Prevention and treatment of anaemia in pregnant women Pregnancy and Childbirth
Conditions
Interventions
Fifty-four clusters (mean population 2582
range 1299 to 4865) meeting cluster eligibility criteria, each surrounded by a buffer zone, have been allocated into two study arms of 27 clusters. Restricted randomization was applied to maximize si
Sponsors
Health Research and Social Development forum (HERD)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 =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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood haemoglobin level is measured using a portable battery-operated electronic Haemoglobin Photometer (HemoCue Hb 301+, Angelhom, Sweden) between 28 and 32 weeks’ gestation. Note that if logistical constraints imposed by the COVID-19 pandemic disrupt follow-up haemoglobin may be measured any time from 28 weeks to delivery | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Prevalence of anaemia in enrolled pregnant women, defined as % with blood haemoglobin <11g/dL measured using a portable battery-operated electronic Haemoglobin Photometer (HemoCue Hb 301+, Angelhom, Sweden) between 28 and 32 weeks’ gestation 2. Pregnant women’s Mid-Upper Arm Circumference (MUAC) in cm, measured SECA head circumference tapes (93/42/EEC) between 28 and 32 weeks’ gestation 3. Count of antenatal care visits (ANC) at a health facility, measured between 28 and 32 weeks’ gestation 4. Mean Probability of micronutrient Adequacy (MPA) of 11 micronutrients in enrolled pregnant women's diets including vitamin A, riboflavin (B2), niacin (B3), pyridoxine (B6), cobalamin (B12), thiamin (B1), folate (B9), vitamin C iron, zinc and calcium, measured between 28 and 32 weeks’ gestation from duplicate quantitative 24-hour dietary recalls taken 2 to 7 days apart | — |
Countries
Nepal, Netherlands
Contacts
Public ContactSushil;Sanju Baral;Bhattarai
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Outcome results
None listed