Overview

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

Status:
Completed
Trial end date:
2020-10-15
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 (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?
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
ahmed nagy shaker ramadan
Treatments:
Isosorbide
Isosorbide Dinitrate
Isosorbide-5-mononitrate
Nitric Oxide
Nitric Oxide Donors
Pyridoxal
Pyridoxine
Vitamin B 6
Criteria
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