Heated Saline in Cervical Balloon for Labor Induction, a RCT

NCT05864326 | Completed DMC

• 1 other identifier: 2022-02120
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a single-center, randomized, two-arm, controlled trial, including women requiring cervical ripening during the process Induction of Labor using Balloon catheter (BC). The primary objective of the study is to determine if the use of heated saline in the BC used for cervical ripening reduces the length of BC duration. Participants will be allocated to :

• Intervention or warm group: the BC will be filled with heated saline water up to 40° C
• Standard or room temperature group: the BC will be filled with saline water at room temperature.

Conditions

Cervical Ripening; Induction of Labor; Unfavorable Cervix; Mechanical Method

Keywords

Cervical ripening; Induction of Labor; Unfavorable cervix; Mechanical method

Outcome Measures

Primary Outcomes (1)

• To determine if the use of heated saline in the Balloon Catheter (BC), used for cervical ripening, reduces the length of BC duration, defined as the time from the insertion to spontaneous expulsion or artificial removal of the BC.

  Duration of BC (i.e., positioning of the transcervical catheter): interval between insertion and retrieval, either after spontaneous expulsion or artificial retrieval.

  Through study completion, an average of 1.5 years

Secondary Outcomes (7)

• To evaluate if the use of heated saline compared with room temperature Decreases the length from the start of the induction until the achievement of a favorable cervix (Bishop score >5)

  Through study completion, an average of 1.5 years

• Decreases the length from the start of the induction until full dilation

  Through study completion, an average of 1.5 years

• Decreases the length from the start of the induction until the delivery

  Through study completion, an average of 1.5 years

• Increases the rate and the speed of spontaneous rupture of membranes (ROM) during cervical ripening

  Through study completion, an average of 1.5 years

• Impacts on the rate of cesarean delivery

  Through study completion, an average of 1.5 years

Study Arms (2)

Warm group

EXPERIMENTAL

The Balloon Catheter will be filled with heated saline water up to 40° C

Device: Warm group

Room temperature group

ACTIVE COMPARATOR

the Balloon Catheter will be filled with saline water at room temperature.

Device: Room temperature group

Interventions

Warm group DEVICE

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.

Warm group

Room temperature group DEVICE

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.

Room temperature group

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Gestational age at or over 35 weeks
• Singleton pregnancy
• Alive fetus
• Cephalic presentation
• Maternal age ≥ 16 years

You may not qualify if:

• Active labor (dilated cervix with spontaneous uterine contractions)
• Prelabor rupture of membranes
• \>1 Previous cesarean delivery
• Fetal malformation leading to a possible obstruction of labor (e.g., hydrocephaly, exteriorized fetal tumors, etc.)
• Maternal or fetal disease with indication to accelerate labor (start oxytocin stimulation within 6 hours after insertion of the BC (e.g., pre-eclampsia, chorioamnionitis, etc.)\]
• Counterindication to vaginal delivery
• Impossibility to give consent to participation

Sponsors & Collaborators

• Begona Martinez de Tejada: lead

Study Sites (1)

Hôpitaux Universitaires de Genève

Geneva, Canton of Geneva, 1205, Switzerland

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Prospective, single-center, randomized, two-arm, controlled trial, including women requiring cervical ripening during the process IOL using Balloon catheter

Study Record Dates

• First Submitted: April 2, 2023
• First Posted: May 18, 2023
• Study Start: October 16, 2023
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)