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Completed

NCT Number: NCT03544606

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

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.

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?

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Key information

Conditions

Induction of Labor Affected Fetus / Newborn

Age range

20 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

faculty of medicine - Kafr Elsheikh university

Kafr ash Shaykh, Egypt

About this study

  • Type of Study : Prospective double blind randomized controlled clinical trial.
  • Study Setting : This study will be conducted in Kafr Elsheikh University maternity hospital.
  • Study Period : Expected 6 months from December 2023 to June 2024.
  • Study Population : Patients will be recruited in this study those attending labor ward at Kafr Elsheikh hospital for induction of labor at term or post-term with unripe cervix (Bishop Score ˂ 6).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • • Previous uterine scar.
  • Patients with regular uterine contractions.
  • Malpresentation.
  • Multifetal gestation.
  • Prelabour rupture of membranes.
  • Established fetal distress.
  • Indication for CS, e.g. Major degree of cephalopelvic disproportion and fetal macrosomia.
  • Antepartum hemorrhage.
  • Active genital herpes infection.
  • Severe maternal illness (e.g. severe preeclampsia).

Treatment and study plan

Isosorbide Mononitrate

Drug

40 mg tablet of intra-vaginal IMN (Effox; MINAPHARMA, Cairo, Egypt) will be placed into the posterior fornix of the vagina, through a digital vaginal examination, every 4 h for a maximum of four doses.

Other names: Effox 40 mg

Placebos

Drug

In placebo group (group 2) 40 mg intra-vaginal pyridoxine placebos every 4 h for a maximum of four doses will be given

Other names: pyridoxine

Primary outcomes

  1. admission-delivery interval

    Time frame: up to 24 hours

    The time from initiation labor induction and delivery of placenta

Sponsors and collaborators

Lead sponsor

ahmed nagy shaker ramadan

Other

Collaborators

  • Kafrelsheikh University

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 4, 2018
Registry last updated
Aug 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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