Multicenter trial for induction of labor with the combination of misoprostol and mechanical ripening of the cervix

Randomized multicenter study of a combination of oral misoprostol (OM) and mechanical dilation of the cervix by double balloon device (COOK CRB [Cervical Ripening Balloon]) versus OM alone to improve efficacy in inducing labor.

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000198921

Enrollment

250

Registered

2011-02-21

Start date

2011-05-01

Completion date

2012-08-31

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Induction of labor is a common obstetric procedure that is being more widely used nowadays than ever before. Pharmacologic and mechanical methods are used to induce labor. As there are different modes of action, a reduced induction-to-delivery time can be expected if the pharmacologic and mechanical methods are used simultaneously. The hypothesis is that a combination of pharmacological (oral misoprostol) and mechanical dilation (CRB - a double balloon device) improve the efficacy of labor induction. In a primary study the combination showed to be beneficial. These results supposed to be checked in a multicenter trial with different misoprostol regimes.

Interventions

Combination of OM and mechanical dilation with a double-balloon catheter for cervical ripening (COOK CRB) is used. Each participating hospital uses its own misoprostol regime plus CRB for a maximum of 12 hours the first day. e.g. the regime of the primary study unit: First day: OM 50 microg with repeat doses 4 and 8 hours later if necessary plus CRB for a maximum of 12 hours Second day: OM 100 microg with repeat doses 4 and 8 hours later if necessary Third day: misoprostol 50 microg vaginally

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

singleton pregnancy at term greater than 259 days of gestation, vertex presentation, indication for induction of labor, and an unfavorable cervix (Bishop score < 8)

Exclusion criteria

Premature Rupture of Membranes (PROM), contraindication for labor induction with misoprostol (e.g. placenta previa, previous cesarean sections), cases of structural or chromosomal malformation, intrauterine fetal death.

Outcome results