Evaluation of Hysterotomy Site After Open Fetal Surgery

NCT02493062 | Terminated Results

• 1 other identifier: FCI-22581
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Myelomeningocele; Pregnancy

Keywords

Hysterotomy; Myelomeningocele; Open fetal surgery; Sonohysterogram

Outcome Measures

Primary Outcomes (5)

• 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.

• 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.

• 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.

• 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.

• 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.

Study Arms (1)

single-arm study

EXPERIMENTAL

This single-arm study is described by women who have undergone prenatal fetal open (uterus was opened to perform a fetal intervention/surgery) surgery and cesarean section delivery. These women will undergo sonohysterogram.

Device: Sonohysterogram

Interventions

Sonohysterogram DEVICE

The sonohysterogram can measure the size and depth of the uterine scar allowing better predictive values for future pregnancies.

Also known as: ultrasound

single-arm study

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• St. Louis University: lead
• SSM Health: collaborator

Study Sites (1)

SSM Cardinal Glennon Fetal Care Institute

St Louis, Missouri, 63104, United States

Location

Related Links

• SSM Cardinal Glennon Fetal Care Institute Website

MeSH Terms

Conditions

Meningomyelocele

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Neural Tube Defects; Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Limitations and Caveats

Enrollment was below the target enrollment goals therefore statistical analysis was not completed.

Results Point of Contact

• Title: Dr. Laura Vricella
• Organization: St. Louis Fetal Care Institute

fetalcare@ssmhealth.com

3146784488

Study Officials

• Laura Vricella, MD

  St. Louis University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, FACOG, Assistant Professor

Study Record Dates

• First Submitted: June 3, 2015
• First Posted: July 9, 2015
• Study Start: June 1, 2013
• Primary Completion: December 20, 2017
• Study Completion: December 20, 2017
• Last Updated: February 5, 2019
• Results First Posted: February 5, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)