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

NCT03665779 | Completed Phase 3

• 1 other identifier: AN1988
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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?

Conditions

Induction of Labor Affected Fetus / Newborn; Rupture of Membranes Prior to Onset of Labor

Outcome Measures

Primary Outcomes (1)

• induction of labor

  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)

  up to 24 hours

Study Arms (2)

isosorbide mono-nitrate group

EXPERIMENTAL

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

Drug: isosorbide mononitrate

placebo group

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

isosorbide mononitrate DRUG

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

Also known as: Effox

isosorbide mono-nitrate group

Placebo DRUG

70 pregnant females, induction will be done by placebo (pyridoxine) administered in the posterior vaginal fornix.repeated every 4 hours maximum 4 times

Also known as: pyridoxine

placebo group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ahmed nagy shaker ramadan: lead

Study Sites (1)

faculty of medicine - Cairo university

Cairo, Kasr El Ainy, 11562, Egypt

Location

Related Publications (1)

• Afifi AN, Taymour MA, El-Khayat WM. Isosorbide mononitrate for cervical ripening in induction of labor for pregnant women with PROM at or post term. Int J Gynaecol Obstet. 2021 Dec;155(3):512-517. doi: 10.1002/ijgo.13604. Epub 2021 Feb 18.

  PMID: 33458819 DERIVED

MeSH Terms

Conditions

Fetal Membranes, Premature Rupture

Interventions

isosorbide-5-mononitrate; Pyridoxine

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Vitamin B 6; Picolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• waleed M EL Khyat, MD

  university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: resident of obstetrics and gynecology

Model Details: 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.

Study Record Dates

• First Submitted: August 30, 2018
• First Posted: September 11, 2018
• Study Start: August 1, 2018
• Primary Completion: April 30, 2019
• Study Completion: May 1, 2019
• Last Updated: June 23, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)