Randomized double blind placebo controlled study of outpatient misoprostol for term pregnant patientswith no risk factors to prevent routine induction of labour and to prevent post dated pregnancy and its complications

Phase 3

Completed

Conditions: PREGNANCY

Registration Number: CTRI/2013/08/003883

Lead Sponsor: CMCH AND HOSPITAL VELLOREHRISTIAN MEDICAL COLL

Brief Summary: POST TERM PREGNANCY IS ONE OF THE MORE COMMON HIGH RISK PROBLEMS CONFRONTING MANY OBSTETRICIANS.UTEROPLACENTAL INSUFFICIENCY ,MACROSOMIA AND MECONIUM ASPIRATION SYNDROME ASSOCIATED WITH POST DATED PREGNANCY RESULTS IN INCREASED MORBIDITY AND MORTALITY.ANTENATAL SURVEILLANCE AND LABOUR INDUCTION ARE TWO WIDELY USED STRATERGIES THAT THEORETICALLY DIMINISH FETAL RISK OF AN ADVERSE OUTCOME.ANTENATAL SURVEILLANCE INSTEAD IS NOT POPULARLY USED IN DEVELOPING COUNTRIES DUE TO EXPENSE INVOLVED WITH SERIAL ANTENATAL SURVEILLANCE. INDUCTION OF LABOUR WITH A POOR CERVICAL SCORE HAS BEEN ASSOCIATED WITH FAILED INDUCTION,PROLONGED LABOUR AND INCREASED CAESAREAN DELIVERY RATES.SEVERAL STUDIES HAVE SHOWN PROSTAGLANDINS AS A SAFE AND EFFECTIVE INDUCING AGENT,WHEN USED IN LOW DOSES.MISOPROSTOL IS A PROSTAGLANDIN E1 ANALOG EFFECTIVE FOR CERVICAL RIPENING AND INDUCTION OF LABOUR.THE DRUG IS INEXPENSIVE,STOERD AT ROOM TEMPERATURE AND FEW SIDE EFFECTS.THERE HAVE BEEN SEVERAL META-ANALYSES AND SYSTEMATIC REVIEWS OF RCT EVALUATING THE USE OF MISOPROSTOL FOR CERVICAL RIPENING.MISOPROSTOL ALSO REDUCES THE INDUCTION TO DELIVERY INTERVAL(4.5+\_4.1DAYS)MEMBRANES SWEEPING HAS SHOWN TO DECREASE THE FORMAL INDUCTION.THE AIM OF THIS RANDOMISED CONTROL TRIAL IS TO COMPARE PLACEBO VERSUS VAGINAL MISOPROSTOL IN OUTPATIENT SETTING AFTER MEMBRANE SWEEPING TO PREVENT POSTDATED PREGNANCY

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 126

Inclusion Criteria

SINGLETON PREGNANCY AT 38+4WEEKS TO 39+4WEEKS GESTATION,CEPHALIC PRESENTATION,BISHOP SCORE LESS THAN 4,LACK OF CURRENT INDICATION FOR INDUCTION OF LABOUR.

Exclusion Criteria

RUPTURE OF MEMBRANES,UNEXPLAINED VAGINAL BLEEDING,PRIOR UTERINE INCISION,GESTATIONAL HYPERTENSION,GESTATIONAL DIABETES ,ESTIMATED FETAL WEIGHT MORE THAN 4500GMS.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
INTERVENTION TO DELIVERY INTERVAL	DURING DELIVERY

Secondary Outcome Measures

Name	Time	Method
Gestational age at delivery,spontaneous onset of labour or induction of labour,LSCS for failed induction,meconium aspiration syndrome,APGAR less than 6 at 5minutes,NICU admissions,rupture of membranes,bleeding per vaginm	same

Trial Locations

Locations (1): CMC OBSTETRICS OPD ROOM NUMBERS 16,17,18,19,20,21,22,26 FLOOR NUMBER 1
🇮🇳
Vellore, TAMIL NADU, India
CMC OBSTETRICS OPD ROOM NUMBERS 16,17,18,19,20,21,22,26 FLOOR NUMBER 1
🇮🇳Vellore, TAMIL NADU, India
DrJIJI E MATHEWS
Principal investigator
04162283387
coronistrial@yahoo.co.in