Comprehensive Anaemia Programme and Personalized Therapies (CAPPT): protocol for a cluster-randomised controlled trial testing the effect women's groups, home counselling and iron supplementation on haemoglobin in pregnancy in southern Nepal.
Comprehensive Anaemia Programme and Personalized Therapies (CAPPT): protocol for a cluster-randomised controlled trial testing the effect women's groups, home counselling and iron supplementation on haemoglobin in pregnancy in southern Nepal.
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DOI：
10.1186/s13063-022-06043-z
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发表时间：
2022-03-01
期刊：
影响因子：
2.5
通讯作者：
Hillman S
中科院分区：
文献类型：
--
作者：
Saville NM;Kharel C;Morrison J;Harris-Fry H;James P;Copas A;Giri S;Arjyal A;Beard BJ;Haghparast-Bidgoli H;Skordis J;Richter A;Baral S;Hillman S
在尼泊尔，妊娠贫血症仍然很普遍，并造成严重的不良健康后果。这项在尼泊尔平原进行的非盲随机分组对照试验有两个研究组：（1）对照组：常规产前护理（ANC）;（2）家访、补铁、辅助性学习和行动（PLA）组，加上常规ANC。（平均2 582人;范围1 299 - 4 865人），如果她们同意月经监测，是居民，已婚，年龄13-49岁，能够回答问题，则有资格参加。在错过1-2次月经和妊娠试验阳性后，同意妊娠< 20周的妇女，计划在妊娠的大部分时间内居住在当地，登记参加试验随访。干预措施包括两次家庭咨询访问（在妊娠12-21周和22-26周），根据妇女的血红蛋白浓度提供铁叶酸补充剂，以及每月举行解放军妇女小组会议，采用对话解决问题的办法，让孕妇及其家人参与。辅助护士助产士将协助进行家访和PLA会议。假设如下：干预组妊娠30 ± 2周的女性血红蛋白比对照组高≥ 0.4 g/dL。假设SD 1.2、ICC 0.09和聚类大小CV 0.27，842名女性样本（每组421名，平均每个聚类15.6名）将提供88%的把握度。在妊娠30 ± 2周时采集结局。主要结局是血红蛋白浓度（g/dL）。次要结果如下：贫血患病率（%）、中上臂围（cm）、微量营养素充足率（MPA）的平均概率和到卫生机构进行产前护理的次数。评估影响途径的指标包括怀孕期间消费的IFA片剂数量、能量摄入量（千卡/天）和膳食铁（毫克/天）、提高生物利用度行为评分和一项营养知识指标的回忆。将从供应商的角度估计干预措施的成本和成本效益。使用约束随机化，我们将群集分配到研究组，确保群集大小，种族，宗教和与医疗机构的距离的相似性。采用混合效应回归，在个体水平上进行意向治疗分析。调查结果将为尼泊尔政府制定政策提供信息，以提高对IFA的遵守，改善饮食和减少怀孕期间的贫血。ISRCTN 12272130。在线版本包含补充材料，可通过10.1186/s13063-022-06043-z获得。
Anaemia in pregnancy remains prevalent in Nepal and causes severe adverse health outcomes. This non-blinded cluster-randomised controlled trial in the plains of Nepal has two study arms: (1) Control: routine antenatal care (ANC); (2) Home visiting, iron supplementation, Participatory Learning and Action (PLA) groups, plus routine ANC. Participants, including women in 54 non-contiguous clusters (mean 2582; range 1299–4865 population) in Southern Kapilbastu district, are eligible if they consent to menstrual monitoring, are resident, married, aged 13–49 years and able to respond to questions. After 1–2 missed menses and a positive pregnancy test, consenting women < 20 weeks’ gestation, who plan to reside locally for most of the pregnancy, enrol into trial follow-up. Interventions comprise two home-counselling visits (at 12–21 and 22–26 weeks’ gestation) with iron folic acid (IFA) supplement dosage tailored to women’s haemoglobin concentration, plus monthly PLA women’s group meetings using a dialogical problem-solving approach to engage pregnant women and their families. Home visits and PLA meetings will be facilitated by auxiliary nurse midwives. The hypothesis is as follows: Haemoglobin of women at 30 ± 2 weeks’ gestation is ≥ 0.4 g/dL higher in the intervention arm than in the control. A sample of 842 women (421 per arm, average 15.6 per cluster) will provide 88% power, assuming SD 1.2, ICC 0.09 and CV of cluster size 0.27. Outcomes are captured at 30 ± 2 weeks gestation. Primary outcome is haemoglobin concentration (g/dL). Secondary outcomes are as follows: anaemia prevalence (%), mid-upper arm circumference (cm), mean probability of micronutrient adequacy (MPA) and number of ANC visits at a health facility. Indicators to assess pathways to impact include number of IFA tablets consumed during pregnancy, intake of energy (kcal/day) and dietary iron (mg/day), a score of bioavailability-enhancing behaviours and recall of one nutrition knowledge indicator. Costs and cost-effectiveness of the intervention will be estimated from a provider perspective. Using constrained randomisation, we allocated clusters to study arms, ensuring similarity with respect to cluster size, ethnicity, religion and distance to a health facility. Analysis is by intention-to-treat at the individual level, using mixed-effects regression. Findings will inform Nepal government policy on approaches to increase adherence to IFA, improve diets and reduce anaemia in pregnancy. ISRCTN 12272130. The online version contains supplementary material available at 10.1186/s13063-022-06043-z.
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影响因子：
5.9
作者：
Chandyo RK;Ulak M;Sommerfelt H;Schneede J;Ueland PM;Strand TA
通讯作者：
Strand TA
影响因子：
4.7
作者：
Chandyo, R. K.;Strand, T. A.;Sommerfelt, H.
通讯作者：
Sommerfelt, H.
DOI：
10.1182/asheducation-2015.1.8
发表时间：
2015-12-01
影响因子：
3
作者：
Camaschella, Clara
通讯作者：
Camaschella, Clara
DOI：
10.1034/j.1600-0412.2000.079005341.x
发表时间：
2000-05-01
影响因子：
4.3
作者：
Bondevik, GT;Ulstein, M;Kvåle, G
通讯作者：
Kvåle, G
DOI：
10.1136/bmj.e7586
发表时间：
2013-01-08
期刊：
BMJ (Clinical research ed.)
影响因子：
--
作者：
Chan AW;Tetzlaff JM;Gøtzsche PC;Altman DG;Mann H;Berlin JA;Dickersin K;Hróbjartsson A;Schulz KF;Parulekar WR;Krleza-Jeric K;Laupacis A;Moher D
通讯作者：
Moher D