N/A N=8 Prevention

Pilot Study to Evaluate a Prototype Electronic Uterine Inhibitor to Prevent Preterm Contractions

Preterm Birth

Bottom Line

View on ClinicalTrials.gov: NCT00212446 ↗

Enrolled (actual)

Serious AEs

—

Results posted

Dec 2018

Primary outcome: Primary: Uterine Contractions — 3.18; 3.78; 3.20 minutes

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Electrical Intervention (EI) (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: St. Luke's-Roosevelt Hospital Center
Primary completion: Apr 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Uterine Contractions	3.18; 3.78; 3.20	—
PRIMARY Number of Newborn With Fetal Heart Arrhythmias	—	—
SECONDARY Latency of Birth	599.76	—
SECONDARY Pain During the Birthing Process	—	—
SECONDARY Apgars Score	8.75; 9.0	—
SECONDARY The Length of NICU Stay	13.42	—
SECONDARY Gestational Age at Discharge	36.61	—

Summary

Use an electrical-inhibition (EI)/uterine pacemaker device similar to an electrical heart pacemaker to deliver a weak electrical current to the human uterus that will rapidly and safely inhibit the unwanted premature uterine contractions of preterm birth.

Eligibility Criteria

Inclusion Criteria

Pending preterm birth
vaginal birth

Exclusion Criteria

disease disorders including but not limited to thyroid, liver disease, HIV, diabetes or drug addiction
using a permanent cardiac pacemaker
have malignancies that are currently being treated or recurrent

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00212446). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.