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

A Comparison of Titrated Oral Misoprostol Solution to Intravenous Oxytocin for Labor Augmentation: A Randomized Controlled Trial

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00695331

Enrollment

143

Registered

2008-06-11

Start date

2008-02-29

Completion date

2009-01-31

Last updated

2008-07-10

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

Conditions

Labor

Keywords

Labor Augmentation, Misoprostol, Oxytocin

Brief summary

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.

Detailed 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.

Interventions

DRUGMisoprostol

Titrated Misoprostol Solution

DRUGOxytocin

Titrated Intravenous Oxytocin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

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

Design outcomes

Primary

Measure	Time frame
the percentage of women delivering infants vaginally within 12 hours of augmentation	post vaginal delivery

Secondary

Measure	Time frame
uterine hyperstimulation rate	post vaginal delivery

Countries

Taiwan

Contacts

Primary ContactMing Ho, MD

mi.ho@msa.hinet.net886-4-22062121

Backup ContactShi-Yann Cheng, MD

shiyann@ms18.url.com.tw886-5-7837901

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 30, 2026