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

• Status: Completed
• Trial end date: 2019-05-01
• Target enrollment: 0
• Participant gender: Female

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?

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ahmed nagy shaker ramadan
• Treatments: Isosorbide; Isosorbide Dinitrate; Isosorbide-5-mononitrate; Pyridoxine

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.