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Evaluation of Hysterotomy Site After Open Fetal Surgery (Hysterotomy)

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ClinicalTrials.gov Identifier: NCT02493062
Recruitment Status : Terminated (Enrollment below the target goal; statistical analysis unable to be completed.)
First Posted : July 9, 2015
Results First Posted : February 5, 2019
Last Update Posted : February 5, 2019
Sponsor:
Collaborator:
SSM St. Mary’s Health Center Foundation.
Information provided by (Responsible Party):
Laura Vricella, MD, St. Louis University

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.


Condition or disease Intervention/treatment Phase
Myelomeningocele Pregnancy Device: Sonohysterogram Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of Hysterotomy Site After Open Fetal Surgery
Study Start Date : June 2013
Actual Primary Completion Date : December 20, 2017
Actual Study Completion Date : December 20, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: single-arm study
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
The sonohysterogram can measure the size and depth of the uterine scar allowing better predictive values for future pregnancies.
Other Name: ultrasound




Primary Outcome Measures :
  1. 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.

  2. Cesarean 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. 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)


  3. 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 to the right and left of the niche resulting in the average myometrium thickness surrounding the niche. This is measured by the sonohysterogram.

  4. 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. 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)


  5. Percent of Participants With/Without Dehiscence (>80% Thinning of the Myometrium) at the Niche [ 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 of the hysterotomy measured by the sonohysterogram.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02493062


Locations
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United States, Missouri
SSM Cardinal Glennon Fetal Care Institute
Saint Louis, Missouri, United States, 63104
Sponsors and Collaborators
St. Louis University
SSM St. Mary’s Health Center Foundation.
Investigators
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Principal Investigator: Laura Vricella, MD St. Louis University
  Study Documents (Full-Text)

Documents provided by Laura Vricella, MD, St. Louis University:

Additional Information:
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Responsible Party: Laura Vricella, MD, MD, FACOG, Assistant Professor, St. Louis University
ClinicalTrials.gov Identifier: NCT02493062     History of Changes
Other Study ID Numbers: FCI-22581
First Posted: July 9, 2015    Key Record Dates
Results First Posted: February 5, 2019
Last Update Posted: February 5, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Enrollment was below the target enrollment goals therefore statistical analysis was not completed.
Keywords provided by Laura Vricella, MD, St. Louis University:
Hysterotomy
Myelomeningocele
Open fetal surgery
Sonohysterogram
Additional relevant MeSH terms:
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Meningomyelocele
Spina Bifida Cystica
Neural Tube Defects
Nervous System Malformations
Nervous System Diseases
Congenital Abnormalities
Spinal Dysraphism