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

NCT03682822 | Terminated

• 1 other identifier: HSC-MS-18-0511
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Labor, Premature

Keywords

Pregnancy; labor induction; preterm

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Labor Outcomes:Time from completion of cervical ripening to delivery

  Induction of labor until delivery (1 hr - 48 hrs)

• Labor Outcomes: Delivery before 24 hours from start of Induction of Labor (IOL)

  Induction of labor until delivery (1 hr - 48 hrs)

• Labor Outcomes: Duration of the 2nd stage of labor

  Induction of labor until delivery (1 hr - 48 hrs)

• Maternal Outcome:Cesarean delivery

  at delivery

• Maternal/Labor Outcomes: Indication for Cesarean delivery

  at delivery

Study Arms (2)

Early artificial rupture of membranes

EXPERIMENTAL

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

Delayed artificial rupture of membranes

ACTIVE COMPARATOR

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

Interventions

Early Artificial rupture of membranes PROCEDURE

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.

Early artificial rupture of membranes

Delayed Artificial rupture of membranes PROCEDURE

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.

Delayed artificial rupture of membranes

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

University of Texas Health Science Center of Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Obstetric Labor, Premature; Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Clifton O Brock, MD

  University of Texas Health Science Center of Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Fellow OBGYN

Study Record Dates

• First Submitted: September 21, 2018
• First Posted: September 25, 2018
• Study Start: November 1, 2018
• Primary Completion: February 22, 2020
• Study Completion: February 24, 2020
• Last Updated: May 5, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)