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Nitric Oxide Donor Isosorbide Mono Nitrate for Cervical Ripening in Induction of Labor

Sponsor
ahmed nagy shaker ramadan (Other)
Overall Status
Completed
CT.gov ID
NCT03544606
Collaborator
(none)
140
Enrollment
1
Location
2
Arms
25.5
Actual Duration (Months)
5.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study aims to evaluate and assess the effectiveness and safety of vaginal administration of isosorbide mono nitrate (ISMN) to induce cervical ripening and shorten the interval time between induction and delivery in women undergoing induction of labor.

Research Hypothesis:

In women undergoing induction of labor, 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?

Condition or Disease Intervention/Treatment Phase
  • Drug: isosorbide mononitrate
  • Drug: Placebos
 Phase 3

Detailed Description

Patient and methods

Type of study:

Prospective double blinded randomized placebo-controlled clinical trial.

Study setting:

The study will be conducted at Cairo university in labor ward of Kasr El Ainy Hospital.

Study period:

approximately 6 months from June 2018 to December 2018.

Study population:

Patients will be recruited in this study those attending labor ward at kasr el ainy hospital for induction of labor after 39 weeks of gestation.

Study Design

Study Type:
Interventional
Actual Enrollment :
140 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
The patients will be divided into 2 groups Group 1: 70 women: patients were induced by Intra vaginal isosorbide mono nitrate (Effox 40 mg MINAPHARM) Group 2: 70 patients induced by placebo (pyridoxine) administered in the posterior vaginal fornix.The patients will be divided into 2 groups Group 1: 70 women: patients were induced by Intra vaginal isosorbide mono nitrate (Effox 40 mg MINAPHARM) Group 2: 70 patients induced by placebo (pyridoxine) administered in the posterior vaginal fornix.
Masking:
Single (Participant)
Masking Description:
To insure that everyone has the chance of participation, Randomization will be done using computer generated randomization sheet using statsdirect version 3. Double blinding will be done by one of the supervisors who will be the only one to know the key, thus the care provider and the patient will not know is it the drug or the placebo.
Primary Purpose:
Supportive Care
Official Title:
Nitric Oxide Donor Isosorbide Mono Nitrate for Cervical Ripening in Induction of Labor
Actual Study Start Date :
Jan 1, 2019
Actual Primary Completion Date :
Jan 1, 2021
Actual Study Completion Date :
Feb 15, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: isosorbide mononitrate group

isosorbide mononitrate group (study group) 70 patients are induced by Intra vaginal isosorbide mono nitrate at 36, 24 , 12 before induction

Drug: isosorbide mononitrate
isosorbide mononitrate group (study group) 70 patients are induced by Intra vaginal isosorbide mono nitrate at 36, 24 , 12 before induction
Other Names:
  • Effox 40 mg

    		•
    Placebo Comparator: placebos group

    70 patients induced by placebo (pyridoxine) placebo tablet of the same size and shape as the isosorbide mononitrate. administered in the posterior vaginal fornix at 36, 24 , 12 before induction

    Drug: Placebos
    70 patients induced by placebo (pyridoxine) administered in the posterior vaginal fornix.
    Other Names:
  • pyridoxine

    		•

    Outcome Measures

    Primary Outcome Measures

    1. admission-delivery interval [up to 24 hours]

      The time from initiation of cervical ripening till delivery of placenta

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Bishop score < or = 6

    • Singleton pregnancy

    • 39 or more completed weeks of gestation

    • Cephalic presentation

    • Average size of the fetus, and absence of pelvic contraction

    Exclusion Criteria:

    • any contraindication of labor induction listed in the American College of Obstetrics and Gynecology

    • Previous classical or inverted T-shaped or unknown uterine incision

    • Previous hysterotomy/ myomectomy of the uterine corpus involving entry of the uterine cavity or extensive myometrial dissection

    • Previous uterine rupture

    • Placenta previa or Vasa previa

    • Abnormal fetal lie

    • Active genital herpes infection

    • Major degree of cephalopelvic disproportion and contracted pelvis

    • Grand multipara

    • Malpresentation

    • Over distension of uterus like polyhydramnios or multiple pregnancy

    • Invasive carcinoma cervix

    • Pregnancy following repair for vesicovaginal fistula

    • Prelabour rupture of membranes

    • Previous Lower segment cesarean section.

    • Umbilical cord prolapse.

    • Established fetal distress

    • Heart disease complicating Pregnancy

    • Liver disease complicating Pregnancy

    • Anemia complicating Pregnancy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 faculty of medicine - Cairo university Cairo Kasr El Ainy Egypt 11562

    Sponsors and Collaborators

    • ahmed nagy shaker ramadan

    Investigators

    • Principal Investigator: waleed M el khyat, MD, Cairo University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    ahmed nagy shaker ramadan, director, Cairo University
    ClinicalTrials.gov Identifier:
    NCT03544606
    Other Study ID Numbers:
    • ISMN and labor induction
    First Posted:
    Jun 4, 2018
    Last Update Posted:
    Jul 26, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Pyridoxine
    Isosorbide
    Isosorbide Dinitrate
    Isosorbide-5-mononitrate

    Study Results

    No Results Posted as of Jul 26, 2022