Cervical Ripening for Induction of Labor: Misoprostol Versus Oxytocin in Conjunction With Foley Balloon

Aultman Health Foundation

Status: Completed

Conditions: Induction of Labor

Treatments: Drug: Misoprostol; Drug: Oxytocin

Study type: Interventional

Funder types: Other

Identifiers

NCT01139801

2009 ED

Details and patient eligibility

About

The purpose of this study is to specifically investigate the efficacy of an alternative pharmacologic cervical ripening agent, misoprostol, versus the standard oxytocin, as an adjunct to Foley balloon for induction of the unfavorable cervix.

Full description

The design of this study is a randomized, controlled study with two arms. Both groups will undergo placement of a Foley catheter, through the external and internal os of the cervix, according to standard practice. In group A, receiving intravenous infusion of oxytocin, will serve as the control group as it is standard protocol at Aultman Hospital. Group B, intravaginal placement of misoprostol, will serve as the experimental group. The expected duration of participation begins at induction of labor and concludes at time of delivery.

Enrollment: 50 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participant or surrogate is capable of giving informed consent
• Anticipated number - 50 patients with 25 in each study arm Female with singleton gestation, live intrauterine pregnancy
• Participant is undergoing an indicated induction of labor
• Participant is found to have cervical Bishop score ≤5 on initial cervical exam
• Participant has no medical or obstetrical contraindications to induction of labor

Exclusion criteria

• Participant has ≥2 painful contractions in 10 min in 2 subsequent 10 min periods
• Manufacturer's contraindications to misoprostol or oxytocin

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Oxytocin

Active Comparator group

Description:

Foley balloon placement with intravenous low dose oxytocin administration starting 2 milliunits per minute.

Treatment:

Drug: Oxytocin

Misoprostol

Experimental group

Description:

Misoprostol, 25 mcg, is placed intravaginally into the posterior fornix of the vagina in conjunction with Foley balloon placement

Treatment:

Drug: Misoprostol