Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00340028
Status:
COMPLETED
Last Update Posted:
2024-07-12
First Post:
2006-06-19
Brief Title:
Hormonal Changes in Early Pregnancy
Sponsor:
National Institute of Environmental Health Sciences NIEHS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Hormonal Changes in Early Pregnancy Pilot Study to Evaluate Stored Urine Specimens
Status:
COMPLETED
Status Verified Date:
2024-08-22
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:
This study will analyze hormones in early pregnancy Hormonal changes in early pregnancy reflect the quality of implantation in the uterus of the fertilized egg the function of the corpus luteum mass of hormone-secreting tissue that forms immediately after ovulation and placenta and the health of the embryo It will determine the following
Whether early pregnancy hormones vary by characteristics of the mother
Whether early pregnancy hormones differ for pregnancies with male or female babies
Whether early pregnancy hormones can predict the gestational age age of the baby during pregnancy and the babys birth weight
Hormone activity at the time pregnancy symptoms begin
How the contribution of the corpus luteum changes during the pregnancy in different women
Stored urine specimens collected from women who participated in the North Carolina Early Pregnancy Study in the 1980s will be used for this study In addition to evaluate the quality of the stored samples new specimens will be collected from women currently enrolled in the University of North Carolinas Right from the Start study Candidates must be white women not of Latino or Hispanic origin who are between 25 and 35 years of age and who are planning to become pregnant within a few months time They must be non-smokers have regular menstrual cycles no known fertility problems and no major chronic disease
Urine specimens are analyzed for hormone levels and other changes in early pregnancy that can be measured in urine Women providing new urine specimens do the following
Pre-Pregnancy
The pre-pregnancy part of the study lasts through no more than three consecutive menstrual cycles Participants who do not become pregnant after three menstrual cycles end the study at that time
Have a short interview with a study staff member
Complete a daily diary recording any vaginal bleeding or spotting health status and use of medications and mail the diary to the study office once a week
Use an ovulation testing kit for up to 7 days during their menstrual cycle
Call the study staff within the first 24 hours of becoming pregnant
Pregnancy
The pregnancy part of the study lasts about 5 weeks
Continue to complete daily diary records for weekly pickup by staff member
Collect urine samples daily and store them in the freezer for weekly pickup by staff member
Have 1 to 2 tablespoons of blood drawn at home weekly for 4 weeks
Have a brief follow-up telephone interview around week 12 of their pregnancy
Urine samples are analyzed for hormones such as human chorionic gonadotropin estrone-3-glucuronide and pregnanedrol glucuronide White blood cells are stored for DNA to study such things as genes controlling hormone metabolism
Whether early pregnancy hormones vary by characteristics of the mother
Whether early pregnancy hormones differ for pregnancies with male or female babies
Whether early pregnancy hormones can predict the gestational age age of the baby during pregnancy and the babys birth weight
Hormone activity at the time pregnancy symptoms begin
How the contribution of the corpus luteum changes during the pregnancy in different women
Stored urine specimens collected from women who participated in the North Carolina Early Pregnancy Study in the 1980s will be used for this study In addition to evaluate the quality of the stored samples new specimens will be collected from women currently enrolled in the University of North Carolinas Right from the Start study Candidates must be white women not of Latino or Hispanic origin who are between 25 and 35 years of age and who are planning to become pregnant within a few months time They must be non-smokers have regular menstrual cycles no known fertility problems and no major chronic disease
Urine specimens are analyzed for hormone levels and other changes in early pregnancy that can be measured in urine Women providing new urine specimens do the following
Pre-Pregnancy
The pre-pregnancy part of the study lasts through no more than three consecutive menstrual cycles Participants who do not become pregnant after three menstrual cycles end the study at that time
Have a short interview with a study staff member
Complete a daily diary recording any vaginal bleeding or spotting health status and use of medications and mail the diary to the study office once a week
Use an ovulation testing kit for up to 7 days during their menstrual cycle
Call the study staff within the first 24 hours of becoming pregnant
Pregnancy
The pregnancy part of the study lasts about 5 weeks
Continue to complete daily diary records for weekly pickup by staff member
Collect urine samples daily and store them in the freezer for weekly pickup by staff member
Have 1 to 2 tablespoons of blood drawn at home weekly for 4 weeks
Have a brief follow-up telephone interview around week 12 of their pregnancy
Urine samples are analyzed for hormones such as human chorionic gonadotropin estrone-3-glucuronide and pregnanedrol glucuronide White blood cells are stored for DNA to study such things as genes controlling hormone metabolism
Detailed Description:
Daily first morning urine specimens were collected throughout the first 8-9 weeks of 151 clinical pregnancies These specimens are now approximately 20 years in storage and the stability of markers of placental and corpus luteum function are not known We will collect new urine specimens for 20 pregnancies to serve as a reference to evaluate the quality of those stored samples
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| 05-E-N087 | None | None | None |