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
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 estima...
| Main Authors: | , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2018-12-01
|
| Series: | BMC Public Health |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1186/s12889-018-6258-z |
| _version_ | 1819230233820135424 |
|---|---|
| author | Shumona Sharmin Salam Nazia Binte Ali Ahmed Ehsanur Rahman Tazeen Tahsina Md. Irteja Islam Afrin Iqbal Dewan Md. Emdadul Hoque Samir Kumar Saha Shams El Arifeen |
| author_facet | Shumona Sharmin Salam Nazia Binte Ali Ahmed Ehsanur Rahman Tazeen Tahsina Md. Irteja Islam Afrin Iqbal Dewan Md. Emdadul Hoque Samir Kumar Saha Shams El Arifeen |
| author_sort | Shumona Sharmin Salam |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-23T11:25:49Z |
| format | Article |
| id | doaj.art-893cf085223442ca954cf09306f13202 |
| institution | Directory Open Access Journal |
| issn | 1471-2458 |
| language | English |
| last_indexed | 2024-12-23T11:25:49Z |
| publishDate | 2018-12-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Public Health |
| spelling | doaj.art-893cf085223442ca954cf09306f132022022-12-21T17:48:56ZengBMCBMC Public Health1471-24582018-12-011811810.1186/s12889-018-6258-zStudy 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 BangladeshShumona Sharmin Salam0Nazia Binte Ali1Ahmed Ehsanur Rahman2Tazeen Tahsina3Md. Irteja Islam4Afrin Iqbal5Dewan Md. Emdadul Hoque6Samir Kumar Saha7Shams El Arifeen8Maternal and Child Health Division, icddr,bMaternal and Child Health Division, icddr,bMaternal and Child Health Division, icddr,bMaternal and Child Health Division, icddr,bMaternal and Child Health Division, icddr,bMaternal and Child Health Division, icddr,bMaternal and Child Health Division, icddr,bDepartment of Microbiology, Dhaka Shishu (Children’s) HospitalMaternal and Child Health Division, icddr,bAbstract 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.http://link.springer.com/article/10.1186/s12889-018-6258-zGestational ageLMPRecallPreterm birthBangladeshMobile phone |
| spellingShingle | Shumona Sharmin Salam Nazia Binte Ali Ahmed Ehsanur Rahman Tazeen Tahsina Md. Irteja Islam Afrin Iqbal Dewan Md. Emdadul Hoque Samir Kumar Saha Shams El Arifeen 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 BMC Public Health Gestational age LMP Recall Preterm birth Bangladesh Mobile phone |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Gestational age LMP Recall Preterm birth Bangladesh Mobile phone |
| url | http://link.springer.com/article/10.1186/s12889-018-6258-z |
| work_keys_str_mv | AT shumonasharminsalam studyprotocolofa4parallelarmsuperioritycommunitybasedclusterrandomizedcontrolledtrialcomparingpaperandeplatformbasedinterventionstoimproveaccuracyofrecalloflastmenstrualperiodlmpdatesinruralbangladesh AT naziabinteali studyprotocolofa4parallelarmsuperioritycommunitybasedclusterrandomizedcontrolledtrialcomparingpaperandeplatformbasedinterventionstoimproveaccuracyofrecalloflastmenstrualperiodlmpdatesinruralbangladesh AT ahmedehsanurrahman studyprotocolofa4parallelarmsuperioritycommunitybasedclusterrandomizedcontrolledtrialcomparingpaperandeplatformbasedinterventionstoimproveaccuracyofrecalloflastmenstrualperiodlmpdatesinruralbangladesh AT tazeentahsina studyprotocolofa4parallelarmsuperioritycommunitybasedclusterrandomizedcontrolledtrialcomparingpaperandeplatformbasedinterventionstoimproveaccuracyofrecalloflastmenstrualperiodlmpdatesinruralbangladesh AT mdirtejaislam studyprotocolofa4parallelarmsuperioritycommunitybasedclusterrandomizedcontrolledtrialcomparingpaperandeplatformbasedinterventionstoimproveaccuracyofrecalloflastmenstrualperiodlmpdatesinruralbangladesh AT afriniqbal studyprotocolofa4parallelarmsuperioritycommunitybasedclusterrandomizedcontrolledtrialcomparingpaperandeplatformbasedinterventionstoimproveaccuracyofrecalloflastmenstrualperiodlmpdatesinruralbangladesh AT dewanmdemdadulhoque studyprotocolofa4parallelarmsuperioritycommunitybasedclusterrandomizedcontrolledtrialcomparingpaperandeplatformbasedinterventionstoimproveaccuracyofrecalloflastmenstrualperiodlmpdatesinruralbangladesh AT samirkumarsaha studyprotocolofa4parallelarmsuperioritycommunitybasedclusterrandomizedcontrolledtrialcomparingpaperandeplatformbasedinterventionstoimproveaccuracyofrecalloflastmenstrualperiodlmpdatesinruralbangladesh AT shamselarifeen studyprotocolofa4parallelarmsuperioritycommunitybasedclusterrandomizedcontrolledtrialcomparingpaperandeplatformbasedinterventionstoimproveaccuracyofrecalloflastmenstrualperiodlmpdatesinruralbangladesh |