Early Amniotomy Following Transcervical Foley Balloon in the Induction of Labor: a Randomized Clinical Trial
| Registry | NCT04573517 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 150 (Actual) |
| Sponsor | The University of Texas Medical Branch, Galveston (Other) |
| Conditions | Labor Induction, Early Amniotomy |
| Interventions | Amniotomy, Foley balloon (Procedure, device) |
| Dates | start 2020-10-15, primary completion 2023-06-22, completion 2023-06-22, first posted 2020-10-05, last updated 2025-03-04 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Labor Induction All trials for Early Amniotomy All trials of Amniotomy All trials of Foley balloon
Amniotomy is commonly done in the management of labor, though there is little research guiding the timing of amniotomy. Recent research largely suggests a benefit to earlier amniotomy, reporting shorter labor courses with no increase in the number of cesarean deliveries. This is some research, however, that reports an increase in cesarean deliveries with early amniotomy. Due to the small number of studies evaluating this topic, as well as the conflicting results, more research is needed. Additionally, the method of cervical ripening prior to amniotomy should be accounted for, as it may have an impact on the overall labor course. The purpose of this study is to evaluate the impact of early versus delayed amniotomy on time of delivery time from induction to the active phase of labor, as well on total time to delivery and maternal and neonatal outcomes in women undergoing cervical ripening with the Foley balloon.
This will be an unblinded randomized clinical trial. The investigators will recruit 174 pregnant women undergoing induction of labor. Recruitment will occur on the Labor and Delivery unit at the time of induction, after the decision has been made to place a Foley balloon for cervical ripening. Enrolled subjects will be randomized to early or delayed amniotomy.
Subjects randomized to early amniotomy will undergo amniotomy within 2 hours of Foley balloon removal. Subjects randomized to delayed amniotomy will undergo amniotomy at least 4 hours after Foley balloon removal.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Early amniotomy | Experimental | Procedure: Amniotomy; Device: Foley balloon | Subjects randomized to this arm will undergo amniotomy within 2 hours of removal of Foley balloon. |
| Delayed amniotomy | Active comparator | Procedure: Amniotomy; Device: Foley balloon | Subjects randomized to this arm will undergo amniotomy at least 4 hours after removal of Foley balloon. |
Sex: Female, ages: 18 Years to any
Inclusion Criteria: * Age 18 * Singleton pregnancy * Term gestation (37 weeks gestation) * Cephalic presentation * Undergoing labor induction with transcervical Foley balloon Exclusion Criteria: * Previous uterine surgery * Prelabor rupture of membranes * Severe pre-eclampsia, HELLP, or eclampsia * HIV, HCV, or HBV * Heart disease * Fever (≥38 0C) at admission * Category II or III fetal heart rate tracing prior to randomization * Polyhydramnios * Fetal growth restriction <3% * EFW > 4200 g * Fetal demise or major congenital anomaly * Prisoners
| Milestone | Early Amniotomy | Delayed Amniotomy |
|---|---|---|
| Started | 75 | 75 |
| Completed | 75 | 74 |
| Not completed | 0 | 1 |
Time frame: Until the time of discharge from the hospital, an average of 3 days
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|---|---|---|
| Early Amniotomy | 0/75 (0.0%) | 0/75 (0.0%) | 0/75 (0.0%) |
| Delayed Amniotomy | 0/74 (0.0%) | 0/74 (0.0%) | 0/74 (0.0%) |
| Facility | City | Country | Status |
|---|---|---|---|
| University of Texas Medical Branch | Galveston, Texas | United States |