Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00212446
Status:
COMPLETED
Last Update Posted:
2018-12-17
First Post:
2005-09-13
Brief Title:
Pilot Study to Evaluate a Prototype Electronic Uterine Inhibitor to Prevent Preterm Contractions
Sponsor:
St Lukes-Roosevelt Hospital Center
Organization:
St Lukes-Roosevelt Hospital Center
Study Overview
Official Title:
Pilot Study to Evaluate a Prototype Electronic Uterine Inhibitor to Prevent Preterm Contractions
Status:
COMPLETED
Status Verified Date:
2018-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Use an electrical-inhibition EIuterine 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
Detailed Description:
The preterm birth rate in the United states has been stubbornly stuck at 105 or higher since the 1950s The 2011 rate 1172 is the most recent level available That comes to about a half a million preterm births per year in the United States alone
Premature birth and the attendant complications are among the greatest health problems in the world today and contribute to about 85 of all neonatal deaths that is deaths of infants from the time of birth until1 month old
During the past ten years there has been developed a novel method to effectively and objectively inhibit uterine contractility during the birthing process
The method is nonpharmaceutical and thus avoids systemic side effects and has the potential to be noninvasive and easy to master
This method uses an electrical intervention EIuterine pacemaker device that will allow for rapid and reversible inhibition of preterm uterine contractions and preterm birth
The following is a brief account of the electrical properties of the myometrium and why these properties may be affected by electrical intervention EI
The contractile activity of the uterus is a direct consequence of the underlying electrical activity in the myometrial cells The sequence of contraction and relaxation of the myometrium results from the cyclic depolarization and repolarization of the membranes of the muscle cells
The uterus at term has been shown to be myogenic just like the heart The uterus will contract spontaneously without neuronal control like the heart and form gap junctions interconnecting the cells just like the syncytium of the heart Also both are excitable tissues with similar current flows
Electrical Intervention EI has successfully inhibited myometrial or uterine contractions in many different species eg sheep rabbit rat and human in vitro The EI was effective in live animals when used on the uterus either directly attached or transvaginally
The electrical pacemaker Inch Inc Brooklyn NY used in this work is a self-contained portable device with integrated circuits housed in a box about eight inches on all sides EI is delivered as 10-second bursts of bipolar constant-current square-wave pulses in 20 duty cycles A 20 duty cycle consists of a pulse of current at the given amperage lasting 20 of the cycle followed by a period without current for the remaining 80 of the cycle The number of cycles per second defines the frequency in Hertz Hz Because the duty cycle is constant at 20 a 10-second burst always delivers current for a total of 2 seconds with the frequency determining the length and number of individual pulses in milliseconds msec during the burst
Participants were enrolled beginning in February 2005 IRB approval was in place at New York Downtown Hospital Manhattan NY from inception until March 2013 when it ceased to be a study site During the study period at Downtown Hospital 3 participants overall were enrolled and studied St Lukes Roosevelt Hospital Center Manhattan NY became a study site when it received IRB approval in January 2010 and at present is the only study site and has continuing IRB approval While under IRB approval 5 patients have been enrolled and studied at St Lukes and Roosevelt Each participant has given written informed consent To date 53 women have been recruited overall and 8 have given informed consent and been studied
Those studied are females 18 years old or older between 24-34 weeks gestation have a reassuring fetal heart rate FHR tracing and in preterm labor as defined by the American College of Obstetrics and Gynecology ACOG The participants must have persistent uterine contractions with 4 every 20 minutes or 8 every 60 minutes and any one or more of the following documented cervical change 1 cm cervical dilation or 80 cervical effacement The exclusion criteria are the same as for most tocolytic therapy most importantly premature rupture of the membranes PROM and additionally severe preeclampsia severe abruption placenta chorioamnionitis fetal death fetal anomaly incompatible with life severe fetal growth restriction or estimated fetal weight EFW 5 mature fetal lung studies maternal cardiac arrhythmias a permanent cardiac pacemaker a fetal cardiac arrhythmia or any other contraindication for tocolysis
The women have a pacemaker electrode placed vaginally A 5 167mm or 6 200mm French electrode catheter with distal 4x2mm platinum alloy rings 5mm apart C R Bard Inc Lowell MA USA is manually placed into the posterior vaginal fornix next to the external cervical os The catheters proximal end is taped to the patients thigh and its connecting cable attached to the pacemaker which can generate a weak bipolar electrical current 0-20 mA 0-50 msecpulse 50 Hz In the study the EI current is increased slowly as needed up to a maximum of 17 mA
The human study begins immediately after placing the catheter and lasts 60 minutes FHR uterine contraction timing and subjective contraction amplitude are monitored during the entire study The first 20 minutes are the control contraction period C1 The second 20 minutes are the EI period with a 10-second burst of current administered just prior to each expected contraction expected contractions are determined by the timing of the C1 contractions andor by the rise of the subjective tocodynamometer tracing above baseline levels The third 20 minutes is the post-intervention control contraction period C2 The contraction intervals the times between contraction peaks P-P were measured in minutes for C1 EI and C2 All statistical analyses for the human study have been performed using Statistical Analysis System SAS software SAS Institute Inc Cary NC USA Version 92 For each period C1 E1 and C2 the mean minutes between contractions are estimated using the mixed-model analysis of variance ANOVA to account for both within-subject and between-subject variability Pairwise differences between mixed-model ANOVA means and corresponding p-values testing for difference from zero were estimated All hypothesis testing is performed at the 005 level of significance
