Clinical trial NCT03682822: Routine Early vs Delayed Amniotomy for Preterm Pregnancies: A Randomized Open Label Trial
Official title: Comparative Effectiveness of Routine Early Versus Delayed Amniotomy for Pregnancies Less Than 37 Weeks Gestational Age: A Randomized Open Label Trial (CEREAL)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Labor, Premature
Keywords: Pregnancy
labor induction
preterm
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2018-09-25
Enrollment: 104
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the duration of preterm induction of labor in women undergoing early vs. late or no artificial rupture of membranes (AROM). Maternal and neonatal outcomes will also be compared between the two groups.

Detailed description: Women presenting with a preterm singleton pregnancy between 28.0 and 36.6 weeks of gestation with cephalic lie and a medical indication for induction of labor will be approached for this study. The patient/provider must be attempting induction with the goal of vaginal delivery. Women with ruptured membranes, suspected intrauterine infection, prior uterine scar, fetal demise, or a fetal anomaly will be excluded. Women that agree to the study will be randomized to 2 groups: the "early amniotomy" group and the "late amniotomy" group.

Women in the early amniotomy group will undergo artificial rupture of membranes (AROM) prior to reaching cervical dilation of 4 cm. Women in the late amniotomy group may not undergo AROM until they reach cervical dilation of greater than 4 cm or they have been on an oxytocin drip for greater than 10 hours with no cervical change. It is possible that a woman in the late amniotomy group will not undergo AROM at all.

The primary outcome under consideration is time in labor. Secondary outcomes include rates of chorioamnionitis, postpartum endometritis, mode of delivery, and neonatal outcomes.

Eligibility criteria: Inclusion Criteria:

* Preterm singleton pregnancy between 28.0 and 36.6 completed weeks of gestation
* Fetus in the cephalic position
* Intent to induce labor for vaginal delivery
* If cervical ripening is planned, patient must be enrolled within an hour of initiation of ripening. If no ripening is planned, enrollment must be complete prior to starting induction.

Exclusion Criteria:

* Preterm premature rupture of membranes (PPROM)
* Fever or suspected chorioamnionitis prior to start of IOL
* Prior uterine scar
* Infection with HIV/Hepatitis B Virus (HBV)/Hepatitis C Virus (HCV) or an active Herpes Simplex Virus (HSV) infection
* Intrauterine fetal demise
* Major fetal anomaly
* Cervical dilation \> 4 cm

Primary outcomes:
measure: Total duration of labor.
timeFrame: Induction of labor until delivery (1 hr - 48 hrs)
Secondary outcomes:
measure: Labor Outcomes:Time from completion of cervical ripening to delivery
timeFrame: Induction of labor until delivery (1 hr - 48 hrs)
measure: Labor Outcomes: Delivery before 24 hours from start of Induction of Labor (IOL)
timeFrame: Induction of labor until delivery (1 hr - 48 hrs)
measure: Labor Outcomes: Duration of the 2nd stage of labor
timeFrame: Induction of labor until delivery (1 hr - 48 hrs)
measure: Maternal Outcome:Cesarean delivery
timeFrame: at delivery
measure: Maternal/Labor Outcomes: Indication for Cesarean delivery
timeFrame: at delivery
measure: Maternal/Labor Outcomes:Operative vaginal delivery
timeFrame: at delivery
measure: Maternal intrapartum fever or chorioamnionitis
timeFrame: during labor to delivery
measure: Post-partum endometritis:
timeFrame: up to 10 days
measure: Epidural anesthesia
timeFrame: during labor
measure: Recurrent variable or late decelerations
timeFrame: during labor
measure: Meconium stained amniotic fluid
timeFrame: during labor and delivery
measure: Tachysystole
timeFrame: during labor
measure: Use of amnioinfusion
timeFrame: during labor
measure: Use of intrapartum tocolytics
timeFrame: during labor
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas Health Science Center of Houston
state: Texas
Study officials:
affiliation: University of Texas Health Science Center of Houston
name: Clifton O Brock, MD
role: PRINCIPAL_INVESTIGATOR
References: