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

Labor, Premature Clinical Trial

— Cereal  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03682822
• Other study ID #: HSC-MS-18-0511
• Status: Terminated
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: February 24, 2020

Study information

• Verified date: April 2021
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 104
• Est. completion date: February 24, 2020
• Est. primary completion date: February 22, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Labor, Premature
• Obstetric Labor, Premature

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Texas Health Science Center of Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	Maternal Outcome:Cesarean delivery	Mode of delivery	at delivery
Secondary	Maternal/Labor Outcomes: Indication for Cesarean delivery	Reason for cesarean delivery	at delivery
Secondary	Maternal/Labor Outcomes:Operative vaginal delivery	Use of either a vacuum device or obstetrical forceps	at delivery
Secondary	Maternal intrapartum fever or chorioamnionitis	Defined as persistent intrapartum fever and/or suspected or confirmed intraamniotic infection (20)	during labor to delivery
Secondary	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 = 38.0° C on any 2 of the first 10 days postpartum, exclusive of the first postpartum day	up to 10 days
Secondary	Epidural anesthesia	Use of epidural regional anesthesia for pain control during induction of labor	during labor
Secondary	Recurrent variable or late decelerations	As defined by The American College of Obstetrics and Gynecology ( ACOG), practice bulletin No 110	during labor
Secondary	Meconium stained amniotic fluid	Meconium is noted in the amniotic fluid after rupture of membranes	during labor and delivery
Secondary	Tachysystole	As defined by ACOG, practice bulletin No 110	during labor
Secondary	Use of amnioinfusion	Placement of an intrauterine catheter and infusion of saline into the uterus during induction of labor	during labor
Secondary	Use of intrapartum tocolytics	Administration of a tocolytic drug during labor	during labor