Experimental Study to Reduce Low Birthweight

NCT04866277 | Unknown DMC

• 1 other identifier: CE20140
• Study Type: interventional
• Target: 2,832
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Infant, Low Birth Weight; Smoking; Alcohol Drinking; Depression; Physical Abuse; Clinical trial

Outcome Measures

Primary Outcomes (1)

• Low birthweight

  Incidence of live births with birthweight \< 2500g

  At birth

Secondary Outcomes (3)

• Preterm birth

  At birth

• Prevalence of risk factors

  First prenatal visit and one month after birth

• Adherence to care services

  One month after birth

Study Arms (2)

Intervention

EXPERIMENTAL

Women who present at least one of the four risk factors - smoking, risk alcohol consumption, risk of depression, physical violence - will be eligible to receive the intervention. The intervention will be the activation of fast-track referral for specialized units and care programs for the four psychosocial and behavioural risk factors under study. All pregnant women referred by the "STOP LBW project" would have access to consultations or other health activities, such as counselling and group meetings, within a maximum of seven days, in reference services available in each metropolitan area. The activation of the fast-track referral will be the responsibility of the doctor/nurse who applies the questionnaires to identify the risk factors. The intervention ends with childbirth, abortion or if the participant decides to abandon the study.

Other: Fast-track referral for reference services

Standard of care

NO INTERVENTION

Women who present at least one of the risk factors - smoking, risk alcohol consumption, risk of depression, physical violence - will receive the standard of care currently existing in each PHCU. The standard of care varies across the various PHCU and may include several approaches: routine screening with care by the antenatal care provider; routine screening with referral to other health professional in the same health unit; and routine screening with referral to other health services, with the time elapsed for consultation depending on the health resources available in each area. In each PHCU, different standards of care may exist for each of the four risk factors.

Interventions

Fast-track referral for reference services OTHER

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

Intervention

Eligibility Criteria

• Age: 14 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Primary Health Care Units (PHCU) located in the metropolitan regions of Porto and Lisbon, Portugal
• Women:

Sponsors & Collaborators

• Instituto de Saude Publica da Universidade do Porto: lead

Related Publications (1)

• Barros H, Baia I, Monjardino T, Pimenta P, Alfredo A, Sorokina A, Domingues R. Fast-track referral for health interventions during pregnancy: study protocol of a randomised pragmatic experimental study to reduce low birth weight in Portugal (STOP LBW). BMJ Open. 2022 Mar 15;12(3):e052964. doi: 10.1136/bmjopen-2021-052964.

  PMID: 35292492 DERIVED

MeSH Terms

Conditions

Smoking; Alcohol Drinking; Depression

Condition Hierarchy (Ancestors)

Behavior; Drinking Behavior; Behavioral Symptoms

Study Officials

• Henrique Barros, Phd

  Instituto de Saude Publica da Universidade do Porto

  STUDY DIRECTOR

Central Study Contacts

Ines Baia, Phd

CONTACT

+351965418274; ines.baia@ispup.up.pt

Henrique Barros, Phd

CONTACT

+351910624580; hbarros@med.up.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the study, there will be no blinding of pregnant women, health professionals or members of the research team after assignment of the intervention. However, those involved in the outcome assessment and data analysis will be blinded as there will be no identification of the intervention and control group.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel superiority pragmatic clinical trial randomized by clusters (Primary Health Care Units)

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: April 29, 2021
• Study Start: May 2, 2021
• Primary Completion: December 30, 2021
• Study Completion: January 31, 2022
• Last Updated: May 4, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF