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临床试验/NCT06409208
NCT06409208已完成不适用

Postnatal Care and Services Utilization in Nepal: Use of mHealth Intervention in Improving Utilization of Postpartum Care

Dhulikhel Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2025年4月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
300
试验地点
1
主要终点
uptake of postnatal visits

研究概览

简要总结

Despite implementation of many activities related to maternal health, maternal mortality ratio is still unacceptably high in Nepal, 239/100,000 in live births. Most maternal deaths occur within 48 hours of delivery (42.7%) and then in the late postpartum period (from 48 hours after birth to up to six weeks after childbirth) (29.5%), postpartum hemorrhage predominate as the most important cause of maternal deaths (23%), with hypertensive disorder (eclampsia/pre-eclampsia) at 14 percent.

Postnatal care service is important for prevention of postnatal complications and to reduce maternal mortality. However, postnatal care service is rare in Nepal. And where it is available quality is poor. Forty-two (42%) percent of women did not receive any postnatal check in Nepal. Lack of awareness of importance to postnatal care, distance of health facility, unsuccessful endorsement of postnatal care by Government and cultural practice of Nepal are major causes of failure to attend postnatal care and visit in Nepal. Mhealth intervention would be the best option to address these constrains to attain or improve postnatal visits according to national protocol.

A qualitative and quantitative study will be conducted. Qualitative study will be conducted as a formative study to explore enabling and barriers to attend postnatal care visit. A focused group discussion will be done among postnatal mothers attending immunization clinic and gynae out patient department (OPD) of Dhulikhel hospital. A COM-B model of behavior change will be applied to identify enablers and barriers among women by conducting focus group discussions. Semi structured topic guide will be developed using sources of behaviors, capability, opportunity and motivation and its sub categories. Intervention package will be designed based on evidence that will support the use of behavioral theory for effective outcomes. Thematic Analysis of barriers and enablers to increase uptake of postnatal care (post natal visits, family planning and exclusive breast feeding) will be done by using same model.

A quantitative study will be conducted among antenatal mothers attending ANC clinic of tertiary care hospital. A randomized control trial method will be used for the study. Total of 300 third trimester antenatal women will be enrolled for the study. Intervention group will received intervention package which includes, health care video related to postnatal care, care of newborn, danger signs etc. This video will be shown to women during their antenatal period for the first time and then video will be downloaded to their respective mobile phone and will be motivated to watched them later at least for minimum of 3 times. Educational reminder messages will be sent to women around 13 times different periods of postpartum days. These SMSs will be mainly focused on reminder for postnatal care visits, use of postpartum family planning methods and importance of exclusive breast feeding practices. Control group will receive a standard care. At the end, health related outcomes will be measured in both groups as numbers of postnatal visit attended, use of postnatal family planning methods, exclusive breast feeding and seeking care for danger signs of mother and newborns by both groups will be evaluated. Implementation outcomes of mHealth intervention strategy will be evaluated using PROCTORs framework.

详细描述

A qualitative and quantitative study will be conducted. Qualitative study will be conducted as a formative study to explore enabling and barriers to attend postnatal care visit. A focused group discussion (FGD) will be done among postnatal mothers attending immunization clinic and gynecologic OPD of Dhulikhel Hospital. About 4 sessions of FGDs will be conducted. However, it will be based on data saturation. Once the data saturation is confirmed extra one more FGD will be conducted for new information.

A COM-B model components of behavior change wheel will be applied to identify enablers and barriers among women by conducting focus group discussions.1 Semi structured topic guide will be developed using sources of behaviors e.g. capability, opportunity and motivation and its sub components. Capability component comprises psychological and physical capabilities. Capability refers to an individual's psychological (mental skills and knowledge) and physical ability (bodily functions) to engage in a behavior. Opportunity component comprises physical and social sub components. Physical opportunity refers to the environment where the behavior takes place and social opportunity deals with social values, culture and social support. Motivation involves reflective and automatic motivation. Reflective motivation involves evaluation and plans and automatic motivation involves emotions and impulses.1 Based on these components topic guides for FGDs will be developed to explore barriers and enablers of postnatal care and visits.

Intervention package will be designed based on evidence that will support the use of behavioral theory for effective outcomes. After developing intervention package, before implementation the intervention package will be validated by experts' team and data safety and management board (DSMB) team. A half day workshop will be conducted. The expert team will include, HOD of gynecology and obstetrics department, obstetric consultant, Nurse manager and in-charge of Antenatal care clinic and postnatal ward and midwives of antenatal clinic. Thematic Analysis of barriers and enablers to increase uptake of postnatal care (post natal visits, family planning and exclusive breast feeding) will be done by using same model.

A quantitative study will be conducted among antenatal mothers attending ANC clinic of tertiary care hospital. A randomized control trial method will be used for the study. About 300 eligible pregnant women of third trimester visiting antenatal OPD of Dhulikhel Hospital will be enrolled for the study after consenting to participate. These women will be divided in to two groups as intervention group and control group.

The participants in each group will be randomly assigned to intervention and control group in 1:1 ratio.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
19 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •- Women age 19 years and above
  • •III trimester pregnant lady
  • •Mobile phone user and able to read and understand Nepali language
  • •Literate and can operate mobile phone (can check text message and read)

排除标准

  • •- Women only come for child birth service at DH without attending ANC clinic of DH.
  • •Women with very sick newborn and neonatal death
  • •Women who has to stay hospital for longer period of time (more than 14 days)
  • •Women with complication during labour and delivery eg. Uterine rupture,
  • •Not able to come for delivery at Dhulikhel Hospital.

研究组 & 干预措施

Intervention, mHealth intervention (video and reminder SMSs)

Experimental

Intervention group of postnatal mothers will get mHealth intervention package which will include video on postnatal care and 13 reminder short text messages (SMS) which will be delivered to women different days of postnatal period. Reminder SMSs will be focused on Postnatal visits, post partum family planning and exclusive breast feeding practice.

干预措施: mHealth intervention (video and reminder SMSs) (Behavioral)

Control arm

No Intervention

Routine antenatal and postnatal care

结局指标

主要结局

uptake of postnatal visits

时间窗: 6 weeks

proportion of participants attended postnatal care clinic as per world health organization (WHO) recommendation (24 hours of child birth, 3days , 7-14 days and on 42days of post partum)

postpartum family planning adoption

时间窗: 3 months

proportion of participants used modern family planning methods

exclusive breast feeding practice

时间窗: 3 months

proportion participants exclusively breastfeeding her newborns

次要结局

  • Sustainability of mHealth Intervention(3 months)
  • Acceptability of mHealth Intervention(3 months)
  • Appropriateness of mHealth Intervention(3 months)
  • Adoption of mHealth Intervention(3 months)
  • Penetration of mHealth Intervention(3 months)
  • Feasibility of mHealth Intervention(3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Subasna Shrestha

Associate Professor

Dhulikhel Hospital

研究点 (1)

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