Cervical RipeningNCT05864326
Heated Saline in Cervical Balloon for Labor Induction, a RCT
A study testing Warm group and Room temperature group in people with Cervical Ripening and Induction of Labor, run by Begona Martinez de Tejada at 1 site in Switzerland.
Trial 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). Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Ripening, Induction of Labor, Unfavorable Cervix
- What is being tested?
- Warm group and Room temperature group
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 1 siteSwitzerland
- Study dates
- 16 Oct 2023to 30 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Gestational age at or over 35 weeks
- Singleton pregnancy
- Alive fetus
- Cephalic presentation
- Maternal age ≥ 16 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Hôpitaux Universitaires de Genève
Geneva, Canton of Geneva, 1205
About this study
Official title: Effect of Heated Saline in Duration of Cervical Ripening in Women Having Labor Induction With Cervical Balloon: a Randomized Controlled Study
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.
Read the detailed description
Background and Rationale:
Induction of Labor (IOL) is one of the most common interventions in obstetrics. IOL is performed due to fetal, maternal or pregnancy complications to reduce the risk of complication. IOL methods will depend of the state of the cervix at the beginning of the procedure. If cervix is considered unfavorable (Bishop score ≤ 5) an initial phase of ripening is usually proposed. There are various methods of cervical ripening, which can be divided into non-pharmacological (e.g., mechanical methods with transcervical Foley catheter or Cook balloon) and pharmacological (e.g., prostaglandins). IOL can be a long-lasting procedure, especially when cervical ripening is necessary.
Two recent, small studies have shown that the use of warm fluid to inflate the balloon catheter (BC) inserted through the cervix reduces the time of cervical ripening, hence potentially reducing the time of IOL. These results are the only data available regarding the use of saline at different temperatures for inflating the balloon in mechanical methods and show promising effects in terms of reduction in the length of the cervical ripening and labor.
The cervix is mainly composed of collagen. Studies show that the use of heat on connective tissue increase the potential elongation of collagen tissue and the denaturation of this protein.
We hypothesize that the use of heat in the cervical ripening can accelerate the denaturation of the collagen and accelerate the softening of the cervix and therefore reduce the duration of cervical ripening and labor.
Objective(s):
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, defined as the time from the insertion to the expulsion or artificial removal of the BC.
The secondary objectives are 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).
- Decreases the length from the start of the induction until full dilation
- Decreases the length from the start of the induction until delivery
- Increases the rate and the speed of spontaneous rupture of membranes (ROM) during cervical ripening
- Impacts on the rate of cesarean delivery.
- Impacts on the pain and the satisfaction in women undergoing cervical ripening
- Impacts on obstetrical and neonatal complications
Study Design:
Prospective, single-center, randomized, two-arm, controlled trial, including women requiring cervical ripening during the process IOL using Balloon catheter
Number of Participants with Rationale:
A total of 290 women will be recruited (145 women in each group) in order to show a reduction in the duration of BC placement, considering a significance criterion set to 0.05 (alpha, two- tailed), and an expected power of at least 90%.
Study procedures:
Patients will be allocated in one of this two groups:
- 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.
In both groups, the insertion of the BC will be done following the same procedure:
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 saline water (NaCl 0.9%) -either heated or unheated, depending on the allocation group- according to the mechanic resistance with a graduated syringe.
Statistical Considerations Main analysis will be performed on an intention-to-treat basis. The main outcome will be evaluated by plotting survival functions according to the allocation group, using the Kaplan-Meier estimator. The associations will be considered as statistically significant when the p-value is below 0.05 (probability of type I error = 0.05). This analysis is also planned for objectives 2 (interval from beginning of IOL and achievement of a favorable cervix) and 3 (interval from beginning of IOL and delivery). For the other outcomes, comparison will be performed using Fisher's exact test, Student's t-test or the Mann-Whitney U test, according to the type of variable.
- Being tested
- Warm group, Room temperature group
- Keywords
- Cervical ripening, Induction of Labor, Unfavorable cervix, Mechanical method
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Warm groupDevice
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.
Room temperature groupDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Warm group | Experimental | The Balloon Catheter will be filled with heated saline water up to 40° C Receives: Device: Warm group |
| Room temperature group | Active comparator | the Balloon Catheter will be filled with saline water at room temperature. Receives: Device: Room temperature group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Length of cervical ripening phase, defined as the interval between catheter insertion and the achievement of a favorable cervix, defined as Bishop score >5.
Measured: Through study completion, an average of 1.5 years
Decreases the length from the start of the induction until full dilation
Length from the start of the BC insertion until fully dilation
Measured: Through study completion, an average of 1.5 years
Decreases the length from the start of the induction until the delivery
Length from the start of the BC insertion until the delivery
Measured: Through study completion, an average of 1.5 years
Increases the rate and the speed of spontaneous rupture of membranes (ROM) during cervical ripening
Spontaneous rupture of membranes (ROM) during cervical ripening or labor (Yes/No)
- If Yes, length from the insertion of the BC until spontaneous ROM.
Measured: Through study completion, an average of 1.5 years
Impacts on the rate of cesarean delivery
Mode of delivery (vaginal delivery vs. cesarean delivery)
Measured: Through study completion, an average of 1.5 years
Impacts on the pain and the satisfaction in women undergoing cervical ripening
Pain after catheter insertion assessed using a numeric rating scale (NRS, where NRS = 0 equals no pain and NRS = 10 represents the worst possible pain suffered by the participant). Participants satisfaction of the whole using a five-point Likert scale (1, very dissatisfied; 2, dissatisfied; 3, Enough Satisfied; 4, Satisfied; and 5, very satisfied)
Measured: Through study completion, an average of 1.5 years
Impacts on obstetrical and neonatal complications
Presence of obstetrical complications or neonatal complications
Measured: Through study completion, an average of 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start16 Oct 2023
- Primary completion30 May 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical RipeningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Prospective, single-center, randomized, two-arm, controlled trial, including women requiring cervical ripening during the process IOL using Balloon catheter
- Masking
- None (open label)
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- Begona Martinez de Tejada
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Begona Martinez de Tejada, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05864326
- Sponsor's protocol ID
- 2022-02120
- Status last verified
- Jun 2025
- First submitted
- 2 Apr 2023
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Heated Saline in Duration of Cervical Ripening in Women Having Labor Induction With Cervical Balloon: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05864326
- Acronym / sponsor ID
- 2022-02120
- Keywords
- Cervical ripening, Induction of Labor, Unfavorable cervix, Mechanical method
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- Begona Martinez de TejadaUniversity, hospital or other
- Study start
- 16 Oct 2023 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 18 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background and Rationale:
Induction of Labor (IOL) is one of the most common interventions in obstetrics. IOL is performed due to fetal, maternal or pregnancy complications to reduce the risk of complication. IOL methods will depend of the state of the cervix at the beginning of the procedure. If cervix is considered unfavorable (Bishop score ≤ 5) an initial phase of ripening is usually proposed. There are various methods of cervical ripening, which can be divided into non-pharmacological (e.g., mechanical methods with transcervical Foley catheter or Cook balloon) and pharmacological (e.g., prostaglandins). IOL can be a long-lasting procedure, especially when cervical ripening is necessary.
Two recent, small studies have shown that the use of warm fluid to inflate the balloon catheter (BC) inserted through the cervix reduces the time of cervical ripening, hence potentially reducing the time of IOL. These results are the only data available regarding the use of saline at different temperatures for inflating the balloon in mechanical methods and show promising effects in terms of reduction in the length of the cervical ripening and labor.
The cervix is mainly composed of collagen. Studies show that the use of heat on connective tissue increase the potential elongation of collagen tissue and the denaturation of this protein.
We hypothesize that the use of heat in the cervical ripening can accelerate the denaturation of the collagen and accelerate the softening of the cervix and therefore reduce the duration of cervical ripening and labor.
Objective(s):
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, defined as the time from the insertion to the expulsion or artificial removal of the BC.
The secondary objectives are 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).
- Decreases the length from the start of the induction until full dilation
- Decreases the length from the start of the induction until delivery
- Increases the rate and the speed of spontaneous rupture of membranes (ROM) during cervical ripening
- Impacts on the rate of cesarean delivery.
- Impacts on the pain and the satisfaction in women undergoing cervical ripening
- Impacts on obstetrical and neonatal complications
Study Design:
Prospective, single-center, randomized, two-arm, controlled trial, including women requiring cervical ripening during the process IOL using Balloon catheter
Number of Participants with Rationale:
A total of 290 women will be recruited (145 women in each group) in order to show a reduction in the duration of BC placement, considering a significance criterion set to 0.05 (alpha, two- tailed), and an expected power of at least 90%.
Study procedures:
Patients will be allocated in one of this two groups:
- 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.
In both groups, the insertion of the BC will be done following the same procedure:
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 saline water (NaCl 0.9%) -either heated or unheated, depending on the allocation group- according to the mechanic resistance with a graduated syringe.
Statistical Considerations Main analysis will be performed on an intention-to-treat basis. The main outcome will be evaluated by plotting survival functions according to the allocation group, using the Kaplan-Meier estimator. The associations will be considered as statistically significant when the p-value is below 0.05 (probability of type I error = 0.05). This analysis is also planned for objectives 2 (interval from beginning of IOL and achievement of a favorable cervix) and 3 (interval from beginning of IOL and delivery). For the other outcomes, comparison will be performed using Fisher's exact test, Student's t-test or the Mann-Whitney U test, according to the type of variable.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, single-center, randomized, two-arm, controlled trial, including women requiring cervical ripening during the process IOL using Balloon catheter
| Arm | Type | Receives |
|---|---|---|
| Warm group | Experimental | Device: Warm groupThe Balloon Catheter will be filled with heated saline water up to 40° C |
| Room temperature group | Active comparator | Device: Room temperature groupthe Balloon Catheter will be filled with saline water at room temperature. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Gestational age at or over 35 weeks
- Singleton pregnancy
- Alive fetus
- Cephalic presentation
- Maternal age ≥ 16 years
Key exclusion criteria (7 listed)
- 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.)]
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Warm groupThe 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 | Warm group |
| Room temperature groupThe 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. | Device | Room temperature group |
Primary outcome
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.
Time frame: Through study completion, an average of 1.5 years
Duration of BC (i.e., positioning of the transcervical catheter): interval between insertion and retrieval, either after spontaneous expulsion or artificial retrieval.
7 secondary outcomes
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)
Time frame: Through study completion, an average of 1.5 years
Decreases the length from the start of the induction until full dilation
Time frame: Through study completion, an average of 1.5 years
Decreases the length from the start of the induction until the delivery
Time frame: Through study completion, an average of 1.5 years
Increases the rate and the speed of spontaneous rupture of membranes (ROM) during cervical ripening
Time frame: Through study completion, an average of 1.5 years
Impacts on the rate of cesarean delivery
Time frame: Through study completion, an average of 1.5 years
Impacts on the pain and the satisfaction in women undergoing cervical ripening
Time frame: Through study completion, an average of 1.5 years
Impacts on obstetrical and neonatal complications
Time frame: Through study completion, an average of 1.5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Warm group and Room temperature group in people with Cervical Ripening and Induction of Labor, run by Begona Martinez de Tejada at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Through study completion, an average of 1.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.