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Enrollment below the target goal; statistical analysis unable to be completed.
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| Name | Class |
|---|---|
| SSM Health | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sonohysterogram | Device | The sonohysterogram can measure the size and depth of the uterine scar allowing better predictive values for future pregnancies. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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) | 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. | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laura Vricella, MD | St. Louis University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SSM Cardinal Glennon Fetal Care Institute | St Louis | Missouri | 63104 | United States |
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| Label | URL |
|---|---|
| SSM Cardinal Glennon Fetal Care Institute Website | View source |
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Enrollment was below the target enrollment goals therefore statistical analysis was not completed.
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Recruitment period was June, 2013 through August, 2016. Patients were recruited for study during fetal surgery evaluation in the St. Louis Fetal Care Institute office. If patients were interested in participating in the study, the research nurse contacted the patient after delivery and set up an appointment at 6 months postpartum.
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| ID | Title | Description |
|---|---|---|
| FG000 | Single-arm Study | 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. Sonohysterogram: The sonohysterogram can measure the size and depth of the uterine scar allowing better predictive values for future pregnancies. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The baseline participants are the women that completed the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Single-arm Study | 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. Sonohysterogram: The sonohysterogram can measure the size and depth of the uterine scar allowing better predictive values for future pregnancies. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Full Range | millimeter | Minimum of 6 months after delivery. |
|
The study was conducted at 6 months or longer after delivery. The shortest time period was 6 months and the longest time period was 2 years from the date of delivery.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single-arm Study | 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. Sonohysterogram: The sonohysterogram can measure the size and depth of the uterine scar allowing better predictive values for future pregnancies. |
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Enrollment was below the target enrollment goals therefore statistical analysis was not completed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Laura Vricella | St. Louis Fetal Care Institute | 3146784488 | fetalcare@ssmhealth.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 20, 2017 | Jan 14, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008591 | Meningomyelocele |
| ID | Term |
|---|---|
| D009436 | Neural Tube Defects |
| D009421 | Nervous System Malformations |
| D009422 | Nervous System Diseases |
| D000013 | Congenital Abnormalities |
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| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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|
| 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. | Minimum of 6 months after delivery. |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Primary | 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) | Posted | Mean | Full Range | percentage of thinning | Minimum of 6 months after delivery. |
|
|
|
| Primary | 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. | Posted | Median | Full Range | millimeter | Minimum of 6 months after delivery. |
|
|
|
| Primary | 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) | Posted | Mean | Full Range | percentage of thinning at the niche | Minimum of 6 months after delivery. |
|
|
|
| Primary | 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. | Posted | Number | percentage of patients with >80% thinnin | Minimum of 6 months after delivery. |
|
|
|
| 0 |
| 23 |
| 0 |
| 23 |
| 0 |
| 23 |
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| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |