Data Element
Pregnancy Outcome
Description

The result of the subject’s delivery, such as live birth or not a live birth.
Submitted By: Adam Bazer, MPD / Integrating the Healthcare Enterprise USA (IHE USA)
Data Element Information
Use Case Description(s)
Use Case Description Monitoring disease and making decisions about public health threats depends on accessible and accurate data. EHRs are a data source with potential to provide timely and relevant data beyond its use by health care providers. EHR data, if made more available for public health professionals and researchers, can lead to new innovations and more rapid disease detection.

The details of a delivery are crucial for providing the best possible post-natal care to the mother and infant. As well, after delivery, public health needs to capture this data as part of birth certification, fetal death reporting and birth defect reporting. In particular, birth certification forms the basis of the patient census required by a large number of other public health programs including newborn screening, birth defect reporting and immunization registries making it critical that birth certification is as automated, timely and accurate as possible.

The public health use case(s) that support the adoption of these added elements are part of the Making EHR Data More Available for Research and Public Health (MedMorph) Reference Architecture. The goal of the MedMorph project is to develop and pilot a scalable and extensible standards-based reference architecture. This reference architecture will enable clinical data exchange with EHR systems and public health systems, specialized registries, national health care survey systems, and research information systems for multiple conditions.
Estimate the breadth of applicability of the use case(s) for this data element Every year there are approximately 3.7 million births in the United States. Consumption of this data is widespread. Every jurisdiction in the country captures birth certification information and immunization administration. Most also capture birth defects and fetal deaths. Healthcare systems which provide care for expectant mothers should be collecting this data.
Link to use case project page https://www.cdc.gov/csels/phio/making-ehr-data-more-available.html https://www.cdc.gov/nchs/nvss/births.htm https://www.cdc.gov/ncbddd/birthdefects/index.html
Healthcare Aims
  • Improving patient experience of care (quality and/or satisfaction)
  • Improving the health of populations
  • Improving provider experience of care
Maturity of Use and Technical Specifications for Data Element
Applicable Standard(s) LOINC codes exist for each of the proposed data elements:
11884-4: Gestational age Estimated
64710-7: Was your pregnancy a live birth, stillbirth, miscarriage, abortion, or ectopic pregnancy [PhenX]
9272-6: 1 minute Apgar Score
9274-2: 5 minute Apgar Score
9271-8: 10 minute Apgar Score

73766-8: Place where birth occurred [US Standard Certificate of Live Birth]
• Freestanding birthing center (Freestanding birthing center is defined as one which has no direct physical connection with an operative delivery center.)
• Home birth
• Planned to deliver at home Yes No
• Clinic/Doctor’s Office
• Other (specify, e.g., taxi cab, train, plane, etc.)

8339-4 - Birth weight Measured
https://loinc.org/ https://phinvads.cdc.gov/vads/SearchHome.action
Additional Specifications Vital Records Common Profiles Library FHIR IG - http://build.fhir.org/ig/HL7/fhir-vr-common-ig/branches/master/index.html
Vital Records Birth and Fetal Death Reporting - https://build.fhir.org/ig/HL7/fhir-bfdr/index.html
HL7 Version 2.6 Implementation Guide: Vital Records Birth and Fetal Death Reporting, Release 1 STU Release 2 - US Realm: https://www.hl7.org/implement/standards/product_brief.cfm?product_id=320

HL7 CDA® R2 Implementation Guide: Birth and Fetal Death Reporting, Release 1, STU Release 2 - US Realm: https://www.hl7.org/implement/standards/product_brief.cfm?product_id=387

IHE Quality, Research and Public Health Technical Framework Supplement – Birth and Fetal Death Reporting-Enhanced (BFDR-E) Revision 3.1: https://www.ihe.net/uploadedFiles/Documents/QRPH/IHE_QRPH_Suppl_BFDR-E.pdf

Birth Defect Reporting FHIR IG: https://build.fhir.org/ig/HL7/fhir-birthdefectsreporting-ig/index.html

HL7 CDA® R2 Implementation Guide: Ambulatory and Hospital Healthcare Provider Reporting to Birth Defect Registries Release 1 , STU 2 -US Realm: https://www.hl7.org/implement/standards/product_brief.cfm?product_id=428
Current Use In limited use in production environments
Supporting Artifacts Level 2 – at scale, or in more widespread production use (routinely collected already) on several different EHR/HIT systems.

