Pregnancy outcomes and it’s determinants at a tribal hospital in south India– A prospective cohort study (PREDICT)

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Description:

a) Background: Tribal population’s inhabitations are scattered throughout the country making it difficult to reach out to them .  With more than a 100 million tribes inhabiting in our country, they have remained marginal with poor health and large unmet needs. Tribal health is definitively different from the non-tribal communities due to various social, environmental and physical factors which are interlinked, which they play a major role during pregnancy and childhood. There is lack of data on some of the maternal and neonatal health indicators of the tribal population what data is available indicates that  they are often poor compared to the non-tribal communities.(2)

Hence there is a need for a strong foundational data to understand how various factors are interlinked and how these factors will affect pregnancy and birth outcomes. This data is crucial, and it will help us formulate better policies and achieve high standards of health for all.

 

b) Aim/objective: Among pregnant women registered at THI-Sittilingi Hospital.

  1. To record the characteristics of pregnant women, their health seeking behaviour and treatment patterns in pregnancy, and up to the neonatal period.
  2. To document all pregnancy outcomes and evaluate their determinants.

c) Methods:

Study setting: Hospital and population-based cohort study - Tribal hospital, Sittilingi, Tamilnadu, South India

Study population: Pregnant women with confirmed pregnancy test / clinically at any gestation age will be enrolled in our study. Consenting women who fulfil any one of the criteria:

1. All women with a confirmed pregnancy test (urine pregnancy test (UPT)/Beta HCG or ultrasound) or clinically confirmed at any gestation age and registered with the THI-Sittilingi hospital.

2. All pregnant women who deliver at THI-Sittilingi hospital in the defined time period but booked outside

3. Any pregnant women identified in the community (define area) by the community health workers irrespective of their plans for delivering at THI-Sittilingi hospital.

Exclusion criteria: Pregnant women who have visited the hospital for pregnancy related or other medical issues and will not continue follow-up at THI.

Study outcomes: The primary outcome measures include proportion of live births, abortions and still births and maternal, neonatal and infant mortality rate. Secondary outcome measures will include sex ratio, proportion of maternal and neonatal complications during pregnancy and delivery, social determinants of pregnancy and its outcomes etc.

Data collection tools: Data will be collected using structured case record forms in electronic and paper formats which will include details of factors that affect pregnancy and its outcomes such as socio-demography, medical history including current and past pregnancies, family history, nutrition and baseline investigations. In addition, social determinants that affect pregnancy and its outcomes will also be captured. 

Method of data collection: Data will be collected by trained personnel who will be a part of the local community to strengthen stakeholder and community engagement. The person will have basic qualification and will be trained in collecting data and conducting telephonic follow-ups.

 All pregnant women visiting THI-Sittilingi hospital will be referred to the study personnel who will collect data. Participants fulfilling the eligibility criteria will be enrolled into the study after obtaining written informed consent. Complete data will be collected using the structured case record forms in electronic database. Participants will be followed up till 28 days after delivery which will cover the neonatal period.

e) Sample size: Universal sampling – Hence no formal sample size estimation. We will collect data on 2400 pregnant women in the span of two years (2022-2024)

f) Study update: Currently we have recruited 1100 antenatal women and 740 deliveries have been completed.

g) Updated as on:  01st January 2024

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