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

Efficacy of Intravaginal Administration of Isosorbide Mononitrate Together With Misoprostol Versus Misoprostol Alone in Induction of Labor in Postdate Women

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

Study Overview

• Status: Unknown
• Conditions: Induction of Labor
• Intervention / Treatment: Drug: Misoprostol; Drug: Isosorbide mononitrate

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11517
    • Recruiting
    • Ain Shams Maternity Hospital
    • Contact: Saed Mousa, PhD; Phone Number: +20 1008687700; Email: drsaedmousa1@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Used intravaginally to ripe the cevix in induction of labor
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: Misoprostol; Used intravaginally to ripe the cevix in induction of labor; Drug: Isosorbide mononitrate; Administration of isosorbide mononitrate vaginaly together with misoprostol in induction of labor in postdate women

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The duration of induction to active phase interval	Measure the time between the beginning of the induction to enter the active phase of labor	12 weeks

Collaborators and Investigators

• Sponsor: Abdelrahman Ali Fadel Youssef Mohamed

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2019
• Primary Completion (Anticipated): May 1, 2019
• Study Completion (Anticipated): July 1, 2019

Study Registration Dates

• First Submitted: February 20, 2019
• First Submitted That Met QC Criteria: February 23, 2019
• First Posted (Actual): February 26, 2019

Study Record Updates

• Last Update Posted (Actual): March 12, 2019
• Last Update Submitted That Met QC Criteria: March 9, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Gastrointestinal Agents; Natriuretic Agents; Diuretics, Osmotic; Diuretics; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Nitric Oxide Donors; Misoprostol; Isosorbide; Isosorbide Dinitrate; Isosorbide-5-mononitrate
• Other Study ID Numbers: 600181

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No