Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00341848
Status:
COMPLETED
Last Update Posted:
2019-06-17
First Post:
2006-06-19
Brief Title:
Postpartum Uterine Regression
Sponsor:
National Institute of Environmental Health Sciences NIEHS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Postpartum Uterine Regression
Status:
COMPLETED
Status Verified Date:
2019-06-13
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Uterine leiomyomas are the leading cause of hysterectomy in the United States accounting for over 200000 procedures each year Most epidemiologic studies of uterine leiomyoma show that parity has a protective association with leiomyoma but the mechanism is not known Both epidemiologic data and data from an animal model indicate that the protective association is not an artifact resulting from reduced fertility among women with fibroids We hypothesize that the process of uterine regression following delivery results in loss of small fibroids due to selective apoptosis of transformed cells and the extensive remodeling of the entire uterus
Detailed Description:
Background Uterine leiomyomas are the leading cause of hysterectomy in the United States accounting for over 200000 procedures each year Most epidemiologic studies of uterine leiomyoma show that parity has a protective association with leiomyoma but the mechanism is not known Both epidemiologic data and data from an animal model indicate that the protective association is not an artifact resulting from reduced fertility among women with fibroids We hypothesize that the process of uterine regression following delivery results in loss of small fibroids due to selective apoptosis of transformed cells and the extensive remodeling of the entire uterus
Study Objectives Monitor fibroids during pregnancy and after postpartum uterine regression to assess any loss of fibroids and change in size of fibroids
Methods Add a postpartum ultrasound examination to an existing epidemiologic study of pregnant women The parent study documents fibroid number size and location with a 7 week ultrasound examination With the additional postpartum ultrasound proposed here data on fibroid number size and location through pregnancy and postpartum uterine regression will be collected on approximately 400 women A subsample of 30 women will also have an MRI after their postpartum ultrasound in order to evaluate the sensitivity of ultrasound imaging
Significance This study will provide the first data on fibroid change with parturitionpostpartum uterine regression for a large sample of women If small fibroids disappear during this time it will document a process that results in natural regression of these tumors in premenopausal women Insights from the biology of this process may be useful in developing treatment that could be used by nonpregnant women with fibroids to induce tumor regression
Study Objectives Monitor fibroids during pregnancy and after postpartum uterine regression to assess any loss of fibroids and change in size of fibroids
Methods Add a postpartum ultrasound examination to an existing epidemiologic study of pregnant women The parent study documents fibroid number size and location with a 7 week ultrasound examination With the additional postpartum ultrasound proposed here data on fibroid number size and location through pregnancy and postpartum uterine regression will be collected on approximately 400 women A subsample of 30 women will also have an MRI after their postpartum ultrasound in order to evaluate the sensitivity of ultrasound imaging
Significance This study will provide the first data on fibroid change with parturitionpostpartum uterine regression for a large sample of women If small fibroids disappear during this time it will document a process that results in natural regression of these tumors in premenopausal women Insights from the biology of this process may be useful in developing treatment that could be used by nonpregnant women with fibroids to induce tumor regression
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 02-E-N075 | None | None | None |