Evaluation of Hysterotomy Site After Open Fetal Surgery

Pregnancy Clinical Trial

— Hysterotomy  

Official title:

Evaluation of Hysterotomy Site After Open Fetal Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02493062
• Other study ID #: FCI-22581
• Status: Terminated
• Phase: N/A
• Start date: June 2013
• Est. completion date: December 20, 2017

Study information

• Verified date: January 2019
• Source: St. Louis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 35
• Est. completion date: December 20, 2017
• Est. primary completion date: December 20, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Meningomyelocele
• Myelomeningocele
• Pregnancy

Intervention

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

Locations

Country	Name	City	State
United States	SSM Cardinal Glennon Fetal Care Institute	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
St. Louis University	SSM St. Mary’s Health Center Foundation.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.

External Links

•   SSM Cardinal Glennon Fetal Care Institute Website