Isosorbide Mononitrate in Induction of Labour

Overview

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.

Full Title of Study: “Isosorbide Mononitrate and Misoprostol in Induction of Labour”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: September 20, 2020

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.

Interventions

  • Drug: Isosorbide Mononitrate 40 MG
    • giving women isosorbide mononitrate 40 MG
  • Drug: Isosorbide Mononitrate 60 MG
    • giving women isosorbide mononitrate 60MG
  • Drug: Misoprostol
    • Giving women misoprostol

Arms, Groups and Cohorts

  • Active Comparator: women receiving isosorbide mononitrates lower dose
    • women who will receive isosorbide mononitrates lower dose
  • Active Comparator: women receiving isosorbide mononitrates higher dose
    • women who will receive isosorbide mononitrates higher dose
  • Active Comparator: Women receiving misoprostol
    • Women who will receive misoprostol

Clinical Trial Outcome Measures

Primary Measures

  • 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

Participating in This Clinical Trial

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.

Gender Eligibility: Female

pregnant women

Minimum Age: 18 Years

Maximum Age: 42 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Aljazeera Hospital
  • Collaborator
    • Suez Canal University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Mahmoud Alalfy, PhD, Principal Investigator, Algezeera hospitaland National Research Centre ,Egypt
  • Overall Contact(s)
    • Mahmoud Alalfy, 01002611058, mahmoudalalfy@ymail.com

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