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

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.

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