Phase 4
Completed N=350
A Trial of Oral Misoprostol for Labor Augmentation
Labor Augmentation
Source: ClinicalTrials.gov NCT00906347 ↗
Enrolled (actual)
350
Serious AEs
0.9%
Results posted
Nov 2012
Primary outcomePrimary: Uterine Tachysystole — 50; 41 participants
Summary
This is a prospective, randomized, controlled trial designed to examine the efficacy of oral misoprostol for labor augmentation compared to a standard regimen of intravenous oxytocin.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Uterine Tachysystole |
50; 41 | — |
| SECONDARY Infant Apgar Score <4 |
0; 0 | — |
| SECONDARY Umbilical Cord Artery pH <7.1 |
3; 4 | — |
| SECONDARY Admission of Neonatal Intensive Care Unit |
1; 0 | — |
| SECONDARY Maternal Chorioamnionitis |
28; 32 | — |
| SECONDARY Maternal Hypovolemia Requiring Blood Transfusion |
6; 2 | — |
| SECONDARY Method of Delivery |
153; 154; 4; 2; 11; 13 | — |
| SECONDARY Time Elapsed From Start of Labor Augmentation to Delivery |
306; 276 | — |
Eligibility Criteria
Inclusion Criteria
- Clinical decision to augment labor
- Gestational age > than or equal to 36 weeks
- Singleton gestation
- Cephalic presentation
- Reassuring fetal heart rate tracing
- Cervical dilation between 4 and 8 cm
- Ruptured membranes with clear amniotic fluid
- Intrauterine pressure catheter in place
- Less than 200 MVUs in a 10 minute period
- 5 or fewer contractions in a 10 minute period
- English or Spanish speaking patient
Exclusion Criteria
- Non-reassuring fetal heart rate tracing at time of enrollment
- Meconium stained amniotic fluid
- Previous uterine incision
- Maternal fever (defined as greater than 37.9 C)
- Known fetal anomalies
- Placenta previa or unexplained vaginal bleeding
- Estimated fetal weight of 4, 500 grams or more
- Abnormal maternal bony pelvis
- Grandmultiparity
Data sourced from ClinicalTrials.gov (NCT00906347). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.