Cervical Ripening
Conditions
Brief summary
When oligohydramnion - decreased amniotic fluid, is diagnosed at term pregnancies, the common practice is to induce labor. Whenever the cervix is not ripened, there are several methods to ripen the cervix, two of which are: mechanical, using a double balloon catheter and pharmacological, with prostaglandins. The aim of the study is to compare those two methods of cervical ripening for patients with significant oligohydramnion at term. The study will be a prospective randomised trial.
Interventions
DEVICEdouble balloon catheter
cervical ripening using double balloon catheter
prostaglandins E2 - Intravaginal Propess for 24 hours
Sponsors
Meir Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* singleton pregnancy * normal pregnancy, well dated, at term * un ripened cervix
Exclusion criteria
* previous cesarean section * multiple pregnancy * intra uterine growth restricted fetus
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time from ripening to active labor and to delivery, rates of cesarean section, rates of nonreassuring fetal heart rate during induction of labor. | during induction of labor, delivery and early post partum |
Secondary
| Measure | Time frame |
|---|---|
| patients satisfaction | induction of labor, delivery and early postpartum |
Countries
Israel
Contacts
Primary ContactTal Biron - Shental, MD
Outcome results
None listed