Not provided
Not provided
Not provided
Not provided
Inadequate enrollment. Key study personnel transitioned to a different role.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a randomized study evaluating the impact of pre-hospital cervical ripening with a transcervical Foley balloon before labor induction in full-term pregnancies on the length of inpatient labor induction and maternal satisfaction with the labor induction process. The investigators hypothesize that women who receive pre-hospital cervical ripening will have a shorter duration of inpatient labor induction as compared to women without pre-hospital cervical ripening.
Labor induction is a common procedure among pregnant patients at term. This process involves a period of cervical preparation ("ripening") for women who have an "unfavorable" cervical examination at the time labor induction is scheduled. Cervical ripening may take place with pharmacologic or mechanical strategies, which at this time are traditionally administered on an inpatient basis. This process can 24 or more hours, resulting in a lengthy hospitalization with the associated costs and frustrations for both patients and L&D staff.
The proposed study is a randomized, controlled trial to explore the following research question: Among women with full-term pregnancies requiring labor induction, does pre-hospital, outpatient cervical ripening reduce the amount of inpatient time needed to achieve delivery as compared to no pre-hospital cervical ripening? As a secondary objective, we also wish to explore if outpatient cervical ripening is acceptable to patients.
This study will involve randomizing eligible and consenting women who have been scheduled for labor induction by their obstetrical providers into a pre-hospital cervical ripening (intervention) group or a no pre-hospital ripening (control) group. A trans-cervical Foley balloon (TCFB) will be used for outpatient pre-hospital cervical ripening in women randomized to the intervention group. No pre-hospital ripening will be performed for women in the control group. Both groups will be admitted for induction as scheduled and will undergo labor induction according to a specified, Bishop-score based induction protocol, which may or may not include a TCFB. We will compare the duration of inpatient stays from admission until delivery between the groups as well as satisfaction with the pre-hospital period and labor and delivery experience. Maternal and neonatal outcomes will also be compared between the two groups.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Management | No Intervention | Patients in the usual management arm will have no pre-hospital cervical ripening and will undergo labor induction according to standard labor induction protocols on an inpatient basis. | |
| Outpatient transcervical Foley balloon | Experimental | Patients in the experimental group will have a 30 cc transcervical Foley balloon placed in the outpatient setting approximately 12-18 hours prior to their labor induction. Once admitted, they will undergo inpatient labor induction as per usual protocols. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Outpatient transcervical Foley balloon | Device | A 30 cc transcervical Foley balloon will be placed in the outpatient setting prior to labor induction. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Inpatient Time Required to Achieve Delivery | Time from admission to the hospital until delivery | From admission to delivery, expected average of 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal Satisfaction | Maternal satisfaction with the period leading up to admission and the hospital stay, measured by interview. | up to 48 hours after delivery |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kirsten Salmeen, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF Benioff Children's Hospital | San Francisco | California | 94143 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36996264 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Usual Management | Patients in the usual management arm will have no pre-hospital cervical ripening and will undergo labor induction according to standard labor induction protocols on an inpatient basis. |
| FG001 | Outpatient Transcervical Foley Balloon | Patients in the experimental group will have a 30 cc transcervical Foley balloon placed in the outpatient setting approximately 12-18 hours prior to their labor induction. Once admitted, they will undergo inpatient labor induction as per usual protocols. Outpatient transcervical Foley balloon: A 30 cc transcervical Foley balloon will be placed in the outpatient setting prior to labor induction. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Study terminated prior to data collection.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Usual Management | Patients in the usual management arm will have no pre-hospital cervical ripening and will undergo labor induction according to standard labor induction protocols on an inpatient basis. |
| BG001 | Outpatient Transcervical Foley Balloon |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical |
| 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 | Duration of Inpatient Time Required to Achieve Delivery | Time from admission to the hospital until delivery | Study terminated prior to data collection. | Posted | From admission to delivery, expected average of 48 hours |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Management | Patients in the usual management arm will have no pre-hospital cervical ripening and will undergo labor induction according to standard labor induction protocols on an inpatient basis. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kirsten Salmeen | UCSF | 628-213-5314 | kesalmeen@gmail.com |
Not provided
Not provided
Not provided
Not provided
Not provided
Patients in the experimental group will have a 30 cc transcervical Foley balloon placed in the outpatient setting approximately 12-18 hours prior to their labor induction. Once admitted, they will undergo inpatient labor induction as per usual protocols. Outpatient transcervical Foley balloon: A 30 cc transcervical Foley balloon will be placed in the outpatient setting prior to labor induction. |
| BG002 | Total | Total of all reporting groups |
|
| Age, Continuous |
| Sex: Female, Male |
|
| Region of Enrollment | participants |
|
|
| Secondary | Maternal Satisfaction | Maternal satisfaction with the period leading up to admission and the hospital stay, measured by interview. | Study terminated prior to data collection. | Posted | up to 48 hours after delivery |
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 0 |
| 3 |
| EG001 | Outpatient Transcervical Foley Balloon | Patients in the experimental group will have a 30 cc transcervical Foley balloon placed in the outpatient setting approximately 12-18 hours prior to their labor induction. Once admitted, they will undergo inpatient labor induction as per usual protocols. Outpatient transcervical Foley balloon: A 30 cc transcervical Foley balloon will be placed in the outpatient setting prior to labor induction. | 0 | 5 | 0 | 5 | 0 | 5 |
Not provided
Not provided
Not provided