Routine Early vs Delayed Amniotomy for Preterm Pregnancies: A Randomized Open Label Trial
NCT ID: NCT03682822
Last Updated: 2021-05-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
104 participants
INTERVENTIONAL
2018-11-01
2020-02-24
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
FEMALE
No
Sponsors
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The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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Clifton O'Neill Brock
Clinical Fellow OBGYN
Principal Investigators
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Clifton O Brock, MD
Role: PRINCIPAL_INVESTIGATOR
University of Texas Health Science Center of Houston
Locations
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University of Texas Health Science Center of Houston
Houston, Texas, United States
Countries
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Other Identifiers
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HSC-MS-18-0511
Identifier Type: -
Identifier Source: org_study_id
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