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Heated Saline in Cervical Balloon for Labor Induction, a RCT

NCT05864326 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 290

Last updated 2025-06-05

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Begona Martinez de Tejada

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-16
Primary Completion
2025-05-30
Completion
2025-05-30

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05864326 on ClinicalTrials.gov