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

Efficacy of Transcervical Foley with and without extra amniotic saline infusion on Induction delivery interval among women undergoing trial of labour after caesarean section at term –A Randomized Controlled trial. - NILL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/09/057237

Enrollment

188

Registered

2023-09-04

Start date

Unknown

Completion date

Unknown

Last updated

2023-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: Transcervical foley with extra amniotic saline infusion: Insertion of 22 French Transcervical Foley catheter with extra amniotic saline infusion at 60 ml/ hour for 6 hours for inductio

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
MATERNAL OUTCOMES 1 Changes in bishop score 2 Duration of foley insitu 3 Oxytocin requirement & duration 4 Mode of delivery 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 6 Maternal adverse events following foley insertion-Rupture of membranes, Change in presentation of fetus. 7 Uterine hyperstimulation 8 Scar dehiscence 9 Abruption PERINATAL OUTCOMES 1 Meconium stained liquor 2 Pathological cardiotocogram 3 Cord prolapse 4 APGAR – APGAR will be measured at one minute & at five minutes after birth 5 Birth weight 6 NICU admission 7 Early Neonatal Sepsis 8 Still born Timepoint: seven days	—

Measure

Time frame

MATERNAL OUTCOMES 1 Changes in bishop score 2 Duration of foley insitu 3 Oxytocin requirement & duration 4 Mode of delivery 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 6 Maternal adverse events following foley insertion-Rupture of membranes, Change in presentation of fetus. 7 Uterine hyperstimulation 8 Scar dehiscence 9 Abruption PERINATAL OUTCOMES 1 Meconium stained liquor 2 Pathological cardiotocogram 3 Cord prolapse 4 APGAR – APGAR will be measured at one minute & at five minutes after birth 5 Birth weight 6 NICU admission 7 Early Neonatal Sepsis 8 Still born Timepoint: seven days

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Countries

India

Contacts

Public ContactDr Suvarnna K

Jawaharlal Institute Of Postgraduate Medical Education And Research

jd1231@jipmer.ac.in9487581663

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026