EVALUATION OF ISOSORBIDE MONONITRATE FOR CERVICAL RIPENING PRIOR TO INDUCTION OF LABOUR FOR POSTDATED PREGNANCY IN OUTPATIENT SETTING

Phase 2

Completed

Registration Number: CTRI/2011/091/000121

Lead Sponsor: KAVITA AGARWA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 200

Inclusion Criteria

?Age 18-35 years
?> 40 completed weeks of gestation
?Singleton fetus
?Cephalic presentation
?Absence of uterine contractions
?Unfavorable cervix (Bishop<6)
?Intact membranes
?Reactive NST

Exclusion Criteria

. Fetal malpresentation
?Antepartum hemorrhage
?Previous uterine incision
?Ruptured membranes
?Contraindication to receive IMN or Prostaglandins (allergy, bronchial asthma, hypotension, palpitation)
?Pregnancy with high risk factors (Preeclampsia, Oligohydramnios, IUGR, medical complications such as diabetes mellitus, heart disease and hypertension.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Bishop score: Pre & Post treatment with the drug<br>2.Time elapsed from hospital admission (for patient induction / admission in labor) to delivery either vaginally or cesarean section. <br>3.Adverse maternal outcome: Uterine hyperstimulation, tachysystole, tachycardia, hypotension, headache, palpitations, fever & shivering.<br>4.Adverse fetal outcome: meconium stained liquor, Apgar at 1 & 5 minutes, neonatal admission.<br>Timepoint: nil

Secondary Outcome Measures

Name	Time	Method
1.Unscheduled admissions for reasons other than labor commencing.<br>2.Requirement of additional inpatient cervical ripening agent.<br>3.Subsequent need for oxytocin.<br>4.Operative delivery rates (Cesarean section done for obstetric indications including failed induction, arrest of dilation, arrest of descent, and persistent non reassuring fetal heart rate pattern after resuscitation).<br>5.Complications: Postpartum hemorrhage.<br>Timepoint: nil