Pilot Study of Electronic Uterine Contraction Inhibitor (NCT00994058) | Clinical Trial Compass
WithdrawnPhase 1
Pilot Study of Electronic Uterine Contraction Inhibitor
Stopped: The Investigator has changed institutions.
United States0Started 2009-10
Plain-language summary
The objective is to test a novel paradigm for the inhibition of human preterm uterine contractions.
The study hypothesis is that human preterm contractions can be safely inhibited with a weak electrical current provided by an electrical inhibition/uterine pacemaker device.
Preterm birth is still a major problem. Current methods of preventing the uterine contractions of preterm are limited and associated with many side-effects affecting both the mother and baby. A reliable method of preventing preterm uterine contractions would be an important discovery. Such a method could eventually lead to a long-term goal of decreasing neonatal morbidity and mortality.
Who can participate
Age range18 Years – 50 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 24 to 34 weeks pregnant
✓. preterm labor
✓. Have received tocolysis therapy
✓. Anticipate a normal spontaneous vaginal delivery (NSVD)
✓. Be at least 18 years of age
✓. Have signed a written informed consent document
✓. Be willing and able to comply with study requirements