Hormonal Changes in Early Pregnancy

December 31, 2024 updated by: National Institute of Environmental Health Sciences (NIEHS)

Hormonal Changes in Early Pregnancy: Pilot Study to Evaluate Stored Urine Specimens

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.

...

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States
        • University of North Carolina
      • Research Triangle Park, North Carolina, United States, 27709
        • NIEHS, Research Triangle Park

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 35 years (Adult)

Accepts Healthy Volunteers

No

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.

Description

  • INCLUSION/EXCLUSION CRITERIA:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time points were daily for urine and weekly blood

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Environmental Health Sciences (NIEHS)

Investigators

  • Principal Investigator: Donna D Baird, Ph.D., National Institute of Environmental Health Sciences (NIEHS)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 18, 2005

Primary Completion (Actual)

February 24, 2006

Study Completion (Actual)

April 22, 2014

Study Registration Dates

First Submitted

June 19, 2006

First Submitted That Met QC Criteria

June 19, 2006

First Posted (Estimated)

June 21, 2006

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 31, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 999905087
  • 05-E-N087

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe