Fast-track Referral for Health Interventions During Pregnancy: a Randomized Pragmatic Experimental Study to Reduce Low Birthweight in Portugal
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 2,832
- 主要终点
- Low birthweight
研究概览
简要总结
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.
详细描述
The investigators will conduct a parallel superiority pragmatic clinical trial randomized by clusters.
The study will be conducted in Primary Health Care Units (PHCU) located in the metropolitan regions of Porto and Lisbon, in Portugal. All 236 PHCU, nested in 13 Primary Care Centres (PCC), will be considered eligible to inclusion (109 PHCU in 7 PCC in Porto; 127 PHCU in 6 PCC in Lisbon).
The investigators will use the PHCU as units of randomization and pregnant/newborn dyads as the unit of analysis. In each of the 13 Primary Care Centres, all PHCU that adhere to the study will be randomized in a 1: 1 ratio for the intervention or control group and will belong to that group until the end of the study. A research team statistician will generate the randomization sequence through Excel Office 365 and implement the random allocation sequence using sequentially numbered, opaque, sealed envelopes.
At each PHCU, all pregnant women, of any gestational age, over the age of 14, who are attending their first prenatal care visit during the study period, that currently reside in Portugal and plan to have a birth in Portugal will be considered eligible and invited to participate in the study.
Health professionals providing prenatal care will be responsible for recruiting pregnant women at their first prenatal visit at the PHCU. Participation in the study is voluntary and non-participation in the study does not affect the routine healthcare provided. The recruitment of participants will last until the planned sample is reached (estimated period of one year).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 14 Years 至 49 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Health units:
- •Inclusion Criteria:
- •Primary Health Care Units (PHCU) located in the metropolitan regions of Porto and Lisbon, Portugal
- •Inclusion criteria: All pregnant women, of any gestational age, over the age of 14, who are attending their first prenatal care visit during the study period, that currently reside in Portugal and plan to have a birth in Portugal.
排除标准
- •Pregnant women unable to answer the questionnaire in Portuguese (language barrier, deafness concomitant with blindness, etc.) and/or unable to provide informed consent at the time of recruitment.
研究组 & 干预措施
Intervention
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.
干预措施: Fast-track referral for reference services (Other)
Standard of care
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.
结局指标
主要结局
Low birthweight
时间窗: At birth
Incidence of live births with birthweight \< 2500g
次要结局
- Preterm birth(At birth)
- Prevalence of risk factors(First prenatal visit and one month after birth)
- Adherence to care services(One month after birth)