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Behavioural Intervention
Materna Prep Device for Vaginal Birth
N/A
Recruiting
Research Sponsored by Materna Medical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject 18 years of age or older at time of consent
Subject 18 years of age or older at time of consent.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3-month and12-month follow-up
Awards & highlights
Study Summary
This trial will help assess if the Materna Prep Device is safe and effective in reducing pelvic muscle injuries during vaginal delivery.
Who is the study for?
This trial is for women over 18, expecting a single baby, planning a vaginal birth without prior pelvic surgeries. They must be able to follow the study plan and provide consent. Excluded are those with less than an hour for device use at hospital arrival, planned C-sections, preterm labor before 36 weeks, certain diseases like lupus or MS, infections including HIV or active herpes, placenta issues, fetal anomalies or risky fetal heart patterns.Check my eligibility
What is being tested?
The EASE study tests the Materna Prep Device against standard care during vaginal births to see if it reduces pelvic muscle injuries. Participants will either use the device once during labor's first stage for up to 90 minutes or receive regular care without it. The involvement lasts about a year from delivery.See study design
What are the potential side effects?
Potential side effects of using the Materna Prep Device aren't detailed in this summary but may include discomfort due to its application and possible tissue reactions given that conditions affecting skin elasticity exclude participation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3-month and12-month follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3-month and12-month follow-up
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The occurrence of pelvic muscle injury, defined as complete detachment of the levator ani muscle diagnosed via ultrasound imaging
Secondary outcome measures
C-Sections
First Push to Delivery
Infant APGAR scores
+11 moreSide effects data
From 2013 Phase 4 trial • 396 Patients • NCT0071180210%
Diarrhoea
5%
Blood creatine phosphokinase increased
5%
Rash
2%
Vomiting
2%
Pyrexia
2%
Upper respiratory tract infection
2%
Rash papular
2%
Dermatitis diaper
2%
Bacteraemia
2%
Urticaria
100%
80%
60%
40%
20%
0%
Study treatment Arm
Age Group 3: SOC
Age Group 2: SOC
Age Group 4: Daptomycin
Age Group 4: SOC
Age Group 1: Daptomycin
Age Group 1: Standard of Care (SOC)
Age Group 2: Daptomycin
Age Group 3: Daptomycin
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Standard of Care (SOC)Experimental Treatment1 Intervention
Standard of Care (SOC)
Group II: Materna Prep DeviceActive Control1 Intervention
Materna Prep Device
Find a Location
Who is running the clinical trial?
Materna MedicalLead Sponsor
2 Previous Clinical Trials
275 Total Patients Enrolled
1 Trials studying Pelvic Organ Prolapse
214 Patients Enrolled for Pelvic Organ Prolapse
University of MichiganOTHER
1,797 Previous Clinical Trials
6,377,608 Total Patients Enrolled
1 Trials studying Pelvic Organ Prolapse
140 Patients Enrolled for Pelvic Organ Prolapse
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I understand the study, can follow its requirements, and can give reliable feedback.My unborn baby has been diagnosed with significant genetic or structural abnormalities.I am likely to need a medical device within 1 hour of arriving at the hospital.I have had surgery on my vaginal area that could affect my pelvic function.I have a condition like scleroderma or lupus affecting my skin or muscle elasticity.I understand the study details and can follow its requirements.I experienced significant vaginal tissue damage during labor.I am 18 years old or older.I have a neurological condition like Multiple Sclerosis or I am diagnosed with HIV.I currently have an infection or active herpes.
Research Study Groups:
This trial has the following groups:- Group 1: Materna Prep Device
- Group 2: Standard of Care (SOC)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the participant recruitment rate for this clinical trial?
"To complete this trial, 212 suitable patients are required. These individuals may join from a selection of medical centres, including The Metro Health System in Cleveland and The Ohio State University Wexner Medical Center in Columbus."
Answered by AI
Is participation in this medical trial accessible to potential participants?
"As of today, this clinical trial is open to participants. It was originally posted on December 11th 2019 and most recently modified on August 22nd 2022; these details can be found at the website for clinicaltrials.gov."
Answered by AI
In what areas can this research project be accessed?
"This clinical trial is conducted at The Metro Health System in Cleveland, Ohio, The Ohio State University Wexner Medical Center in Columbus, California and the University of California Los Angeles in Los Angeles. An additional 16 sites are also participating across the United States."
Answered by AI
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