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Protocol - Current Pregnancy Status - Self-Report

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Protocol Name from Source:

National Health and Nutrition Examination Survey (NHANES) Reproductive Health Module

Availability:

Publicly available

Description:

A single interviewer-administered item.

Protocol:

1. {Are you/Is SP} pregnant now?

MARK IF KNOWN. OTHERWISE ASK.

[ ] YES ............................................................... 1

[ ] NO................................................................. 2

[ ] REFUSED ..................................................... 7

[ ] DON’T KNOW ............................................... 9

SP = study participant

Personnel and Training Required

The interviewer must be trained to conduct personal interviews with individuals from the general population. The interviewer must be trained and found to be competent (i.e., tested by an expert) at the completion of personal interviews. The interviewer should be trained to prompt respondents further if a "don’t know" response is provided.

Equipment Needs

The PhenX Working Group acknowledges these questions can be administered in a computerized or noncomputerized format (i.e., paper-and-pencil instrument). Computer software is necessary to develop computer-assisted instruments. The interviewer will require a laptop computer/handheld computer to administer a computer-assisted questionnaire.

Requirements

Requirement CategoryRequired
Average time of greater than 15 minutes in an unaffected individualNo
Major equipmentNo
Specialized requirements for biospecimen collectionNo
Specialized trainingNo

Mode of Administration

Self-administered

Life Stage:

Adolescent, Adult, Pregnancy

Specific Instructions:

Although menarche typically occurs after age 12, the Pregnancy Working Group acknowledges this could be applicable for females following menarche.

Note that a Current Pregnancy Status - Bioassay assay is the most accurate method and should be used to confirm pregnancy, if pregnancy determination is critical to the study.

Research Domain Information

Release Date:

January 31, 2017

Definition

This measure is used to determine if a woman is currently pregnant or not.

Purpose

A biological assay is the most accurate pregnancy test. It may be important to know whether or not a woman is pregnant prior to some tests (e.g., dual-energy X-ray absorptiometry) or to the use of pharmaceutical agents as in a clinical trial. In addition, pregnancy may influence the results of several physical and health measures such as weight, blood pressure, stress, and depression. This measure can also be used to make a determination of whether the subject can be included or excluded from a research study or whether she should be excluded.

Selection Rationale

Current pregnancy status can be a critical inclusion or exclusion criterion to many research protocols. Depending on specific needs and implications, researchers may accept self-report of pregnancy or require a biological sample to test for pregnancy (urine or blood). The National Health and Nutrition Examination Survey (NHANES) question on current pregnancy status was chosen as valid source from a major national study.

Language

English, Spanish

Standards

StandardNameIDSource
Common Data Elements (CDE)Patient Pregnancy Ind-3b2958020CDE Browser

Process and Review

The Expert Review Panel has not reviewed this measure yet.

Source

National Health and Nutrition Examination Survey (NHANES) 2007-2008 REPRODUCTIVE HEALTH - RHQ Target Group: Female SPs Ages 12+ item: RHQ.143.

General References

Blehar, M. C., Spong, C., Grady, C., Goldkind, S. F., Sahin, L., & Clayton, J. A. (2013). Enrolling pregnant women: Issues in clinical research. Women’s Health Issues, 23(1), e39-e45.

Protocol ID:

240602

Variables:

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