NCT01132924

A Follow-up of the Early Pregnancy Study Cohort.

Completed Last updated 29 September 2023

What this trial tests

trial in Gestational Age in 173 participants. Completed in 24 February 2017.

Timeline

5 May 2010

Primary endpoint
2 September 2011

24 February 2017

Quick facts

Lead sponsor	National Institute of Environmental Health Sciences (NIEHS)
Status	Completed
Study type	OBSERVATIONAL
Enrollment	173
Start date	5 May 2010
Primary completion	2 September 2011
Estimated completion	24 February 2017
Sites	1 location across United States

Conditions studied

• Gestational Age — all drugs for Gestational Age →
• Time to Pregnancy — all drugs for Time to Pregnancy →
• Early Pregnancy Loss — all drugs for Early Pregnancy Loss →

Sponsor

National Institute of Environmental Health Sciences (NIEHS)

Who can join

Adults 45 to 75, female only, with Gestational Age or Time to Pregnancy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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....

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Normalizing Untargeted Periconceptional Urinary Metabolomics Data: A Comparison of Approaches.
   Rosen Vollmar AK, Rattray NJW, Cai Y, Santos-Neto ÁJ, et al · · 2019 · cited 39× · PMID 31546636 · DOI 10.3390/metabo9100198