as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • age (20-35 yrs)
  • single fetus
  • gestational age > 40weeks
  • not in labor
  • bishop score \< 7
  • no medical disorder

Exclusion criteria

Exclusion Criteria:

  • Gestational age ≤40 weeks
  • patient with a ripe cervix
  • rupture of membranes
  • suspected chorioamnionitis
  • placenta previa
  • history of major uterine surgery
  • hypertonic uterine pattern
  • contraindicated to receive PG
  • fetal malpresentation
  • multiple pregnancy
  • intrauterine growth retardation
  • women with any general medical disorder
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • Sham comparator
    Misoprostol alone

    Enrolled women will receive 25 πg of misoprostol which will be placed intravaginally 4 hourly, maximum up to 5 doses

    Drug: Misoprostol

  • Active comparator
    Isosorbide mononitrate with misoprostol

    Enrolled women will receive 25 πg of misoprostol together with 40 mg isosorbide mononitrate which will be placed intravaginally 4 hourly, maximum up to 5 doses

    Drug: Isosorbide mononitrate · Drug: Misoprostol

Interventions

  • DrugIsosorbide mononitrate

    Administration of isosorbide mononitrate vaginaly together with misoprostol in induction of labor in postdate women

  • DrugMisoprostol

    Used intravaginally to ripe the cevix in induction of labor

06

What researchers measure

Primary outcomes

  1. The duration of induction to active phase interval

    Measure the time between the beginning of the induction to enter the active phase of labor

    Time frame: 12 weeks

07

Study locations

1 of 1 sites recruiting
  • Ain Shams maternity hospital
    Cairo, 11517, Egypt
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 12, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03854383
Lead sponsor
Abdelrahman Ali Fadel Youssef Mohamed
Responsible party
Abdelrahman Ali Fadel Youssef Mohamed (Principal investigator, Ain Shams University) — Sponsor-investigator
First posted
Feb 26, 2019
Start date
Mar 3, 2019
Primary completion
May 1, 2019 (estimated)
Completion
Jul 1, 2019 (estimated)
Last update
Mar 12, 2019

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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