Pilot Study of Electronic Uterine Contraction Inhibitor
Withdrawn before enrolling · Phase 1
Conditions studied: Prematurity
In brief
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.
Key facts
- Study ID
- NCT00994058
- Run by
- Winthrop University Hospital
- People needed
- 0
- Starts
- 2009-10-01
- Expected to finish
- 2010-08-01
- Last updated by the study team
- 2015-12-24
Who can join
Age: 18 and older, up to 50. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 24 to 34 weeks pregnant
- preterm labor
- at least one contraction every 5 minutes for 30 minutes
- > 3 cm cervical dilation; > 80% cervical effacement
- 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
You may not qualify if…
- Severe preeclampsia
- Severe abruption placenta
- Rupture of amnionic membranes
- Frank chorioamnionitis
- Fetal death
- Fetal anomaly incompatible with life
- Severe fetal growth restriction (estimated fetal weight <5%)
- Mature fetal lung studies
- Maternal cardiac arrythmias
- A permanent cardiac pacemaker
- A fetal cardiac arrhythmia
Where it is running
- Winthrop University Hospital — Mineola, New York, United States
Full record on ClinicalTrials.gov
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