Labor Induction Clinical Trial
Official title:
Preterm Induction of Labor Timing of Amniotomy: A Randomized Controlled Trial
Artificial rupture of membranes (amniotomy) is a commonly used technique to safely induce and augment labor. It has been shown to reduce the duration of spontaneous and induced labor in term patients (≥37 weeks' gestation). The utility of amniotomy in preterm patients (<37 weeks' gestation) undergoing medically-indicated induction of labor is unknown. However, it remains a commonly used strategy. We will conduct a trial comparing early amniotomy versus late amniotomy during medically-indicated induction of labor between 23.0 and 35.6 weeks gestation. Women will be randomized to early or late amniotomy after the obstetrician has decided to induce labor for a medical indication. We hypothesize that more women in the early amniotomy group will require cesarean delivery, and the duration of labor will increase in the early amniotomy group.
The rate of preterm birth in the United States is nearly 10%. Up to one-third of these births are the result of a medically-indicated delivery. While induction of labor in women at term gestation has been extensively studied, the same is not true for preterm gestations. Consequently, the same methods of labor induction are used in term and preterm gestations, although preterm gestations may have different responses to induction agents compared to term gestations. At our institution, a standard induction of labor - for term or preterm women - is performed using a cervical Foley catheter or misoprostol for cervical ripening with the addition of intravenous oxytocin for labor augmentation. As membranes do not typically spontaneously rupture during the induction process, amniotomy is commonly utilized by providers to help augment labor. Amniotomy releases prostaglandin-rich amniotic fluid. These prostaglandins are important mediators of uterine contractility and ultimately active labor. It has been shown to reduce the duration of spontaneous and induced labor in term patients. The timing of amniotomy is left up to the discretion of the treating providers, as there are no randomized controlled trials to support early versus late amniotomy at preterm gestations. However, a retrospective cohort of nulliparous and multiparous women at our institution undergoing induction at 23-34 weeks, and evaluating early amniotomy at <4cm cervical dilation versus late amniotomy at ≥4cm dilation, showed an increased risk of cesarean delivery and increased time from start of induction to delivery for early amniotomy, although only the cesarean delivery outcome was significant after adjusting for confounders. We will conduct an intention-to-treat randomized controlled trial comparing early amniotomy versus late amniotomy during medically-indicated induction of labor between 23.0 and 35.6 weeks gestation. Women will be randomized to early or late amniotomy after the attending obstetrician has decided to induce labor for a medical indication. Early amniotomy will be performed prior to 4cm cervical dilation being reached. Late amniotomy will be performed at greater than or equal to 4cm cervical dilation. The purpose of this study is to determine whether timing of amniotomy during medically-indicated preterm induction of labor affects labor outcomes. We will specifically be looking at risk of cesarean delivery, duration of labor, maternal morbidity, and neonatal morbidity. We hypothesize that more women in the early amniotomy group will require cesarean delivery and that the duration of labor will increase in the early amniotomy group. ;
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
|
||
Active, not recruiting |
NCT04573517 -
Early Amniotomy Following Transcervical Foley Balloon in the Induction of Labor
|
N/A | |
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 |
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 |
NCT01170819 -
Double Balloon Catheter Versus Dinoprostone Vaginal Insert for Cervical Ripening.
|
Phase 4 | |
Completed |
NCT01402050 -
Foley Catheter Versus Cervidil for Induction of Labor at Term
|
N/A | |
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 |