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

Labor, Premature Clinical 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)

Status Terminated

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Labor, Premature
• Obstetric Labor, Premature

• NCT number: NCT03682822
• Study type: Interventional
• Source: The University of Texas Health Science Center, Houston
• Status: Terminated
• Phase: N/A
• Start date: November 1, 2018
• Completion date: February 24, 2020