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The purpose of this study is to compare the efficacy of the combination of the supracervical foley bulb and vaginal misoprostol to vaginal misoprostol alone for labor induction. We hypothesize that use of the foley bulb plus vaginal misoprostol will result in shorter induction to delivery time.
More than 22% of all gravid women undergo induction of labor in the United States for various indications. Although there are several techniques and methods for induction of labor, the best agent and method still remains uncertain. To date, there has been no randomized trial comparing foley bulb plus vaginal misoprostol versus vaginal misoprostol alone. The combination of a mechanical device (foley bulb) and synthetic prostaglandin may have an additive or synergistic effect, resulting in greater degree of cervical ripening and shorter induction to delivery time (IDT). The addition of a synthetic prostaglandin to the foley bulb may also overcome the frequent observation of cervical dilation to 4cm by the foley bulb without effacement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Foley Bulb plus Misoprostol | Experimental |
| |
| Misoprostol | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Foley bulb | Device | This is a randomized trial comparing foley bulb with the use of misoprostol versus use of misoprostol alone for cervical ripening and labor induction. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time From Start of Labor Induction to Vaginal Delivery | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Successful Number of Vaginal and Cesarean Deliveries | To compare the number of vaginal deliveries to failed inductions requiring cesarean deliveries. | 72 hours |
| Number of Participants Experiencing Tachysystole With Deceleration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeanine F Carbone, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barnes Jewish Hospital | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23303106 | Result | Carbone JF, Tuuli MG, Fogertey PJ, Roehl KA, Macones GA. Combination of Foley bulb and vaginal misoprostol compared with vaginal misoprostol alone for cervical ripening and labor induction: a randomized controlled trial. Obstet Gynecol. 2013 Feb;121(2 Pt 1):247-252. doi: 10.1097/AOG.0b013e31827e5dca. | |
| 36996264 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | Foley Bulb Plus Misoprostol | In the combination arm participants received vaginal misoprostol at 25 micrograms every 4 hours. The foley bulb was also inserted in these participants. |
| FG001 | Misoprostol | The participants in this arm received misoprostol 25 micrograms every 4 hours. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Foley Bulb Plus Misoprostol | In the combination arm participants received vaginal misoprostol at 25 micrograms every 4 hours. The foley bulb was also inserted in these participants. |
| BG001 | Misoprostol |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 From Start of Labor Induction to Vaginal Delivery | Posted | Mean | Standard Deviation | hour | 72 hours |
|
|
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PI has left the institution and no adverse event information is available for this study.
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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 | Foley Bulb Plus Misoprostol | In the combination arm participants received vaginal misoprostol at 25 micrograms every 4 hours. The foley bulb was also inserted in these participants. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeanine Carbone MD | Washington University School of Medicine | 314-362-8523 | jfcarbone@hotmail.com |
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|
| 72 hours |
| Number of Participants With Post-partum Hemorrhage | 96 hours |
| Chorioamnionitis | 96 hours |
| Neonatal APGAR Scores | APGAR scores will be recorded at 1 and 5 minutes after birth. In the test, five things are used to check a baby's health. Each is scored on a scale of 0 to 2, with 2 being the best score: Appearance (skin color) Pulse (heart rate) Grimace response (reflexes) Activity (muscle tone) Respiration (breathing rate and effort) | 5 minutes |
| NICU Admission | 96 hours |
| Time to Complete Cervical Dilation | We will record the start time of induction until the patient's cervix is 10cm dilated | 72 hours |
| Delivery Within 24 Hours | Delivery within 24 hours of induction |
| Admission to NICU or Special Care Nursery | birth to 96 hours of age |
| 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. |
The participants in this arm received misoprostol 25 micrograms every 4 hours.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Maternal weight | Mean | Standard Deviation | kg |
|
| Indication for labor inductions | Count of Participants | Participants |
|
| Participants |
|
|
|
| Secondary | Successful Number of Vaginal and Cesarean Deliveries | To compare the number of vaginal deliveries to failed inductions requiring cesarean deliveries. | Posted | Count of Participants | Participants | 72 hours |
|
|
|
|
| Secondary | Number of Participants Experiencing Tachysystole With Deceleration | Posted | Count of Participants | Participants | 72 hours |
|
|
|
| Secondary | Number of Participants With Post-partum Hemorrhage | Posted | Count of Participants | Participants | 96 hours |
|
|
|
| Secondary | Chorioamnionitis | Posted | Count of Participants | Participants | 96 hours |
|
|
|
| Secondary | Neonatal APGAR Scores | APGAR scores will be recorded at 1 and 5 minutes after birth. In the test, five things are used to check a baby's health. Each is scored on a scale of 0 to 2, with 2 being the best score: Appearance (skin color) Pulse (heart rate) Grimace response (reflexes) Activity (muscle tone) Respiration (breathing rate and effort) | Posted | Median | Full Range | score on a scale | 5 minutes |
|
|
|
| Secondary | NICU Admission | Posted | Count of Participants | Participants | 96 hours |
|
|
|
| Secondary | Time to Complete Cervical Dilation | We will record the start time of induction until the patient's cervix is 10cm dilated | Posted | Mean | Standard Deviation | hour | 72 hours |
|
|
|
| Secondary | Delivery Within 24 Hours | Posted | Count of Participants | Participants | Delivery within 24 hours of induction |
|
|
|
| Secondary | Admission to NICU or Special Care Nursery | Posted | Count of Participants | Participants | birth to 96 hours of age |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Misoprostol | The participants in this arm received misoprostol 25 micrograms every 4 hours. | 0 | 0 | 0 | 0 |
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| 0.90 |
| Risk Ratio (RR) |
| 1.03 |
| 2-Sided |
| 95 |
| 0.57 |
| 1.90 |
| Superiority |