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Facteurs influençant la fertilité ou la santé de la grossesse

Background:

The North Carolina Early Pregnancy Study (EPS) was held from 1982 to 1986. Women who were trying to get pregnant took part in the study. They collected urine samples. They kept diaries. They filled out surveys. They answered questions about their partners. They were asked about their drug use. Data about air pollution and other exposures were also collected. A follow-up study was held from 2010 to 2011. Researchers want to use the data and samples to study factors that affect reproductive success.

Objective:

To examine behavioral and environmental exposures and reproductive health, such as menstrual cycles, conception, pregnancy loss, and pregnancy outcomes.

Eligibility:

The 221 healthy women age 21-42 who were planning to get pregnant and took part in the 1982-86 North Carolina EPS at the time they stopped using all birth control. A 2010-11 follow-up included 173 of these women.

Design:

This study uses existing data. No new data will be collected in this study.

Stored urine samples may be used. Data from surveys and other sources will be used. All of the women who gave data and samples will be included.

Electronic data is held in secure databases. The data is kept on computers that are password protected. Hard-copy data are stored in locked file cabinets.

The study will take place at more than one site. Data will be shared with groups outside the NIH....

Aperçu de l'étude

Description détaillée

Existing self-reported data and assay results from the 1982-1986 North Carolina Early Pregnancy Study (EPS) and a subsequent 2010-2011 cohort follow-up study will be used to examine predictors of fertility and pregnancy outcomes. Some of these data will be harmonized with data from other studies by our collaborator (Harville PI, Tulane University) to examine factors, such as marijuana use in women and their partners, influencing reproductive success, including (but not limited to) conception, pregnancy loss, and birth outcomes. Women enrolled in the original EPS 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 hormonal endpoints. Thus, each woman s time to pregnancy was prospectively measured. In the EPS Follow-up study, women completed a questionnaire that included their recall of their time to pregnancy during the study. This allowed analysis of two major questions, one regarding the recall of time- to-pregnancy, and the other regarding the natural length of gestation. Several exposure metrics based on address geolocation data were calculated, including the distance from residence to nearest major road, air pollution and related exposures, light at night, and other exposures. Existing urine specimens can be assayed for numerous environmental contaminants including metals, pesticides, and drug metabolites (both over-the-counter medications like acetaminophen and drugs of abuse like marijuana or opioids). Urine specimens can also be used to examine nutritional markers such as phytoestrogen exposure and caffeine metabolites. Additional hormone measures may also be possible as metabolomics and technology improve. Thus, the stored EPS specimens can be leveraged to answer multiple, relevant fertility research questions. Women in the original tudy answered questions regarding their tobacco smoking and marijuana smoking. In addition, partners of the women were asked the same series of questions regarding tobacco and marijuana use.

We intend to use all of this existing data, assay results, and to perform additional urine assays, to examine factors influencing reproductive success, including (but not limited to) conception, pregnancy loss, and birth outcomes. To address some of these questions, de-identified data from the Early Pregnancy Study will be harmonized with data from other studies in the Preconception Period Analysis of Risks and Exposures Influencing Health and Development (PrePARED) consortium. Further, de-identified data and specimens will be shared with Dr. Ashley Boggs and colleagues to address the objectives below. Data and specimens will be shared with other qualified investigators in the future to address relevant research questions.

Type d'étude

Observationnel

Inscription (Réel)

231

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • Maryland
      • Bethesda, Maryland, États-Unis, 20892
        • National Institute of Environmental Health Sciences (NIEHS)

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

21 ans à 42 ans (Adulte)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Femelle

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

Women who participated in the 1982-1986 North Carolina Early Pregnancy Study (EPS)

La description

  • INCLUSION CRITERIA:
  • healthy white women aged 21-42 who were planning to become

pregnant

-women enrolled in the 1982-1986 North Carolina Early Pregnancy

Study (EPS) at the time they discontinued all methods of birth control

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Modèles d'observation: COHORT
  • Perspectives temporelles: PROSPECTIVE

Cohortes et interventions

Groupe / Cohorte
EPS Study Participants

Women who participated in the 1982-1986 North Carolina Early Pregnancy Study (EPS)

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Time-to-pregnancy
Délai: Prospectively measured

Reproductive function includes a spectrum of relevant endpoints and outcomes. We will examine behavioral and environmental exposures and reproductive health including menstrual cycles, conception, pregnancy loss, and pregnancy outcomes

Prospectively measured

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Pregnancy loss, hormone levels, birth outcomes, pregnancy complications
Délai: Prospectively measured

Reproductive function includes a spectrum of relevant endpoints and outcomes. We will examine behavioral and environmental exposures and reproductive health including menstrual cycles, conception, pregnancy loss, and pregnancy outcomes.

Prospectively measured

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: Anne Marie Z Jukic, Ph.D., National Institute of Environmental Health Sciences (NIEHS)

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

19 octobre 2020

Achèvement primaire (Estimé)

31 décembre 2030

Achèvement de l'étude (Estimé)

31 décembre 2030

Dates d'inscription aux études

Première soumission

20 octobre 2020

Première soumission répondant aux critères de contrôle qualité

20 octobre 2020

Première publication (Réel)

22 octobre 2020

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

12 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

10 novembre 2026

Dernière vérification

2 décembre 2025

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

INDÉCIS

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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