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The goal of this study is to compare cook catheter placement for 6 vs. 12 hours to see if there is faster time to delivery for people admitted to labor and delivery undergoing induction of labor.
Upon presentation to labor and delivery the participant will have a cook catheter inserted digitally or by direct visualization with a speculum. The uterine component of the balloon will be inflated to maximum 60mL. The catheter will be taped to the inner thigh with gentle traction. In both groups participants will be started on hospital-based oxytocin protocol. This protocol beings with 2 milliunits/min of oxytocin, increasing by 2 milliunits every 15 minutes until regular uterine contractions occur. The maximum dose of oxytocin is considered to be 30 milliunits. The cook catheter will then be removed at 6 vs. 12 hours based on randomization. At that point health care providers will manage active labor. Health care providers many perform amniotomy at any point during the induction process with recommendation for amniotomy with cervix more than 4cm dilated. Labor interventions are at the discretion of the healthcare provider. The participants will have continuous fetal monitoring throughout their induction, labor and delivery. Need for operative delivery or cesarean section will be at the discretion of the health provider.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 6 hour foley | Experimental | The participant will have a cook catheter inserted digitally or by direct visualization with a speculum with the uterine component of the balloon inflated to maximum 60mL. The catheter will be taped to the inner thigh with gentle traction. Participants will be started on hospital-based oxytocin protocol. The cook catheter will then be removed at 6 hours, determined by randomization. At that point health care providers will manage active labor. |
|
| 12 hour foley | No Intervention | The participant will have a cook catheter inserted digitally or by direct visualization with a speculum with the uterine component of the balloon inflated to maximum 60mL. The catheter will be taped to the inner thigh with gentle traction. Participants will be started on hospital-based oxytocin protocol. The cook catheter will then be removed at 12 hours, determined by randomization. At that point health care providers will manage active labor. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Foley catheter length | Device | see arm description |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Delivery | Time to delivery | Assessed following delivery (delivery day, day 0) |
| Measure | Description | Time Frame |
|---|---|---|
| Cesarean Delivery Rate | Cesarean delivery rate | Assessed following delivery (delivery day, day 0) |
| Time to Active Labor | Time to reaching active labor (defined as 5cm) |
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Inclusion Criteria: Women undergoing cervical ripening for labor induction at term (37-41 6/7 weeks) with a singleton gestation in cephalic presentation. Women will need to have a bishop score <6 or cervical dilation <2cm with intact membranes to be included.
Exclusion Criteria:
Pregnant women only
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| Name | Affiliation | Role |
|---|---|---|
| Sarah E Little, MD | Brigham and Women's Hospital, Harvard Medical School, Boston MA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02116 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27500341 | Background | Battarbee AN, Palatnik A, Peress DA, Grobman WA. Association of Early Amniotomy After Foley Balloon Catheter Ripening and Duration of Nulliparous Labor Induction. Obstet Gynecol. 2016 Sep;128(3):592-597. doi: 10.1097/AOG.0000000000001563. | |
| 11687101 | Background | Boulvain M, Kelly A, Lohse C, Stan C, Irion O. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2001;(4):CD001233. doi: 10.1002/14651858.CD001233. |
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Research only shared within study staff
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| ID | Title | Description |
|---|---|---|
