Status:
WITHDRAWN
Pilot Study of Electronic Uterine Contraction Inhibitor
Lead Sponsor:
Winthrop University Hospital
Conditions:
Prematurity
Eligibility:
FEMALE
18-50 years
Phase:
PHASE1
Brief 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 electri...
Detailed Description
The study design is a Pilot Study to confirm the safety of the uterine inhibitor/pacemaker and measure its effect on women experiencing preterm labor. A total of 10 (ten) patients will be enrolled in...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00994058
Start Date
October 1 2009
End Date
August 1 2010
Last Update
December 24 2015
Active Locations (1)
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1
Winthrop University Hospital
Mineola, New York, United States, 11501