This data is exchanged routinely as part of birth certification, fetal death reporting and birth defect reporting, however these workflows typically are executed on paper or via flat files rather than through electronic interoperability.

EPIC FHIR APIs for patient, vitals, obstetric details (DSTU2, DSTU3, R4)
In production use:
EPIC stork module (obstetrics) for birth reporting


https://www.cdc.gov/nchs/data/dvs/facility-worksheet-2016-508.pdf https://www.cdc.gov/nchs/data/dvs/fetal-death-mother-worksheet-english-2019-508.pdf https://www.epic.com/software#PatientEngagement https://fhir.epic.com/Specifications?api=932
Extent of exchange 4
Supporting Artifacts Level 2 – exchanged between 4 or more different EHR/HIT systems.

IHE Connectathon integration profiles for BFDR-E (2013 - 2020)

HL7 FHIR Connectathon results (Sept 2020): birth and fetal death reporting results testing between electronic birth registration system vendors (FHIR)

NACCHO 360X Interoperability Demonstrations for Birth and Fetal Death reporting 2020 between NextGen and two state electronic birth registrations system vendors using FHIR.

HIMSS Interoperability showcase (2018 – 2019)

ONC Interoperability Standards Advisory - Sending Birth and Fetal Death Information to Public Health Agencies
https://www.healthit.gov/isa/reporting-birth-and-fetal-death-public-health-agencies https://confluence.hl7.org/display/FHIR/2020-09+Public+Health+Track https://www.interoperabilityshowcase.org/ https://connectathon-results.ihe.net/view_result.php?rows=com
Potential Challenges
Restrictions on Standardization (e.g. proprietary code) None
Restrictions on Use (e.g. licensing, user fees) None
Privacy and Security Concerns No concerns over and above the typically privacy and security considerations associated with any health related data.
Estimate of Overall Burden These data elements are straightforward in nature and should not present a large burden to implement provided the EHR system is capturing the data as part of caring for the newborn.
Other Implementation Challenges When using FHIR there may be associated costs with development of tools needed to access specific data. Often these costs may be a limitation for states who need to develop tools to access certain data.

Comment

Submitted by BLampkins_CSTE on

CSTE Comment - v6

CSTE supports inclusion of this data element in USCDI V6. Please see previously submitted CSTE comments for additional recommendations.

Submitted by nedragarrett_CDC on

CDC comments on Pregnancy Outcome

CDC requests this data element be considered for inclusion in USCDI V6.  A recent CDC/NACHC postpartum care services project documented the feasibility of collecting the data element in EHRs, and the importance for interoperability standards to support data exchange between health organizations to enhance quality improvement initiatives to improve perinatal outcomes.

Justification: This critical data element documents pregnancy outcome to assess care processes and develop effective approaches to maternal care. The outcome of the pregnancy includes: 1) live birth; 2) still birth or intrauterine fetal death (>20 weeks' gestation); 3) miscarriage/spontaneous abortion (<20 weeks' gestation); 4) termination (elective, medical, surgical, or induced abortion); 5) ectopic pregnancy; 6) non-live birth, not otherwise specified.  This data element is routinely captured for birth certification, fetal death reporting, and birth defect reporting and used by providers using electronic health records or self-reported by patient as patient generated health data.  Capturing the data related to pregnancy outcome in a standardized way will support the collection of sufficient pregnancy information to identify cases and measure outcomes of pregnancy on a population level. Standardization will also benefit the data exchange between EHR systems and public health, specialized registries, national health care survey systems, and research entities.  

