Trial Outcomes & Findings for Evaluation of Hysterotomy Site After Open Fetal Surgery (NCT NCT02493062)
NCT ID: NCT02493062
Last Updated: 2019-02-05
Results Overview
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.
TERMINATED
NA
35 participants
Minimum of 6 months after delivery.
2019-02-05
Participant Flow
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.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
35
|
|
Overall Study
COMPLETED
|
23
|
|
Overall Study
NOT COMPLETED
|
12
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Physician Decision
|
12
|
Baseline Characteristics
Evaluation of Hysterotomy Site After Open Fetal Surgery
Baseline characteristics by cohort
| Measure |
Single-arm Study
n=23 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
28 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
23 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
23 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Single-arm Study
n=23 Participants
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.
|
|---|---|
|
Cesarean Hysterotomy Myometrial Thickness
|
1.11 millimeter
Interval 0.56 to 1.68
|
PRIMARY outcome
Timeframe: 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)
Outcome measures
| Measure |
Single-arm Study
n=23 Participants
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.
|
|---|---|
|
Cesarean Hysterotomy Site Myometrial Percentage of Thinning at the Niche
|
44 percentage of thinning
Interval 0.0 to 85.0
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Single-arm Study
n=23 Participants
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.
|
|---|---|
|
Fetal Myelomeningocele Hysterotomy Site Myometrial Thickness
|
1.37 millimeter
Interval 0.91 to 2.08
|
PRIMARY outcome
Timeframe: 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)
Outcome measures
| Measure |
Single-arm Study
n=23 Participants
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.
|
|---|---|
|
Fetal Myelomeningocele Hysterotomy Site Myometrial Percentage of Thinning at the Niche
|
33 percentage of thinning at the niche
Interval 12.0 to 73.0
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Single-arm Study
n=23 Participants
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.
|
|---|---|
|
Percent of Participants With/Without Dehiscence (>80% Thinning of the Myometrium) at the Niche
Dehisence
|
0 percentage of patients with >80% thinnin
|
|
Percent of Participants With/Without Dehiscence (>80% Thinning of the Myometrium) at the Niche
No Dehisence
|
100 percentage of patients with >80% thinnin
|
Adverse Events
Single-arm Study
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place