ChildbirthNCT06698185
A Clinical Phase II Study of the Materna Device to Shorten Delivery Time During Childbirth
A study testing Materna Prep Device in people with Childbirth, run by Materna Medical at 1 site in United States.
Trial summary
This feasibility study is a prospective, non-randomized, single arm study to evaluate safety and prevention of maternal pelvic soft-tissue damage using the Materna Medical Device. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Childbirth
- What is being tested?
- Materna Prep Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Dec 2014
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older 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 affects elasticity of tissue such as scleroderma or lupus.
- Local or systemic infection e.g. HIV, herpes
- Any prior surgical procedures to the vaginal anatomy that 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
Trial locations and contacts
1 site in 1 country.
About this study
This feasibility study is a prospective, non-randomized, single arm study to evaluate safety and prevention of maternal pelvic soft-tissue damage using the Materna Medical Device. The device will be used during the first stage of labor, following initiation of epidural anesthesia and after the cervix has dilated to between 3-8 cm. Up to 20 subjects will be included in the initial study, with the option to increase the number of subjects to 50 based on early data.
Read the detailed description
Study Inclusion Criteria are:
- Patients attending for antenatal care at El Camino Hospital with the Altos Oaks Obstetrics Group
- First ongoing pregnancy beyond 20 weeks
- Singleton, cephalic presentation
- No pregnancy complications which are likely to require Caesarean Section
- Planned vaginal delivery
The primary outcome measure is device safety as defined by freedom of device related adverse events. Secondary efficacy outcome measures are:
- Pelvic muscle damage as determined by ultrasound imaging
- Length of the 2nd stage of labour
- Delivery mode
- Perineal and anal sphincter trauma
- Symptoms of incontinence, prolapse and sexual dysfunction 2 years postpartum
- Pelvic organ support (ICS POP-Q system) and pelvic organ descent on ultrasound
Interested patients will have the study presented to them during their pre-natal visits with the Altos Oaks Obstetrics group. Interested patients will have the study explained to them and will be given the Informed Consent document.After the informed consent procedure, patients will undergo an interview and 4D translabial ultrasound.
The screened patients will have the Materna device administered by a researcher from the Altos Oaks Obstetrics group. The patients will be flagged in their charts regarding their participation in this study. When an enrolled patient arrives at the hospital and is deemed to be in labor, the Altos Oaks physician on call will be notified, and called to administer the use of the device. All other obstetric services are provided by routine staff. The device will be dilated up to a maximum diameter of 8-10cm and is then removed to allow delivery. The Control arm patients will experience normal care during labor. Participants are followed up at 3 months and 1 year after childbirth with an interview, including validated questionnaires on bladder, bowel and sexual function, and repeat ultrasound. Delivery details will be collected by the midwives and through the institutional database.
The study's primary efficacy outcome measure is levator avulsion injury diagnosed on volume ultrasound data obtained at the 1-3 month follow-up appointment. Secondary outcomes include both objective findings related to pelvic floor function and anatomy, as well as symptoms of pelvic floor dysfunction such as pelvic organ prolapse, urinary / fecal incontinence and dyspareunia, as ascertained by interview and questionnaire, at 3 months after childbirth. Assessment of stored ultrasound volume data (obtained on pelvic floor muscle contraction, or, if that is not possible, at rest) is undertaken at a later date by one single operator within the Altos Oaks Obstetrics group.
- Conditions
- Childbirth
- Being tested
- Materna Prep Device, Sham Control
- Keywords
- Childbirth, Tearing, perineal lacerations, pelvic muscle, avulsion, pelvic floor disorders, vaginal delivery, instrument delivery, delivery time, ultrasound
- Medical subject headings
- Lacerations, Fractures, Avulsion, Pelvic Floor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Materna Prep DeviceDevice
Materna Prep Device
Sham ControlDevice
Sham Control
| Study group | Role | What they receive |
|---|---|---|
| Materna Prep Device | Experimental | Materna Prep Device Receives: Device: Materna Prep Device |
| Sham Control | Sham comparator | Sham Control Receives: Device: Sham Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Freedom from device related adverse events
Measured: 3 months post-delivery follow-up
Secondary outcomes (5)
Pelvic Muscle Avulsion
Binary, determined with ultrasound imaging
Measured: 1-3 months post delivery
Pelvic Muscle Damage
Measured by changes in levator hiatus area, determined with ultrasound imaging
Measured: 1-3 Months Post-Delivery
Delivery Time
Measure the length of the second phase of labor
Measured: Immediate after delivery
Perineal Lacerations
Record the grade of perineal lacerations, and if sutures were used to repair lacerations
Measured: Immediate Post Delivery
Instrument Deliveries
Record if instruments were used for delivery
Measured: Immediate Post-Delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study startSep 2014
- Primary completionDec 2014
- Study completionDec 2014
Why it stopped: Change in IRB jurisdiction for study, study is suspended
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChildbirthStudies of the same condition, open and under way.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Materna Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- El Camino Hospital, Mountain View, CA, Altos Oaks Medical Group, Mountain View, CA
- Responsible party
- Sponsor
- Investigators
- Kenneth Weber, MD, Principal investigator, Obstatrician, Altos Oaks Medical Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06698185
- Sponsor's protocol ID
- MAT-2002
- Status last verified
- Nov 2024
- First submitted
- 14 Mar 2016
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Phase II Study of the Materna Device to Shorten Delivery Time During Childbirth
- ClinicalTrials.gov ID
- NCT06698185
- Acronym / sponsor ID
- MAT-2002
- Conditions
- Childbirth
- Keywords
- Childbirth, Tearing, perineal lacerations, pelvic muscle, avulsion, pelvic floor disorders, vaginal delivery, instrument delivery, delivery time, ultrasound
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Change in IRB jurisdiction for study, study is suspended
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Materna MedicalIndustry (pharma, biotech, devices)
- Collaborators
- El Camino Hospital, Mountain View, CA, Altos Oaks Medical Group, Mountain View, CA
- Study start
- Sep 2014 (actual)
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 20 Nov 2024 (actual)
- 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.
