Status:
COMPLETED
Postpartum Uterine Regression
Lead Sponsor:
National Institute of Environmental Health Sciences (NIEHS)
Conditions:
Uterine Leiomyoma
Eligibility:
FEMALE
18-45 years
Brief Summary
Uterine leiomyomas are the leading cause of hysterectomy in the United States, accounting for over 200,000 procedures each year. Most epidemiologic studies of uterine leiomyoma show that parity has a ...
Detailed Description
Background: Uterine leiomyomas are the leading cause of hysterectomy in the United States, accounting for over 200,000 procedures each year. Most epidemiologic studies of uterine leiomyoma show that p...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Participants in the Right From The Start Study must be 18 years old or older, pregnant, enrolled by 10 weeks of gestation, planning to carry pregnancy to term, no plans to move before delivery, and English speaking. Those who are found to have fibroids at either their 7-week, or 22-week ultrasound examination are eligible for this further postpregnancy study.
- A small substudy of 30 women having MRIs to evaluate the sensitivity of the ultrasound imaging will include only participants with a single fibroid found at the early pregnancy ultrasound.
- EXCLUSION CRITERIA FOR MRI:
- Exclusion criteria for the MRI are weight greater than 250 pounds, currently pregnant, metal of specific types in the body (an artificial hip, a clip for brain aneurysm, a medical implant in the ear, metal fragment in the eye, or a pacemaker), history of claustrophobia, previous severe reaction to MRI contrast, and chronic kidney disease. A severe reaction would consist of bronchospasm (shortness of breath/difficulty breathing) or shock (sudden loss of blood pressure). Risk is less than 1/100,000 with Gd based contrast material. Any potential subject with a history of kidney disease will be excluded from the study.
Exclusion
Key Trial Info
Start Date :
December 6 2001
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 13 2019
Estimated Enrollment :
374 Patients enrolled
Trial Details
Trial ID
NCT00341848
Start Date
December 6 2001
End Date
June 13 2019
Last Update
June 17 2019
Active Locations (1)
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1
NIEHS, Research Triangle Park
Research Triangle Park, North Carolina, United States, 27709