Hormonal Changes in Early Pregnancy

NCT00340028 | Completed

• 2 other identifiers: 99990508705-E-N087
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 2

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 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: 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. ...

Conditions

Pregnancy

Keywords

Ovulation; Diary Record; Urine Collection; Blood Collection; Hormone; Natural History

Outcome Measures

Primary Outcomes (1)

• We will assay both old urines and new urines for the estrogen metabolite, the progesterone metabolite, and hCG.

  no disease treatment monitored

  Time points were daily for urine and weekly blood

Study Arms (1)

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

Eligibility Criteria

• Age: 25 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Environmental Health Sciences (NIEHS): lead

Study Sites (2)

University of North Carolina

Chapel Hill, North Carolina, United States

Location

NIEHS, Research Triangle Park

Research Triangle Park, North Carolina, 27709, United States

Location

Study Officials

• Donna D Baird, Ph.D.

  National Institute of Environmental Health Sciences (NIEHS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2006
• First Posted: June 21, 2006
• Study Start: January 18, 2005
• Primary Completion: February 24, 2006
• Study Completion: April 22, 2014
• Last Updated: January 1, 2025

Record last verified: 2024-12

Locations

US (2)