Hormonal Changes in Early Pregnancy
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|ClinicalTrials.gov Identifier: NCT00340028|
Recruitment Status : Completed
First Posted : June 21, 2006
Last Update Posted : August 6, 2020
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 baby's 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 Carolina's 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:
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
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.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||40 participants|
|Official Title:||Hormonal Changes in Early Pregnancy: Pilot Study to Evaluate Stored Urine Specimens|
|Actual Study Start Date :||January 18, 2005|
Women in Early Pregnancy
Women enrolled in the University of North Carolina's Right from the Start study are followed while trying to become pregnant and through 9 weeks of pregnancy
- We will assay both old urines and new urines for the estrogen metabolite, the progesterone metabolite, and hCG. [ Time Frame: Time points were daily for urine and weekly blood ]no disease treatment monitored
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00340028
|United States, North Carolina|
|University of North Carolina|
|Chapel Hill, North Carolina, United States|
|NIEHS, Research Triangle Park|
|Research Triangle Park, North Carolina, United States, 27709|
|Principal Investigator:||Donna D Baird, Ph.D.||National Institute of Environmental Health Sciences (NIEHS)|