NCT04866277: STOP-LBW

Experimental Study to Reduce Low Birthweight

Status unknown NA Last updated 4 May 2021

What this trial tests

NA trial testing Fast-track referral for reference services in Infant, Low Birth Weight in 2,832 participants. Status unknown.

Timeline

2 May 2021

Primary endpoint
30 December 2021

31 January 2022

Quick facts

Lead sponsor	Instituto de Saude Publica da Universidade do Porto
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	health services research
Enrollment	2,832
Start date	2 May 2021
Primary completion	30 December 2021
Estimated completion	31 January 2022

Drugs / interventions tested

• Fast-track referral for reference services

Conditions studied

• Infant, Low Birth Weight — all drugs for Infant, Low Birth Weight →

Sponsor

Instituto de Saude Publica da Universidade do Porto

Who can join

Adults 14 to 49, female only, with Infant, Low Birth Weight. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Psychosocial and medication interventions to stop or reduce alcohol consumption during pregnancy.
   Minozzi S, Ambrosi L, Saulle R, Uhm SS, et al · · 2024 · cited 6× · PMID 38682758 · DOI 10.1002/14651858.cd015042.pub2
2. 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).
   Barros H, Baia I, Monjardino T, Pimenta P, et al · · 2022 · cited 3× · PMID 35292492 · DOI 10.1136/bmjopen-2021-052964