A clinical trail to study the efficacy and safety of two dose regimens of misoprostol for labor inductio

Phase 3

Completed

Conditions: Health Condition 1: null- labor induction

Registration Number: CTRI/2008/091/000115

Lead Sponsor: Kasturba Medical College

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 100

Inclusion Criteria

inclusion criteria

1.Women with singleton pregnancy

2.Past date pregnancy of 40 weeks or more

3.At term (between 37 and 42 completed weeks of pregnancy)

4.Cephalic presentation

5.Bishop score < 5

6.Amniotic fluid index > 5

7.Reactive fetal heart rate pattern

8.Membranes could be intact or ruptured

Exclusion Criteria

Exclusion criteria were as follows
1.Parity >3
2.Prior uterine scars ( previous cesarean section and myomectomy)
3.Multiple pregnancy
4.Estimated fetal weight > 4500 or < 2000g
5.Abnormal fetal heart rate tracings on non stress test
6.Placenta previa
7.Hypersensitivity to prostaglandins
8.Renal, hepatic or cardiovascular disease
9.Severe asthma

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
vaginal delivery within 24 hours of induction with misoprostolTimepoint: A primary outcome measure is the interval from the first dose of misoprostol to vaginal delivery.

Secondary Outcome Measures

Name	Time	Method
Change in the Bishop score <br/ ><br>Time interval from induction to onset of adequate uterine contractions <br/ ><br>Number of women delivering within 12 hours of induction <br/ ><br>Mode of delivery,spontaneous vaginal, instrumental delivery or Cesarean section and indications for the same <br/ ><br>Number of doses of misoprostol used <br/ ><br>Oxytocin augmentation <br/ ><br>Incidence of adverse effects: hyperstimulaton, fetal heart rate abnormalities. <br/ ><br>Incidence of postpartum hemorrhage, <br/ ><br>Neonatal outcome and patient satisfactionTimepoint: Maternal and neonatal outcome