Combination of Misoprostol and Mechanical Dilation for Induction of Labor

Randomized study of a combination of oral misoprostol (OM) and mechanical dilation of the cervix by a 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

ACTRN12611000126910

Enrollment

122

Registered

2011-02-04

Start date

2009-08-01

Completion date

Unknown

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.

Interventions

Combination of OM and mechanical dilation with a double-balloon catheter for cervical ripening (COOK CRB) was used. First day: OM 50 microg with repeat doses 4 and 8 hours later if necessary plus CRB for a maximum of 24 hours Second day: OM 100 microg with repeat doses 4 and 8 hours later if necessary Third day: misoprostol 50 microg vaginally with repeat doses 4 and 8 hours later if necessary

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 (= 259 days of gestation), vertex presentation, indication for induction of labor, and an unfavorable cervix (Bishop score < 8)

Exclusion criteria

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

Outcome results