Outcomes of Foley vs EASI among women undergoing trial of labor after caesarean sectio

Phase 2

Conditions: Health Condition 1: O60-O77- Complications of labor and delivery

Registration Number: CTRI/2023/09/057237

Lead Sponsor: il

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

All pregnant women more than 18 years with single live intrauterine gestation, BISHOP score = 5, with intact membranes and reassuring fetal heart tracing and who are eligible for trial of labour after caesa-rean section at term.

TOLAC eligibility criteria

Women with Inter pregnancy interval greater than 18 months, scan estimated foetal weight less than 3.5 kg, non-recurrent indication for the previous section, the previous scar restricted to lower seg-ment, scar thickness more than 3 mm on ultrasono-graphy, and no clinical evidence of cephalopelvic disproportion will be considered eligible for TO-LAC.

Exclusion Criteria

The previous caesarean carried out for placenta pre-via, transverse lie, preterm and late in the second stage of labour, or clinical evidence of uterocervical infections after the previous caesarean section will not be considered eligible for TOLAC

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Induction - delivery intervalTimepoint: Primary outcome will be studied only at one time point (Time between Induction of labor and delivery of the baby)

Secondary Outcome Measures

Name	Time	Method
MATERNAL OUTCOMES <br/ ><br>1 Changes in bishop score <br/ ><br>2 Duration of foley insitu <br/ ><br>3 Oxytocin requirement & duration <br/ ><br>4 Mode of delivery <br/ ><br>5 Maternal pyrexia- Fever within 24 hrs of insertion- Fever will be defined as one or more recorded oral temperatures of 38°C or higher, & the diagnoses of chorioamnionitis & endometritis will be made by the managing obstetrician <br/ ><br>6 Maternal adverse events following foley insertion-Rupture of membranes, Change in presentation of fetus. <br/ ><br>7 Uterine hyperstimulation <br/ ><br>8 Scar dehiscence <br/ ><br>9 Abruption <br/ ><br> <br/ ><br> <br/ ><br>PERINATAL OUTCOMES <br/ ><br>1 Meconium stained liquor <br/ ><br>2 Pathological cardiotocogram <br/ ><br>3 Cord prolapse <br/ ><br>4 APGAR – APGAR will be measured at one minute & at five minutes after birth <br/ ><br>5 Birth weight <br/ ><br>6 NICU admission <br/ ><br>7 Early Neonatal Sepsis <br/ ><br>8 Still born <br/ ><br>Timepoint: seven days