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

ahmed nagy shaker ramadan

Status and phase: Completed; Phase 4

Conditions: Induction of Labor Affected Fetus / Newborn

Treatments: Drug: Placebos; Drug: isosorbide mononitrate

Study type: Interventional

Funder types: Other

Identifiers

NCT03544606

ISMN and labor induction

Details and patient eligibility

About

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?

Full description

• 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).

Enrollment: 160 patients

Sex: Female

Ages: 20 to 35 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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160 participants in 2 patient groups, including a placebo group

isosorbide mononitrate group

Experimental group

Description:

In vaginal IMN group (group 1) 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.

Treatment:

Drug: isosorbide mononitrate

placebos group

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebos