Pilot Study to Evaluate a Prototype Electronic Uterine Inhibitor to Prevent Preterm Contractions

NACompletedINTERVENTIONAL
Enrollment

8

Participants

Timeline

Start Date

February 28, 2005

Primary Completion Date

April 30, 2012

Study Completion Date

April 30, 2012

Conditions
Preterm Birth
Interventions
DEVICE

Electrical Intervention (EI)

Electrical intervention (EI) is bipolar, constant-current (1-20 mA), square-wave pulses in 20% duty cycles. Women in preterm labor have an electrode placed vaginally; tocodynamometric contraction timing and fetal heart rate are monitored continuously. Successive 20-minute periods include pre-control period (C1); the EI period, in which a 10-second current burst is delivered at expected contraction times; and a post-EI control period (C2).

Trial Locations (1)

10019

St. Luke's-Roosevelt Hospital Center, New York

All Listed Sponsors
lead

St. Luke's-Roosevelt Hospital Center

OTHER

NCT00212446 - Pilot Study to Evaluate a Prototype Electronic Uterine Inhibitor to Prevent Preterm Contractions | Biotech Hunter | Biotech Hunter