Preeclampsia
Conditions
Keywords
Adherence, Calcium supplementation, Prevention of preeclampsia, Adherence to calcium supplementation
Brief summary
The World Health Organization (WHO) now recommends prenatal calcium supplementation for prevention of preeclampsia in populations with inadequate dietary intake. This study seeks to compare the effect of two dosing strategies on the amount of supplement ingested by pregnant women and adherence to related recommendations.
Detailed description
This study is a non-inferiority trial that compares the effect of a dosing strategy involving lower overall dose and fewer administrations per day to the current WHO recommendation. The comparator arm, Regimen B, prescribes 3 doses per day (consistent with current WHO standard) and was found to be burdensome in qualitative studies. The experimental arm, Regimen A, prescribes 2 doses per day and has been associated with greater satisfaction. On face value Regimen A should result in 33% less amount of supplement ingested than Regimen B. However, we hypothesize that the difference in amount ingested, when rolled out in routine practice will be MUCH LESS than that BECAUSE THE LOWER DOSE REGIMEN RESULTS IN HIGHER LEVELS OF ADHERENCE. We hypothesize that THE DIFFERENCE IN AMOUNT CONSUMED WILL BE NEGLIGIBLE OR will not exceed 15%. Hence, we hypothesize that Regimen A is not inferior to Regimen B in terms of total amount of supplement ingested (within a 15% margin of inferiority).
Interventions
DIETARY_SUPPLEMENTRegimen A calcium and iron/folic acid
Comparison of recommended administration schedule for calcium and iron/folic acid supplements in pregnant women
DIETARY_SUPPLEMENTRegimen B calcium and iron/folic acid
Comparison of recommended administration schedule for calcium and iron/folic acid supplements in pregnant women
Sponsors
Kenya Ministry of Health
University of Nairobi
Micronutrient Initiative
Cornell University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
15 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Attendance at ANC clinic in a primary care facility in Kakamega north
Exclusion criteria
* Gestational age \< 16 weeks, * Gestational age \> 30 weeks, * Dietary or medicinal consumption of adequate calcium (according to the screening survey), * Intention to leave study community before 8weeks from date of interview
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Amount of calcium supplement ingested | 8 weeks after ANC consultation, during which recruitment into the study occurred | This is the actual number of supplements ingested expressed as a percentage of the number of supplements expected to be ingested since the ANC consultation if 100% adherent to the current WHO recommendation. \[Total number of calcium supplements consumed/(Number of days since last ANC consultation X 3)\] X 100 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to related recommendations | 8 weeks after ANC consultation, during which recruitment into the study occurred | Adherence to other features of the WHO recommendation (taking supplements with food). |
| Motivation | 8 weeks after ANC consultation, during which recruitment into the study occurred | Motivation scores extracted from the survey instrument administered at follow up. |
| Self-efficacy | 8 weeks after ANC consultation, during which recruitment into the study occurred | Self-efficacy scores extracted from the survey instrument administered at follow up. |
| Satisfaction | 8 weeks after ANC consultation, during which recruitment into the study occurred | Satisfaction scores extracted from the survey instrument administered at follow up. |
Countries
Kenya
Outcome results
None listed