Intravaginal Isosorbide Mononitrate in Addition to Misoprostol Versus Misoprostol Only for Induction of Labor

NCT03523754 | Unknown Phase 1 DMC

• 1 other identifier: Vaginal nitric oxide donor
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluation of safety \& efficacy of nitric oxide donors such as intravaginal isosorbide mononitrate in addition to misoprostol Versus misoprostol only for the whole process of induction of labor.

Conditions

Induction of Labor

Keywords

Induction of labor; isosorbide mononitrate; misoprostol

Outcome Measures

Primary Outcomes (1)

• Decrease interval between drug use to delivery

  Adding Isosorbide Mononitrate to Misoprostol will decrease time required for induction of labor.

  6 months

Study Arms (2)

Misoprostol only

OTHER

This group will receive Intravaginal Misoprostol only.

Drug: Isosorbide Mononitrate 40 MG to study group

Isosorbide Mononitrate & Misoprostol

OTHER

This group will reveive intravaginal Isosorbide Mononitrate \& Misoprostol.

Drug: Isosorbide Mononitrate 40 MG to study group

Interventions

Isosorbide Mononitrate 40 MG to study group DRUG

Isosorbide Mononitrate will be added to Misoprostol, to determine their combined effect on cervical ripening \& induction of labor in study group

Also known as: Misoprostol 25Mcg

Isosorbide Mononitrate & Misoprostol; Misoprostol only

Eligibility Criteria

• Age: 20 Years - 35 Years
• Gender Eligibility Details: Pregnant women only.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Primigravida.
• From 20 to 30 years old.
• Singleton term (between 40 to 42 weeks of gestation).
• Good general condition with straightforward enthusiasm for the trial.

You may not qualify if:

• IUGR.
• Rupture of membranes.
• Favorable cervix (Bishop score : '8' or more)
• Cephalopelvic disproportion,fetal malpresentation.
• Antepartum hemorrhage, any abnormal placentation such as placenta previa, accreta, increta and percreta
• Uterine fibroid.
• Previous uterine major surgery such as : myomectomy, uterine repair caused by trauma and metroplasty for Mullerian anomalies.
• Any medical disorder such as : gestational diabetes, diabetes mellitus, hypertension, preeclampsia, renal \& hepatic dysfunction, coagulation disorders.

Sponsors & Collaborators

• Dina Yahia Mansour: lead

Study Sites (1)

Department of Obs & Gyn,Faculty of Medicine, Ain shams University.

Cairo, Egypt

Location

MeSH Terms

Interventions

isosorbide-5-mononitrate; Misoprostol

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Hesham M. Harb, MD

  Professor of Obstetrics & Gynecology

  PRINCIPAL INVESTIGATOR

• Dina Y. Mansour, MD

  Lecturer of Obstetrics & Gynecology

  PRINCIPAL INVESTIGATOR

• Yahia M. A. Mohamed ELBoukhary A.A., M.B.B.Ch

  Msc Student, Resident of Obstetrics & Gynecology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer of Obstetrics & Gynecology

Model Details: * Primigravida. * From 20 to 30 years old. * Singleton term (between 40 to 42 weeks of gestation). * Good general condition with straightforward enthusiasm for the trial.

Study Record Dates

• First Submitted: February 13, 2018
• First Posted: May 14, 2018
• Study Start: January 1, 2018
• Primary Completion: October 1, 2018
• Study Completion: November 30, 2018
• Last Updated: August 7, 2018

Record last verified: 2018-08

Locations

EG (1)