The Centers for Disease Control and Prevention, in partnership with the National Association of Community Health Centers (NACHC), worked to build capacity of Federally Qualified Health Centers to improve the health informatics infrastructure for perinatal care measures and use perinatal care measures to identify and address gaps in postpartum care (https://liebertpub.com/doi/10.1089/jwh.2024.0364). Partner health center-controlled networks (Alliance Chicago, Health Choice Network, OCHIN, and Aliados Health) and nine Community Health Centers, implemented strategies to integrate evidence-based recommendations into the clinic workflow and use data-driven health information technology (HIT) systems to improve data standardization for quality improvement of postpartum care services. The respective EHRs were able electronically capture, access and exchange this data element through adequate testing in staging and development EHR environments. NACHC developed an implementation Guide (Improving Quality in Pregnancy and Postpartum Care) to provide practical strategies to leverage data from electronic clinical data systems for improved maternal health care (NACHC-WHPP-Implementation-Guide-2024_3.pdf).   

Pregnancy Outcome is currently standardized with value set OID 2.16.840.1.114222.4.11.7494 with child concept names and codes in the Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT) and in the CDC Public Health Information Network and Vocabulary Access and Distribution System (PHINVADS).

 

*Matcho A, Ryan P, Fife D, Gifkins D, Knoll C, Friedman A. Inferring pregnancy episodes and outcomes within a network of observational databases. PLoS One. 2018 Feb 1;13(2):e0192033. doi: 10.1371/journal.pone.0192033. 

Submitted by BLampkins_CSTE on

CSTE Comment - v5

CSTE supports inclusion of pregnancy-related data elements in USCDI v5. A single variable (pregnancy status) is not sufficient to capture critical data that are needed for a large variety of conditions affecting the public's health, including maternal mortality, Hepatitis B and C, COVID-19, Zika, syphilis, and influenza, to name only a few. CSTE urges the inclusion of the following variables in the core data for exchange - as defined by the ONC Public Health Task Force on Capturing Pregnancy Data in Electronic Health Records and found here https://www.healthit.gov/sites/default/files/facas/HITJC_PHTF_Meeting_Slides_2017-03-30_0.pdf

https://www.healthit.gov/topic/federal-advisory-committees/collaboration-health-it-policy-and-standards-committees (See May 19 transmittal letter to the NC.  Click on charge 1 - Capturing Pregnancy Status, see MS Excel Spreadsheet)

1) Pregnancy Status - Yes, No, Possible, Unknown

2) Date pregnancy status recorded

3) Estimated delivery date

4) Pregnancy outcome

5) Date of pregnancy outcome

and optionally 

6) Postpartum status (this is important since if the mother recently gave birth and is diagnosed with a condition that could affect the neonate, public health action might be indicated).

Currently there are large gaps in the ability for data from electronic health records or ELR to capture sufficient pregnancy information to identify cases and measure the burden and outcome of medical conditions and infections in pregnancy on a population level. Standardizing these data for exchange would be a substantial step forward.

CSTE strongly urges ONC to include Estimated due date and not just gestational age as an element in USCDI since data are exchanged at points in time and gestational age at the time of recording may differ from gestational age at the time of the data transmission or receipt. Including estimated due date fixes the maturity of the pregnancy in time, as opposed to gestational age. If gestational age is favored as a variable to use then it must be accompanied by a date of recording of the gestational age which requires additional data capture.

Finally, it is very important for electronic health records to develop a way to link the mother and infant records. A unique identifier for the mother which can be included in the infant's record, and a similar unique identifier for the infant which can be included in the mother's records would help to rectify this problem, which would be beneficial for both clinical care as well for public health when we receive data on mothers and infants but cannot link them (important for diseases such as HIV, listeria, Zika, syphilis, Hepatitis B, and others).

