Trials / Unknown
UnknownNCT03399266
Balloon Induction of Labor in PROM for TOLAC
Mechanical Induction of Labor in Women With Previous Cesarean Section and Premature Rupture of Membranes Who Desire TOLAC: A Prospective Randomized Study
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- Sponsor
- Soroka University Medical Center · Academic / Other
- Sex
- Female
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
A prospective randomized controlled trial to evaluate the safety and efficacy of labor induction with a double balloon catheter (Atad Ripener Device) in women desiring TOLAC (trial of labor after cesarean) with PROM (pre labor rupture of membranes).
Conditions
- Previous; Cesarean Section, Cicatricial, Complicating Pregnancy or Childbirth, Affecting Fetus or Newborn
- Prelabor Rupture of Membranes
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Double Balloon catheter for induction of labor | With the patient in lithotomy position or lying supine in bed, a speculum is inserted to visualise the cervix. The device is inserted into the cervix using long forceps until both balloons enter the cervical canal. Then, the uterine balloon is inflated with 20 ml of saline (by means of a 20 ml syringe). The device is then pulled out until stopped by the uterine balloon covering the internal cervical os. At this point the cervico-vaginal balloon located at the external os is inflated with 20 ml of saline and the speculum is removed. Then both balloons are additionally inflated with alternate increments of 20 ml normal saline to a total volume of 80 ml in each balloon. The device is loosely taped to the patient's inner thigh. |
Timeline
- Start date
- 2018-03-01
- Primary completion
- 2020-03-01
- Completion
- 2021-03-01
- First posted
- 2018-01-16
- Last updated
- 2018-11-14
Locations
1 site across 1 country: Israel
Source: ClinicalTrials.gov record NCT03399266. Inclusion in this directory is not an endorsement.