Cervical Ripening, Premature Birth
Conditions
Keywords
Preterm gestation, Cervical ripening, Labor induction, Misoprostol, Foley bulb
Brief summary
The purpose of this study is to compare the time to delivery of two different cervical ripening methods on the preterm gestation.
Detailed description
Labor induction for the preterm gestation is indicated for various maternal and fetal indications. The preterm cervix, however, is frequently not favorable for induction. Multiple methods have been evaluated in the term gestation. As these comparison studies have not included the preterm gestation, this study seeks to evaluate these two methods in terms of safety, efficacy and time to delivery.
Interventions
DRUGMisoprostol
DEVICEFoley bulb
Sponsors
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* singleton gestation, gestational age 23-35 weeks, indication for induction
Exclusion criteria
* multiple gestation, non-cephalic presentation, previous uterine surgery, rupture of membranes, intrauterine fetal death
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to vaginal delivery | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of chorioamnionitis | — |
| Incidence of abnormal fetal heart rate tracings | — |
| Rate of postpartum hemorrhage | — |
| Incidence of NICU admissions | — |
Countries
United States
Outcome results
None listed