Benefits of placing Foleys catheter with saline in the neck of the womb before the initiation of labour with vaginal prostaglandin E1

The efficacy of Transcervical Foleyâ??s catheter with extra amniotic saline infusion in cervical ripening before the induction of labour with intravaginal Prostaglandin E1- A randomized controlled trial.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2013/10/004106

Enrollment

106

Registered

2013-10-28

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- gravidas with singleton pregnancy ,intact membranes and cephalic presentation

Interventions

Intervention1: misoprostol, foleys catheter: labour induction with misoprostol Intervention2: intra cervical foleys catheter with 200 ml extra amniotic saline infusion: intra cervical foleys catheter

Eligibility

Inclusion criteria

Inclusion criteria: Two samples of gravidas with cephalic presentation, singleton pregnancy with intact membranes having Bishop score less than or equal to two

Exclusion criteria

Exclusion criteria: Patients with previous scar on uterus, in active labour, ruptured membranes, hypersensitive to prostaglandins

Design outcomes

Primary

Measure	Time frame
induction to delivery durationTimepoint: Time interval from introduction of intravaginal PgE1 to the time of delivery , assessed in both groups	—

Secondary

Measure	Time frame
To calculate the rate of vaginal delivery in both groupsTimepoint: After a maximum 3 doses of intra vaginal PgE1, total number of vaginal deliveries and caesarian sections will be assessed separately in both groups	—

Countries

India

Contacts

Public ContactDR NEETHURANI V K

ADDITIONAL PROFESSOR DEPT. OF OBSTETRICS AND GYNAECOLOGY GOVT. MEDICAL COLLEGE THIRUVANANTHAPURAM

patsyvarghese@yahoo.com9349880773

Outcome results

None listed

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