ZEN Columbia: Pregnant Women Eligibility - English 08SEP

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 _ _ - _ - _ _ _ _ _ _ _ _ _ _ _

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