Anaemia in Pregnancy Clinical Trial
Official title:
Development and Effectiveness of 'MyPinkMom' Educational Intervention With Anaemia in Petaling District
This study will use cluster randomised controlled trial design. It will be conducted at four antenatal clinics in Petaling district, Selangor, Malaysia. Two antenatal clinics will be randomised as intervention group. Other two antenatal clinics will be the control group. The investigators will recruit 60 participants from intervention and 60 participants from control group to evaluate effectiveness of 'MyPinkMom' educational intervention. Participants from intervention group will receive usual antenatal care and 'MyPinkMom' educational intervention through WhatsApp application, while those from control group receive usual antenatal care only. The outcome measurements are mean haemoglobin level, knowledge score, Theory of Planned Behaviour (TPB) construct and dietary iron intake between intervention and control group.
Status | Not yet recruiting |
Enrollment | 120 |
Est. completion date | August 31, 2020 |
Est. primary completion date | June 30, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 20 Years to 40 Years |
Eligibility |
Inclusion Criteria: 1. Age 20-40 years old 2. Women with pregnancy at 13-28 weeks gestation 3. Women diagnosed with anaemia with haemoglobin 7.0-10.9g/dl 4. Able to read and write in Malay and/or English 5. Participants have a smartphone installed with WhatsApp application Exclusion Criteria: 1. Symptomatic anaemia (breathlessness, chest pain, syncope, signs of heart failure) 2. Anaemia due to thalassemia or other haematological disease 3. Anaemia due to other diseases such as renal failure or cancer 4. Planned for termination of pregnancy |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Universiti Kebangsaan Malaysia Medical Centre |
Type | Measure | Description | Time frame | Safety issue |
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Primary | haemoglobin level changes | Haemoglobin level will be measure at baseline, at week 4 (2 weeks post intervention) and at week 8 (6 weeks post intervention). Change from baseline haemoglobin level at week 8 (6 weeks post intervention) between intervention and control groups will be evaluated. Haemoglobin level will be traced from full blood count result from respondents' antenatal cards or laboratory. Blood for full blood count is taken by trained staff respective clinics for every monthly antenatal visit. | From baseline to week 8 (6 weeks post intervention) | |
Secondary | knowledge score changes | Knowledge level on anaemia in pregnancy will be evaluated at baseline, at week 4 (2 weeks post intervention) and at week 8 (6 weeks post intervention), using validated questionnaire of knowledge on anaemia in pregnancy. It contains 16 items. The items are statement related to anaemia in pregnancy. Responses for each item are 'True','False','Not sure'. 1 mark will be only given to correct answer. Incorrect answer and 'Not sure' answer will not be given marks. Total marks will be converted to percentage. Marks of 60-100 will be considered as good knowledge and marks of less than 60 will considered as poor knowledge. Change from baseline knowledge on anaemia in pregnancy at week 8 (6 weeks post intervention) between study groups will be evaluated. | From baseline to week 8 (6 weeks post intervention) | |
Secondary | Amount of dietary iron changes | Dietary iron intake will be measured at baseline, at week 4 (2 weeks post intervention) and at week 8 (6 weeks post intervention). This will be assessed using validated Pregnancy Food Frequency Questionnaire (FFQ). Amount of iron from diet will be presented in grams. Change from baseline amount of iron intake from diet at week 8 (6 weeks post intervention) between study groups will be determined. | From baseline to week 8 (6 weeks post intervention) | |
Secondary | Theory of Planned Behavior construct score changes | Theory of Planned Behavior construct score will be measured at baseline, at week 4 (2 weeks post intervention) and at week 8 (6 weeks post intervention). The score will be evaluated using validated Theory of Planned Behavior construct questionnaire. It contains 4 domains (intention, attitudes towards adherence to daily iron tablet, subjective norms and perceived behavior). It contains 17 items. Response for each item will be seven-point bipolar scale (1 to 7). '1' is 'strongly disagree' and '7' is 'strongly agree'. Change of Theory of Planned Behavior construct score on adherence to daily iron tablet intake from baseline to week 8 (6 weeks post intervention) between study groups will be evaluated. | From baseline to week 8 (6 weeks post intervention) |