MyelomeningoceleHysterotomyNCT02493062
Evaluation of Hysterotomy Site After Open Fetal Surgery
A study testing Sonohysterogram in people with Myelomeningocele and Pregnancy, run by St. Louis University at 1 site in United States.
Trial summary
This study is to review how the uterus heals after having open fetal surgery. Open fetal surgery causes a scar perhaps two: one from the open fetal surgery and a second from delivery by cesarean section; rarely, the same area of your uterus was used for both open fetal surgery and delivery. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Myelomeningocele, Pregnancy
- What is being tested?
- Sonohysterogram
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to 20 Dec 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- SSM Cardinal Glennon Fetal Care Institute evaluation
- Received Open Fetal Surgery
- Open fetal surgery of myelomeningocele: maternal age of >= 18 yrs. and <=50 yrs.
- If a woman < 18 years old presented with a fetal tumor requiring open fetal repair, this would be done if deemed ethically sound by both CG and St. Mary's Health Center (SMHC) ethics committees. Given this, then the patient may qualify for this study. This is a RARE event.
- Agree to travel to SSM St. Mary's in St. Louis for sonohysterogram 6 or more months after delivery.
Who cannot join
- Presently pregnant
- Hysterectomy after delivery
- Menopause
- Using IUD (Intrauterine Device) for birth control
- There is no exclusion criteria for infants
Trial locations and contacts
1 site in 1 country.
United States1 site
SSM Cardinal Glennon Fetal Care Institute
St Louis, Missouri, 63104
About this study
This study is to review how the uterus heals after having open fetal surgery. Open fetal surgery causes a scar perhaps two: one from the open fetal surgery and a second from delivery by cesarean section; rarely, the same area of your uterus was used for both open fetal surgery and delivery. From other studies of surgery performed on a uterus, some of the uterine scars do not heal well. This study's intervention uses sterile saline to spread open the inside of the uterus. The saline is slowly injected into the uterus using a catheter. An ultrasound called a sonohysterogram is performed to take pictures of the uterus, its inside and the walls of the uterus. In this way, the healed areas from the uterine surgery can be seen with ultrasound and evaluated. This is performed at least 6 months after delivery.
Primary Outcome:
Measure the depth of the scar and location of the scar 6 months or longer after delivery.
Read the detailed description
This is an Investigator initiated, prospective study reviewing medical records and performing a sonohysterogram on non-pregnant women at 6 or more months after delivery of an infant who received open fetal repair.
An evaluation is completed at SSM Cardinal Glennon (CG), Fetal Care Institute (FCI) of a woman who has decided to have open fetal surgery to complete a fetal repair before the infant is born.
- After open fetal surgery participant will be monitored and delivered appropriately.
- After the infant is born investigators will review the mother's and infant's electronic health records and FCI database records
- 6 months or more after delivery of an infant who has received open fetal repair the participant will go to Saint Louis University (SLU) Care for a sonohysterogram to evaluate the healing process.
- Conditions
- Myelomeningocele, Pregnancy
- Being tested
- Sonohysterogram
- Keywords
- Hysterotomy, Myelomeningocele, Open fetal surgery, Sonohysterogram
- Medical subject headings
- Meningomyelocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SonohysterogramDevice
Also called ultrasound
The sonohysterogram can measure the size and depth of the uterine scar allowing better predictive values for future pregnancies.
| Study group | Role | What they receive |
|---|---|---|
| single-arm study | Experimental | This single-arm study is described by women who have undergone prenatal fetal open (uterus was opened to perform a fetal intervention/surgery) surgery and cesarean section delivery. These women will undergo sonohysterogram. Receives: Device: Sonohysterogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cesarean Hysterotomy Myometrial Thickness
Average myometrium thickness surrounding niche is measured by measuring Average thickness of the myometrium toward the cervix and toward the fundus resulting in the average myometrium thickness surrounding the niche, measured by the sonohysterogram.
Measured: Minimum of 6 months after delivery.
Cesarean Hysterotomy Site Myometrial Percentage of Thinning at the Niche
Average myometrium will be calculated, measured by the sonohysterogram. The myometrium will be measured caudad and cephalad of the niche and averaged ((Caudad side in mm + Cephalad side in mm)/2)=Average myometrium thickness The myometrium at niche will be measured (niche mm). Average myometrium-niche mm= niche thinning (mm).
Niche thinning / Average myometrium thickness= Percentage of thinning at the niche.
Ex:
Average thickness at niche: 0.5 mm Caudad myometrium thickness: 1.5 mm Cephalad myometrium thickness: 1.5 mm
1.5mm + 1.5mm= 3mm/ 2= 1.5mm (average Myometrium Thickness)
1.5mm- 0.5mm = 1.0 mm (Niche thinning)
0.5mm / 1.0 mm (% of thinning at the niche)
Measured: Minimum of 6 months after delivery.
