Induction of Labor in Oligohydramnios

Clalit Health Services

Status and phase: Unknown; Phase 3

Conditions: Cervical Ripening

Treatments: Drug: prostaglandins E2; Device: double balloon catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT00815542

034-2011-MMC

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups, including a placebo group

double balloon catheter

Active Comparator group

Description:

Cervical ripening by double balloon catheter

Treatment:

Device: double balloon catheter

prostaglandins E2

Placebo Comparator group

Description:

cervical ripening using prostaglandins E2

Treatment:

Drug: prostaglandins E2