PregnancyNCT00340028
Hormonal Changes in Early Pregnancy
An observational study of Pregnancy, run by National Institute of Environmental Health Sciences (NIEHS) at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 35 years, women only
- Conditions the study is for
- Pregnancy
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Jan 2005to 22 Apr 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 35 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of North Carolina
Chapel Hill, North Carolina
NIEHS, Research Triangle Park
Research Triangle Park, North Carolina, 27709
About this study
Official title: 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
Read more
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.
...
Read the 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.
- Conditions
- Pregnancy
- Keywords
- Ovulation, Diary Record, Urine Collection, Blood Collection, Hormone, Natural History
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
We will assay both old urines and new urines for the estrogen metabolite, the progesterone metabolite, and hCG.
no disease treatment monitored
Measured: Time points were daily for urine and weekly blood
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study start18 Jan 2005
- Primary completion24 Feb 2006
- Study completion22 Apr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Donna D Baird, Ph.D., Principal investigator, National Institute of Environmental Health Sciences (NIEHS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00340028
- Sponsor's protocol ID
- 999905087
- Other IDs
- 05-E-N087
- Status last verified
- Dec 2024
- First submitted
- 19 Jun 2006
- Last updated
- 1 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hormonal Changes in Early Pregnancy: Pilot Study to Evaluate Stored Urine Specimens
- ClinicalTrials.gov ID
- NCT00340028
- Acronym / sponsor ID
- 999905087
- Conditions
- Pregnancy
- Keywords
- Ovulation, Diary Record, Urine Collection, Blood Collection, Hormone, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)US National Institutes of Health
- Study start
- 18 Jan 2005 (actual)
- Primary completion
- 24 Feb 2006 (actual)
- Study completion
- 22 Apr 2014 (actual)
- First posted
- 21 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- 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.
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donna D Baird, Ph.D. principal investigator
National Institute of Environmental Health Sciences (NIEHS)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, run by National Institute of Environmental Health Sciences (NIEHS) at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jan 2025.