Fetal Myelomeningocele Hysterotomy Site Myometrial Thickness
Average myometrium thickness surrounding niche is measured by measuring average thickness of the myometrium to the right and left of the niche resulting in the average myometrium thickness surrounding the niche. This is measured by the sonohysterogram.
Measured: Minimum of 6 months after delivery.
Fetal Myelomeningocele Hysterotomy Site Myometrial Percentage of Thinning at the Niche
Average myometrium will be calculated, measured by the sonohysterogram. The myometrium will be measure to the right and left of the niche and averaged ((Right side in mm + Left side in mm)/2)=Average myometrium thickness The myometrium at niche will be measured (niche mm). Average myometrium-niche mm= niche thinning (mm).
Niche thinning / Average myometrium thickness= Percentage of thinning at the niche.
Ex:
Average thickness at niche: 0.5 mm Right sided myometrium thickness: 1.5 mm Left sided myometrium thickness: 1.5 mm
1.5mm + 1.5mm= 3mm/ 2= 1.5mm (average Myometrium Thickness)
1.5mm- 0.5mm = 1.0 mm (Niche thinning)
0.5mm / 1.0 mm (% of thinning at the niche)
Measured: Minimum of 6 months after delivery.
Percent of Participants With/Without Dehiscence (>80% Thinning of the Myometrium) at the Niche
Yes >80% of thinning of the myometrium at the niche or No < 80% of thinning of the myometrium at the niche of the hysterotomy measured by the sonohysterogram.
Measured: Minimum of 6 months after delivery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2015 (estimated)
- Study startJun 2013
- Primary completion20 Dec 2017
- Study completion20 Dec 2017
Why it stopped: Enrollment below the target goal; statistical analysis unable to be completed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MyelomeningoceleStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Louis University
- Sponsor type
- University, hospital or other
- Collaborators
- SSM Health
- Responsible party
- Principal investigator, Laura Vricella, MD, St. Louis University
- Investigators
- Laura Vricella, MD, Principal investigator, St. Louis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02493062
- Sponsor's protocol ID
- FCI-22581
- Acronym
- Hysterotomy
- Status last verified
- Jan 2019
- First submitted
- 3 Jun 2015
- Last updated
- 5 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: Enrollment was below the target enrollment goals therefore statistical analysis was not completed.
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Hysterotomy Site After Open Fetal Surgery
- ClinicalTrials.gov ID
- NCT02493062
- Acronym / sponsor ID
- Hysterotomy / FCI-22581
- Conditions
- Myelomeningocele, Pregnancy
- Keywords
- Hysterotomy, Myelomeningocele, Open fetal surgery, Sonohysterogram
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment below the target goal; statistical analysis unable to be completed.
- Enrolment
- 35 participants (actual)
- Lead sponsor
- St. Louis UniversityUniversity, hospital or other
- Collaborators
- SSM Health
- Study start
- Jun 2013
- Primary completion
- 20 Dec 2017 (actual)
- Study completion
- 20 Dec 2017 (actual)
- First posted
- 9 Jul 2015 (estimated)
- Results
- Posted 5 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to review how the uterus heals after having open fetal surgery. Open fetal surgery causes a scar perhaps two: one from the open fetal surgery and a second from delivery by cesarean section; rarely, the same area of your uterus was used for both open fetal surgery and delivery. From other studies of surgery performed on a uterus, some of the uterine scars do not heal well. This study's intervention uses sterile saline to spread open the inside of the uterus. The saline is slowly injected into the uterus using a catheter. An ultrasound called a sonohysterogram is performed to take pictures of the uterus, its inside and the walls of the uterus. In this way, the healed areas from the uterine surgery can be seen with ultrasound and evaluated. This is performed at least 6 months after delivery.
Primary Outcome:
Measure the depth of the scar and location of the scar 6 months or longer after delivery.
Detailed description
This is an Investigator initiated, prospective study reviewing medical records and performing a sonohysterogram on non-pregnant women at 6 or more months after delivery of an infant who received open fetal repair.
An evaluation is completed at SSM Cardinal Glennon (CG), Fetal Care Institute (FCI) of a woman who has decided to have open fetal surgery to complete a fetal repair before the infant is born.
- After open fetal surgery participant will be monitored and delivered appropriately.
