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NCT04595760 · ClinicalTrials.gov registry record
Factors Influencing Fertility or Pregnancy Health
A clinical trial of Early Pregnancy Loss and Pregnancy Outcomes, sponsored by National Institute of Environmental Health Sciences (NIEHS).
- Active
- Registry status
- 231
- Enrollment target
- 1
- Study location
NCT04595760: Active study of Early Pregnancy Loss and Pregnancy Outcomes, sponsored by National Institute of Environmental Health Sciences (NIEHS).
NCT04595760 is a study of Early Pregnancy Loss and Pregnancy Outcomes that is active but no longer recruiting, run by National Institute of Environmental Health Sciences (NIEHS). The registered enrollment target is 231 participants, above the 147-participant average among 3 other Early Pregnancy Loss trials with a reported enrollment target (57% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04595760, a study of Early Pregnancy Loss and Pregnancy Outcomes, is active but no longer recruiting, sponsored by National Institute of Environmental Health Sciences (NIEHS).
- ACTIVE NOT RECRUITING
- Registry status
- 231 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
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
Conditions Studied
Study Locations (1)
Maryland
- National Institute of Environmental Health Sciences (NIEHS) - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 231 participants |
| Start Date | 2020-10-19 |
| Est. Completion | 2030-12-31 |
What the registry record for NCT04595760 still lists
NCT04595760 is an observational study that tracks outcomes without assigning an intervention. The registered 231 participants enrollment target is mid-sized for trials with a published cap, above the 147-participant average among 3 other Early Pregnancy Loss trials with a reported enrollment target (57% higher).
The record links to 4 conditions, with Early Pregnancy Loss appearing as the primary indexed condition, and to 0 interventions.
NCT04595760 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT04595760 about?
NCT04595760 is a clinical study titled "Factors Influencing Fertility or Pregnancy Health". 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 dr...
What is the current status of trial NCT04595760?
This trial is currently active not recruiting. The enrollment target is 231 participants. The study started on 2020-10-19. Estimated completion is 2030-12-31.
What conditions does trial NCT04595760 study?
This clinical trial studies the following conditions: Early Pregnancy Loss, Pregnancy Outcomes, Menstrual Cycles, Conception.
Who is sponsoring clinical trial NCT04595760?
This trial is sponsored by National Institute of Environmental Health Sciences (NIEHS), which has 145 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04595760 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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