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

Study Overview
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Brief Summary
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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?

Detailed Description
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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.

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

Conditions
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Induction of Labor Affected Fetus / Newborn

Intervention / Treatment
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* Drug: isosorbide mononitrate
* Drug: Placebos


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: isosorbide mononitrate group<br>isosorbide mononitrate group (study group) 70 patients are induced by Intra vaginal isosorbide mono nitrate at 36, 24 , 12 before induction | Drug: isosorbide mononitrate<br>* isosorbide mononitrate group (study group) 70 patients are induced by Intra vaginal isosorbide mono nitrate at 36, 24 , 12 before induction<br>* Other names: Effox 40 mg;|
| Placebo Comparator: placebos group<br>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<br>* 70 patients induced by placebo (pyridoxine) administered in the posterior vaginal fornix.<br>* Other names: pyridoxine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| admission-delivery interval | The time from initiation of cervical ripening till delivery of placenta | up to 24 hours |