This feasibility study is a prospective, non-randomized, single arm study to evaluate safety and prevention of maternal pelvic soft-tissue damage using the Materna Medical Device. The device will be used during the first stage of labor, following initiation of epidural anesthesia and after the cervix has dilated to between 3-8 cm. Up to 20 subjects will be included in the initial study, with the option to increase the number of subjects to 50 based on early data.
Detailed description
Study Inclusion Criteria are:
- Patients attending for antenatal care at El Camino Hospital with the Altos Oaks Obstetrics Group
- First ongoing pregnancy beyond 20 weeks
- Singleton, cephalic presentation
- No pregnancy complications which are likely to require Caesarean Section
- Planned vaginal delivery
The primary outcome measure is device safety as defined by freedom of device related adverse events. Secondary efficacy outcome measures are:
- Pelvic muscle damage as determined by ultrasound imaging
- Length of the 2nd stage of labour
- Delivery mode
- Perineal and anal sphincter trauma
- Symptoms of incontinence, prolapse and sexual dysfunction 2 years postpartum
- Pelvic organ support (ICS POP-Q system) and pelvic organ descent on ultrasound
Interested patients will have the study presented to them during their pre-natal visits with the Altos Oaks Obstetrics group. Interested patients will have the study explained to them and will be given the Informed Consent document.After the informed consent procedure, patients will undergo an interview and 4D translabial ultrasound.
The screened patients will have the Materna device administered by a researcher from the Altos Oaks Obstetrics group. The patients will be flagged in their charts regarding their participation in this study. When an enrolled patient arrives at the hospital and is deemed to be in labor, the Altos Oaks physician on call will be notified, and called to administer the use of the device. All other obstetric services are provided by routine staff. The device will be dilated up to a maximum diameter of 8-10cm and is then removed to allow delivery. The Control arm patients will experience normal care during labor. Participants are followed up at 3 months and 1 year after childbirth with an interview, including validated questionnaires on bladder, bowel and sexual function, and repeat ultrasound. Delivery details will be collected by the midwives and through the institutional database.
The study's primary efficacy outcome measure is levator avulsion injury diagnosed on volume ultrasound data obtained at the 1-3 month follow-up appointment. Secondary outcomes include both objective findings related to pelvic floor function and anatomy, as well as symptoms of pelvic floor dysfunction such as pelvic organ prolapse, urinary / fecal incontinence and dyspareunia, as ascertained by interview and questionnaire, at 3 months after childbirth. Assessment of stored ultrasound volume data (obtained on pelvic floor muscle contraction, or, if that is not possible, at rest) is undertaken at a later date by one single operator within the Altos Oaks Obstetrics group.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Materna Prep Device | Experimental | Device: Materna Prep DeviceMaterna Prep Device |
| Sham Control | Sham comparator | Device: Sham ControlSham Control |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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 (7 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 affects 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 Prep DeviceMaterna Prep Device | Device | Materna Prep Device |
| Sham ControlSham Control | Device | Sham Control |
Primary outcome
Safety
Time frame: 3 months post-delivery follow-up
Freedom from device related adverse events
5 secondary outcomes
Pelvic Muscle Avulsion
Time frame: 1-3 months post delivery
Pelvic Muscle Damage
Time frame: 1-3 Months Post-Delivery
Delivery Time
Time frame: Immediate after delivery
Perineal Lacerations
Time frame: Immediate Post Delivery
Instrument Deliveries
Time frame: Immediate Post-Delivery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
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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.
Kenneth Weber, MD principal investigator
Obstatrician, Altos Oaks Medical Group
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 Prep Device in people with Childbirth, run by Materna Medical 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 7 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: withdrawn, as of the sponsor's last update on 20 Nov 2024. 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. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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?
Safety (time frame: 3 months post-delivery 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 20 Nov 2024; AzTrials last refreshed its copy on 7 Nov 2026.