Saving Lives With Better Gestational Age Estimation
2 other identifiers
interventional
3,360
1 country
1
Brief Summary
Background (brief):
- 1.Burden: Bangladesh has a high maternal (194 per 100,000 live births) and newborn mortality (28 per 1000 live births). In 2010, prematurity represented \~14% of all births and directly and indirectly contributed to 45% of all neonatal deaths. 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.
- 2.Knowledge gap: Last menstrual period (LMP) is a simple, low-cost self reported information, recommended by the World Health Organization for estimating gestational age 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.
- 3.Relevance: The goal of this study is to improve maternal and newborn outcomes by increasing the accuracy of gestational age estimation, using menstrual based dating, that is vital for providing timely and necessary obstetric and newborn care interventions. The study will determine the efficacy of three community based interventions using e-platform targeted to improve the recall and reporting of the date of last menstrual period in a rural resource poor setting. The innovative e-platform based interventions, if successful, can provide substantial evidence to scale-up in a low resource setting where e-Health and m-Health initiatives are proliferating with active support from all sectors in policy and implementation.
- 4.Implementation of conventional and e-platform based interventions will lead to a 30% improvement in recall of the date of the LMP in adolescent girls and married women in rural Bangladesh.
- 5.Intervention triggered improvement in LMP date recall among pregnant women in rural Bangladesh will improve the accuracy in GA estimation.
- 6.Determine whether a set of conventional and e-platform based interventions improve recall of the date of the LMP in adolescent girls and married women in rural Bangladesh.
- 7.Determine whether intervention triggered improvement in LMP date recall in rural Bangladesh improves the accuracy in GA estimation or not
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 24, 2016
CompletedFirst Posted
Study publicly available on registry
October 26, 2016
CompletedStudy Start
First participant enrolled
January 24, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2022
CompletedFebruary 11, 2022
January 1, 2022
5.7 years
October 24, 2016
February 10, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Improvement in the recall of LMP date among enrolled participants in the intervention arms compared to control arm
This outcome will be assessed by comparing recall date of LMP from surveys with recorded dates extracted from the intervention tools and actual LMP dates collected from LMP surveillance. In order to do so, first we will compare the distribution of LMP of the enrolled participants in the intervention arms recorded in the intervention tools along with the actual LMP dates collected by LMP surveillance for validation of the tools. Later differences in differences method will be employed to measure the change in coverage of accurately recalled LMP date and level of certainty for recalling LMP dates
12 months after enrollment
Increased accuracy of LMP-based gestational age measurement, as compared to USG
The second outcome will be assessed by comparing gestational age measured by LMP with GA from USG assessments. The study will not attempt to make any comparison across interventions.
12 months after enrollment
Other Outcomes (1)
Validation of the tools(calender, SMS & smartphone based LMP recording)
12 months after enrollment
Study Arms (4)
Education & paper based calendar
EXPERIMENTALThe participants will be counseled on importance of remembering LMP. In addition, a free calendar will be provided to the participant who will be asked to record menstrual bleeding and spotting dates in each month. The women will be asked to record "no bleeding" if she did not bleed for any particular month. Likewise, if anybody forgets to record, she will ask to keep a record of it in the subsequent month. Female counselors from the study team will conduct the group or individual education sessions.
Education & SMS system
EXPERIMENTALCell-phones will be provided free of cost to participants who will be asked to text the bleeding dates of their menstruation and spotting every month within 3 days of the start of the bleeding. Study team will collaborate with a mobile phone company and the charge of SMS for reporting LMP dates will be free for the user. In situations, where the participant fails to text, she will be provided with several SMS reminders after the due date.
Education & smart-phone application
EXPERIMENTALSmart phones with an application and an inbuilt reminder system will be provided free of cost to participants who will be asked for recording menstruation dates. Experienced programmer from icddr,b will be involved in developing the application. Again, participants will be asked to record bleeding dates each month and will upload the data in the central server via internet. If participants fail to record the dates and upload the data, an automatic reminder will be sent.
Comparison
NO INTERVENTIONThe participants will not receive any of the interventions that are focused in this study.
Interventions
The participants will be counseled on importance of remembering LMP. In addition, they will be provided a free calendar to record their LMP dates.
The participants will be counseled on importance of remembering LMP. They will be asked to send the LMP date via SMS. Participants will be reminded via SMS if they have not sent their dates (max -3 reminders)
The participants will be counseled on importance of remembering LMP. Participants will be asked to record the LMP on a calendar app. This will be transferred to central server via internet Participants will be reminded via SMS if they have not sent their dates (max -3 reminders)
Eligibility Criteria
You may qualify if:
- For Adolescent girls:
- Permanent resident of the study area (Adolescents who are usual residents of the households and living or intend to live in the area for 6 or more months)
- Aged between 15-17 years at the time of recruitment
- Parent or legal guardian is present at the time of recruitment and is willing to give assent for the adolescent's participation
- For Recently married women:
- Permanent resident of the study area (Recently married women who are usual residents of the households living or intend to live in the area for 6 or more months)
- Married within the past two years with no children or a single child
You may not qualify if:
- For Adolescent girls:
- Married at the time of recruitment
- Parent or the legal guardian is mentally/physically unable to give assent
- For Recently married women:
- \. Pregnant or exclusively breastfeeding at the time of recruitment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mirzapur
Tāngāil, Bangladesh
Related Publications (1)
Salam SS, Ali NB, Rahman AE, Tahsina T, Islam MI, Iqbal A, Hoque DME, Saha SK, El Arifeen S. 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. 2018 Dec 10;18(1):1359. doi: 10.1186/s12889-018-6258-z.
PMID: 30526560DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shams El Arifeen, DrPH
International Centre for Diarrhoeal Disease Research, Bangladesh
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 24, 2016
First Posted
October 26, 2016
Study Start
January 24, 2017
Primary Completion
October 1, 2022
Study Completion
October 1, 2022
Last Updated
February 11, 2022
Record last verified: 2022-01