N/A
Completed N=8
Pilot Study to Evaluate a Prototype Electronic Uterine Inhibitor to Prevent Preterm Contractions
Source: ClinicalTrials.gov NCT00212446 ↗Enrolled (actual)
8
Serious AEs
—
Results posted
Dec 2018
Primary outcomePrimary: Uterine Contractions — 3.18; 3.78; 3.20 minutes
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.
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 | — |
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
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. Informational only — not medical advice.