Premature Birth Clinical Trial
— EIOfficial title:
Electrical Inhibition (EI): A Preliminary Study To Prevent The Uterine Contractions Of Human Preterm Labor And Preterm Birth
Verified date | November 2017 |
Source | New York University School of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
An electrical-inhibition (EI) uterine pacemaker device similar to an electrical heart pacemaker delivers a weak electrical current to the human uterus during active preterm labor to rapidly and safely inhibit the unwanted premature uterine contractions and possibly a preterm birth.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | August 15, 2016 |
Est. primary completion date | August 15, 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 55 Years |
Eligibility |
Inclusion Criteria: - between 24 to 34 weeks pregnant with a singleton gestation; - in preterm labor as defined by the American College of Obstetricians and Gynecologists and the American Academy of Pediatrics,78 as follows: - persistent uterine contractions (4 every 20 minutes or 8 every 60 minutes) - And any one or more of the following: - Documented cervical change - > 1cm cervical dilatation and progressing - > 80% cervical effacement - anticipate a normal spontaneous vaginal delivery (NSVD). - at least 18 years of age - signed a written Informed Consent Document - willing and able to comply with study requirements Exclusion Criteria: - severe preeclampsia - severe abruption placenta - rupture of amniotic membranes - frank chorioamnionitis - fetal death - fetal anomaly incompatible with life - severe fetal growth restriction (EFW <5%) - mature fetal lung studies - maternal cardiac arrhythmias - a permanent cardiac pacemaker - a fetal cardiac arrhythmia - contraindication for tocolysis |
Country | Name | City | State |
---|---|---|---|
United States | New York University Hospital | Manhattan | New York |
Lead Sponsor | Collaborator |
---|---|
New York University School of Medicine |
United States,
Karsdon J, El Daouk M, Huang WM, Ashmead GG. Electrical pacemaker as a safe and feasible method for decreasing the uterine contractions of human preterm labor. J Perinat Med. 2012 Nov;40(6):697-700. doi: 10.1515/jpm-2012-0136. — View Citation
Karsdon J, Garfield RE, Shi SQ, Maner W, Saade G. Electrical inhibition of preterm birth: inhibition of uterine contractility in the rabbit and pup births in the rat. Am J Obstet Gynecol. 2005 Dec;193(6):1986-93. Erratum in: Am J Obstet Gynecol. 2006 Feb; — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Decrease tocodynamometric monitored preterm uterine contraction frequency | Measure changes in preterm uterine mechanical contraction frequency as assessed by the tocodynamometer. This will be done for the duration of the study. | 30 seconds | |
Secondary | Decrease adjunct electrohysterographic monitored preterm uterine contraction electrical activity. | Measure changes in preterm uterine electrical contraction activity as assessed by the electrohysterogram. This will be done for the duration of the study. | 20 seconds |
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