| FG000 | 6 Hour Foley | The participant will have a cook catheter inserted digitally or by direct visualization with a speculum with the uterine component of the balloon inflated to maximum 60mL. The catheter will be taped to the inner thigh with gentle traction. Participants will be started on hospital-based oxytocin protocol. The cook catheter will then be removed at 6 hours, determined by randomization. At that point health care providers will manage active labor. Foley catheter length: see arm description |
| FG001 | 12 Hour Foley | The participant will have a cook catheter inserted digitally or by direct visualization with a speculum with the uterine component of the balloon inflated to maximum 60mL. The catheter will be taped to the inner thigh with gentle traction. Participants will be started on hospital-based oxytocin protocol. The cook catheter will then be removed at 12 hours, determined by randomization. At that point health care providers will manage active labor. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 6 Hour Foley | Foley for up to 6 hours |
| BG001 | 12 Hour Foley | Foley up to 12 hours |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Delivery | Time to delivery | Posted | Median | Inter-Quartile Range | hours | Assessed following delivery (delivery day, day 0) |
|
Up to 4 week postpartum
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 6 Hour Foley - Mothers | The participant will have a cook catheter inserted digitally or by direct visualization with a speculum with the uterine component of the balloon inflated to maximum 60mL. The catheter will be taped to the inner thigh with gentle traction. Participants will be started on hospital-based oxytocin protocol. The cook catheter will then be removed at 6 hours, determined by randomization. At that point health care providers will manage active labor. Foley catheter length: see arm description |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sarah Little | Brigham and Women's Hospital | 617-732-5452 | selittle@bwh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 21, 2018 | Feb 22, 2022 | Prot_SAP_000.pdf |
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Randomized controlled trial
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| Assessed following delivery (delivery day, day 0) |
| Delivery Within 12 Hours | The number of women in each group who deliver within 12 hours | Assessed following delivery (delivery day, day 0) |
| Delivery Within 24 Hours | The number of women in each group who deliver within 24 hours | Assessed following delivery (delivery day, day 0) |
| Maternal Length of Stay | Length of hospital stay from start of induction to postpartum discharge | Assessed at end of study period (week 4) |
| Indication for Cesarean Delivery | Number of Patient with Indication for Cesarean Delivery | Assessed following delivery (delivery day, day 0) |
| Maternal Complications | Estimated blood loss, blood transfusion, higher order laceration, endometritis, wound infection, venous thromboembolism, hysterectomy, ICU admission, maternal death | Assessed at end of study period (week 4) |
| Neonatal Complications | culture-proven neonatal sepsis, neonatal blood transfusion, hypoxic-ischemic encephalopathy, intraventricular hemorrhage grade 3 or 4, or therapeutic hypothermia | Assessed at end of study period (week 4) |
| NICU Admission | Number of infants admitted to NICU | Assessed at end of study period (week 4) |
| NICU Admission >48 Hours | Number of infants admitted to NICU for >48 hours | Assessed at end of study period (week 4) |
| Neonatal Length of Stay | Days of hospital stay | Assessed at end of study period (week 4) |
| 21272849 | Background | Cromi A, Ghezzi F, Agosti M, Serati M, Uccella S, Arlant V, Bolis P. Is transcervical Foley catheter actually slower than prostaglandins in ripening the cervix? A randomized study. Am J Obstet Gynecol. 2011 Apr;204(4):338.e1-7. doi: 10.1016/j.ajog.2010.11.029. Epub 2011 Jan 26. |
| 26727629 | Background | Hamilton BE, Martin JA, Osterman MJ, Curtin SC, Matthews TJ. Births: Final Data for 2014. Natl Vital Stat Rep. 2015 Dec;64(12):1-64. |
| 27824758 | Background | Levine LD, Downes KL, Elovitz MA, Parry S, Sammel MD, Srinivas SK. Mechanical and Pharmacologic Methods of Labor Induction: A Randomized Controlled Trial. Obstet Gynecol. 2016 Dec;128(6):1357-1364. doi: 10.1097/AOG.0000000000001778. |
| 33771496 | Derived | Lassey 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. |
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Nulliparous | Count of Participants | Participants |
|