- After the infant is born investigators will review the mother's and infant's electronic health records and FCI database records
- 6 months or more after delivery of an infant who has received open fetal repair the participant will go to Saint Louis University (SLU) Care for a sonohysterogram to evaluate the healing process.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single-arm study | Experimental | Device: SonohysterogramThis single-arm study is described by women who have undergone prenatal fetal open (uterus was opened to perform a fetal intervention/surgery) surgery and cesarean section delivery. These women will undergo sonohysterogram. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- SSM Cardinal Glennon Fetal Care Institute evaluation
- Received Open Fetal Surgery
- Open fetal surgery of myelomeningocele: maternal age of >= 18 yrs. and <=50 yrs.
- If a woman < 18 years old presented with a fetal tumor requiring open fetal repair, this would be done if deemed ethically sound by both CG and St. Mary's Health Center (SMHC) ethics committees. Given this, then the patient may qualify for this study. This is a RARE event.
- Agree to travel to SSM St. Mary's in St. Louis for sonohysterogram 6 or more months after delivery.
Key exclusion criteria (5 listed)
- Presently pregnant
- Hysterectomy after delivery
- Menopause
- Using IUD (Intrauterine Device) for birth control
- There is no exclusion criteria for infants
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 |
|---|---|---|
| SonohysterogramAlso: ultrasoundThe sonohysterogram can measure the size and depth of the uterine scar allowing better predictive values for future pregnancies. | Device | single-arm study |
Primary outcome
Cesarean Hysterotomy Myometrial Thickness
Time frame: Minimum of 6 months after delivery.
Average myometrium thickness surrounding niche is measured by measuring Average thickness of the myometrium toward the cervix and toward the fundus resulting in the average myometrium thickness surrounding the niche, measured by the sonohysterogram.
Cesarean Hysterotomy Site Myometrial Percentage of Thinning at the Niche
Time frame: Minimum of 6 months after delivery.
Average myometrium will be calculated, measured by the sonohysterogram. The myometrium will be measured caudad and cephalad of the niche and averaged ((Caudad side in mm + Cephalad side in mm)/2)=Average myometrium thickness The myometrium at niche will be measured (niche mm). Average myometrium-niche mm= niche thinning (mm). Niche thinning / Average myometrium thickness= Percentage of thinning at the niche. Ex: Average thickness at niche: 0.5 mm Caudad myometrium thickness: 1.5 mm Cephalad myometrium thickness: 1.5 mm 1.5mm + 1.5mm= 3mm/ 2= 1.5mm (average Myometrium Thickness) 1.5mm- 0.5mm = 1.0 mm (Niche thinning) 0.5mm / 1.0 mm (% of thinning at the niche)
Fetal Myelomeningocele Hysterotomy Site Myometrial Thickness
Time frame: Minimum of 6 months after delivery.
Average myometrium thickness surrounding niche is measured by measuring average thickness of the myometrium to the right and left of the niche resulting in the average myometrium thickness surrounding the niche. This is measured by the sonohysterogram.
Fetal Myelomeningocele Hysterotomy Site Myometrial Percentage of Thinning at the Niche
Time frame: Minimum of 6 months after delivery.
Average myometrium will be calculated, measured by the sonohysterogram. The myometrium will be measure to the right and left of the niche and averaged ((Right side in mm + Left side in mm)/2)=Average myometrium thickness The myometrium at niche will be measured (niche mm). Average myometrium-niche mm= niche thinning (mm). Niche thinning / Average myometrium thickness= Percentage of thinning at the niche. Ex: Average thickness at niche: 0.5 mm Right sided myometrium thickness: 1.5 mm Left sided myometrium thickness: 1.5 mm 1.5mm + 1.5mm= 3mm/ 2= 1.5mm (average Myometrium Thickness) 1.5mm- 0.5mm = 1.0 mm (Niche thinning) 0.5mm / 1.0 mm (% of thinning at the niche)
Percent of Participants With/Without Dehiscence (>80% Thinning of the Myometrium) at the Niche
Time frame: Minimum of 6 months after delivery.
Yes >80% of thinning of the myometrium at the niche or No < 80% of thinning of the myometrium at the niche of the hysterotomy measured by the sonohysterogram.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- SSM Cardinal Glennon Fetal Care Institute WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. Enrollment was below the target enrollment goals therefore statistical analysis was not completed.
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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.
Laura Vricella, MD principal investigator
St. Louis University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sonohysterogram in people with Myelomeningocele and Pregnancy, run by St. Louis University 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 5 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: stopped early, as of the sponsor's last update on 5 Feb 2019. 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?
Yes. Results are posted in the registry (first posted 5 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Cesarean Hysterotomy Myometrial Thickness (time frame: Minimum of 6 months after delivery.). The study lists 5 primary outcomes in all. 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 5 Feb 2019.