Change Request Memo

Change Memo for

“COVID-19 Pregnancy Module”

(OMB Control No. 0920-1297)

Expiration Date: 11/30/2020

Program Contact

Sascha Ellington

Pregnancy and Infant Linked Outcomes Team

Epidemiology and Surveillance Task Force

[email protected]

Submission Date: 9/8/2020

Background:

CDC is collaborating with state, local, and territorial health departments to better understand COVID-19 during pregnancy. The COVID-19 Pregnancy Module was developed as a supplement to the standard COVID-19 case report form.

The standard COVID-19 Case Report Form asks whether an individual is currently pregnant at the time of COVID-19 infection. If the individual is pregnant, the COVID-19 Pregnancy Module is an optional data collection that consists of two forms: 1) Pregnancy form and 2) Neonate form.

The COVID-19 Pregnancy Module collects data on the pregnant individual’s obstetric history and pregnancy complications, as well as the outcome of the pregnancy and basic information about the neonate. Health departments can choose to participate in this optional information collection. Data collected for the COVID-19 Pregnancy Module will be used to describe risk for severe illness or adverse outcomes among pregnant individuals with COVID-19 during pregnancy, or their newborns. Aggregate data will be shared with jurisdictions and CDC COVID-19 Response leadership to better inform clinical guidance and risk communication messages.

Proposed additions to the Forms:

Pregnant Women Form:

1. Date of first positive specimen by SARS-CoV-2 PCR testing

2. Admission to an intensive care unit (ICU) for COVID-19?

   • Date of ICU admission

   • Date of ICU discharge

3. Date for ICU admission during the birth hospitalization

Neonate Form:

1. Multiple gestation pregnancy indicator (repeated from pregnancy form)

2. Pregnancy outcome (repeated from pregnancy form)

3. Delivery type (repeated from pregnancy form)

4. Neonatal intensive care unit discharge date

5. Type of test conducted, specimen collection date, and specimen type were added.

   1. Additional slots have been added to collect more than one test conducted on the neonate

Justification:

Data have been collected with the initial version of the COVID-19 Pregnancy Module since May 2020. During this time several improvements have been identified by CDC that would improve data interpretation, data quality, and linkages with the standard COVID-19 case report form and between pregnancy and neonatal forms. Additionally, implementing jurisdictions have requested additions such as multiple response options for neonatal testing.

Other data systems: N/A

Data collection activity	Estimated number of respondents	Estimated number of responses per respondent	Estimated time spent per response (in hours)	Estimated total burden (in hours)
Pregnant Women Form	15	1,000	30/60	7,500
Neonate Form	15	950	30/60	7,125
	Total			14,625

Attachments: revised COVID-19 Pregnancy Module