A Trial of Oral Misoprostol for Labor Augmentation

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Controlled Trial of Oral Misoprostol for Labor Augmentation

Conditions
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Labor Augmentation

Intervention / Treatment
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* Drug: Misoprostol
* Drug: Oxytocin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oxytocin augmentation<br>Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive intravenous oxytocin. | Drug: Oxytocin<br>* Intravenous oxytocin will be administered per the established Labor and Delivery protocol at Parkland Memorial Hospital<br>* Other names: Pitocin;|
| Active Comparator: Misoprostol augmentation<br>Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive oral misoprostol. | Drug: Misoprostol<br>* 75 micrograms orally every 4 hours for up to 2 doses.<br>* Other names: Cytotec;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uterine Tachysystole | Defined as six contractions in two consecutive 10-minute periods | Up to four hours after administration of study drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infant Apgar Score <4 | Assigned on a scale of 0-10 by pediatric provider attending delivery. A lower score reflects need for further resuscitation and is potentially associated with increased risk of adverse neurological outcomes. | 5 minutes after delivery | 
| Umbilical Cord Artery pH <7.1 |  | Obtained at delivery | 
| Admission of Neonatal Intensive Care Unit |  | Until hospital discharge | 
| Maternal Chorioamnionitis | Temperature 38 degrees C or higher in the absence of other sources of infection | During labor | 
| Maternal Hypovolemia Requiring Blood Transfusion |  | Until hospital discharge | 
| Method of Delivery |  | At delivery | 
| Time Elapsed From Start of Labor Augmentation to Delivery |  | Initiation of augmentation until delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Labor augmentation, Oral misoprostol