1. Study protocol of a 4- parallel arm, superiority, community based cluster randomized controlled trial comparing paper and e-platform based interventions to improve accuracy of recall of last menstrual period (LMP) dates in rural Bangladesh
- Author
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Tazeen Tahsina, Samir K. Saha, Dewan Md Emdadul Hoque, Shams El Arifeen, Md. Irteja Islam, Afrin Iqbal, Nazia Binte Ali, Shumona Sharmin Salam, and Ahmed Ehsanur Rahman
- Subjects
Adult ,Counseling ,Paper ,Rural Population ,medicine.medical_specialty ,Adolescent ,Psychological intervention ,Abortion ,law.invention ,Young Adult ,Study Protocol ,03 medical and health sciences ,0302 clinical medicine ,Randomized controlled trial ,law ,medicine ,Cluster Analysis ,Humans ,Community Health Services ,030212 general & internal medicine ,Menstrual Cycle ,Text Messaging ,Bangladesh ,LMP ,030219 obstetrics & reproductive medicine ,Recall ,business.industry ,Data Collection ,lcsh:Public aspects of medicine ,Public Health, Environmental and Occupational Health ,Reproducibility of Results ,Gestational age ,Calendars as Topic ,Preterm birth ,lcsh:RA1-1270 ,Guideline ,Mobile Applications ,Research Design ,Family medicine ,Mental Recall ,Female ,Smartphone ,Biostatistics ,Rural area ,M-health ,business ,Mobile phone - Abstract
Background Gestational age (GA) is a key determinant of newborn survival and long-term impairment. Accurate estimation of GA facilitates timely provision of essential interventions to improve maternal and newborn outcomes. Menstrual based dating, ultrasound based dating, and neonatal estimates are the primarily used methods for assessing GA; all of which have some strength and weaknesses that require critical consideration. Last menstrual period (LMP) is simple, low-cost self-reported information, recommended by the World Health Organization for estimating GA but has issues of recall mainly among poorer, less educated women and women with irregular menstruation, undiagnosed abortion, and spotting during early pregnancy. Several studies have noted that about 20–50% of women cannot accurately recall the date of LMP. The goal of this study is therefore to improve recall and reporting of LMP and by doing so increase the accuracy of LMP based GA assessment in a rural population of Bangladesh where antenatal care-seeking, availability and utilization of USG is low. Method We propose to conduct a 4- parallel arm, superiority, community based cluster randomized controlled trial comparing three interventions to improve recall of GA with a no intervention arm. The interventions include (i) counselling and a paper based calendar (ii) counselling and a cell phone based SMS alert system (iii) counselling and smart-phone application. The trial is being conducted among 3360 adolescent girls and recently married women in Mirzapur sub-district of Bangladesh. Discussion Enrolment of study participants continued from January 24, 2017 to March 29, 2017. Data collection and intervention implementation is ongoing and will end by February, 2019. Data analysis will measure efficacy of interventions in improving the recall of LMP date among enrolled participants. Results will be reported following CONSORT guideline. The innovative conventional & e-platform based interventions, if successful, can provide substantial evidence to scale-up in a low resource setting where m-Health initiatives are proliferating with active support from all sectors in policy and implementation. Trial registration ClinicalTrials.gov NCT02944747. The trial has been registered before starting enrolment on 24 October 2016. Electronic supplementary material The online version of this article (10.1186/s12889-018-6258-z) contains supplementary material, which is available to authorized users.
- Published
- 2018