| BMI | Median | Inter-Quartile Range | kg/m2 |
|
| Gestational Age | Median | Inter-Quartile Range | Weeks |
|
| Bishop score at randomization | Scale 0-12, higher is more favorable cervix for induction | Median | Inter-Quartile Range | units on a scale |
|
| Birthweight (g) | Median | Inter-Quartile Range | grams |
|
|
|
|
| Secondary | Cesarean Delivery Rate | Cesarean delivery rate | Posted | Count of Participants | Participants | Assessed following delivery (delivery day, day 0) |
|
|
|
|
| Secondary | Time to Active Labor | Time to reaching active labor (defined as 5cm) | Posted | Median | Inter-Quartile Range | hours | Assessed following delivery (delivery day, day 0) |
|
|
|
|
| Secondary | Delivery Within 12 Hours | The number of women in each group who deliver within 12 hours | Posted | Count of Participants | Participants | Assessed following delivery (delivery day, day 0) |
|
|
|
|
| Secondary | Delivery Within 24 Hours | The number of women in each group who deliver within 24 hours | Posted | Count of Participants | Participants | Assessed following delivery (delivery day, day 0) |
|
|
|
|
| Secondary | Maternal Length of Stay | Length of hospital stay from start of induction to postpartum discharge | Posted | Median | Inter-Quartile Range | days | Assessed at end of study period (week 4) |
|
|
|
| Secondary | Indication for Cesarean Delivery | Number of Patient with Indication for Cesarean Delivery | Posted | Count of Participants | Participants | Assessed following delivery (delivery day, day 0) |
|
|
|
|
| Secondary | Maternal Complications | Estimated blood loss, blood transfusion, higher order laceration, endometritis, wound infection, venous thromboembolism, hysterectomy, ICU admission, maternal death | Posted | Count of Participants | Participants | Assessed at end of study period (week 4) |
|
|
|
| Secondary | Neonatal Complications | culture-proven neonatal sepsis, neonatal blood transfusion, hypoxic-ischemic encephalopathy, intraventricular hemorrhage grade 3 or 4, or therapeutic hypothermia | Posted | Count of Participants | Participants | Assessed at end of study period (week 4) |
|
|
|
| Secondary | NICU Admission | Number of infants admitted to NICU | Posted | Count of Participants | Participants | Assessed at end of study period (week 4) |
|
|
|
| Secondary | NICU Admission >48 Hours | Number of infants admitted to NICU for >48 hours | Posted | Count of Participants | Participants | Assessed at end of study period (week 4) |
|
|
|
| Secondary | Neonatal Length of Stay | Days of hospital stay | Posted | Median | Inter-Quartile Range | days | Assessed at end of study period (week 4) |
|
|
|
| 0 |
| 89 |
| 0 |
| 89 |
| 0 |
| 89 |
| EG001 | 12 Hour Foley - Mothers | The participant will have a cook catheter inserted digitally or by direct visualization with a speculum with the uterine component of the balloon inflated to maximum 60mL. The catheter will be taped to the inner thigh with gentle traction. Participants will be started on hospital-based oxytocin protocol. The cook catheter will then be removed at 12 hours, determined by randomization. At that point health care providers will manage active labor. | 0 | 89 | 0 | 89 | 0 | 89 |
| EG002 | 6 Hour Foley - Neonates | The participant will have a cook catheter inserted digitally or by direct visualization with a speculum with the uterine component of the balloon inflated to maximum 60mL. The catheter will be taped to the inner thigh with gentle traction. Participants will be started on hospital-based oxytocin protocol. The cook catheter will then be removed at 6 hours, determined by randomization. At that point health care providers will manage active labor. Foley catheter length: see arm description | 0 | 89 | 0 | 89 | 0 | 89 |
| EG003 | 12 Hour Foley - Neonates | The participant will have a cook catheter inserted digitally or by direct visualization with a speculum with the uterine component of the balloon inflated to maximum 60mL. The catheter will be taped to the inner thigh with gentle traction. Participants will be started on hospital-based oxytocin protocol. The cook catheter will then be removed at 12 hours, determined by randomization. At that point health care providers will manage active labor. | 0 | 89 | 0 | 89 | 0 | 89 |
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| Wound infection |
|
| Endometritis |
|
| chorioamnionitis |
|