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

Induction of Labor Affected Fetus / Newborn Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03544606
• Other study ID #: ISMN and labor induction
• Status: Completed
• Phase: Phase 3
• Start date: January 1, 2019
• Est. completion date: February 15, 2021

Study information

• Verified date: July 2022
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: February 15, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Induction of Labor Affected Fetus / Newborn

Intervention

Drug:
• isosorbide mononitrate
isosorbide mononitrate group (study group) 70 patients are induced by Intra vaginal isosorbide mono nitrate at 36, 24 , 12 before induction
• Placebos
70 patients induced by placebo (pyridoxine) administered in the posterior vaginal fornix.

Locations

Country	Name	City	State
Egypt	faculty of medicine - Cairo university	Cairo	Kasr El Ainy

Sponsors (1)

Lead Sponsor	Collaborator
ahmed nagy shaker ramadan

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	admission-delivery interval	The time from initiation of cervical ripening till delivery of placenta	up to 24 hours