NCT06409208

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 10, 2024

Completed
11 months until next milestone

Study Start

First participant enrolled

April 18, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 17, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 17, 2026

Completed
Last Updated

May 7, 2025

Status Verified

May 1, 2025

Enrollment Period

12 months

First QC Date

May 4, 2024

Last Update Submit

May 4, 2025

Conditions

Keywords

mHealth Intervention

Outcome Measures

Primary Outcomes (3)

  • uptake of postnatal visits

    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)

    6 weeks

  • postpartum family planning adoption

    proportion of participants used modern family planning methods

    3 months

  • exclusive breast feeding practice

    proportion participants exclusively breastfeeding her newborns

    3 months

Secondary Outcomes (6)

  • Acceptability of mHealth Intervention

    3 months

  • Adoption of mHealth Intervention

    3 months

  • Appropriateness of mHealth Intervention

    3 months

  • Feasibility of mHealth Intervention

    3 months

  • Penetration of mHealth Intervention

    3 months

  • +1 more secondary outcomes

Other Outcomes (1)

  • knowledge on postnatal care

    3 months

Study Arms (2)

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.

Behavioral: mHealth intervention (video and reminder SMSs)

Control arm

NO INTERVENTION

Routine antenatal and postnatal care

Interventions

intervention includes educational video related to postnatal care and reminder SMSs related to postnatal visits, family planning adoption and exclusive breast feeding practice.

Intervention, mHealth intervention (video and reminder SMSs)

Eligibility Criteria

Age19 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \- 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)

You may not qualify if:

  • \- 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dhulikhel Hospital, Kathamandu University Hospital

Dhulikhel, Bagmati, 45210, Nepal

RECRUITING

Related Publications (12)

  • Dhakal S, Chapman GN, Simkhada PP, van Teijlingen ER, Stephens J, Raja AE. Utilisation of postnatal care among rural women in Nepal. BMC Pregnancy Childbirth. 2007 Sep 3;7:19. doi: 10.1186/1471-2393-7-19.

    PMID: 17767710BACKGROUND
  • Sharma S, van Teijlingen E, Hundley V, Angell C, Simkhada P. Dirty and 40 days in the wilderness: Eliciting childbirth and postnatal cultural practices and beliefs in Nepal. BMC Pregnancy Childbirth. 2016 Jul 5;16(1):147. doi: 10.1186/s12884-016-0938-4.

    PMID: 27381177BACKGROUND
  • Lama TP, Munos MK, Katz J, Khatry SK, LeClerq SC, Mullany LC. Assessment of facility and health worker readiness to provide quality antenatal, intrapartum and postpartum care in rural Southern Nepal. BMC Health Serv Res. 2020 Jan 6;20(1):16. doi: 10.1186/s12913-019-4871-x.

    PMID: 31906938BACKGROUND
  • Adanikin AI, Awoleke JO, Adeyiolu A. Role of reminder by text message in enhancing postnatal clinic attendance. Int J Gynaecol Obstet. 2014 Aug;126(2):179-80. doi: 10.1016/j.ijgo.2014.02.009. Epub 2014 Apr 2. No abstract available.

    PMID: 24794692BACKGROUND
  • Olajubu AO, Fajemilehin BR, Olajubu TO, Afolabi BS. Effectiveness of a mobile health intervention on uptake of recommended postnatal care services in Nigeria. PLoS One. 2020 Sep 14;15(9):e0238911. doi: 10.1371/journal.pone.0238911. eCollection 2020.

    PMID: 32925971BACKGROUND
  • Unger JA, Ronen K, Perrier T, DeRenzi B, Slyker J, Drake AL, Mogaka D, Kinuthia J, John-Stewart G. Short message service communication improves exclusive breastfeeding and early postpartum contraception in a low- to middle-income country setting: a randomised trial. BJOG. 2018 Nov;125(12):1620-1629. doi: 10.1111/1471-0528.15337. Epub 2018 Aug 28.

    PMID: 29924912BACKGROUND
  • Beraki GG, Tesfamariam EH, Gebremichael A, Yohannes B, Haile K, Tewelde S, Goitom S. Knowledge on postnatal care among postpartum mothers during discharge in maternity hospitals in Asmara: a cross-sectional study. BMC Pregnancy Childbirth. 2020 Jan 6;20(1):17. doi: 10.1186/s12884-019-2694-8.

    PMID: 31906883BACKGROUND
  • Chaudhary K, Nepal J, Shrestha K, Karmacharya M, Khadka D, Shrestha A, Shakya PR, Rawal S, Shrestha A. Effect of a social media-based health education program on postnatal care (PNC) knowledge among pregnant women using smartphones in Dhulikhel hospital: A randomized controlled trial. PLoS One. 2023 Jan 20;18(1):e0280622. doi: 10.1371/journal.pone.0280622. eCollection 2023.

    PMID: 36662821BACKGROUND
  • Michie S, van Stralen MM, West R. The behaviour change wheel: a new method for characterising and designing behaviour change interventions. Implement Sci. 2011 Apr 23;6:42. doi: 10.1186/1748-5908-6-42.

    PMID: 21513547BACKGROUND
  • martins et al. European Portuguese Validation of the System Usability Scale (SUS) https://linkinghub.elsevier.com/retrieve/pii/S1877050915031191

    BACKGROUND
  • WHO recommendations on maternal and newborn care for a positive postnatal experience [Internet]. Geneva: World Health Organization; 2022. Available from http://www.ncbi.nlm.nih.gov/books/NBK579657/

    PMID: 35467813BACKGROUND
  • Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, Griffey R, Hensley M. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011 Mar;38(2):65-76. doi: 10.1007/s10488-010-0319-7.

Related Links

MeSH Terms

Interventions

Videotape Recording

Intervention Hierarchy (Ancestors)

Tape RecordingAudiovisual AidsEducational TechnologyTechnologyTechnology, Industry, and AgricultureTelevision

Central Study Contacts

Subasna Shrestha, MN

CONTACT

Anjana Dongol, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 4, 2024

First Posted

May 10, 2024

Study Start

April 18, 2025

Primary Completion

April 17, 2026

Study Completion

April 17, 2026

Last Updated

May 7, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

all collected information

Locations