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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03523754
Recruitment Status : Active, not recruiting
First Posted : May 14, 2018
Last Update Posted : August 7, 2018
Sponsor:
Information provided by (Responsible Party):
Dina Yahia Mansour, Ain Shams University

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.

Condition or disease Intervention/treatment Phase
Induction of Labor Drug: Isosorbide Mononitrate 40 MG to study group Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
  • 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.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Intravaginal Isosorbide Mononitrate in Addition to Misoprostol Versus Misoprostol Only for Induction of Labor: A Randomized Controlled Trial
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : October 1, 2018
Estimated Study Completion Date : November 30, 2018

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Arm Intervention/treatment
Misoprostol only
This group will receive Intravaginal Misoprostol only.
Drug: Isosorbide Mononitrate 40 MG to study group
Isosorbide Mononitrate will be added to Misoprostol, to determine their combined effect on cervical ripening & induction of labor in study group
Other Name: Misoprostol 25Mcg

Isosorbide Mononitrate & Misoprostol
This group will reveive intravaginal Isosorbide Mononitrate & Misoprostol.
Drug: Isosorbide Mononitrate 40 MG to study group
Isosorbide Mononitrate will be added to Misoprostol, to determine their combined effect on cervical ripening & induction of labor in study group
Other Name: Misoprostol 25Mcg




Primary Outcome Measures :
  1. Decrease interval between drug use to delivery [ Time Frame: 6 months ]
    Adding Isosorbide Mononitrate to Misoprostol will decrease time required for induction of labor.



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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant women only.
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03523754


Locations
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Egypt
Department of Obs & Gyn,Faculty of Medicine, Ain shams University.
Cairo, Egypt
Sponsors and Collaborators
Dina Yahia Mansour
Investigators
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Principal Investigator: 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
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Responsible Party: Dina Yahia Mansour, Lecturer of Obstetrics & Gynecology, Ain Shams University
ClinicalTrials.gov Identifier: NCT03523754    
Other Study ID Numbers: Vaginal nitric oxide donor
First Posted: May 14, 2018    Key Record Dates
Last Update Posted: August 7, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: We will see if the study may add new to the scientific society or no, if the study is done, completed in a good environment and we are convinced that it may provide new information to others, we will share it.

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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
Keywords provided by Dina Yahia Mansour, Ain Shams University:
Induction of labor
isosorbide mononitrate
misoprostol
Additional relevant MeSH terms:
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Isosorbide
Isosorbide Dinitrate
Isosorbide-5-mononitrate
Misoprostol
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics
Diuretics, Osmotic
Diuretics
Natriuretic Agents
Vasodilator Agents
Nitric Oxide Donors
Molecular Mechanisms of Pharmacological Action