ISRCTN12272130暂停未知
Comprehensive Anaemia Programme and Personalized Therapies (CAPPT): a non-blinded cluster-randomised controlled trial testing the effect upon haemoglobin in pregnancy of participatory learning and action women’s groups with home-counselling and tailored iron supplementation compared with standard care in southern Nepal.
Health Research and Social Development forum (HERD)0 个研究点目标入组 842 人开始时间: 2021年4月22日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 暂停
- 发起方
- 入组人数
- 842
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •Cluster inclusion criteria:
- •1. Cluster does not adjoin the main East-West which crosses the country Prithivi highway
- •2. Located in the southern part of Kapilbastu district (closer to the Indian border) where there is low population heterogeneity and low forest coverage
- •3. Rural area with no major market
- •4. Populated by predominantly Madhesi (plains ethnicity) population since the burden of anaemia is higher in this group
- •5. Projected population was =1100 and <3200 (although actual populations were found to be higher when the pre-trial census was conducted)
- •6. Surrounded by a buffer zone of non-study clusters
- •Menstrual monitoring:
- •1. Married woman
- •2. Aged between 13 to 49 years
- •3. Able to respond to questions
- •4. Resident of study cluster (whether husband’s or parental home)
- •5. Husband and women have not had permanent family planning (tubal ligation or vasectomy)
- •6. Intact uterus (not had hysterectomy)
- •7. Non-menopausal
- •8. Has not been told by a doctor that they are infertile
- •9. Consenting to being asked about menstrual status (to detect pregnancy) once every 4 weeks for up to 7 months
- •For trial enrolment and follow up
- •1. Same inclusion criteria as for menstrual monitoring (above)
- •2. Tested positive for pregnancy
- •3. Less than 20 weeks’ gestation estimated from recall of last menstrual period or uterus not clearly visible above the level of the umbilicus if LMP is not recalled/not available
- •4. Plans to live in the cluster most of pregnancy or is able to return for counselling and/or data collection
- •5. Consents to participate in interventions (in intervention arm) and data collection
排除标准
- •1. Woman is unable to become pregnant (is infertile, has had a hysterectomy, post-menopausal, tubal ligation or husband has had a vasectomy) or does not have a positive pregnancy test
- •2. Aged <=12 years or >=50 years
- •3. Not-consenting
- •4. Unable to respond to questions
- •5. =20 weeks’ gestation as estimated from LMP (or uterus clearly visible above the level of the umbilicus if LMP is not recalled/not available)
- •6. Not planning to reside in the study cluster for most of her pregnancy
研究者
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