Labor InductionNCT05257187
Foley Catheter Induction
A study testing Transcervical foley catheter in people with Labor Induction, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
The foley catheter (single lumen balloon) is one of the most cost effective, readily available methods for cervical ripening to begin an induction of labor. It is most commonly used in conjunction with oxytocin, a medication given to induce contractions. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Labor Induction
- What is being tested?
- Transcervical foley catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2021to Mar 2022
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18 through 50 years old
- Bishop score of 6 or less
- Singleton pregnancies at 37 weeks or more
- Absence of labor or rupture of membranes.
Who cannot join
- COVID positive patients
- Previous history of cesarean delivery
- Ruptured membranes (the institutional policy states women cannot have foley catheters placed if membranes are ruptured)
- Documented labor on admission (will include only patients being induced)
- Fetal distress on admission (e.g. indication for induction of labor being category 2 tracing as these patients may have increased risk of cesarean delivery)
- Certain fetal anomalies (e.g. brain anomalies, abdominal wall or neural tube defects, fetal cardiac arrhythmias)
- Contraindication to vaginal delivery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Shortening the Duration of Labor: Can We Remove Transcervical Foley Catheters Earlier
The foley catheter (single lumen balloon) is one of the most cost effective, readily available methods for cervical ripening to begin an induction of labor. It is most commonly used in conjunction with oxytocin, a medication given to induce contractions. However, there is no clear timeline for when to remove the foley catheter or how long foley catheters can be safely kept in place.
The study team's goal is to conduct a randomized controlled trial (RCT) in nulliparous and multiparous patients to determine the optimal length of time to retain foley catheters (single balloon) for induction of labor to achieve vaginal delivery while shortening the overall length of labor. Based on our power analysis, the study team plans to enroll a total of 356 patients (218 nulliparous patients and 138 multiparous patients) over the course of 18 months.
Then the study team will randomize patients to one of the following two groups: foley catheter removal after 6 hours or foley catheter removal after 12 hours. All patients will receive simultaneous pitocin and a foley catheter, and the remainder of the induction course (i.e. rupture of membranes, etc.) will be left to the discretion of the obstetric provider. The primary outcome will be time of foley catheter insertion to delivery. Secondary outcomes will be rates of cesarean delivery and obstetric/neonatal outcomes.
Read the detailed description
The study team's goal is to conduct a randomized controlled trial in nulliparous and multiparous patients to determine the optimal length of time to retain foley catheters (single balloon) for induction of labor to achieve vaginal delivery while shortening the overall length of labor. The primary hypothesis is that removal of the single balloon foley catheter at 6 hours after insertion compared to removal at 12 hours results in no difference in time to delivery and does not increase the cesarean delivery rate for nulliparous patient or for multiparous patients.
Background Nearly one quarter of all deliveries at term, in developed countries, involve an induction of labor. When labor induction begins, a baseline cervical exam is performed to determine a Bishop score and whether cervical ripening is indicated with medications (e.g misoprostol) or mechanical methods (foley catheter single catheter or cook catheter double balloon). The literature suggests that foley catheters can be removed without waiting for spontaneous expulsion with no difference in the length of labor, but there is no clear timeline for when to remove the foley catheter or how long foley catheters can be safely kept in place. One RCT found that the time from Cook catheter insertion to delivery is shorter by 5.8 hours for nulliparous patients and by 4.7 hours for multiparous patients without worsening maternal or neonatal outcomes
.
A recent publication found similar results applicable to single balloon foley catheters. In that study, patients randomized to foley balloon removal at 6 hours had a statistically significant shorter insertion-to-delivery time by 5 hours compared to the 12-hour removal group with no increase in the cesarean delivery rate. Although this study was the first randomized controlled trial to compare the use of foley catheters for labor induction for up to 6 hours retention vs. 12 hours retention, the study was underpowered for multiparous patients. The researchers are hoping to contribute the knowledge gap about the optimal time to retain foley catheters particularly in multiparous patients.
Longer labors have been associated with an increased risk of a prolonged second stage, maternal fever, shoulder dystocia, and admission to a level 2 or 3 nursery. In the advent of the ARRIVE Trial, more patients are now undergoing induction of labor, so obstetric providers are incentivized to provide efficient and safe methods of labor induction that are effective at achieving vaginal delivery. The study team's goal is to conduct a randomized controlled trial in nulliparous and multiparous women to determine the optimal length of time to retain foley catheters (single balloon) for induction of labor to achieve vaginal delivery while shortening the overall length of labor.
