ZEN Columbia: Pregnant Women Eligibility - English 08SEP

ZEN Colombia Study: Zika in Pregnant Women and Children in Colombia

Att B1 - Woman Eligibility Screening Form_090617_clean

Pregnant Women - Pregnant Women Eligibility Questionnaire

OMB: 0920-1190

Document [docx]
Download: docx | pdf




Appendix B1 ZEN Colombia Pregnant Woman Eligibility

Last updated 09/06/17

Form Approved

OMB No. 0920-1190

Exp. Date 07/31/2017


Pregnant Woman Eligibility

Note: Before enrolling a woman, make sure you have enough supplies (study kits, blood and urine collection materials, paper forms, etc.)


Name of Person Completing the Form: _______________________________________________


Cedula of Pregnant Woman: _________________________________


Today’s date: _____/______/________ (DD/MMM/YYYY)


IPS Information


Clinic name: _________________________________________


City: Barranquilla Bucaramanga Tuluá


Pregnant Woman Information


Last names: _________________________________________


First name(s): _________________________________________


Pregnant woman date of birth _____/_______/_____ (DD/MMM/YYYY): Age today: __________


If under 18, date of pregnant woman 18th birthday _____/_______/_____ (DD/MMM/YYYY)


Expected delivery date (EDD): _____/_______/_____ (DD/MMM/YYYY) Unsure


How determined: ____ by LMP ____ by ultrasound

Date of LMP: ______/_______/______ (DD/MMM/YYYY) Unsure


Gestational age at eligibility: ______ weeks ________ days


NOTE: Use EDD to calculate gestational age, and if ED is unknown, then use LMP

Inclusion Criteria


Is the woman pregnant? (by confirmed clinic pregnancy test or ultrasound)

Yes No


Is the woman in the first trimester of pregnancy (≤14+6)? (by LMP or ultrasound)

Yes No

Is the woman planning to have prenatal care at a participating clinic?

Yes No

Is the woman 16 years of age or older?

Yes No

Does this woman speak Spanish?

Yes No




CDC estimates the average public reporting burden for this collection of information as 5 minutes per response, including the time for reviewing instructions, searching existing data/information sources, gathering and maintaining the data/information needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to CDC/ATSDR Information Collection Review Office, 1600 Clifton Road NE, MS D-74, Atlanta, Georgia 30333; ATTN: PRA (0920-XXXX).

Exclusion Criteria

Is the pregnancy an ectopic or a molar pregnancy?

Yes No

Is the woman incarcerated?

Yes No

Is the woman unable to physically or psychologically participate

based on clinical judgement?

Yes No



Eligibility Determination

The woman is eligible for the study. (All answers to inclusion criteria questions are Yes AND all answers to exclusion criteria are No.)

Yes Eligible

No Not Eligible –STOP, thank the participant and fill out non-participant ID

Unsure If unsure, then fill out Appendix E1 (contact information) and

follow-up in one week.

Notes about eligibility determination: _______________________________________________________

_______________________________________________________________________________________

_______________________________________________________________________________________

If eligible, please complete the sections below.


Informed Consent Determination

Did the woman receive and provide informed consent or assent for participation?

Yes Enroll

Unsure If unsure, then fill out Appendix E1 (contact information) and follow-

up in one week.

No If no, do not enroll, thank the patient for their time and note that they

declined participation in the study.

Reason(s) for declining (check all that apply):

Not interested

Concerned about study protocol (safety, invasive)

Concerns about time/transportation

Concerns about family member approval (e.g. partner, parents)

Other concern:_____________________________

Zika Study Kit

Did you give the woman a Study Kit before she left?

Yes, she took it

Offered it to her, but she didn’t want/take it

Did not offer STOP. Do not enroll if no study kit is available. Schedule enrollment visit for another day.

If not offered, why?: _______________________________


ZEN Participant and Non-Participant Identification Numbers

If the woman was eligible and has consented, assign a ZEN Participant ID. If the woman was not eligible or was eligible and did not consent, assign a ZEN Non-Participant ID (see SOP ZEN-2-02).

ZEN Participant ID: _ _ _ _ _ _- _ - _ _ _ _ _ _ _ _ _ _ _


ZEN Non-Participant ID: N _ _ - _ - _ _ _ _ _ _ _ _ _ _ _

Page 4 of 4



File Typeapplication/vnd.openxmlformats-officedocument.wordprocessingml.document
AuthorJohnson, Candice Y. (CDC/NIOSH/DSHEFS)
File Modified0000-00-00
File Created2021-01-22

© 2024 OMB.report | Privacy Policy