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

NCT ID: NCT03854383

Last Updated: 2019-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-03

Study Completion Date

2019-07-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Induction of Labor

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Misoprostol alone

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

Group Type SHAM_COMPARATOR

Misoprostol

Intervention Type DRUG

Used intravaginally to ripe the cevix in induction of labor

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

Group Type ACTIVE_COMPARATOR

Isosorbide mononitrate

Intervention Type DRUG

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

Misoprostol

Intervention Type DRUG

Used intravaginally to ripe the cevix in induction of labor

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Isosorbide mononitrate

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

Intervention Type DRUG

Misoprostol

Used intravaginally to ripe the cevix in induction of labor

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Abdelrahman Ali Fadel Youssef Mohamed

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Abdelrahman Ali Fadel Youssef Mohamed

Principal investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ain Shams maternity hospital

Cairo, , Egypt

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Saed Mousa, PhD

Role: primary

1008687700 ext. +20

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

600181

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.