Heated Saline in Cervical Balloon for Labor Induction, a RCT

NACompletedINTERVENTIONAL
Enrollment

290

Participants

Timeline

Start Date

October 16, 2023

Primary Completion Date

May 30, 2025

Study Completion Date

May 30, 2025

Conditions
Cervical RipeningInduction of LaborUnfavorable CervixMechanical Method
Interventions
DEVICE

Warm group

The operator will introduce a 14Fr or 18Fr Balloon catheter through the cervical canal, up above the internal orifice using a long Pean clamp and inflate the internal balloon with 30 to 80ml of Heated saline water (NaCl 0.9%) at 40°C - according to the mechanic resistance with a graduated syringe.

DEVICE

Room temperature group

The operator will introduce a 14Fr or 18Fr Balloon catheter through the cervical canal, up above the internal orifice using a long Pean clamp and inflate the internal balloon with 30 to 80ml of unheated saline water (NaCl 0.9%) - according to the mechanic resistance with a graduated syringe.

Trial Locations (1)

1205

Hôpitaux Universitaires de Genève, Geneva

All Listed Sponsors
lead

Begona Martinez de Tejada

OTHER

NCT05864326 - Heated Saline in Cervical Balloon for Labor Induction, a RCT | Biotech Hunter | Biotech Hunter