Trial Outcomes & Findings for Pilot Study to Evaluate a Prototype Electronic Uterine Inhibitor to Prevent Preterm Contractions (NCT NCT00212446)

Results Overview

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 and/or by the rise of the subjective tocodynamometer tracing above baseline levels. The third 20 minutes is the post-intervention control contraction period (C2).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

8 participants

Primary outcome timeframe

20 minutes, 40 minutes, 60 minutes

Results posted on

2018-12-17

Participant Flow

The study period was from February 2005 through April 2012 and was performed on the labor and delivery floor of the study sites.

Participant milestones

Participant milestones
Measure	Electrical Intervention Electrical intervention (EI) is bipolar, constant-current (1-20 mA), square-wave pulses in 20% duty cycles. Women in preterm labor have an electrode placed vaginally; tocodynamometric contraction timing and fetal heart rate are monitored continuously. Successive 20-minute periods include pre-control period (C1); the EI period, in which a 10-second current burst is delivered at expected contraction times; and a post-EI control period (C2).
Overall Study STARTED	8
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Electrical Intervention n=8 Participants Electrical intervention (EI) is bipolar, constant-current (1-20 mA), square-wave pulses in 20% duty cycles. Women in preterm labor have an electrode placed vaginally; tocodynamometric contraction timing and fetal heart rate are monitored continuously. Successive 20-minute periods include pre-control period (C1); the EI period, in which a 10-second current burst is delivered at expected contraction times; and a post-EI control period (C2).
Age, Continuous	31.65 years STANDARD_DEVIATION 8.00 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Gestational Age	31.11 weeks STANDARD_DEVIATION 2.19 • n=5 Participants
pre-EI cervical dilatation	3.0 cm STANDARD_DEVIATION 2.33 • n=5 Participants
pre-EI effacement	80.00 percent of effacement STANDARD_DEVIATION 17.73 • n=5 Participants

PRIMARY outcome

Timeframe: 20 minutes, 40 minutes, 60 minutes

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 and/or by the rise of the subjective tocodynamometer tracing above baseline levels. The third 20 minutes is the post-intervention control contraction period (C2).

Outcome measures

Outcome measures
Measure	Electrical Intervention n=8 Participants Electrical intervention (EI) is bipolar, constant-current (1-20 mA), square-wave pulses in 20% duty cycles. Women in preterm labor have an electrode placed vaginally; tocodynamometric contraction timing and fetal heart rate are monitored continuously. Successive 20-minute periods include pre-control period (C1); the EI period, in which a 10-second current burst is delivered at expected contraction times; and a post-EI control period (C2).
Uterine Contractions C1	3.18 minutes Standard Deviation 1.30
Uterine Contractions E1	3.78 minutes Standard Deviation 1.44
Uterine Contractions C2	3.20 minutes Standard Deviation 1.33

PRIMARY outcome

Timeframe: 60 minutes

Number of newborn with fetal heart arrhythmias noted

Outcome measures

Outcome measures
Measure	Electrical Intervention n=8 Participants Electrical intervention (EI) is bipolar, constant-current (1-20 mA), square-wave pulses in 20% duty cycles. Women in preterm labor have an electrode placed vaginally; tocodynamometric contraction timing and fetal heart rate are monitored continuously. Successive 20-minute periods include pre-control period (C1); the EI period, in which a 10-second current burst is delivered at expected contraction times; and a post-EI control period (C2).
Number of Newborn With Fetal Heart Arrhythmias	0 newborns with fetal heart arrhythmias

SECONDARY outcome

Timeframe: Time until delivery, up to 4 weeks

Latency is defined as the time from admission into hospital until birth

Outcome measures

Outcome measures
Measure	Electrical Intervention n=8 Participants Electrical intervention (EI) is bipolar, constant-current (1-20 mA), square-wave pulses in 20% duty cycles. Women in preterm labor have an electrode placed vaginally; tocodynamometric contraction timing and fetal heart rate are monitored continuously. Successive 20-minute periods include pre-control period (C1); the EI period, in which a 10-second current burst is delivered at expected contraction times; and a post-EI control period (C2).
Latency of Birth	599.76 hours Standard Deviation 56.00

SECONDARY outcome

Timeframe: Until birthing process is complete

Population: not collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 minute and 5 minute after childbirth

The 1-minute score determines how well the baby tolerated the birthing process. The 5-minute score tells the health care provider how well the baby is doing outside the mother's womb. Five factors: Appearance (skin color), Pulse (heart rate), Grimace response (reflexes), Activity (muscle tone), Respiration (breathing rate and effort) are used to evaluate the baby's condition and each factor is scored on a scale of 0 to 2, with full scale from 0 to 10 being the best score

Outcome measures

Outcome measures
Measure	Electrical Intervention n=8 Participants Electrical intervention (EI) is bipolar, constant-current (1-20 mA), square-wave pulses in 20% duty cycles. Women in preterm labor have an electrode placed vaginally; tocodynamometric contraction timing and fetal heart rate are monitored continuously. Successive 20-minute periods include pre-control period (C1); the EI period, in which a 10-second current burst is delivered at expected contraction times; and a post-EI control period (C2).
Apgars Score 1 minute	8.75 units on a scale Standard Deviation 0.71
Apgars Score 5 minute	9.0 units on a scale Standard Deviation 0.53

SECONDARY outcome

Timeframe: up to one month

The length of Neonatal intensive care unit (NICU) stay

Outcome measures

Outcome measures
Measure	Electrical Intervention n=8 Participants Electrical intervention (EI) is bipolar, constant-current (1-20 mA), square-wave pulses in 20% duty cycles. Women in preterm labor have an electrode placed vaginally; tocodynamometric contraction timing and fetal heart rate are monitored continuously. Successive 20-minute periods include pre-control period (C1); the EI period, in which a 10-second current burst is delivered at expected contraction times; and a post-EI control period (C2).
The Length of NICU Stay	13.42 days Standard Deviation 11.02

SECONDARY outcome

Timeframe: until after childbirth

Gestational age at discharge.

Outcome measures

Outcome measures
Measure	Electrical Intervention n=8 Participants Electrical intervention (EI) is bipolar, constant-current (1-20 mA), square-wave pulses in 20% duty cycles. Women in preterm labor have an electrode placed vaginally; tocodynamometric contraction timing and fetal heart rate are monitored continuously. Successive 20-minute periods include pre-control period (C1); the EI period, in which a 10-second current burst is delivered at expected contraction times; and a post-EI control period (C2).
Gestational Age at Discharge	36.61 weeks Standard Deviation 2.68

Adverse Events

Electrical Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jeffrey Karsdon

New York Downtown Hospital (hospital bankrupt/closed)

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place