Pregnancy Clinical Trial
— HysterotomyOfficial title:
Evaluation of Hysterotomy Site After Open Fetal Surgery
NCT number | NCT02493062 |
Other study ID # | FCI-22581 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | June 2013 |
Est. completion date | December 20, 2017 |
Verified date | January 2019 |
Source | St. Louis University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 35 |
Est. completion date | December 20, 2017 |
Est. primary completion date | December 20, 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - Presently pregnant - Hysterectomy after delivery - Menopause - Using IUD (Intrauterine Device) for birth control - There is no exclusion criteria for infants |
Country | Name | City | State |
---|---|---|---|
United States | SSM Cardinal Glennon Fetal Care Institute | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
St. Louis University | SSM St. Mary’s Health Center Foundation. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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. | Minimum of 6 months after delivery. | |
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) |
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. | 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) |
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. | Minimum of 6 months after delivery. |
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