Tear, Pelvic Organ, Obstetric TraumaNCT02332759
A Pilot Study To Evaluate The Preliminary Safety And Feasibility Of The Materna Medical Device
A study testing Materna Medical in people with Tear, Pelvic Organ, Obstetric Trauma, run by Baylor College of Medicine at 1 site in United States.
Trial summary
The Materna device aims to prevent pelvic tissue damage by preventing overstretching of pelvic floor muscle fibers during delivery. The device is a single use, disposable, mechanical dilator that penetrates the first 4 cm or ½ of the vaginal canal and gradually expands the vagina from a resting diameter of 2-3 cm to… Read more about this study
- Who is it for?
- Ages 18 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Tear, Pelvic Organ, Obstetric Trauma
- What is being tested?
- Materna Medical
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Primiparas, or previous pregnancy terminated before 24 weeks gestation
- Single fetus birth
- Subject is able to understand the risks and potential benefits of participating in the study and is willing to provide written informed consent
- Subject is willing and able to comply with specified follow-up evaluations
- Planned to have epidural during birthing process
Who cannot join
- Previous delivery, or previous pregnancy beyond 24 weeks gestation
- Less than 36 weeks gestation
- Neurological diseases e.g. Multiple Sclerosis that may result in unrelated pelvic disorders
- Muscular or skin disorder that effects elasticity of tissue such as scleroderma or lupus
- Local or systemic infection e.g. HIV, herpes
- Diabetes
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- Clinically estimated fetal weight > 4,500 grams
- Any prior surgical procedures to the vaginal anatomy which could lead to pelvic dysfunction, pelvic fractures, or pelvic soft tissue injuries. Evaluated during baseline screening
- High likelihood of less than 1 hour of potential device dilation time after the woman arrives at the center and receives epidural
- A cervical dilation of greater than or equal to 6 cm
- BMI > 32.5 prior to becoming pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas Children's Hospital Pavilion For Women
Houston, Texas, 77030
About this study
Official title: A PILOT STUDY TO EVALUATE THE PRELIMINARY SAFETY AND FEASIBILITY OF THE MATERNA MEDICAL DEVICE FOR THE PREVENTION OF PERINEAL LACERATIONS AND OCCULT DISRUPTION OF THE PELVIC FLOOR AND ASSOCIATED SEQUELA DURING VAGINAL DELIVERY.
The Materna device aims to prevent pelvic tissue damage by preventing overstretching of pelvic floor muscle fibers during delivery. The device is a single use, disposable, mechanical dilator that penetrates the first 4 cm or ½ of the vaginal canal and gradually expands the vagina from a resting diameter of 2-3 cm to the fully expanded size of a delivering fetus, roughly 8-10 cm. The Materna device will be used during the first stage of labor, for roughly 1-2 hours, in a hospital Labor and Delivery unit, under the supervision of trained clinical labor and delivery providers
Read the detailed description
Over 80% of women who deliver vaginally will sustain a vaginal tear, and roughly half of all women will suffer from permanent pelvic muscle damage that may lead to pelvic disorders later in life.(1-8) The consequences of vaginal tearing are acute and chronic pain, longer recovery times, sexual dysfunction and permanent disfigurement.(1-4) Additionally, women often say that the prospect of tearing is one the things they fear most regarding childbirth. Tearing during childbirth is well documented as occurring during most deliveries, however there is additional damage now being discovered that occurs internally to the pelvic muscles.
It has long been thought that childbirth is the leading factor contributing to the development of pelvic floor disorders such as pelvic organ prolapse, urinary and fecal incontinence. (6,9,10) In the last 10 years, new imaging studies have shown that approximately 20-30% of women will have their pelvic muscles permanently separated from the pelvic bone during vaginal delivery.(5-11) In an additional 20-30% of cases, the muscles may remain attached to the pelvic bone but have been stretched to the point of becoming functionally compromised
One of the most promising ideas to prevent this damage is to slowly prepare the pelvic muscles, during labor while the cervix is dilating, in order to maximize their stretch.
The previous data and preliminary findings of Materna suggest the following overall working hypotheses:
- Vaginal lacerations and pelvic floor muscle damage lead to increased incidence of pelvic floor disorders and other negative sequelae.
- Vaginal lacerations and pelvic floor muscle damage are caused by over straining of pelvic muscles and vaginal tissues without maximizing the tissue strain using appropriate viscoelastic relaxation during the second phase of labor.
- The incidence and severity of vaginal lacerations and pelvic floor muscle damage can be reduced by inducing a more gradual strain of the vaginal tissues using a device-based approach
Currently there are no devices available in the U.S. to protect the pelvic muscles from damage during childbirth. The Materna device takes advantage of well-proven biomechanical data in the fields of sports medicine and orthopedics showing that tissue is viscoelastic, meaning that the more slowly it is stretched the easier it is to stretch. Materna aims to take advantage of this biomechanical phenomena as well as the length of the first phase of labor to reduce the tension in the tissue, slowly maximizing the stretch of the tissue in order to prepare it for a delivery with less injury. There is also evidence showing that reducing the tension in the pelvic muscles could lead to a shorter delivery time, resulting in a less stressful and healthier delivery for the baby
- Conditions
- Tear, Pelvic Organ, Obstetric Trauma
- Being tested
- Materna Medical
- Medical subject headings
- Lacerations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Materna MedicalDevice
| Study group | Role | What they receive |
|---|---|---|
| Materna Device | Experimental | The device will be inserted vaginally for one hour during active phase of labor to dilate the vaginal canal. Receives: Device: Materna Medical |
What is being measured
The primary outcome is the main question the study is designed to answer.
