Arrest of Dilation in Labor
Conditions
Keywords
oral misoprostol, labor augmentation, arrest of dilation, nulliparous
Brief summary
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.
Interventions
DRUGMisoprostol
Oral misoprostol
Sponsors
University of Texas Southwestern Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| uterine hyperstimulation | — |
Secondary
| Measure | Time frame |
|---|---|
| need for oxytocin augmentation | — |
| time from administration of study drug to delivery | — |
| adequate uterine activity | — |
| maternal and neonatal infectious morbidity | — |
| neonatal outcomes | — |
| route of delivery and indications | — |
Countries
United States
Outcome results
None listed