# EPIDEMIOLOGICAL STUDY OF RISKS TO REPRODUCTIVE OUTCOMES

> **NIH NIH R01** · UNIVERSITY OF MINNESOTA · 1993 · $270,169

## Abstract

The primary purpose of the proposed study is to determine the
effects of nutritional exposures present in women before and during
pregnancy on infant birth weight for gestational age.  It is
postulated that maternal nutrition exposures before and during
pregnancy, and changes in them over time, influence birth weight.
Other lifestyle, biological, and psychosocial exposures may also
influence birth weight, or they may interact with nutrition
exposures.  The effects of these exposures on birth weight and
their interactions with the nutrition exposures will be assessed
and accounted for in the analyses.  Birth weight has been chosen
as the primary outcome variable because it is the measure most
closely associated with infant morbidity and mortality in the U.S.
Nutritional factors have been chosen as the exposure variables
because they are often modifiable.

The long-term objective of the study is to increase the
availability of information that could be applied toward the
prevention of poor pregnancy outcomes.  The study may contribute
particularly useful information as it would be the first
prospective, analytical investigation that accounts for the
influence of prepregnancy exposure on birth weight.  Enrollment of
a large number of subjects needed prior to pregnancy is currently
possible due to the collaborative arrangement established with a
health maintenance organization that serves a large number of women
of child bearing age who tend to plan their pregnancies.  A system
for repeated contacts with potential participants will be set up
to ensure successful recruitment.

The study design calls for enrolling a cohort of 1,000 eligible
women over a 26 month period.  A total of 700 deliveries are needed
to test nutrition exposures - birth weight hypotheses.  Following
standardized protocols, repeated assessments of nutritional,
biological, lifestyle, and psychosocial exposures would be
undertaken before and during pregnancy.  Prepregnancy data
collection will be concentrated in a two-month period after
enrollment to avoid a length bias in women who conceive relatively
quickly.  Women who fail to conceive within 12 months, and those
who experience an early fetal loss would be exited from the study.
Women who conceive and maintain a pregnancy for over 20 weeks will
be followed through parturition.  After controlling for
confounders, the effects of the exposures on birth weight for
gestational age would be determined by regression methods and by
comparing exposed to unexposed women.

## Key facts

- **NIH application ID:** 2197856
- **Project number:** 5R01HD019724-05
- **Recipient organization:** UNIVERSITY OF MINNESOTA
- **SAM.gov UEI:** KABJZBBJ4B54
- **Principal Investigator:** JUDITH EVELYN BROWN
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 1993
- **Award amount:** $270,169
- **Award type:** 5
- **Project period:** 1989-04-01 → 1995-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/2197856

## Citation

> US National Institutes of Health, RePORTER application 2197856, EPIDEMIOLOGICAL STUDY OF RISKS TO REPRODUCTIVE OUTCOMES (5R01HD019724-05). Retrieved via MORVS 2026-10-25 from https://api.morvs.ai/grant/nih/2197856. Licensed CC0.

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