No adverse events related to device
Measured: 12-20 week postpartum follow up
Secondary outcomes (1)
Reduction in perineal lacerations and pelvic floor trauma
Measured: 12-20 week postpartum follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2015 (estimated)
- Study startJul 2014
- Primary completionNov 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tear, Pelvic Organ, Obstetric TraumaStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Materna Medical
- Responsible party
- Principal investigator, Francisco Orejuela, Baylor College of Medicine
- Investigators
- Susan M Ramin, M.D., Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02332759
- Sponsor's protocol ID
- H- 31936
- Status last verified
- Aug 2020
- First submitted
- 2 Jan 2015
- Last updated
- 6 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PILOT STUDY TO EVALUATE THE PRELIMINARY SAFETY AND FEASIBILITY OF THE MATERNA MEDICAL DEVICE FOR THE PREVENTION OF PERINEAL LACERATIONS AND OCCULT DISRUPTION OF THE PELVIC FLOOR AND ASSOCIATED SEQUELA DURING VAGINAL DELIVERY.
- ClinicalTrials.gov ID
- NCT02332759
- Acronym / sponsor ID
- H- 31936
- Conditions
- Tear, Pelvic Organ, Obstetric Trauma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- Materna Medical
- Study start
- Jul 2014
- Primary completion
- Nov 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 7 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Materna device aims to prevent pelvic tissue damage by preventing overstretching of pelvic floor muscle fibers during delivery. The device is a single use, disposable, mechanical dilator that penetrates the first 4 cm or ½ of the vaginal canal and gradually expands the vagina from a resting diameter of 2-3 cm to the fully expanded size of a delivering fetus, roughly 8-10 cm. The Materna device will be used during the first stage of labor, for roughly 1-2 hours, in a hospital Labor and Delivery unit, under the supervision of trained clinical labor and delivery providers
Detailed description
Over 80% of women who deliver vaginally will sustain a vaginal tear, and roughly half of all women will suffer from permanent pelvic muscle damage that may lead to pelvic disorders later in life.(1-8) The consequences of vaginal tearing are acute and chronic pain, longer recovery times, sexual dysfunction and permanent disfigurement.(1-4) Additionally, women often say that the prospect of tearing is one the things they fear most regarding childbirth. Tearing during childbirth is well documented as occurring during most deliveries, however there is additional damage now being discovered that occurs internally to the pelvic muscles.
It has long been thought that childbirth is the leading factor contributing to the development of pelvic floor disorders such as pelvic organ prolapse, urinary and fecal incontinence. (6,9,10) In the last 10 years, new imaging studies have shown that approximately 20-30% of women will have their pelvic muscles permanently separated from the pelvic bone during vaginal delivery.(5-11) In an additional 20-30% of cases, the muscles may remain attached to the pelvic bone but have been stretched to the point of becoming functionally compromised
One of the most promising ideas to prevent this damage is to slowly prepare the pelvic muscles, during labor while the cervix is dilating, in order to maximize their stretch.
The previous data and preliminary findings of Materna suggest the following overall working hypotheses:
- Vaginal lacerations and pelvic floor muscle damage lead to increased incidence of pelvic floor disorders and other negative sequelae.
- Vaginal lacerations and pelvic floor muscle damage are caused by over straining of pelvic muscles and vaginal tissues without maximizing the tissue strain using appropriate viscoelastic relaxation during the second phase of labor.
- The incidence and severity of vaginal lacerations and pelvic floor muscle damage can be reduced by inducing a more gradual strain of the vaginal tissues using a device-based approach
Currently there are no devices available in the U.S. to protect the pelvic muscles from damage during childbirth. The Materna device takes advantage of well-proven biomechanical data in the fields of sports medicine and orthopedics showing that tissue is viscoelastic, meaning that the more slowly it is stretched the easier it is to stretch. Materna aims to take advantage of this biomechanical phenomena as well as the length of the first phase of labor to reduce the tension in the tissue, slowly maximizing the stretch of the tissue in order to prepare it for a delivery with less injury. There is also evidence showing that reducing the tension in the pelvic muscles could lead to a shorter delivery time, resulting in a less stressful and healthier delivery for the baby
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Materna Device | Experimental | Device: Materna MedicalThe device will be inserted vaginally for one hour during active phase of labor to dilate the vaginal canal. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Primiparas, or previous pregnancy terminated before 24 weeks gestation
- Single fetus birth
- Subject is able to understand the risks and potential benefits of participating in the study and is willing to provide written informed consent
- Subject is willing and able to comply with specified follow-up evaluations
- Planned to have epidural during birthing process
Key exclusion criteria (11 listed)
- Previous delivery, or previous pregnancy beyond 24 weeks gestation
- Less than 36 weeks gestation
- Neurological diseases e.g. Multiple Sclerosis that may result in unrelated pelvic disorders
- Muscular or skin disorder that effects elasticity of tissue such as scleroderma or lupus
- Local or systemic infection e.g. HIV, herpes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Materna Medical | Device | Materna Device |
Primary outcome
No adverse events related to device
Time frame: 12-20 week postpartum follow up
1 secondary outcome
Reduction in perineal lacerations and pelvic floor trauma
Time frame: 12-20 week postpartum follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2020.
- Individual participant dataSharing planned: No
Related trials for Tear, Pelvic Organ, Obstetric Trauma
Not yet recruiting
Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
Pelvic Floor Dysfunction, Perineal Laceration
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan M Ramin, M.D. principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Materna Medical in people with Tear, Pelvic Organ, Obstetric Trauma, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
No adverse events related to device (time frame: 12-20 week postpartum follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2020.