Hormonal Changes in Early Pregnancy
Condition: Pregnancy
Study type: Observational

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.
    

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.
    

Observational model: Cohort
Time perspective: Prospective
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.
      
Keywords: Ovulation; Diary Record; Urine Collection; Blood Collection; Hormone; Natural History