Isosorbide Mononitrate in Induction of Labour

NCT ID: NCT04482881

Last Updated: 2020-07-23

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

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-21

Study Completion Date

2020-09-25

Brief Summary

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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.

Detailed Description

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

Conditions

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Labor Fast

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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women receiving isosorbide mononitrates lower dose

women who will receive isosorbide mononitrates lower dose

Group Type ACTIVE_COMPARATOR

Isosorbide Mononitrate 40 MG

Intervention Type DRUG

giving women isosorbide mononitrate 40 MG

women receiving isosorbide mononitrates higher dose

women who will receive isosorbide mononitrates higher dose

Group Type ACTIVE_COMPARATOR

Isosorbide Mononitrate 60 MG

Intervention Type DRUG

giving women isosorbide mononitrate 60MG

Women receiving misoprostol

Women who will receive misoprostol

Group Type ACTIVE_COMPARATOR

Misoprostol

Intervention Type DRUG

Giving women misoprostol

Interventions

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Isosorbide Mononitrate 40 MG

giving women isosorbide mononitrate 40 MG

Intervention Type DRUG

Isosorbide Mononitrate 60 MG

giving women isosorbide mononitrate 60MG

Intervention Type DRUG

Misoprostol

Giving women misoprostol

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

42 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Suez Canal University

OTHER

Sponsor Role collaborator

Aljazeera Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mahmoud Alalfy, PhD

Role: PRINCIPAL_INVESTIGATOR

Algezeera hospitaland National Research Centre ,Egypt

Locations

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Algazeerah

Giza, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Mahmoud Alalfy

Role: CONTACT

01002611058

Facility Contacts

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Mahmoud Alalfy, master

Role: primary

+201002611058

Ahmed Elgazzar, M.D

Role: backup

+201014005959

Other Identifiers

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labour induction

Identifier Type: -

Identifier Source: org_study_id

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