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Experimental Study to Reduce Low Birthweight

NCT04866277 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2832

Last updated 2021-05-04

No results posted yet for this study

Summary

Introduction: Low birthweight (LBW) is associated with a wide range of short- and long-term consequences and is related to a complex set of maternal psychosocial and behavioural determinants. The objective of this study is to assess the effect of implementing fast-track referral for early intervention on psychosocial and behavioural risk factors - smoking, alcohol consumption, depression and interpersonal violence - on reducing the incidence of LBW.

Methods and analysis: Parallel superiority pragmatic clinical trial randomized by clusters. Primary health care units (PHCU) located in Portugal will be randomized (1:1) to intervention or control groups. Pregnant women over 14 years of age attending these PHCU will be eligible to the study. Risk factors will be assessed through face-to-face interviews. In the intervention group, women who report at least one risk factor will have immediate access to referral services. The comparison group will be the local standard of care for these risk factors. The investigators will use intention-to-treat analyses to compare intervention and control groups. A sample size of 2,832 pregnant women was estimated to detect a 30% reduction in the incidence rate of LBW (primary outcome) between the control and intervention groups. Secondary outcomes are the reduction of preterm births and reduction of risk factors targeted by the intervention.

Conditions

  • Infant, Low Birth Weight

Interventions

OTHER

Fast-track referral for reference services

Activation of fast-track referral for specialized units and care programs for the four psychosocial and behavioural risk factors under study.

Sponsors & Collaborators

  • Instituto de Saude Publica da Universidade do Porto

    lead OTHER

Principal Investigators

  • Henrique Barros, Phd · Instituto de Saude Publica da Universidade do Porto

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
49 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-02
Primary Completion
2021-12-30
Completion
2022-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04866277 on ClinicalTrials.gov