Efficacy and Safety Study of Titrated Oral Misoprostol Solution for Labor Augmentation

China Medical University

Status and phase: Unknown; Phase 4

Conditions: Labor

Treatments: Drug: Oxytocin; Drug: Misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT00695331

DMR96-IRB-176

CMUBH R96007

Details and patient eligibility

About

The purpose of this study is to compare the efficacy and safety of titrated oral misoprostol solution with intravenous oxytocin for labor augmentation in women without adequate uterine contractions.

Full description

Numerous labor course necessitate augmentation when uterine contractions are inadequate. When the cervix is favorable, labor augmentation attempts are more likely to be successful. Augmentation is these women is traditionally undertaken with intravenous oxytocin and amniotomy, either alone or in combination.

In our previous trial, it has been proven that the method of titrated oral misoprostol is associated with a lower incidence of uterine hyperstimulation and a lower cesarean delivery rate than vaginal misoprostol for labor induction in patients with unfavorable cervix. Because administering Misoprostol solution is easy and cost saving, it is worth to develop this novel method in labor augmentation.

Enrollment: 143 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pregnancy between 36 and 42 weeks of gestation
• Live singleton
• Cephalic presentation
• A reassuring fetal heart rate pattern
• Bishop score greater than 6
• Inadequate uterine contraction (less than or equal to 2 per 10 minutes)

Exclusion criteria

• Nonreassuring fetal heart rate pattern
• Parity more than five
• Uterine scar
• Suspected placental abruption with abnormal fetal heart rate
• Vaginal bleeding other than "bloody show"
• Significant maternal cardiac, renal, or hepatic disease
• hypersensitivity to oxytocin, misoprostol or prostaglandin analogues

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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143 participants in 2 patient groups

1

Experimental group

Description:

Titrated Oral Misoprostol Solution

Treatment:

Drug: Misoprostol

2

Active Comparator group

Description:

Intravenous Oxytocin

Treatment:

Drug: Oxytocin