Clinical trial NCT02493062: Evaluation of Hysterotomy Site After Open Fetal Surgery
Official title: Evaluation of Hysterotomy Site After Open Fetal Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Myelomeningocele
Pregnancy
Keywords: Hysterotomy
Myelomeningocele
Open fetal surgery
Sonohysterogram
Lead sponsor: St. Louis University
Sponsor class: OTHER
Collaborators: name: SSM Health
First posted: 2015-07-09
Enrollment: 35
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Cesarean Hysterotomy Myometrial Thickness
timeFrame: Minimum of 6 months after delivery.
measure: Cesarean Hysterotomy Site Myometrial Percentage of Thinning at the Niche
timeFrame: Minimum of 6 months after delivery.
measure: Fetal Myelomeningocele Hysterotomy Site Myometrial Thickness
timeFrame: Minimum of 6 months after delivery.
measure: Fetal Myelomeningocele Hysterotomy Site Myometrial Percentage of Thinning at the Niche
timeFrame: Minimum of 6 months after delivery.
measure: Percent of Participants With/Without Dehiscence (>80% Thinning of the Myometrium) at the Niche
timeFrame: Minimum of 6 months after delivery.
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: SSM Cardinal Glennon Fetal Care Institute
state: Missouri
Study officials:
affiliation: St. Louis University
name: Laura Vricella, MD
role: PRINCIPAL_INVESTIGATOR
References: