Evaluation of Hysterotomy Site After Open Fetal Surgery

• Sponsor: St. Louis University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02493062
• Collaborator: SSM Health (Other)
• Enrollment: 35
• Location: 1
• Arm: 1
• Duration (Months): 54.6
• Patients Per Site Per Month: 0.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Myelomeningocele; Pregnancy	Device: Sonohysterogram	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 35 participants
• Allocation: N/A
• 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: Jun 1, 2013
• Actual Primary Completion Date: Dec 20, 2017
• Actual Study Completion Date: Dec 20, 2017

Arms and Interventions

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 Names: ultrasound

Outcome Measures

Primary Outcome Measures

1. Cesarean Hysterotomy Myometrial Thickness [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 [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 [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 [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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	SSM Cardinal Glennon Fetal Care Institute	Saint Louis	Missouri	United States	63104

Sponsors and Collaborators

• St. Louis University
• SSM Health

Investigators

• Principal Investigator: Laura Vricella, MD, St. Louis University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 20, 2017

More Information

Additional Information:

• SSM Cardinal Glennon Fetal Care Institute Website

Publications

None provided.

• Responsible Party: Laura Vricella, MD, MD, FACOG, Assistant Professor, St. Louis University
• ClinicalTrials.gov Identifier: NCT02493062
• Other Study ID Numbers: FCI-22581
• First Posted: Jul 9, 2015
• Last Update Posted: Feb 5, 2019
• Last Verified: Jan 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Laura Vricella, MD, MD, FACOG, Assistant Professor, St. Louis University: Hysterotomy; Myelomeningocele; Open fetal surgery; Sonohysterogram
• Additional relevant MeSH terms: Meningomyelocele; Spina Bifida Cystica

Study Results

Participant Flow

Recruitment Details	Recruitment period was June, 2013 through August, 2016. Patients were recruited for study during fetal surgery evaluation in the St. Louis Fetal Care Institute office. If patients were interested in participating in the study, the research nurse contacted the patient after delivery and set up an appointment at 6 months postpartum.

Arm/Group Title	Single-arm Study
Arm/Group 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. Sonohysterogram: The sonohysterogram can measure the size and depth of the uterine scar allowing better predictive values for future pregnancies.
Period Title: Overall Study
STARTED	35
COMPLETED	23
NOT COMPLETED	12

Baseline Characteristics

Arm/Group Title	Single-arm Study
Arm/Group 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. Sonohysterogram: The sonohysterogram can measure the size and depth of the uterine scar allowing better predictive values for future pregnancies.
Overall Participants	23
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	23 100%
>=65 years	0 0%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	28
Sex: Female, Male (Count of Participants)
Female	23 100%
Male	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	0 0%
More than one race	0 0%
Unknown or Not Reported	23 100%
Region of Enrollment (Count of Participants)
United States	23 100%

Outcome Measures

1. Primary Outcome

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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Single-arm Study
Arm/Group 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. Sonohysterogram: The sonohysterogram can measure the size and depth of the uterine scar allowing better predictive values for future pregnancies.
Measure Participants	23
Mean (Full Range) [millimeter]	1.11

2. Primary Outcome

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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Single-arm Study
Arm/Group 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. Sonohysterogram: The sonohysterogram can measure the size and depth of the uterine scar allowing better predictive values for future pregnancies.
Measure Participants	23
Mean (Full Range) [percentage of thinning]	44

3. Primary Outcome

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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Single-arm Study
Arm/Group 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. Sonohysterogram: The sonohysterogram can measure the size and depth of the uterine scar allowing better predictive values for future pregnancies.
Measure Participants	23
Median (Full Range) [millimeter]	1.37

4. Primary Outcome

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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Single-arm Study
Arm/Group 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. Sonohysterogram: The sonohysterogram can measure the size and depth of the uterine scar allowing better predictive values for future pregnancies.
Measure Participants	23
Mean (Full Range) [percentage of thinning at the niche]	33

5. Primary Outcome

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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Single-arm Study
Arm/Group 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. Sonohysterogram: The sonohysterogram can measure the size and depth of the uterine scar allowing better predictive values for future pregnancies.
Measure Participants	23
Dehisence	0
No Dehisence	100

Adverse Events

Time Frame	The study was conducted at 6 months or longer after delivery. The shortest time period was 6 months and the longest time period was 2 years from the date of delivery.
Arm/Group Title	Single-arm Study
Arm/Group 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. Sonohysterogram: The sonohysterogram can measure the size and depth of the uterine scar allowing better predictive values for future pregnancies.
All Cause Mortality
	Single-arm Study
	Affected / at Risk (%)	# Events
Total	0/23 (0%)
Serious Adverse Events
	Single-arm Study
	Affected / at Risk (%)	# Events
Total	0/23 (0%)
Other (Not Including Serious) Adverse Events
	Single-arm Study
	Affected / at Risk (%)	# Events
Total	0/23 (0%)

Limitations/Caveats

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

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.