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Status | Withdrawn |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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05048550 -
Babies in Glasses; a Feasibility Study.
|
N/A | |
Active, not recruiting |
NCT03655639 -
Local Version of the Multi-center PREVENT Study Evaluating Cardio-respiratory Instability in Premature Infants
|
||
Enrolling by invitation |
NCT05542108 -
Adding Motion to Contact: A New Model for Low-cost Family Centered Very-early Onset Intervention in Very Preterm-born Infants
|
N/A | |
Completed |
NCT03680157 -
Comparing Rater Reliability of Familiar Practitioners to Blinded Coders
|
||
Completed |
NCT03337659 -
A Cluster Randomized Controlled Trial of FICare at 18 Months
|
N/A | |
Completed |
NCT03649932 -
Enteral L Citrulline Supplementation in Preterm Infants - Safety, Efficacy and Dosing
|
Phase 1 | |
Completed |
NCT03251729 -
Cerclage On LOw Risk Singletons: Cervical Cerclage for Prevention of Spontaneous Preterm Birth in Low Risk Singleton Pregnancies With Short Cervix
|
Phase 4 | |
Not yet recruiting |
NCT05039918 -
Neonatal Experience of Social Touch
|
N/A | |
Not yet recruiting |
NCT03418012 -
Prevention of sPTB With Early Cervical Pessary Treatment in Women at High Risk for PTB
|
N/A | |
Not yet recruiting |
NCT03418311 -
Cervical Pessary Treatment for Prevention of s PTB in Twin Pregnancies on Children`s Long-Term Outcome
|
N/A | |
Completed |
NCT02952950 -
Is it Possible to Prolong the Duration of Breastfeeding in Premature Infants? a Prospectivt Study
|
N/A | |
Not yet recruiting |
NCT02880696 -
Perception of Temporal Regularity in Tactile Stimulation: a Diffuse Correlation Spectroscopy Study in Preterm Neonates
|
N/A | |
Completed |
NCT02913495 -
Vaginal Versus Intramuscular Progesterone for the Prevention of Recurrent Preterm Birth
|
Phase 4 | |
Completed |
NCT02879799 -
Family Integrated Care (FICare) in Level II NICUs
|
N/A | |
Completed |
NCT02661360 -
Effects of Swaddling on Infants During Feeding
|
N/A | |
Completed |
NCT02743572 -
Iron-fortified Parenteral Nutrition in the Prevention and Treatment of Anemia in Premature Infants
|
N/A | |
Completed |
NCT01352234 -
Comparison of Doses of Acetylsalicylic Acid in Women With Previous History of Preeclampsia
|
Phase 4 | |
Completed |
NCT01163188 -
Social Adjustment and Quality of Life After Very Preterm Birth
|
N/A | |
Terminated |
NCT00675753 -
Three Interacting Single Nucleotide Polymorphisms (SNPs) and the Risk of Preterm Birth in Black Families
|
N/A | |
Completed |
NCT00271115 -
Kangaroo Holding and Maternal Stress
|
N/A |