Labor Induction Clinical Trial
Official title:
Early Amniotomy Following Transcervical Foley Balloon in the Induction of Labor: a Randomized Clinical Trial
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT00141895 -
A Randomized Trial of Two Regimens of Misoprostol for Second Trimester Termination for Intrauterine Fetal Death
|
Phase 3 | |
Completed |
NCT03039036 -
Early Amniotomy Versus Delayed Amniotomy Following Foley Catheter Ripening in Nulliparous Labor Induction
|
N/A | |
Completed |
NCT05827731 -
Cervical Double Balloon Combined With Oxytocin
|
N/A | |
Recruiting |
NCT04035382 -
BMI-Associated Labor Induction: A Prospective Trial
|
N/A | |
Withdrawn |
NCT00771511 -
Cervical Capsaicin for Labor Induction and Pain Relief
|
Phase 4 | |
Recruiting |
NCT04075630 -
Observatory on Artificial Labour-induction Methods and Measuring Immediate Postpartum Maternal Satisfaction
|
||
Withdrawn |
NCT05257187 -
Foley Catheter Induction
|
N/A | |
Recruiting |
NCT03016442 -
Dinoprostone Vaginal Insert Versus Double Balloon Catheter for Preinduction Cervical Ripening
|
Phase 2 | |
Not yet recruiting |
NCT00984347 -
Breast Stimulation Versus Pitocin for Induction of Labor
|
N/A | |
Completed |
NCT04596397 -
Oral Misoprostol for Outpatient Induction of Labor
|
N/A | |
Completed |
NCT03504670 -
Preterm Induction of Labor Timing of Amniotomy: A Randomized Controlled Trial
|
N/A | |
Completed |
NCT00886860 -
The Comparison of Efficacy for Cervical Ripening in Labor Induction Between Titrated and Conventional Oral Misoprostol
|
Phase 4 | |
Completed |
NCT00504465 -
Combined Agent Randomized Trial of Induction of Labor
|
N/A | |
Completed |
NCT01402050 -
Foley Catheter Versus Cervidil for Induction of Labor at Term
|
N/A | |
Completed |
NCT01170819 -
Double Balloon Catheter Versus Dinoprostone Vaginal Insert for Cervical Ripening.
|
Phase 4 | |
Completed |
NCT00529295 -
Titrated Oral Compared With Vaginal Misoprostol for Labor Induction at Term
|
Phase 3 | |
Completed |
NCT00442663 -
Trial of Foley Catheter With and Without Extra-Amniotic Saline Infusion for Labor Induction
|
N/A | |
Completed |
NCT00346840 -
Safety and Efficacy Study of Misoprostol Vaginal Insert for Induction of Labour
|
Phase 2 | |
Withdrawn |
NCT03218735 -
Early Term Delivery Versus Expectant Management of the Large for Gestational Age Fetus
|
N/A | |
Completed |
NCT02639429 -
Cervical Ripening for Obese Women: A Randomized, Comparative Effectiveness Trial
|
Phase 4 |