An observational study in Pregnancy, sponsored by National Institute of Environmental Health Sciences (NIEHS). Completed at 2 sites in United States. Open to female participants aged 25 Years to 35 Years. Per ClinicalTrials.gov, last updated 2025-01-01.
Sponsored by National Institute of Environmental Health Sciences (NIEHS) · Observational
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:
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:
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.
Pregnancy
The pregnancy part of the study lasts about 5 weeks.
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.
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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.
National Institute of Environmental Health Sciences (NIEHS) is the lead sponsor of 183 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
We will recruit from the pre-pregnancy participants in the Right From the Start UNC study entitled, Consequences and Course of Uterine Fibroid in Pregnancies.
The women will be selected to be similar to the majority of women in the NC-EPS because we need to have a comparable sample of women in order to best compare hormone levels.
Entry requirements will be:
white (including Hispanic and latino), age 25-35, regular menstrual cycles, nonsmoker (i.e., no smoking in past year), no major chronic disease, no known fertility problems, no more than 3 months of trying for this current 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.
no disease treatment monitored
Time frame: Time points were daily for urine and weekly blood
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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