Isosorbide Mononitrate in Induction of Labour

July 19, 2020 updated by: Aljazeera Hospital

Isosorbide Mononitrate and Misoprostol in Induction of Labour

Induction of labor is defined as the process of artificially initiating uterine contractions, prior to their spontaneous onset, with progressive effacement and dilatation of the cervix and ultimately, the delivery of the baby.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

There are many indications for induction of labor in the obstetric practice, of which prolonged gestational age stands as the most common cause.

Study Type

Interventional

Enrollment (Anticipated)

130

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Giza, Egypt
        • Algazeerah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 42 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Single vertex presentation. 2. Gestational age > 37weeks calculated from last menstrual period or U/S scanning.

Exclusion Criteria:

  1. Patients with rupture of membranes.
  2. Previous uterine scar.
  3. Fetal malpresentation.
  4. Multiple pregnancies.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: women receiving isosorbide mononitrates lower dose
women who will receive isosorbide mononitrates lower dose
Drug: Isosorbide Mononitrate 40 MG
giving women isosorbide mononitrate 40 MG
ACTIVE_COMPARATOR: women receiving isosorbide mononitrates higher dose
women who will receive isosorbide mononitrates higher dose
Drug: Isosorbide Mononitrate 60 MG
giving women isosorbide mononitrate 60MG
ACTIVE_COMPARATOR: Women receiving misoprostol
Women who will receive misoprostol
Drug: Misoprostol
Giving women misoprostol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the number of women who will be reach active phase within 24 hours
Time Frame: 24 hours
how many women will reach active phase within 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aljazeera Hospital

Collaborators

Suez Canal University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

July 21, 2020

Primary Completion (ANTICIPATED)

September 20, 2020

Study Completion (ANTICIPATED)

September 25, 2020

Study Registration Dates

First Submitted

July 19, 2020

First Submitted That Met QC Criteria

July 19, 2020

First Posted (ACTUAL)

July 23, 2020

Study Record Updates

Last Update Posted (ACTUAL)

July 23, 2020

Last Update Submitted That Met QC Criteria

July 19, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • labour induction

Drug and device information, study documents

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.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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