Evaluation of Hysterotomy Site After Open Fetal Surgery
Stopped early · Not applicable
Conditions studied: Myelomeningocele, Pregnancy
In brief
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.
Key facts
- Study ID
- NCT02493062
- Run by
- St. Louis University
- People needed
- 35
- Starts
- 2013-06-01
- Expected to finish
- 2017-12-20
- Last updated by the study team
- 2019-02-05
Who can join
Age: 18 and older, up to 50. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Presently pregnant
- Hysterectomy after delivery
- Menopause
- Using IUD (Intrauterine Device) for birth control
- There is no exclusion criteria for infants
Where it is running
- SSM Cardinal Glennon Fetal Care Institute — St Louis, Missouri, United States
Full record on ClinicalTrials.gov
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