Clinical trial NCT02381197: Longitudinal Study: Diagnosis and Prediction of Pre-Eclampsia by Using Congo Red Dot Test in Bangladesh and Mexico
Official title: Diagnosis and Prediction of Preeclampsia: A Longitudinal Study of the Clinical Utility of Congo Red Dot Test in Bangladesh and Mexico
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Preeclampsia
Keywords: Congo Red Dot Test
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
Collaborators: name: Nationwide Children's Hospital
First posted: 2015-03-06
Enrollment: 2000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In Bangladesh, pregnant women will be identified during monthly home visits of Community Health Workers (CHW) affiliated with Matlab in Chandpur and asked to participate. In Mexico, women will be identified at routine antenatal appointments at Hospital Materno-Infantil Inguarán.

Brief summary: A population-based prospective cohort design will evaluate the progression of urine congophilia in pregnancy using the Congo Red Dot test by following patients longitudinally across gestation in Bangladesh and Mexico City.

Detailed description: A population-based prospective cohort design will evaluate the progression of urine congophilia in pregnancy using the Congo Red Dot test by following patients longitudinally across gestation in Bangladesh and Mexico City. A total of 2000 women presenting for prenatal care will be enrolled (1000 at each site). In Bangladesh, pregnant women will be identified during monthly home visits of Community Health Workers (CHW) affiliated with Matlab in Chandpur and asked to participate. In Mexico, women will be identified at routine antenatal appointments. If the woman agrees to participate, investigators will ask her to consent to donation of urine for testing (Congo Red Dot test and Proteinuria dipstick test) at the time of enrollment, four times during her pregnancy (first trimester 6-12 weeks; second trimester 13-28 weeks; third trimester 29-36 weeks; term 37-41 weeks) and possibly three times postpartum (24 hours after delivery and daily until discharge). As a result, the enrolled patients will be followed longitudinally throughout pregnancy until delivery of the baby either at term for an uncomplicated gestation or preterm/term for preeclampsia. The group of women who develop preeclampsia will represent the study group. At the end of the study, the results will be analyzed to identify how many weeks in advance the women who developed preeclampsia displayed congophilia.

Eligibility criteria: Inclusion Criteria:

* Pregnant
* Willing to give urine samples at prenatal visits
* Eligible to consent to research

Exclusion Criteria:

- None

Primary outcomes:
measure: Prevalence of urine congophilia
timeFrame: within 15 days of urine sample collection
Secondary outcomes:
Other outcomes:
Locations:
city: Chandpur
country: Bangladesh
facility: Matlab
city: Mexico City
country: Mexico
facility: Hospital Materno-Infantil Inguarán
Study officials:
affiliation: Nationwide Children's Hospital
name: Irina Buhimschi, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Gynuity Health Projects
name: Beverly Winikoff, Dr
role: PRINCIPAL_INVESTIGATOR
References: