Evaluation of Hysterotomy Site After Open Fetal Surgery

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02493062

Acronym

Hysterotomy

Enrollment

Registered

2015-07-09

Start date

2013-06-30

Completion date

2017-12-20

Last updated

2019-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myelomeningocele, Pregnancy

Keywords

Hysterotomy, Myelomeningocele, Open fetal surgery, Sonohysterogram

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.

Interventions

DEVICESonohysterogram

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 50 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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.
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)
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.
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)
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.

Countries

United States

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.

Participants by arm

Arm	Count
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. Sonohysterogram: The sonohysterogram can measure the size and depth of the uterine scar allowing better predictive values for future pregnancies.	23
Total	23

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Physician Decision	12

Baseline characteristics

Characteristic	Single-arm Study
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	0 Participants
Age, Categorical Between 18 and 65 years	23 Participants
Age, Continuous	28 years
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	0 Participants
Race (NIH/OMB) Black or African American	0 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	23 Participants
Race (NIH/OMB) White	0 Participants
Region of Enrollment United States	23 Participants
Sex: Female, Male Female	23 Participants
Sex: Female, Male Male	0 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 23
other Total, other adverse events	0 / 23
serious Total, serious adverse events	0 / 23

Outcome results

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.