Gestational AgeNCT01132924
A Follow-up of the Early Pregnancy Study Cohort.
An observational study of Gestational Age and Time to Pregnancy, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.
Trial summary
Background: The purpose of the 1982 1986 North Carolina Early Pregnancy Study was to determine how often pregnancy loss occurs before women know they are pregnant. Women planning to become pregnant were asked to collect daily urine specimens and fill out daily diaries of their intercourse and menstrual bleeding. Read more about this study
- Who is it for?
- Ages 45 to 75 years, women only
- Conditions the study is for
- Gestational Age, Time to Pregnancy, Early Pregnancy Loss
- How many people
- 173 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2010to 24 Feb 2017
- 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 45 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women who participated in the 1982-1986 North Carolina Early Pregnancy Study (EPS)
Who may be able to join
- This study is a follow-up study of women who participated in the NIEHS EPS. All of the women who participated in that study are eligible for this follow-up.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
NIEHS, Research Triangle Park
Research Triangle Park, North Carolina, 27709
About this study
Official title: A Follow-up of the Early Pregnancy Study Cohort
Background:
- The purpose of the 1982 1986 North Carolina Early Pregnancy Study was to determine how often pregnancy loss occurs before women know they are pregnant. Women planning to become pregnant were asked to collect daily urine specimens and fill out daily diaries of their intercourse and menstrual bleeding. Researchers are interested in re-contacting this cohort to gather new information and to examine how accurately women can recall events that occurred earlier in their lives.
Read more
Objectives:
- To follow-up with and gather additional information from women who were involved in the Early Pregnancy Study.
Eligibility:
- Women who participated in the 1982 1986 North Carolina Early Pregnancy Study.
Design:
- Participants will receive and complete a questionnaire that includes the following topics:
- Their pregnancy history.
- The infant s birth, including method of delivery and induction of labor.
- Early life exposures such as their own birth weight and their parents ages at their birth.
- Tap water use during their attempt to conceive
- General description of their behaviors during their participation in the original study, these include: physical activity, caffeine, alcohol, and soy food consumption.
- Participants will return the surveys to the researchers in the stamped envelope provided with the questionnaire....
Read the detailed description
We propose a follow-up study of women who participated in the North Carolina Early Pregnancy Study (EPS) in 1982-1986. Women enrolled in the study after discontinuing birth control and were followed for the occurrence of a pregnancy. Participants completed daily diaries and collected first morning urine specimens which allowed the identification of menstrual cycles. Thus each woman s time to pregnancy was prospectively measured. We intend to trace the women and ask them to complete a questionnaire that includes their recall of their time to pregnancy during the study. This will allow us to address two major questions, one regarding the recall of time-to-pregnancy, and the other regarding the natural length of gestation. In addition, we will investigate associations of bisphenal A (BPA), phthalate metabolites, 2,4- and 2,5-dichlorophenols, Triclosan, benzophenone-3, and methyl-, propyl- and butyl-parabens with reproductive outcomes. This is described in a separate section at the end of this protocol because it does not involve recontacting participants, only assay of stored urine samples for purposes within the goals of the original study.
- Recall of time-to-pregnancy Time to pregnancy is a commonly studied estimate of fecundability. This outcome has been used to study the reproductive effects of environmental toxins, cigarette smoking, obesity and numerous other exposures. Prospective studies of time to pregnancy require enrollment of women who are just starting to attempt pregnancy and following them until a pregnancy is conceived. This type of study can be time-consuming and costly. It is also difficult to identify a population of women who are just beginning to attempt pregnancy. A more efficient design is to ask women to recall their time to pregnancy. This design is limited however, as it is unknown how well women can recall their time to pregnancy. Only two studies have examined this question in a population with both prospective and retrospectively recalled time to pregnancy. One of the studies involved women from the Netherlands, the recall period was short (3-20 months), and only part of the woman s time to pregnancy was prospectively observed. The second study had a longer recall period (1-10 years) but included only 43 women.
- Length of gestation
Gestational length is the time from conception to delivery. The EPS has very good data on the first data point, and we know date of delivery. However, our data on delivery is limited by the fact that we do not know which deliveries were induced and which were the product of natural onset of labor and delivery. We plan to collect this information from the mothers. Such information will not only allow us to consider the natural variability in gestational age (a measure that does not exist at present) but also to estimate associations between events in very early pregnancy and the subsequent duration of pregnancy. The EPS has detailed measurements of the time from ovulation to implantation, the rate of increase in human chorionic gonadotropin and corpus luteum rescue. To our knowledge, these early pregnancy characteristics have not been investigated for associations with length of gestation.
- Conditions
- Gestational Age, Time to Pregnancy, Early Pregnancy Loss
- Keywords
- Early Pregnancy, Gestational Age, Fecundability, Ovulation, Recall, Natural History
- Medical subject headings
- Abortion, Spontaneous
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 |
|---|---|---|
| EPS Study Participants | Women who participated in the 1982-1986 North Carolina Early Pregnancy Study (EPS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gestation Length
Recall of time to pregnancy.
