一项预防加纳孕妇早产和低出生体重的无提升干预措施：阶梯式楔形整群随机对照试验方案

A Liftless Intervention to Prevent Preterm Birth and Low Birthweight Among Pregnant Ghanaian Women: Protocol of a Stepped-Wedge Cluster Randomized Controlled Trial.

作者信息

Kwegyir-Afful Emma, Verbeek Jos, Aziato Lydia, Seffah Joseph D, Räsänen Kimmo

机构信息

Institute of Public Health and Clinical Nutrition, School of Medicine, University of Eastern Finland, Kuopio, Finland.

Finnish Institute of Occupational Health, Kuopio, Finland.

出版信息

JMIR Res Protoc. 2018 Aug 23;7(8):e10095. doi: 10.2196/10095.

DOI:10.2196/10095

PMID:30139723

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6127499/

Abstract

BACKGROUND

Preterm birth (PTB) is a leading cause of infant morbidity and mortality worldwide. Every year, 20 million babies are born with low birthweight (LBW), about 96% of which occur in low-income countries. Despite the associated dangers, in about 40%-50% of PTB and LBW cases, the causes remain unexplained. Existing evidence is inconclusive as to whether occupational physical activities such as heavy lifting are implicated. African women bear the transport burden of accessing basic needs for their families. Ghana's PTB rate is 14.5%, whereas the global average is 9.6%. The proposed liftless intervention aims to decrease lifting exposure during pregnancy among Ghanaian women. We hypothesize that a reduction in heavy lifting among pregnant women in Ghana will increase gestational age and birthweight.

OBJECTIVE

To investigate the effects of the liftless intervention on the incidence of PTB and LBW among pregnant Ghanaian women.

METHODS

A cohort stepped-wedge cluster randomized controlled trial in 10 antenatal clinics will be carried out in Ghana. A total of 1000 pregnant participants will be recruited for a 60-week period. To be eligible, the participant should have a singleton pregnancy between 12 and 16 weeks gestation, be attending any of the 10 antenatal clinics, and be exposed to heavy lifting. All participants will receive standard antenatal care within the control phase; by random allocation, two clusters will transit into the intervention phase. The midwife-led 3-component liftless intervention consists of health education, a take-home reminder card mimicking the colors of a traffic light, and a shopping voucher. The primary outcome are gestational ages of <28, 28-32, and 33-37 weeks. The secondary outcomes are LBW (preterm LBW, term but LBW, and postterm), compliance, prevalence of low back and pelvic pain, and premature uterine contractions. Study midwives and participants will not be blinded to the treatment allocation.

RESULTS

Permission to conduct the study at all 10 antenatal clinics has been granted by the Ghana Health Service. Application for funding to begin the trial is ongoing. Findings from the main trial are expected to be published by the end of 2019.

CONCLUSIONS

To the best of our knowledge, there has been no randomized trial of this nature in Ghana. Minimizing heavy lifting among pregnant African women can reduce the soaring rates of PTB and LBW. The findings will increase the knowledge of the prevention of PTB and LBW worldwide.

TRIAL REGISTRATION

Pan African Clinical Trial Register (PACTR201602001301205); http://apps.who.int/trialsearch/ Trial2.aspx?TrialID=PACTR201602001301205 (Archived by WebCite at http://www.webcitation.org/71TCYkHzu).

REGISTERED REPORT IDENTIFIER

RR1-10.2196/10095.

摘要

背景

早产是全球婴儿发病和死亡的主要原因。每年有2000万婴儿出生时体重过低，其中约96%发生在低收入国家。尽管存在相关风险，但在约40%-50%的早产和低体重出生病例中，病因仍不明。关于诸如重物搬运等职业体力活动是否与此有关，现有证据尚无定论。非洲女性承担着为家人获取基本生活所需的运输负担。加纳的早产率为14.5%，而全球平均水平为9.6%。拟议的无搬运干预措施旨在减少加纳女性孕期的搬运接触。我们假设，加纳孕妇减少重物搬运将增加孕周和出生体重。

目的

调查无搬运干预措施对加纳孕妇早产和低体重出生发生率的影响。

方法

将在加纳的10家产前诊所开展一项队列逐步楔形整群随机对照试验。共招募1000名怀孕参与者，为期60周。符合条件的参与者应怀有单胎，孕周在12至16周之间，在10家产前诊所中的任何一家就诊，且有重物搬运经历。所有参与者在对照阶段将接受标准产前护理；通过随机分配，两个整群将过渡到干预阶段。由助产士主导的三部分无搬运干预措施包括健康教育、一张模仿交通信号灯颜色的带回家提醒卡以及一张购物券。主要结局是孕周小于28周、28 - 32周和33 - 37周。次要结局是低体重出生（早产低体重、足月但低体重以及过期产低体重）、依从性、下背部和骨盆疼痛患病率以及子宫过早收缩。研究助产士和参与者不会对治疗分配情况设盲。