At the institution (Mount Sinai West), the study team will use foley catheters instead of cook catheters and there is a trend towards waiting for spontaneous expulsion. The study team will collect demographic and pregnancy data about patients and determine if they meet inclusion criteria. Then the study team will randomize patients to one of the following two groups: foley catheter removal after 6 hours or foley catheter removal after 12 hours. All patients will receive simultaneous pitocin and foley catheter. The remainder of the induction course (i.e. rupture of membranes, etc.) will be left to the discretion of the obstetric provider.
- Conditions
- Labor Induction
- Being tested
- Transcervical foley catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcervical foley catheterDevice
The foley catheter is inserted manually by an obstetric provider through the cervix and inflated with 60cc of saline. Once in the correct position, the catheter is inflated, which puts pressure on the cervix, allowing it to release hormones that soften the cervix and help the cervix to open. The foley catheter can be left in place up to 12 hours but typically will fall out when the cervix is dilated to 3-4 centimeters.
| Study group | Role | What they receive |
|---|---|---|
| 6 hour foley catheter retention | Active comparator | Patients will have the foley catheter in place for up to 6 hours starting from insertion time to removal. If the catheter falls out earlier than the 6 hour mark, the patient will still be included for analysis. Receives: Device: Transcervical foley catheter |
| 12 hour foley balloon retention | Placebo comparator | Patients will have the foley catheter in place for up to 12 hours starting from insertion time to removal. If the catheter falls out earlier than the 12 hour mark, the patient will still be included for analysis. Receives: Device: Transcervical foley catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Labor
Length of time from foley catheter insertion to delivery time in minutes at the time of infant delivery
Measured: Day 1, at time of infant delivery
Secondary outcomes (7)
Number of Cesarean delivery
Number of delivery by Cesarean delivery
Measured: Day 1, at time of infant delivery
Number of Maternal Intrapartum Fever
Number of participants with intrapartum fever
Measured: Day 1, at time of infant delivery
Number of Participants that require Intrapartum antibiotic administration
Number of Participants that require Intrapartum antibiotic administration
Measured: Day 1, at time of infant delivery
Number of Participants with Postpartum Hemorrhage
Number of participants who had postpartum hemorrhage
Measured: 6 Days Postpartum
Number of NICU admission
The number of babies delivered by patients enrolled in the study who ended up admitted to the Neonatal Intensive Care Unity (NICU) for any amount of time
Measured: 6 Days Postpartum
Number of neonatal participants with APGAR score <7
Number of neonatal participants with 5 minute APGAR <7. APGAR score range is from 0-10, with the higher scores indicating better health outcome.
Measured: Day 1, 5 minutes of infant delivery
Number of neonatal participants with hospital stay greater than 6 days
Number of neonatal participants with hospital stay greater than 6 days
Measured: 6 Days Postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study start7 Nov 2021 (estimated)
- Primary completionMar 2022 (estimated)
- Study completionMar 2022 (estimated)
Why it stopped: unable to recruit participants due to COVID pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Labor InductionStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- 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
- Parallel groups
- Model description
- The study team will randomize patients to one of the following two groups: foley balloon removal after 6 hours or foley balloon removal after 12 hours. All patients will receive simultaneous pitocin and foley balloon. The remainder of the induction course (i.e. rupture of membranes, etc.) will be left to the discretion of the obstetric provider. The study is intention-to-treat meaning that if the foley balloon falls out earlier than the 6 hour or the 12 hour mark, the patient will still be included in the study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melissa Lozano, Icahn School of Medicine at Mount Sinai
- Investigators
- Lois Brustman, MD, Study director, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05257187
- Sponsor's protocol ID
- STUDY-21-00129
- Status last verified
- Nov 2023
- First submitted
- 16 Feb 2022
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification.
Publications
Bleicher I, Dikopoltsev E, Kadour-Ferro E, Sammour R, Gonen R, Sagi S, Eshel A, Nussam L, Vitner D. Double-Balloon Device for 6 Compared With 12 Hours for Cervical Ripening: A Randomized Controlled Trial. Obstet Gynecol. 2020 May;135(5):1153-1160. doi: 10.1097/AOG.0000000000003804.
