Summary

Eligibility
for females ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion
Principal Investigator
by Tammy Grisales (ucla)

Description

Summary

This study is designed to evaluate the safety and effectiveness of the Materna Prep Device in reducing pelvic muscle injuries during vaginal delivery. Subjects are randomized to Materna Prep Device or Standard of Care without use of the Materna Prep Device Intervention with the Materna Prep Device is expected to be a one-time use of approximately 30-90 minutes during the 1st stage of labor. Subject participation in the study is targeted to be 3 months from the time of the use of the device during delivery. Subjects who elect to continue participation in the long term follow up portion of the study will extend their time in the study to 10 years.

Official Title

A Randomized, Controlled Study to Evaluate the Safety and Effectiveness of the Materna Prep Device to Pre-stretch (i.e., Dilate) the Vaginal Canal and Pelvic Floor Tissues in Preparation for Vaginal Delivery

Details

Primary effectiveness endpoint: Reduction in the rate of pelvic muscle injury defined as complete or partial detachment of the levator ani muscle diagnosed via ultrasound imaging at 3-month follow-up. Primary safety endpoint: Data on maternal and neonatal adverse events will be gathered and evaluated. Adverse events will be further summarized by relatedness to the device and/or procedure, seriousness, and level of severity. Secondary endpoints - Reduction in the length of second stage of labor, defined as the time from when the cervix is dilated to 10cm to the complete delivery of the baby. - Reduction in Levator Hiatus Area (measurement between pelvic muscle and pelvic bone) determined at 3-month ultrasound follow-up. - Reduction in the rate of perineal lacerations determined by visual inspection post-delivery. - Reduction in the rate of instrument use in vaginal deliveries. - Reduction in the rate of OASI - Rate of C-Sections due to cephalopelvic disproportion. - Infant APGAR scores. - Qualitative pain and pelvic health feedback. - User satisfaction

Keywords

Childbirth Shorten Delivery Time, Pelvic Muscle Injury, Vaginal Delivery, Complications, Childbirth, prevention Materna Prep Device

Eligibility

You can join if…

Open to females ages 18 years and up

Criteria for inclusion 1. Subject scheduled for vaginal birth. 2. Subject gestating a single fetus. 3. Subject nulliparous, or had a previous pregnancy terminated within 24 weeks gestation. 4. Subject able and willing to comply with the protocol required follow-up visits. 5. Subjects able and willing to provide written informed consent prior to enrollment. 6. Subject has sufficient mental capacity to: understand the informed consent form (ICF), comply with the protocol requirements, and provide clinically relevant and reliable feedback regarding their experience with the device. 7. Subject receives epidural anesthesia during labor prior to using the device. 8. Subject 18 years of age or older at time of consent.

You CAN'T join if...

Criteria for exclusion 1. Subject has high likelihood of less than 1 hours of potential device dilation time after she arrives at the hospital 2. Subject has need for or is planning a Caesarean-section 3. Subject begins labor with less than 36 weeks gestation 4. Subject has neurological diseases, e.g. Multiple Sclerosis, that may result in unrelated pelvic disorders or has been diagnosed with HIV. 5. Subject has muscular or skin disorder that affects elasticity of tissue, such as scleroderma or lupus.6. Subject has evidence of local or systemic infection, or has active herpes infection. 7. Subject has any prior surgical procedures to the vaginal anatomy which could lead to pelvic dysfunction, pelvic fractures, or pelvic soft tissue injuries. 8. Subject has any general health condition or systemic disease that may represent, in the opinion of the investigator, a potential increased risk associated with device use or pregnancy. 9. Subject has placenta previa or vasa previa 10. Known significant chromosomal or structural fetal anomalies 11. Category 2 and/or 3 fetal tracing that is unresolved

Locations

  • University of California Los Angeles accepting new patients
    Los Angeles California 90095 United States
  • El Camino Hospital accepting new patients
    Mountain View California 94040 United States

Lead Scientist at University of California Health

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Materna Medical
ID
NCT03973281
Study Type
Interventional
Participants
Expecting 212 study participants
Last Updated