Cesarean, Endometritis, Induction of Labor
Conditions
Keywords
Induction of labor, Cesarean, Endometritis, Foley, Infections
Brief summary
Hypothesis: The induction of labor in patients with unfavorable Bishop score is a challenging obstetrical process, and may be influenced or complicated by the cervical ripening method used. We will conduct a comparative study of the foley catheter vs the cervical ripening double balloon (Cook medical, GPN: G48149). We will compare the failure rates, cesarean section rate, infections and postpartum complications, especially endometritis.
Detailed description
We will conduct a comparative study of the foley catheter vs the cervical ripening double balloon (Cook medical, GPN: G48149). We will compare the failure rates, cesarean section rate, infections and postpartum complications, especially endometritis. The study will include 200 parturients, 100 primiparous and 100 multiparous women. We will randomize each group to induction with the foley catheter or the cervical ripening double balloon. We will compare the failure rates, cesarean section rate, infectious and other postpartum complications, especially endometritis.
Interventions
Sponsors
Western Galilee Hospital-Nahariya
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Term pregnancy * Parturients candidates for mechanical induction of labor
Exclusion criteria
* Suspected amnionitis * Vaginal discharge * Pre induction pyrexia * Immunocompromised parturients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Success of labor induction | Postpartum period |
Secondary
| Measure | Time frame |
|---|---|
| Postpartum endometritis rate | The postpartum period |
| Cesarean section rate | Delivery |
Countries
Israel
Outcome results
None listed