Outpatient Cervical Ripening With Orally Administered Misoprostol in Diabetics
Status:
Terminated
Trial end date:
2008-12-01
Target enrollment:
Participant gender:
Summary
A. Null Hypothesis:
In term pregnancies complicated by diabetes, there is no difference in the time interval from
start of induction to delivery when outpatient cervical ripening and labor induction is
initiated with orally administered misoprostol, a prostaglandin El analogue, compared to
placebo.
B. Specific aims:
1. Demonstrate that oral misoprostol is effective for cervical ripening compared to placebo
when given in an outpatient basis to women with pregnancies complicated by diabetes
mellitus.
2. Demonstrate that oral misoprostol can be administered safely in an outpatient setting.
The patients will be observed for a period of four hours in an outpatient antepartum
testing unit after the medication is administered to demonstrate fetal well being and
verify that there is no evidence of uterine hyperstimulation. (We acknowledge that
markers of serious adverse maternal and neonatal outcomes are rare, and can only be
adequately addressed in large multicenter trials.)
3. Assess the cost differential in inpatient and outpatient utilization of misoprostol for
cervical ripening and labor induction. In order to estimate the impact that outpatient
cervical ripening may have on total hospitalization costs, we will use daily hospital
charges and published data regarding pharmaceutical costs.