Comparing Two Methods of Contractions Monitoring for Clinical Decision Making Regarding Treatment Among Pregnant Women With Preterm Contractions.

NCT02875418 | Unknown Phase 3 DMC

• 1 other identifier: 171-16-TLV
• Study Type: interventional
• Target: 1,500
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background: Identification and measurement of uterine contractions throughout pregnancy and labor is crucial to the well being of both mother and fetus. Prematurity is one of the major causes for adverse pregnancy outcomes, and clinical decision-making often relies on uterine frequency as recorded by a tocodynamometer, as well as on other methods including sonographic cervical length, pelvic examination. Objective: To show that the use of the EUM in preterm labor is effective in establishing true preterm labor.

Conditions

Fetal Heartbeat Tracings

Outcome Measures

Primary Outcomes (1)

• Rate of preterm deliveries

  Week of gestation will be documented.

  4 month

Study Arms (1)

EUM and tocodynamometry

EXPERIMENTAL

Pregnant women with gestational age 24+0/7 to 33+6/7 weeks of gestation and contractions, cramping, pelvic pressure or backache.

Device: EUM; Device: Tocodynamometry

Interventions

EUM DEVICE

STUDY DESIGN 1. Explanation regarding the study and assessing eligibility criteria. 2. Signing an informed consent. 3. Recording of uterine contractions by both EUM and tocodynamometry. A correlation between EUM and tocodynamometry will be calculated. For the purpose of this study, a positive EUM or tocodynamometry will be defined as 3 at least 3 contractions in 30 minutes.

EUM and tocodynamometry

Tocodynamometry DEVICE

STUDY DESIGN 1. Explanation regarding the study and assessing eligibility criteria. 2. Signing an informed consent. 3. Recording of uterine contractions by both EUM and tocodynamometry. A correlation between EUM and tocodynamometry will be calculated. For the purpose of this study, a positive EUM or tocodynamometry will be defined as 3 at least 3 contractions in 30 minutes.

EUM and tocodynamometry

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Gestational age 24+0/7 to 33+6/7 weeks of gestation.
• Maternal age \> 18 years.
• Contractions, cramping, pelvic pressure or backache.
• Reactive fetal heart rate monitoring at enrollment.
• Subjects are willing and able to comply with the requirements of the protocol.
• Fully understand all elements of the study, and have signed and dated, the written informed consent form before initiation of protocol-specified procedures.

You may not qualify if:

• Refusal to participate.
• Maternal age \< 18 years.
• Woman with implanted electronic device of any kind.
• Woman with allergy to silver.
• Irritated skin or open wound.

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

MeSH Terms

Interventions

Uterine Monitoring

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Obstetrical and Gynecological; Diagnostic Techniques and Procedures; Diagnosis; Monitoring, Physiologic

Study Officials

• yariv yogev, professor

  Tel Aviv Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

yariv yogev, professor

CONTACT

97236925603; yarivy@tlvmc.gov.il

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2016
• First Posted: August 23, 2016
• Study Start: September 1, 2016
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: August 23, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share