NCT02493062

Evaluation of Hysterotomy Site After Open Fetal Surgery

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: St. Louis University · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Myelomeningocele
• Pregnancy

Interventions

Type	Name	Description
DEVICE	Sonohysterogram	The sonohysterogram can measure the size and depth of the uterine scar allowing better predictive values for future pregnancies.

Timeline

• Start date: 2013-06-01
• Primary completion: 2017-12-20
• Completion: 2017-12-20
• First posted: 2015-07-09
• Last updated: 2019-02-05
• Results posted: 2019-02-05

Locations

1 site across 1 country: United States