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Table 4 Schedule of surveillance, interviews and consent interactions in the main JiVitA-1 trial

From: A cluster-randomized, placebo-controlled, maternal vitamin a or beta-carotene supplementation trial in bangladesh: design and methods

Survey/Questionnaire

Scheduled at

Contents

Conducted by *

Consent/Reconsent

Women's Enrollment Survey

Beginning of trial

Baseline census of all women of reproductive age, enrollment into surveillance

FD

Y

Newly Married Woman Survey

Ongoing, 5- weekly

Allows enrollment of eligible, newly married women

FD

Y

Pregnancy Surveillance Survey

Ongoing, 5- weekly

Urinary hCG-based identification of new pregnancies

FD

Y, for urine test

Women's Consent

Interview

Pregnancy identification

Informing women about the trial, obtaining consent for interviews and supplementation

TL

Y

Pregnancy Dosing Visits

Weekly

Weekly supplementation of enrolled pregnant women

FD

N

Pregnancy Enrollment Questionnaire

First week after consent

Baseline characteristics, pregnancy history, 7 d diet, 7 d/30 d morbidity, exposures

FI

N

Socioeconomic Status Questionnaire

First week after consent

Education, employment of self and husband, household assets

FI

N

Family History Questionnaire

First week after consent

Parental vital status, cause of death, chronic morbidity

FI

N

Late Pregnancy Questionnaire

At 28 weeks gestation

7 d diet, 7 d/30 d morbidity, exposures

FI

N

Three-Month Postpartum Questionnaire

At 12 weeks postpartum

Complications of labor and delivery, 7 d diet, 7 d/30 d morbidity, exposures

FI

N

Six-Month Postpartum Questionnaire

At 24 weeks postpartum

7 d diet, 7 d/30 d morbidity, exposures

FI

N

Miscarriage/Stillbirth Questionnaire

4 weeks after event

Complications of labor and delivery, care-seeking

FI

Y

Verbal Autopsy - Infant

4 weeks after event

Enhanced from WHO standard instrument

FI

Y

Verbal Autopsy - Mother

4 weeks after event

Enhanced from WHO standard instrument

RP

Y

  1. * FD = Field Distributor, must be local resident with minimum education level of 8th grade TL = Team Leader, must be local resident with a minimum of a college degree
  2. FI = Field Interviewer, must be local resident with a minimum of a college degree
  3. RP = Research Physician, minimum MBBS-degree, with specific verbal autopsy training