early inducing labour in women whose amniotic fluid leaked before the on set of labour vs waiting for some time and induction of labour, because that waiting period there is chance to progress spontaneously here oral misoprostol tablet is used for inducing

Phase 3

Not yet recruiting

Conditions: Other specified complications of labor and delivery,

Registration Number: CTRI/2021/04/033187

Lead Sponsor: AIIMS

Brief Summary: Pre labour rupture of membranes (PROM)is defined

as rupture ofmembranes before the onset of labour. It occurs in about 8% of totalpregnancies and generally is followed by prompt onset of spontaneous labour anddelivery. A delay in the onset oflabour leads to an increased risk of maternal and neonatal infections.

The American College of Obstetrics and Gynaecologyrecommended induction of labour over expectant management as a management of TermPROM).

But any method of induction orintervention have their owncomplications. Many studies showed that 60-70% of term PROM cases go intospontaneous labour within 24hrs, So we can wait for short period like 12hrsbecause chance of progression in to spontaneous labour with less chance ofmaternal and neonatal infections.

Thereare two major methods for induction labour with unripe cervix. Mechanicalintervention and pharmacological agents, pharmacological methods of inductionincludes prostaglandins and oxytocin. Prostaglandins are one of the preffered method ofcervical ripening and includes agents like misoprostol and dinoprostone butvaginal misoprostol and dinoprostone have increased chance of wash out andchance of introducing infection, Dinoprostone (PGE2) is expensive and unstableat room temperature. Hence oral misoprostol is theoretically better due toreduced need for a vaginal intervention,easy availability and as it is stable at room temperature.

primary aim is to know the induction to delivery interval in both early induction and late induction groups

sample size 80 including drop outs

study not yet started

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Female

Target Recruitment: 80

Inclusion Criteria

Pregnant women with gestational age greater than or equal to 37weeks to 42weeks,membranes ruptured, modified BISHOP score<6,Live fetus, singleton pregnancy, cephalic presentation.

Exclusion Criteria

premature prelabour rupture of membranes, multifetal gestation, non cephalic presentation, previous uterine scar and uterine rupture, antepartum hemorrhage, fetal anomalies, active genital herpes, pelvic structural deformities associated with cephalopelvic disproportions, invasive cervical carcinoma, previous pelvic surgeries.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
12-24 hours	To compare the induction to delivery interval in both groups \| 12-24 hours
To compare the induction to delivery interval in both groups	To compare the induction to delivery interval in both groups \| 12-24 hours

Secondary Outcome Measures

Name	Time	Method
to compare the mode of delivery in both the groups.	to compare fetal and maternal outcomes

Trial Locations

Locations (1): AIIMS Bhubaneswar
🇮🇳
Khordha, ORISSA, India
AIIMS Bhubaneswar
🇮🇳Khordha, ORISSA, India
Dr Deepthy Balakrishnan
Principal investigator
9446439373
balakrishnandeepthy@gmail.com