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临床试验/NCT02944747
NCT02944747Unknown不适用

Saving Lives With Better Gestational Age Estimation: Improving the Accuracy of Recall and Reporting of the Date of Last Menstrual Period (LMP) in Rural Bangladesh

International Centre for Diarrhoeal Disease Research, Bangladesh1 个研究点 分布在 1 个国家目标入组 3,360 人开始时间: 2017年1月24日最近更新:
适应症

试验速览

阶段
不适用
入组人数
3,360
试验地点
1
主要终点
Increased accuracy of LMP-based gestational age measurement, as compared to USG

研究概览

简要总结

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.

Hypothesis :

  1. 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.
  2. Intervention triggered improvement in LMP date recall among pregnant women in rural Bangladesh will improve the accuracy in GA estimation.

Objectives: The main objectives of the study are to:

  1. 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.
  2. Determine whether intervention triggered improvement in LMP date recall in rural Bangladesh improves the accuracy in GA estimation or not

Methods: A 4- parallel arm, superiority, community based cluster randomized controlled trial comparing three conventional and e-platform based interventions is proposed to improve recall of GA with a control arm. The trial will be conducted among adolescent girls and recently married women (within past two years) with no children or a single child in Mirzapur sub-district of Bangladesh.The interventions include (i) education and calendar for recording date of LMP (ii) education and SMS based system for recording dates of LMP and reminders using mobile phone (normal) (iii) education and smart-phone based application for recording dates of LMP with an inbuilt reminder system.

Outcome measures/variables: The trial has two primary outcomes, (i) improvement in the recall of LMP date among enrolled participants in the three different intervention compared to control arm and (ii) increased accuracy of LMP-based gestational age measurement, as compared to USG, following the intervention.

详细描述

Background:

Bangladesh has a high maternal (194 per 100,000 live births) and newborn mortality (28 per 1000 live births)(1-3). In 2010, prematurity represented ~14% of all births and directly and indirectly contributed to 45% of all neonatal deaths(4, 5). Accurate estimation of gestational age (GA) is a critical for providing optimal clinical care during the prenatal, delivery and postnatal period and for public health interventions(6). Knowing GA to the week is essential for determining the adequacy of fetal growth, correct diagnosis of preterm or post-term labor and also for the correct use of many interventions (e.g., antenatal corticosteroids therapy, tocolytics, continuous positive airway pressure) targeted to improve maternal and newborn outcomes(7).

Three methods of GA estimation are primarily used - menstrual based dating (LMP), ultrasonography (USG) and neonatal assessment, all of which have some strengths and weaknesses(8). USG, based on biometric measurements of the fetus, is considered to be the gold standard when done before 20 weeks of gestation i.e., when biologic variations in fetal size and the effects of growth restriction are low(9). However, the accuracy of USG decreases when done in the latter trimesters, particularly in settings with high intrauterine growth restriction, as in Bangladesh(10). However, USG is often unavailable in low-resource countries, especially in rural areas. Even if it is available, the equipment can be of poor quality and operated by personnel with minimal expertise(10). In addition, pregnancies are often not identified until the 2nd or 3rd trimesters and women often seek antenatal care late in their pregnancies, which further limits the use of USG to assess GA(10-12).

Alternate methods of assessing GA are therefore preferred in such settings. One approach is to use neonatal assessments that are based on standardized scoring systems of physical and neuromuscular maturity. These are, however, less precise then obstetric estimates and also require skilled personnel which is frequently not practical(13). Dating based on the LMP is another alternative. It is a simple, low-cost method recommended by the World Health Organization(14). However, several studies have shown that that approximately 15-45% of pregnant women are unable to recall their LMP accurately resulting in an unreliable estimate and digit preference(15-17). Recall period is crucial determinant influencing accuracy of LMP. Literature suggests that LMP recall is more precise with shorter recall period.(15) Accuracy in recall of LMP is also limited due to irregularity or individual variations in the length of the menstrual cycle, short birth spacing, preconception amenorrhea and implantation bleeding(18, 19). This is further complicated by late presentation for first antenatal care consultation and providers with minimal skills in probing for an accurate LMP date. Reliance on LMP alone has shown a tendency to overestimate GA at the extremes of gestation which is more common in women with no or low education and those living in poverty(15, 20). Despite the limitations, studies conducted in Bangladesh and Guatemala has suggested LMP to be the preferred method for determining GA in low-resource settings(10, 21).

The study therefore aim to determine the efficacy of three interventions targeted to improve the recall and reporting of the LMP among women in rural Bangladesh. The interventions include both conventional LMP dating calendar as well as an innovative e-platform - mobile phones and smart phone applications.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
17 Years 至 49 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Increased accuracy of LMP-based gestational age measurement, as compared to USG

时间窗: 12 months after enrollment

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.

Improvement in the recall of LMP date among enrolled participants in the intervention arms compared to control arm

时间窗: 12 months after enrollment

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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