Oral Misoprostol for Labor Augmentation: A Pilot Study

Study Overview
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Brief Summary
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A phase I, open-label trial to determine a safe dose of oral misoprostol required to augment labor in nulliparous women diagnosed with arrest of dilation.

Official Title
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Oral Misoprostol for Labor Augmentation: A Dose-Finding Pilot Study

Conditions
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Arrest of Dilation in Labor

Intervention / Treatment
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* Drug: Misoprostol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: nulliparous gestational age of at least 36 weeks singleton gestation cephalic presentation reassuring fetal heart rate 4 cm or greater cervical dilation ruptured membranes with clear amnionic fluid intrauterine pressure catheter in place less than 200 MVU's Exclusion Criteria: non-reassuring fetal heart rate meconium-stained amnionic fluid previous uterine incision maternal fever pregnancy-induced hypertension or other pregnancy-related complications known fetal anomalies placenta previa or unexplained vaginal bleeding estimated fetal weight of 4,500 grams or greater evidence of cephalopelvic disproportion any moderate or severe preexisting disease contraindication to the use of prostaglandins

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral Misoprostol 1<br>Oral misoprostol 25 micrograms every 4 hours for up to two doses. | Drug: Misoprostol<br>* Oral misoprostol<br>* Other names: Cytotec;|
| Experimental: Oral Misoprostol 2<br>Oral misoprostol 50 micrograms every 4 hours for up to two doses. | Drug: Misoprostol<br>* Oral misoprostol<br>* Other names: Cytotec;|
| Experimental: Oral Misoprostol 3<br>Oral misoprostol 100 micrograms every 4 hours for up to two doses. | Drug: Misoprostol<br>* Oral misoprostol<br>* Other names: Cytotec;|
| Experimental: Oral Misoprostol 4<br>Oral Misoprostol 50 micrograms every 2 hours for up to two doses. | Drug: Misoprostol<br>* Oral misoprostol<br>* Other names: Cytotec;|
| Experimental: Oral Misoprostol 5<br>Oral Misoprostol 75 micrograms every 4 hours for up to two doses. | Drug: Misoprostol<br>* Oral misoprostol<br>* Other names: Cytotec;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| uterine hyperstimulation |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adequate uterine activity |  |  | 
| need for oxytocin augmentation |  |  | 
| time from administration of study drug to delivery |  |  | 
| route of delivery and indications |  |  | 
| maternal and neonatal infectious morbidity |  |  | 
| neonatal outcomes |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oral misoprostol, labor augmentation, arrest of dilation, nulliparous