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Evaluation of Hysterotomy Site After Open Fetal Surgery (Hysterotomy)

Primary Purpose

Myelomeningocele, Pregnancy

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sonohysterogram
Sponsored by
St. Louis University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Myelomeningocele focused on measuring Hysterotomy, Myelomeningocele, Open fetal surgery, Sonohysterogram

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • SSM Cardinal Glennon Fetal Care Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

single-arm study

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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)
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.
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)
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.

Secondary Outcome Measures

Full Information

First Posted
June 3, 2015
Last Updated
January 14, 2019
Sponsor
St. Louis University
Collaborators
SSM Health
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1. Study Identification

Unique Protocol Identification Number
NCT02493062
Brief Title
Evaluation of Hysterotomy Site After Open Fetal Surgery
Acronym
Hysterotomy
Official Title
Evaluation of Hysterotomy Site After Open Fetal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Terminated
Why Stopped
Enrollment below the target goal; statistical analysis unable to be completed.
Study Start Date
June 2013 (undefined)
Primary Completion Date
December 20, 2017 (Actual)
Study Completion Date
December 20, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Louis University
Collaborators
SSM Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelomeningocele, Pregnancy
Keywords
Hysterotomy, Myelomeningocele, Open fetal surgery, Sonohysterogram

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
single-arm study
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Sonohysterogram
Other Intervention Name(s)
ultrasound
Intervention Description
The sonohysterogram can measure the size and depth of the uterine scar allowing better predictive values for future pregnancies.
Primary Outcome Measure Information:
Title
Cesarean Hysterotomy Myometrial Thickness
Description
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.
Time Frame
Minimum of 6 months after delivery.
Title
Cesarean Hysterotomy Site Myometrial Percentage of Thinning at the Niche
Description
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)
Time Frame
Minimum of 6 months after delivery.
Title
Fetal Myelomeningocele Hysterotomy Site Myometrial Thickness
Description
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.
Time Frame
Minimum of 6 months after delivery.
Title
Fetal Myelomeningocele Hysterotomy Site Myometrial Percentage of Thinning at the Niche
Description
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)
Time Frame
Minimum of 6 months after delivery.
Title
Percent of Participants With/Without Dehiscence (>80% Thinning of the Myometrium) at the Niche
Description
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.
Time Frame
Minimum of 6 months after delivery.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Vricella, MD
Organizational Affiliation
St. Louis University
Official's Role
Principal Investigator
Facility Information:
Facility Name
SSM Cardinal Glennon Fetal Care Institute
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Enrollment was below the target enrollment goals therefore statistical analysis was not completed.
Links:
URL
https://www.ssmhealth.com/cardinal-glennon/fetal-care-institute
Description
SSM Cardinal Glennon Fetal Care Institute Website

Learn more about this trial

Evaluation of Hysterotomy Site After Open Fetal Surgery

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