PubMed 32282603Lassey SC, Haber HR, Kanbergs A, Robinson JN, Little SE. Six versus twelve hours of single-balloon catheter placement with oxytocin administration for labor induction: a randomized controlled trial. Am J Obstet Gynecol. 2021 Jun;224(6):611.e1-611.e8. doi: 10.1016/j.ajog.2021.03.021. Epub 2021 Mar 23.
PubMed 33771496
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shortening the Duration of Labor: Can We Remove Transcervical Foley Catheters Earlier
- ClinicalTrials.gov ID
- NCT05257187
- Acronym / sponsor ID
- STUDY-21-00129
- Conditions
- Labor Induction
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: unable to recruit participants due to COVID pandemic
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 7 Nov 2021 (estimated)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 25 Feb 2022 (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.
The foley catheter (single lumen balloon) is one of the most cost effective, readily available methods for cervical ripening to begin an induction of labor. It is most commonly used in conjunction with oxytocin, a medication given to induce contractions. However, there is no clear timeline for when to remove the foley catheter or how long foley catheters can be safely kept in place.
The study team's goal is to conduct a randomized controlled trial (RCT) in nulliparous and multiparous patients to determine the optimal length of time to retain foley catheters (single balloon) for induction of labor to achieve vaginal delivery while shortening the overall length of labor. Based on our power analysis, the study team plans to enroll a total of 356 patients (218 nulliparous patients and 138 multiparous patients) over the course of 18 months.
Then the study team will randomize patients to one of the following two groups: foley catheter removal after 6 hours or foley catheter removal after 12 hours. All patients will receive simultaneous pitocin and a foley catheter, and the remainder of the induction course (i.e. rupture of membranes, etc.) will be left to the discretion of the obstetric provider. The primary outcome will be time of foley catheter insertion to delivery. Secondary outcomes will be rates of cesarean delivery and obstetric/neonatal outcomes.
Detailed description
The study team's goal is to conduct a randomized controlled trial in nulliparous and multiparous patients to determine the optimal length of time to retain foley catheters (single balloon) for induction of labor to achieve vaginal delivery while shortening the overall length of labor. The primary hypothesis is that removal of the single balloon foley catheter at 6 hours after insertion compared to removal at 12 hours results in no difference in time to delivery and does not increase the cesarean delivery rate for nulliparous patient or for multiparous patients.
Background Nearly one quarter of all deliveries at term, in developed countries, involve an induction of labor. When labor induction begins, a baseline cervical exam is performed to determine a Bishop score and whether cervical ripening is indicated with medications (e.g misoprostol) or mechanical methods (foley catheter single catheter or cook catheter double balloon). The literature suggests that foley catheters can be removed without waiting for spontaneous expulsion with no difference in the length of labor, but there is no clear timeline for when to remove the foley catheter or how long foley catheters can be safely kept in place. One RCT found that the time from Cook catheter insertion to delivery is shorter by 5.8 hours for nulliparous patients and by 4.7 hours for multiparous patients without worsening maternal or neonatal outcomes
.
A recent publication found similar results applicable to single balloon foley catheters. In that study, patients randomized to foley balloon removal at 6 hours had a statistically significant shorter insertion-to-delivery time by 5 hours compared to the 12-hour removal group with no increase in the cesarean delivery rate. Although this study was the first randomized controlled trial to compare the use of foley catheters for labor induction for up to 6 hours retention vs. 12 hours retention, the study was underpowered for multiparous patients. The researchers are hoping to contribute the knowledge gap about the optimal time to retain foley catheters particularly in multiparous patients.
Longer labors have been associated with an increased risk of a prolonged second stage, maternal fever, shoulder dystocia, and admission to a level 2 or 3 nursery. In the advent of the ARRIVE Trial, more patients are now undergoing induction of labor, so obstetric providers are incentivized to provide efficient and safe methods of labor induction that are effective at achieving vaginal delivery. The study team's goal is to conduct a randomized controlled trial in nulliparous and multiparous women to determine the optimal length of time to retain foley catheters (single balloon) for induction of labor to achieve vaginal delivery while shortening the overall length of labor.
At the institution (Mount Sinai West), the study team will use foley catheters instead of cook catheters and there is a trend towards waiting for spontaneous expulsion. The study team will collect demographic and pregnancy data about patients and determine if they meet inclusion criteria. Then the study team will randomize patients to one of the following two groups: foley catheter removal after 6 hours or foley catheter removal after 12 hours. All patients will receive simultaneous pitocin and foley catheter. The remainder of the induction course (i.e. rupture of membranes, etc.) will be left to the discretion of the obstetric provider.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The study team will randomize patients to one of the following two groups: foley balloon removal after 6 hours or foley balloon removal after 12 hours. All patients will receive simultaneous pitocin and foley balloon. The remainder of the induction course (i.e. rupture of membranes, etc.) will be left to the discretion of the obstetric provider. The study is intention-to-treat meaning that if the foley balloon falls out earlier than the 6 hour or the 12 hour mark, the patient will still be included in the study.
| Arm | Type | Receives |
|---|---|---|
| 6 hour foley catheter retention | Active comparator | Device: Transcervical foley catheterPatients will have the foley catheter in place for up to 6 hours starting from insertion time to removal. If the catheter falls out earlier than the 6 hour mark, the patient will still be included for analysis. |
| 12 hour foley balloon retention | Placebo comparator | Device: Transcervical foley catheterPatients will have the foley catheter in place for up to 12 hours starting from insertion time to removal. If the catheter falls out earlier than the 12 hour mark, the patient will still be included for analysis. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 18 through 50 years old
- Bishop score of 6 or less
- Singleton pregnancies at 37 weeks or more
- Absence of labor or rupture of membranes.
Key exclusion criteria (7 listed)
- COVID positive patients
- Previous history of cesarean delivery
- Ruptured membranes (the institutional policy states women cannot have foley catheters placed if membranes are ruptured)
- Documented labor on admission (will include only patients being induced)
- Fetal distress on admission (e.g. indication for induction of labor being category 2 tracing as these patients may have increased risk of cesarean delivery)
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 |
|---|---|---|
| Transcervical foley catheterThe foley catheter is inserted manually by an obstetric provider through the cervix and inflated with 60cc of saline. Once in the correct position, the catheter is inflated, which puts pressure on the cervix, allowing it to release hormones that soften the cervix and help the cervix to open. The foley catheter can be left in place up to 12 hours but typically will fall out when the cervix is dilated to 3-4 centimeters. | Device | 12 hour foley balloon retention, 6 hour foley catheter retention |
Primary outcome
Length of Labor
Time frame: Day 1, at time of infant delivery
Length of time from foley catheter insertion to delivery time in minutes at the time of infant delivery
7 secondary outcomes
Number of Cesarean delivery
Time frame: Day 1, at time of infant delivery
Number of Maternal Intrapartum Fever
Time frame: Day 1, at time of infant delivery
Number of Participants that require Intrapartum antibiotic administration
Time frame: Day 1, at time of infant delivery
Number of Participants with Postpartum Hemorrhage
Time frame: 6 Days Postpartum
Number of NICU admission
Time frame: 6 Days Postpartum
Number of neonatal participants with APGAR score <7
Time frame: Day 1, 5 minutes of infant delivery
Number of neonatal participants with hospital stay greater than 6 days
Time frame: 6 Days Postpartum
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Background: PubMed 32282603Bleicher I, Dikopoltsev E, Kadour-Ferro E, Sammour R, Gonen R, Sagi S, Eshel A, Nussam L, Vitner D. Double-Balloon Device for 6 Compared With 12 Hours for Cervical Ripening: A Randomized Controlled Trial. Obstet Gynecol. 2020 May;135(5):1153-1160. doi: 10.1097/AOG.0000000000003804.
- Background: PubMed 33771496Lassey SC, Haber HR, Kanbergs A, Robinson JN, Little SE. Six versus twelve hours of single-balloon catheter placement with oxytocin administration for labor induction: a randomized controlled trial. Am J Obstet Gynecol. 2021 Jun;224(6):611.e1-611.e8. doi: 10.1016/j.ajog.2021.03.021. Epub 2021 Mar 23.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification.
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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.
Lois Brustman, MD study director
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcervical foley catheter in people with Labor Induction, run by Icahn School of Medicine at Mount Sinai 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 4 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: withdrawn, as of the sponsor's last update on 18 Nov 2023. 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. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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?
Length of Labor (time frame: Day 1, at time of infant delivery). 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 NCT05257187, which also lists 2 linked publications.
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 18 Nov 2023.