Adherence in a pragmatic randomized controlled trial on prophylactic iron supplementation during pregnancy in Maputo, Mozambique

Abstract

Objective: Assessing the level of adherence and its determinants is important in appraising the overall effectiveness of trials. The present study aimed to evaluate the extent of adherence and its determinants in a pragmatic randomized controlled trial of Fe prophylaxis during pregnancy in Maputo, Mozambique. Design: A pragmatic randomized controlled trial. Setting: Two health centres (1 o de Maio and Machava) in Maputo, Mozambique. Subjects: Pregnant women (≥12 weeks' gestation, ≥18 years old, non-high-risk pregnancy; n 4326) attending prenatal care consultations at two health centres were randomized to receive routine Fe (n 2184; 60 mg ferrous sulfate plus 400 μg folic acid daily throughout pregnancy) or selective Fe (n 2142; screening and treatment for anaemia and daily intake of 1 mg folic acid). Results: The level of adherence was 79 % for having two or more visits, 53 % for adequate prenatal care and 67 % for complete intake of Fe/folic acid tablets during the trial. The correlation between the adherence measures ranged between 0·151 and 0·739. Adherence did not differ by trial arm, but there were centre differences in adequate prenatal visits and intake of tablets. Older women (>20 years) and those with a history of abortion were more likely to achieve greater adherence, whereas an increased number of previous births decreased the likelihood of adherence. HIV positivity decreased the likelihood of adherence in one trial centre and increased it in the other. Conclusions: The variation in adherence by trial centre, women's characteristics and outcome measures suggests that adherence in trials fully depends on participants' behaviour and can be increased by paying attention to contextual factors.

Is selective prenatal iron prophylaxis better than routine prophylaxis: final results of a trial (PROFEG) in Maputo, Mozambique

“…Women were asked some additional questions related to compliance. 20 Overall adherence to the trial (number of prenatal visits and intake of iron and folic acid tablets) was above the 50th centile. 20 …”

“…Both with regard to the compliance of nurses to the trial protocol and women's reported uptake of iron and folic acid tablets, we achieved adequate adherence. 17 18 20 …”

“…Study nurses abstracted pregnancy data from women's maternity cards and asked some additional questions related to compliance and symptoms. 17 18 20 Birth data were abstracted by study nurses from maternity cards originally filled by delivery nurses. Delivery nurses were informed of the study and asked to put the birth records of the study women into separate study boxes.…”

Practical Management of HIV-Associated Anemia in Resource-Limited Settings: Prospective Observational Evaluation of a New Mozambican Guideline

“…In pregnant Pakistani women with severe anemia thought to be caused primarily by iron deficiency, better than 85% adherence was required to achieve a 65% response to therapy, 47 but adherence to iron supplementation in pregnant Mozambican women has been reported as 67%. 48 Lack of adherence could be caused by both patient factors and increasingly frequent pharmacy stockouts in the study environment.…”

Antenatal care and mothers’ education improved iron-folic acid adherence at Denbiya district health centers, Northwest Ethiopia: using pills count method

“…Forget fullness, vomiting, nausea, heartburn, and diarrheas were the main reasons of drug interruption [8–10]. In Mozambique, the iron sulfate adherence was 79% for having two or more visits, 53% for those having adequate prenatal care, and 67% for those who complete their intake of IFA tablets [11]. In Tigray, Ethiopia the rate of adherence to IFA supplementation was 37.2% [12] and Addis Ababa 60% [13].…”