Clinical trial NCT00148473: Oral Versus Vaginal Misoprostol for Induction of Labor
Official title: A Single Dose of Oral Versus Vaginal Misoprostol for Induction of Labor: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Termed Pregnancy With Indications for Labor Induction.
Keywords: Cervical ripening.
Induction of labor.
Misoprostol.
Lead sponsor: Bangkok Metropolitan Administration Medical College and Vajira Hospital
Sponsor class: OTHER_GOV
First posted: 2005-09-08
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the efficacy between a single dose of oral misoprostol 100 microgram and vaginal misoprostol 50 microgram for induction of labor.

Detailed description: Induction of labor is widely carried out all over the world in cases where continuation of pregnancy is hazardous to both the mother and/or fetus. The induction in a ripe cervix is not difficult but complications are significantly increased when the cervix is unripe. The only agent approved for cervical ripening and induction of labor in patients with an unripe cervix is dinoprostone(PGE2). Misoprostol is a synthetic PGE1 analogue marketed for the prevention and treatment of gastro-duodenal ulcers. Misoprostol costs much less than dinoprostone and does not require refrigeration and has few systemic side effects.In addition, it is rapidly absorbed orally and vaginally. Although misoprostol is not registered for such use, it has been widely used for obstetric indications such as induction of abortion and of labor. Misoprostol for induction of labor in preceding literatures mainly prescribed in multiple dosing regimen. The adverse effects on uterus potentially occur owing to the frequent administration of misoprostol. The objective of this study was to compare a single dose oral misoprostol with vaginal misoprostol.

Eligibility criteria: Inclusion Criteria:

* A live singleton pregnancy at a gestation of \>37 weeks, with obstetric or medical indications for induction, and unfavorable cervix (the initial Bishop score of \<717), vertex presentation, reactive fetal heart rate pattern, absence of labor, and intact membranes without previous stripping. Post-term inductions were considered when gestational age was \>41 weeks.

Exclusion Criteria:

* Suspected cephalo-pelvic disproportion, estimated fetal weight of \>4000 grams, maternal age of \<18 years, parity of \>5, previous cesarean delivery or history of uterine incision, any contraindication for vaginal delivery or prostaglandins administration and suspected chorioamnionitis.

Primary outcomes:
measure: The time interval from induction to vaginal delivery and vaginal delivery rate within 24 hours.
Secondary outcomes:
measure: Rate of vaginal delivery within 24 hours.
measure: Cesarean section rate.
measure: Uterine tachysystole.
measure: Uterine hyperstimulation syndrome.
measure: Number of women received oxytocin.
measure: Neonatal outcomes.
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: BMA Medical College and Vajira Hospital
Study officials:
affiliation: BMA Medical College and Vajira Hospital
name: Manit Sripramote, MD
role: PRINCIPAL_INVESTIGATOR
References: