Cervical Dilation25148NCT02606643
Balloon Catheter for Cervical Ripening
A study testing Slight traction and Foley Catheter to no traction in people with Cervical Dilation, run by St. Louis University at 1 site in United States.
Trial summary
Once admitted, women who will have a transcervical balloon catheter inserted for induction will be approached for participation in this study. If they agree to be take part in this study (tape or no tape) they will be randomized into the study. Read more about this study
- Who is it for?
- Ages 14 to 55 years, women only
- Conditions the study is for
- Cervical Dilation
- What is being tested?
- Slight traction and Foley Catheter to no traction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Nov 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 14 to 55 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- singleton gestation
- Bishop score less than or equal to 6
- cephalic presentation
Who cannot join
- prostaglandins given this admission
- any medical conditions precluding vaginal delivery
- significant cervical or intrauterine infection
- significant vaginal bleeding
- intrauterine fetal demise
- low lying placenta
- prior cervical surgery
- latex allergy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Balloon Catheter for Cervical Ripening With or Without Traction: A Randomized Controlled Trial
Once admitted, women who will have a transcervical balloon catheter inserted for induction will be approached for participation in this study. If they agree to be take part in this study (tape or no tape) they will be randomized into the study. After the balloon catheter is inserted, the balloon will then be filled with approximately 50-60 mL of normal saline, this is normal procedure.
Study related: If randomized to "No Taping" the foley will be positioned comfortable and not placed to tension. For the "Tension" arm, tension will be placed on the balloon catheter, which will then be taped to the patient's inner thigh. The tension will be assessed and retaped as needed approximately every 30 minutes by the research and/or the nursing staff.
Read the detailed description
Once admitted, women who are schedule for induction and who's physician has order a balloon catheter, they will have a transcervical balloon catheter inserted-this is normal care. Patients will be placed in the dorsal lithotomy position in the delivery bed. The cervix will be examined digitally (this is the standard of care). The balloon catheter will be inserted by feel and passed through the cervix until the balloon is above the internal os. The balloon will then filled with approximately 50-60 mL of normal saline. This procedure is standard of care.
Randomization: 63 cards will be prepared to read "tape for tension" and 63 will be prepared to read "No tape/No Tension". These cards will be sealed in opaque envelopes and kept in the PI's office. After consent is obtained the PI will be notified and a sealed envelope will be opened and the patient and staff will be notified.
If randomized to "No tension" the catheter will be positioned comfortable and not placed to tension (this is currently the standard at SSM - Saint Mary's Hospital ).
For the "Tension" arm (research related), slight tension will be placed on the catheter, which will then be taped to the patient's inner thigh. The tension will be assessed and retaped as needed every 30 minutes by the research and/or the nursing staff.
Only slight tension will be applied to those catheters assign to the tension group. The catheter will be taped to the inner thigh so there is no "sag" in the catheter from the urethra to the tape. There is no method or device to "measure" the tension placed on these catheters, if the patient moves her leg it can lessen or increase the tension, these are known factors.
As part of the induction process, patients will be started on an infusion of oxytocin, this is the practice at SSMHC, unless there is a reason not to use oxytocin such as nonreassuring fetal heart tracing. In this situation it is the physician's choice of what to use for induction. Oxytocin is initiated at 2 milliunits/minute and increased 1-2 milliunits/minute approximately every 20 minutes to a maximum of 6 milliunits/minute while the Foley is in place.
After expulsion of the balloon, the resident or attending physician will performed a cervical examination to document the time and the cervical examination, and the oxytocin will be titrated to achieve acceptable contraction rates without tachysystole -this is standard care.
The patient's labor and delivery will be managed according to routine obstetric and institutional protocols. All patients will have continuous fetal heart rate and uterine activity monitoring.
Chart review will be performed on both the maternal and infant medical record from admission to discharge.
- Conditions
- Cervical Dilation
- Being tested
- Slight traction, Foley Catheter to no traction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Slight tractionProcedure or surgery
Slight traction will be applied to the balloon catheter
Foley Catheter to no tractionProcedure or surgery
Foley Catheter to no traction
| Study group | Role | What they receive |
|---|---|---|
| Group 1 Catheter to slight traction | Active comparator | For the "Tension" arm (research related), slight tension will be placed on the catheter, which will then be taped to the patient's inner thigh. The tension will be assessed and retaped as needed every 30 minutes by the research and/or the nursing staff.
Only slight tension will be applied to those catheters assign to the tension group. The catheter will be taped to the inner thigh so there is no "sag" in the catheter from the urethra to the tape. There is no method or device to "measure" the tension placed on these catheters, if the patient moves her leg it can lessen or increase the tension, these are known factors. Receives: Procedure: Slight traction |
| Group 2 Catheter to no traction | Active comparator | Foley catheter to no traction placed as SOC "No traction" applied Receives: Procedure: Foley Catheter to no traction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration
Hours of labor
Measured: hours to delivery 0-26
Secondary outcomes (2)
Deliveries Via Cesarean Delivery
What number of deliveries in the tension and no tension groups were via Cesarean delivery
Measured: intraoperative
Vaginal Delivery Within 24 Hours
vaginal delivery within 24 hours-not all deliveries were within 24hours
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2015 (estimated)
- Study startOct 2014
- Primary completionJul 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical DilationStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Louis University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gary Fruhman, MD, Principal investigator, St. Louis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02606643
- Sponsor's protocol ID
- StLouisU
- Acronym
- 25148
- Status last verified
- Feb 2018
- First submitted
- 24 Aug 2015
- Last updated
- 7 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.
PubMed 36996264
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Balloon Catheter for Cervical Ripening With or Without Traction: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02606643
- Acronym / sponsor ID
- 25148 / StLouisU
- Conditions
- Cervical Dilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- St. Louis UniversityUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 17 Nov 2015 (estimated)
- Results
- Posted 7 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Once admitted, women who will have a transcervical balloon catheter inserted for induction will be approached for participation in this study. If they agree to be take part in this study (tape or no tape) they will be randomized into the study. After the balloon catheter is inserted, the balloon will then be filled with approximately 50-60 mL of normal saline, this is normal procedure.
Study related: If randomized to "No Taping" the foley will be positioned comfortable and not placed to tension. For the "Tension" arm, tension will be placed on the balloon catheter, which will then be taped to the patient's inner thigh. The tension will be assessed and retaped as needed approximately every 30 minutes by the research and/or the nursing staff.
Detailed description
Once admitted, women who are schedule for induction and who's physician has order a balloon catheter, they will have a transcervical balloon catheter inserted-this is normal care. Patients will be placed in the dorsal lithotomy position in the delivery bed. The cervix will be examined digitally (this is the standard of care). The balloon catheter will be inserted by feel and passed through the cervix until the balloon is above the internal os. The balloon will then filled with approximately 50-60 mL of normal saline. This procedure is standard of care.
Randomization: 63 cards will be prepared to read "tape for tension" and 63 will be prepared to read "No tape/No Tension". These cards will be sealed in opaque envelopes and kept in the PI's office. After consent is obtained the PI will be notified and a sealed envelope will be opened and the patient and staff will be notified.
If randomized to "No tension" the catheter will be positioned comfortable and not placed to tension (this is currently the standard at SSM - Saint Mary's Hospital ).
For the "Tension" arm (research related), slight tension will be placed on the catheter, which will then be taped to the patient's inner thigh. The tension will be assessed and retaped as needed every 30 minutes by the research and/or the nursing staff.
Only slight tension will be applied to those catheters assign to the tension group. The catheter will be taped to the inner thigh so there is no "sag" in the catheter from the urethra to the tape. There is no method or device to "measure" the tension placed on these catheters, if the patient moves her leg it can lessen or increase the tension, these are known factors.
As part of the induction process, patients will be started on an infusion of oxytocin, this is the practice at SSMHC, unless there is a reason not to use oxytocin such as nonreassuring fetal heart tracing. In this situation it is the physician's choice of what to use for induction. Oxytocin is initiated at 2 milliunits/minute and increased 1-2 milliunits/minute approximately every 20 minutes to a maximum of 6 milliunits/minute while the Foley is in place.
After expulsion of the balloon, the resident or attending physician will performed a cervical examination to document the time and the cervical examination, and the oxytocin will be titrated to achieve acceptable contraction rates without tachysystole -this is standard care.
The patient's labor and delivery will be managed according to routine obstetric and institutional protocols. All patients will have continuous fetal heart rate and uterine activity monitoring.
Chart review will be performed on both the maternal and infant medical record from admission to discharge.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 Catheter to slight traction | Active comparator | Procedure: Slight tractionFor the "Tension" arm (research related), slight tension will be placed on the catheter, which will then be taped to the patient's inner thigh. The tension will be assessed and retaped as needed every 30 minutes by the research and/or the nursing staff. Only slight tension will be applied to those catheters assign to the tension group. The catheter will be taped to the inner thigh so there is no "sag" in the catheter from the urethra to the tape. There is no method or device to "measure" the tension placed on these catheters, if the patient moves her leg it can lessen or increase the tension, these are known factors. |
| Group 2 Catheter to no traction | Active comparator | Procedure: Foley Catheter to no tractionFoley catheter to no traction placed as SOC "No traction" applied |
Who may qualify
- Ages
- 14 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- singleton gestation
- Bishop score less than or equal to 6
- cephalic presentation
Key exclusion criteria (8 listed)
- prostaglandins given this admission
- any medical conditions precluding vaginal delivery
- significant cervical or intrauterine infection
- significant vaginal bleeding
- intrauterine fetal demise
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 |
|---|---|---|
| Slight tractionSlight traction will be applied to the balloon catheter | Procedure or surgery | Group 1 Catheter to slight traction |
| Foley Catheter to no tractionFoley Catheter to no traction | Procedure or surgery | Group 2 Catheter to no traction |
Primary outcome
Duration
Time frame: hours to delivery 0-26
Hours of labor
2 secondary outcomes
Deliveries Via Cesarean Delivery
Time frame: intraoperative
Vaginal Delivery Within 24 Hours
Time frame: 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36996264de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.
- Individual participant dataSharing planned: No
Related trials for Cervical Dilation
Not yet recruitingObservational study
Effect of Dural Puncture Epidural Analgesia on Oxytocin in Early vs Late Labor
Labor Analgesia, Labor Pain
Recruiting
Cervical Ripening Balloons for Same-Day Cervical Prep
Dilation and Evacuation
Recruiting
Cervical Preparation for Same-Day Dilation & Evacuation
Abortion, Second Trimester, Procedural Pain
RecruitingPhase 2/3
Anticholinergics for Cervical Edema in Labor
Labor Dystocia
Recruiting
Foley Balloon for Cervical Preparation Before Dilation and Evacuation
Abortion, Second Trimester, Abortion, Medical
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.
Gary Fruhman, MD principal investigator
St. Louis University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Slight traction and Foley Catheter to no traction in people with Cervical Dilation, run by St. Louis University at 1 site in United States.
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 3 inclusion and 8 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 7 Nov 2018. 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 United States. 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?
Yes. Results are posted in the registry (first posted 7 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Duration (time frame: hours to delivery 0-26). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02606643, which also lists 1 linked publication.
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 7 Nov 2018.