Uterine Electrical Activity Before and After Progesterone Treatment for Preterm Labor

• Status: Withdrawn
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

This study will examine the effects of various formulations of progesterone on uterine electromyographic (EMG) activity in pregnant patients in premature labor to determine if progesterone will suppress uterine electrical activity and which formulation may be best for inhibition of uterine activity. Patients will be monitored prior to treatment and following treatment (every 2 to 4 hours) with one of three different formulations of progesterone for up to two days. Patients will continue to be observed until they deliver. Comparisons will be for uterine EMG activity from before treatment to that following treatments at 2, 4, 8, 12 24 and 48 hours and times of delivery after treatments (hours or days following treatments). Comparisons between mean values for EMG activity between the various treatments at the various times will also be made.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: St. Joseph's Hospital and Medical Center, Phoenix
• Treatments: Progesterone

Criteria

Inclusion Criteria:

• Healthy patients in preterm labor between 24 to 34 weeks of gestation presenting to St. Joseph's Hospital and Medical Center.

• Preterm labor is defined as at least 6 contractions in 60 minutes with a cervix either dilated to 2 centimeters or effaced to 80% and a cervical length measured by ultrasound of less than 3 centimeters, and a positive fetal fibronectin.

• Maternal ages will be within 17 to 40 year-old range.

Exclusion Criteria:

• Patients with preterm premature rupture of membranes (PPROM) will be excluded from the study, due to possibility of ascending infection, as will those patients with suspected chorioamnionitis.

• Patients with medical conditions that contraindicate tocolysis, such as non-reassuring fetal heart tracings, will also be excluded.