Premature birth and the attendant complications are among the greatest health problems in the world today and contribute to about 85 of all neonatal deaths that is deaths of infants from the time of birth until1 month old
During the past ten years there has been developed a novel method to effectively and objectively inhibit uterine contractility during the birthing process
The method is nonpharmaceutical and thus avoids systemic side effects and has the potential to be noninvasive and easy to master
This method uses an electrical intervention EIuterine pacemaker device that will allow for rapid and reversible inhibition of preterm uterine contractions and preterm birth
The following is a brief account of the electrical properties of the myometrium and why these properties may be affected by electrical intervention EI
The contractile activity of the uterus is a direct consequence of the underlying electrical activity in the myometrial cells The sequence of contraction and relaxation of the myometrium results from the cyclic depolarization and repolarization of the membranes of the muscle cells
The uterus at term has been shown to be myogenic just like the heart The uterus will contract spontaneously without neuronal control like the heart and form gap junctions interconnecting the cells just like the syncytium of the heart Also both are excitable tissues with similar current flows
Electrical Intervention EI has successfully inhibited myometrial or uterine contractions in many different species eg sheep rabbit rat and human in vitro The EI was effective in live animals when used on the uterus either directly attached or transvaginally
The electrical pacemaker Inch Inc Brooklyn NY used in this work is a self-contained portable device with integrated circuits housed in a box about eight inches on all sides EI is delivered as 10-second bursts of bipolar constant-current square-wave pulses in 20 duty cycles A 20 duty cycle consists of a pulse of current at the given amperage lasting 20 of the cycle followed by a period without current for the remaining 80 of the cycle The number of cycles per second defines the frequency in Hertz Hz Because the duty cycle is constant at 20 a 10-second burst always delivers current for a total of 2 seconds with the frequency determining the length and number of individual pulses in milliseconds msec during the burst
Participants were enrolled beginning in February 2005 IRB approval was in place at New York Downtown Hospital Manhattan NY from inception until March 2013 when it ceased to be a study site During the study period at Downtown Hospital 3 participants overall were enrolled and studied St Lukes Roosevelt Hospital Center Manhattan NY became a study site when it received IRB approval in January 2010 and at present is the only study site and has continuing IRB approval While under IRB approval 5 patients have been enrolled and studied at St Lukes and Roosevelt Each participant has given written informed consent To date 53 women have been recruited overall and 8 have given informed consent and been studied
Those studied are females 18 years old or older between 24-34 weeks gestation have a reassuring fetal heart rate FHR tracing and in preterm labor as defined by the American College of Obstetrics and Gynecology ACOG The participants must have persistent uterine contractions with 4 every 20 minutes or 8 every 60 minutes and any one or more of the following documented cervical change 1 cm cervical dilation or 80 cervical effacement The exclusion criteria are the same as for most tocolytic therapy most importantly premature rupture of the membranes PROM and additionally severe preeclampsia severe abruption placenta chorioamnionitis fetal death fetal anomaly incompatible with life severe fetal growth restriction or estimated fetal weight EFW 5 mature fetal lung studies maternal cardiac arrhythmias a permanent cardiac pacemaker a fetal cardiac arrhythmia or any other contraindication for tocolysis
The women have a pacemaker electrode placed vaginally A 5 167mm or 6 200mm French electrode catheter with distal 4x2mm platinum alloy rings 5mm apart C R Bard Inc Lowell MA USA is manually placed into the posterior vaginal fornix next to the external cervical os The catheters proximal end is taped to the patients thigh and its connecting cable attached to the pacemaker which can generate a weak bipolar electrical current 0-20 mA 0-50 msecpulse 50 Hz In the study the EI current is increased slowly as needed up to a maximum of 17 mA
The human study begins immediately after placing the catheter and lasts 60 minutes FHR uterine contraction timing and subjective contraction amplitude are monitored during the entire study The first 20 minutes are the control contraction period C1 The second 20 minutes are the EI period with a 10-second burst of current administered just prior to each expected contraction expected contractions are determined by the timing of the C1 contractions andor by the rise of the subjective tocodynamometer tracing above baseline levels The third 20 minutes is the post-intervention control contraction period C2 The contraction intervals the times between contraction peaks P-P were measured in minutes for C1 EI and C2 All statistical analyses for the human study have been performed using Statistical Analysis System SAS software SAS Institute Inc Cary NC USA Version 92 For each period C1 E1 and C2 the mean minutes between contractions are estimated using the mixed-model analysis of variance ANOVA to account for both within-subject and between-subject variability Pairwise differences between mixed-model ANOVA means and corresponding p-values testing for difference from zero were estimated All hypothesis testing is performed at the 005 level of significance
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None