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

Stopped early · Not applicable

Conditions studied: Labor, Premature

In brief

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.

Key facts

Study ID

NCT03682822

Run by

The University of Texas Health Science Center, Houston

People needed

104

Starts

2018-11-01

Expected to finish

2020-02-24

Last updated by the study team

2021-05-05

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

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

Where it is running

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

Full record on ClinicalTrials.gov

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