Pregnancy Status and Outcome are critical fields which must be included in USCDI v5. Pregnancy Status and Outcome are critical for prioritization of public health actions and without this information adverse outcomes may occur. Many conditions of public health importance can result in spontaneous abortion, prematurity, or fetal death. CSTE stresses the importance of restricting access or sharing of reproductive health data to ensure it cannot be used for purposes beyond the immediate public health purpose for which it was reported.

Submitted by nedragarrett_CDC on

CDC's comment for USCDI Draft v5

CDC supports the inclusion of this data element in USCDI v5 as it is an element that may be necessary for calculation of our digital quality metrics from FHIR data.

Submitted by nedragarrett_CDC on

CDC's comment on behalf of CSTE for USCDI v5

  • Outcome of pregnancy is a critical field which must be included in USCDI v5. Many conditions of public health importance can result in spontaneous abortion, prematurity or fetal death.
  • CSTE is currently working on standards for value sets for this variable. In addition, the HITAC convened a task force in 2017 and recommended standards for this data element.
  • See https://www.healthit.gov/sites/default/files/facas/HITJC_PHTF_Meeting_Slides_2017-03-30_0.pdf.  
  • Value sets for outcome recommended by the task force included: molar pregnancy 44782008^Molar pregnancy (disorder)^SCT, elective termination 57797005^Induced termination of pregnancy (disorder)^SCT, spontaneous termination <20 weeks' gestation 17369002^Miscarriage (disorder)^SCT, still birth 237364002^Stillbirth (finding)^SCT, ectopic/tubal 34801009^Ectopic pregnancy (disorder)^SCT and live birth 281050002^Livebirth (finding)^SCT
  • It is also critical to include the date of pregnancy outcome.

Submitted by RUy on

Standards and value sets need more granularity

There are multiple value sets on VSAC that represent Pregnancy Outcome with more detail that is not on PhenX

  1. Pregnancy ending in delivery
  2. Pregnancy with abortive outcome

Recommend more specificity to make this information actionable by clinicians.

Submitted by nedragarrett_CDC on

CDC's Consolidated Comment

  • STD - Congenital syphilis: this is very important because if pregnancy unfortunately ends in a still birth, the female should be screened for syphilis. This is part of current recommendations for stillbirth but is not followed routinely, estimates are that only about 60% get screened. 

CSTE Comment:

  • CSTE strongly recommends that pregnancy status be included in USCDI v3. However, a single variable is not sufficient to capture critical data that is needed for a large variety of conditions affecting the public's health, including maternal mortality, Hepatitis B and C, COVID-19, Zika, syphilis, and influenza, to name only a few. CSTE urges the inclusion of the following variables in the core data  for exchange - as defined by the ONC Public Health Task Force on Capturing Pregnancy Data in Electronic Health Records and found here: https://www.healthit.gov/sites/default/files/facas/HITJC_PHTF_Meeting_Slides_2017-03-30_0.pdf
  1. Pregnancy Status - Yes, No, Possible, Unknown
  2. Date pregnancy status recorded
  3. Estimated delivery date
  4. Pregnancy outcome
  5. Date of pregnancy outcome and optionally
  6. Postpartum status (this is important since if the mother recently gave birth and is diagnosed with a condition that could affect the neonate, public health action might be indicated).

 

  • Currently there are large gaps in the ability for data from electronic health records or ELR to capture sufficient pregnancy information to identify cases and measure the burden and outcome of medical conditions and infections in pregnancy on a population level. Standardizing these data for exchange would be a substantial step forward.
  • Finally, it is very important for electronic health records to develop a way to link the mother and infant records. A unique identifier for the mother which can be included in the infant's record, and a similar unique identifier for the infant which can be included in the mother's records would help to rectify this problem, which would be beneficial for both clinical care as well for public health when we receive data on mothers and infants but cannot link them (important for diseases such as listeria, Zika, syphilis, Hepatitis B, and others)

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