Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Nitric Oxide Donor Isosorbide Mono Nitrate for Induction of Labor With Pre-labor Rupture of Membranes

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03665779
Recruitment Status : Recruiting
First Posted : September 11, 2018
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
ahmed nagy shaker ramadan, Cairo University

Brief Summary:

The study aims to evaluate and assess the effectiveness and safety of vaginal administration of isosorbide mono nitrate (IMN) to induce cervical ripening and shorten the interval time between induction and delivery in women undergoing induction of labor at term or post term with prelabor rupture of membrane.

Research Hypothesis:

In women undergoing induction of labor at term or post term with pre-labor rupture of membrane, vaginal administration of isosorbide mono nitrate (IMN) is effective to induce cervical ripening and shorten the interval time between induction and delivery.

Research Questions:

Does vaginal administration of isosorbide mono nitrate (IMN) induce cervical ripening and shorten the interval time between induction and delivery in women undergoing induction of labor at term or post term with prelabor rupture of membrane?


Condition or disease Intervention/treatment Phase
Induction of Labor Affected Fetus / Newborn Rupture of Membranes Prior to Onset of Labor Drug: isosorbide mononitrate Drug: Placebo Phase 3

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

The patients will be divided into 2 groups:

Group 1:

70 pregnant females, induction of labor will be done by Intra vaginal isosorbide mono nitrate (Effox 40 mg MINAPHARM)

Group 2:

70 pregnant females, induction will be done by placebo (pyridoxine) administered in the posterior vaginal fornix.

Masking: Double (Participant, Investigator)
Masking Description: A double-blind study is one in which neither the participants nor the experimenters know who is receiving a particular treatment. This procedure is utilized to prevent bias in research results. Double-blind studies are particularly useful for preventing bias due to demand characteristics or the placebo effect. In a double-blind study, the investigators who interact with the participants would not know who was receiving the actual drug and who was receiving a placebo.
Primary Purpose: Supportive Care
Official Title: Nitric Oxide Donor Isosorbide Mono Nitrate for Cervical Ripening in Induction of Labor in Term or Post Term Pregnancies in Females With Pre-labor Rupture of Membranes
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : May 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Arm Intervention/treatment
Experimental: isosorbide mono-nitrate group
70 pregnant females, induction of labor will be done by Intra vaginal isosorbide mono nitrate (Effox 40 mg MINAPHARM)
Drug: isosorbide mononitrate
70 pregnant females, induction of labor will be done by Intra vaginal isosorbide mono nitrate (Effox 40 mg MINAPHARM) repeated every 4 hours maximum 4 times
Other Name: Effox

Placebo Comparator: placebo group
70 pregnant females, induction will be done by placebo (pyridoxine) administered in the posterior vaginal fornix.
Drug: Placebo
70 pregnant females, induction will be done by placebo (pyridoxine) administered in the posterior vaginal fornix.repeated every 4 hours maximum 4 times
Other Name: pyridoxine




Primary Outcome Measures :
  1. induction of labor [ Time Frame: up to 24 hours ]
    the effectiveness and safety of vaginal administration of isosorbide mono nitrate (IMN) to induce cervical ripening for induction of labor at term or post term pregnancy with prelabor rupture of membrane regarding (Induction to onset of labor time, Induction to delivery time)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Singleton pregnancy.
  • Cephalic presentation.
  • Bishop score < or = 6.
  • Average size of the fetus.
  • Adequate pelvic dimensions.
  • Prelabour rupture of membranes.
  • Term or post-term pregnancies with an indication for labor induction either maternal or fetal.

Exclusion Criteria:

  • Previous uterine scar (e.g. caesarian delivery or unknown uterine incision , previous hysterotomy or myomectomy of the uterine corpus involving entry of the uterine cavity or extensive myometrial dissection, previous uterine rupture)
  • Patients with regular uterine contractions.
  • Malpresentation.
  • Multifetal gesta1tion.
  • Established fetal distress ( e.g. thick meconium stained liguor or non reassuring CTG changes)
  • Indication for CS, e.g. Major degree of cephalopelvic disproportion and fetal macrosomia.
  • Placenta previa or vasa previa.
  • Active genital herpes infection.
  • Severe maternal illness (e.g. severe preeclampsia).
  • Laboratory and clinical sign of chorioamnionitis.

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): NCT03665779


Locations
Layout table for location information
Egypt
faculty of medicine - Cairo university Recruiting
Cairo, Kasr El Ainy, Egypt, 11562
Contact: mohamed T aneis, MD    202 23653269    viced.research@cu.edu.eg   
Principal Investigator: waleed M El khyat, MD         
Sponsors and Collaborators
ahmed nagy shaker ramadan
Investigators
Layout table for investigator information
Principal Investigator: waleed M EL Khyat, MD university

Layout table for additonal information
Responsible Party: ahmed nagy shaker ramadan, resident of obstetrics and gynecology, Cairo University
ClinicalTrials.gov Identifier: NCT03665779     History of Changes
Other Study ID Numbers: AN1988
First Posted: September 11, 2018    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Rupture
Fetal Membranes, Premature Rupture
Wounds and Injuries
Obstetric Labor Complications
Pregnancy Complications
Nitric Oxide
Isosorbide Dinitrate
Isosorbide-5-mononitrate
Isosorbide
Nitric Oxide Donors
Pyridoxine
Pyridoxal
Vitamin B 6
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Gasotransmitters
Protective Agents
Diuretics, Osmotic
Diuretics
Natriuretic Agents