Clinical Trial: Evaluation of Hysterotomy Site After Open Fetal Surgery

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Evaluation of Hysterotomy Site After Open Fetal Surgery

Brief 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 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 Summary:

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.

Sponsor: St. Louis University

Current 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 Myometrial percentage of thinning at the niche [ Time Frame: Minimum of 6 months after delivery. ]
    Average myometrium will be calculated, measured by the sonohysterogram.
  • 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 toward the cervix and toward the fundus resulting in the average myometrium thickness surrounding the niche. 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.
  • Dehiscence [ 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 measured by the sonohysterogram.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: St. Louis University

Dates:
Date Received: June 3, 2015
Date Started: January 2015
Date Completion: January 2020
Last Updated: March 2, 2017
Last Verified: March 2017