Routine Early vs Delayed Amniotomy for Preterm Pregnancies: A Randomized Open Label Trial (Cereal)

Comparative Effectiveness of Routine Early Versus Delayed Amniotomy for Pregnancies Less Than 37 Weeks Gestational Age: A Randomized Open Label Trial (CEREAL)

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.

Study Overview

• Status: Terminated
• Conditions: Labor, Premature
• Intervention / Treatment: Procedure: Early Artificial rupture of membranes; Procedure: Delayed Artificial rupture of membranes

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.

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • University of Texas Health Science Center of Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Early artificial rupture of membranes; Women in this arm will undergo artificial rupture of membranes before 4 cm of cervical dilation is reached during induction of labor as long as the procedure is deemed clinically safe and feasible.	Procedure: Early Artificial rupture of membranes; Women in this arm will undergo artificial rupture of membranes before 4 cm of cervical dilation is reached during induction of labor as long as the procedure is deemed clinically safe and feasible.
ACTIVE_COMPARATOR: Delayed artificial rupture of membranes; Women in this arm may undergo artificial rupture of membranes performed only after 4 cm of cervical dilation is reached during induction of labor. Rupture may also be performed after 10 hours of oxytocin administration with no cervical change.	Procedure: Delayed Artificial rupture of membranes; Women in this arm may undergo artificial rupture of membranes performed only after 4 cm of cervical dilation is reached during induction of labor. Rupture may also be performed after 10 hours of oxytocin administration with no cervical change.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total duration of labor.	The duration of labor begins with administration of the first induction agent (i.e. Cook balloon, Foley catheter, prostaglandins, or oxytocin) and ends with delivery.	Induction of labor until delivery (1 hr - 48 hrs)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Labor Outcomes:Time from completion of cervical ripening to delivery	When the last induction agent is a foley/Cook balloon, or cervidil (dinoprostone), "completion of cervical ripening" will be defined as the time when the agent is removed. When the last induction agent is misoprostol, "completion of cervical ripening" will be defined as 4 hours after administration of the last dose.	Induction of labor until delivery (1 hr - 48 hrs)
Labor Outcomes: Delivery before 24 hours from start of Induction of Labor (IOL)	A dichotomization of duration of labor	Induction of labor until delivery (1 hr - 48 hrs)
Labor Outcomes: Duration of the 2nd stage of labor	Defined as time from the first cervical exam with complete dilation and effacement to the time of delivery	Induction of labor until delivery (1 hr - 48 hrs)
Maternal Outcome:Cesarean delivery	Mode of delivery	at delivery
Maternal/Labor Outcomes: Indication for Cesarean delivery	Reason for cesarean delivery	at delivery
Maternal/Labor Outcomes:Operative vaginal delivery	Use of either a vacuum device or obstetrical forceps	at delivery
Maternal intrapartum fever or chorioamnionitis	Defined as persistent intrapartum fever and/or suspected or confirmed intraamniotic infection (20)	during labor to delivery
Post-partum endometritis:	defined as postpartum febrile morbidity in the absence of another causative factor (i.e. wound infection, deep venous thrombosis). Postpartum febrile morbidity is defined as oral temperature ≥ 38.0⁰ C on any 2 of the first 10 days postpartum, exclusive of the first postpartum day	up to 10 days
Epidural anesthesia	Use of epidural regional anesthesia for pain control during induction of labor	during labor
Recurrent variable or late decelerations	As defined by The American College of Obstetrics and Gynecology ( ACOG), practice bulletin No 110	during labor
Meconium stained amniotic fluid	Meconium is noted in the amniotic fluid after rupture of membranes	during labor and delivery
Tachysystole	As defined by ACOG, practice bulletin No 110	during labor
Use of amnioinfusion	Placement of an intrauterine catheter and infusion of saline into the uterus during induction of labor	during labor
Use of intrapartum tocolytics	Administration of a tocolytic drug during labor	during labor

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Clifton O Brock, MD, University of Texas Health Science Center of Houston

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2018
• Primary Completion (ACTUAL): February 22, 2020
• Study Completion (ACTUAL): February 24, 2020

Study Registration Dates

• First Submitted: September 21, 2018
• First Submitted That Met QC Criteria: September 24, 2018
• First Posted (ACTUAL): September 25, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 5, 2021
• Last Update Submitted That Met QC Criteria: April 29, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Pregnancy; preterm; labor induction
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature
• Other Study ID Numbers: HSC-MS-18-0511

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No