Measured: Retrospective recall
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2010 (estimated)
- Study start5 May 2010
- Primary completion2 Sep 2011
- Study completion24 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational AgeStudies 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
- Retrospective
- Enrolment
- 173 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
- Anne Marie Z Jukic, Ph.D., Principal investigator, National Institute of Environmental Health Sciences (NIEHS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01132924
- Sponsor's protocol ID
- 999910108
- Other IDs
- 10-E-N108
- Status last verified
- Sep 2023
- First submitted
- 27 May 2010
- Last updated
- 29 Sep 2023
- 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 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Follow-up of the Early Pregnancy Study Cohort
- ClinicalTrials.gov ID
- NCT01132924
- Acronym / sponsor ID
- 999910108
- Conditions
- Gestational Age, Time to Pregnancy, Early Pregnancy Loss
- Keywords
- Early Pregnancy, Gestational Age, Fecundability, Ovulation, Recall, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)US National Institutes of Health
- Study start
- 5 May 2010 (actual)
- Primary completion
- 2 Sep 2011 (actual)
- Study completion
- 24 Feb 2017 (actual)
- First posted
- 28 May 2010 (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.
Background:
- The purpose of the 1982 1986 North Carolina Early Pregnancy Study was to determine how often pregnancy loss occurs before women know they are pregnant. Women planning to become pregnant were asked to collect daily urine specimens and fill out daily diaries of their intercourse and menstrual bleeding. Researchers are interested in re-contacting this cohort to gather new information and to examine how accurately women can recall events that occurred earlier in their lives.
Objectives:
- To follow-up with and gather additional information from women who were involved in the Early Pregnancy Study.
Eligibility:
- Women who participated in the 1982 1986 North Carolina Early Pregnancy Study.
Design:
- Participants will receive and complete a questionnaire that includes the following topics:
- Their pregnancy history.
- The infant s birth, including method of delivery and induction of labor.
- Early life exposures such as their own birth weight and their parents ages at their birth.
- Tap water use during their attempt to conceive
- General description of their behaviors during their participation in the original study, these include: physical activity, caffeine, alcohol, and soy food consumption.
- Participants will return the surveys to the researchers in the stamped envelope provided with the questionnaire....
Detailed description
We propose a follow-up study of women who participated in the North Carolina Early Pregnancy Study (EPS) in 1982-1986. Women enrolled in the study after discontinuing birth control and were followed for the occurrence of a pregnancy. Participants completed daily diaries and collected first morning urine specimens which allowed the identification of menstrual cycles. Thus each woman s time to pregnancy was prospectively measured. We intend to trace the women and ask them to complete a questionnaire that includes their recall of their time to pregnancy during the study. This will allow us to address two major questions, one regarding the recall of time-to-pregnancy, and the other regarding the natural length of gestation. In addition, we will investigate associations of bisphenal A (BPA), phthalate metabolites, 2,4- and 2,5-dichlorophenols, Triclosan, benzophenone-3, and methyl-, propyl- and butyl-parabens with reproductive outcomes. This is described in a separate section at the end of this protocol because it does not involve recontacting participants, only assay of stored urine samples for purposes within the goals of the original study.
- Recall of time-to-pregnancy Time to pregnancy is a commonly studied estimate of fecundability. This outcome has been used to study the reproductive effects of environmental toxins, cigarette smoking, obesity and numerous other exposures. Prospective studies of time to pregnancy require enrollment of women who are just starting to attempt pregnancy and following them until a pregnancy is conceived. This type of study can be time-consuming and costly. It is also difficult to identify a population of women who are just beginning to attempt pregnancy. A more efficient design is to ask women to recall their time to pregnancy. This design is limited however, as it is unknown how well women can recall their time to pregnancy. Only two studies have examined this question in a population with both prospective and retrospectively recalled time to pregnancy. One of the studies involved women from the Netherlands, the recall period was short (3-20 months), and only part of the woman s time to pregnancy was prospectively observed. The second study had a longer recall period (1-10 years) but included only 43 women.
- Length of gestation
Gestational length is the time from conception to delivery. The EPS has very good data on the first data point, and we know date of delivery. However, our data on delivery is limited by the fact that we do not know which deliveries were induced and which were the product of natural onset of labor and delivery. We plan to collect this information from the mothers. Such information will not only allow us to consider the natural variability in gestational age (a measure that does not exist at present) but also to estimate associations between events in very early pregnancy and the subsequent duration of pregnancy. The EPS has detailed measurements of the time from ovulation to implantation, the rate of increase in human chorionic gonadotropin and corpus luteum rescue. To our knowledge, these early pregnancy characteristics have not been investigated for associations with length of gestation.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EPS Study Participants | – | –Women who participated in the 1982-1986 North Carolina Early Pregnancy Study (EPS) |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women who participated in the 1982-1986 North Carolina Early Pregnancy Study (EPS)
Key inclusion criteria (1 listed)
- This study is a follow-up study of women who participated in the NIEHS EPS. All of the women who participated in that study are eligible for this follow-up.
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
Gestation Length
Time frame: Retrospective recall
Recall of time to pregnancy.
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 29 Sep 2023.
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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.
Anne Marie Z Jukic, Ph.D. principal investigator
National Institute of Environmental Health Sciences (NIEHS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gestational Age and Time to Pregnancy, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site 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 1 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 29 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Gestation Length (time frame: Retrospective recall). 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 29 Sep 2023.