The population for the present study was drawn from participants of the ongoing Pregnancy Outcomes, Maternal and Infant Study (PrOMIS) Cohort, designed to examine maternal social and behavioral risk factors of preterm birth and other adverse pregnancy outcomes among Peruvian women. The study population consists of women attending prenatal care clinics at the Instituto Nacional Materno Perinatal (INMP) in Lima, Peru. The INMP is the primary reference establishment for maternal and perinatal care operated by the Ministry of Health of the Peruvian government. Recruitment began in February 2012. Women eligible for inclusion were those who initiated prenatal care prior to 16 weeks gestation since, on average, less than 10% of women initiate prenatal care after 16 weeks of gestation at INMP. Women were ineligible if they were younger than 18 years of age, did not speak and read Spanish, or had completed more than 16 weeks gestation.The eligibility criteria threshold of initiating prenatal care prior to the completion of 16 weeks gestation was set so as to mitigate concerns about reverse causality and recall bias while enrolling a study population that is sufficiently generalizable to the source population of women seeking care at the study site. Before setting this threshold, we determined that over 90% of women delivering at INMP initiate prenatal care prior to 16 weeks gestation.
Enrolled participants were invited to take part in an interview where trained research personnel used a structured questionnaire to elicit information regarding maternal socio-demographic, lifestyle characteristics, medical and reproductive histories, and early life experiences of abuse and with symptoms of mood and anxiety disorders. All participants provided written informed consent. The institutional review boards of the INMP, Lima, Peru and the Harvard School of Public Health Office of Human Research Administration, Boston, MA approved all procedures used in this study.
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