Impact of Mothers Touch Program to Improve Maternal Health After Birth
Indian Postpartum Care: A-randomised Trial to Improve Maternal Health Six Weeks After Birth
1 other identifier
interventional
160
1 country
1
Brief Summary
After the child birth most women experience major health issues such as depression, severe fatigue, back pain, perineal pain, mastitis, urinary or faecal incontinence, sexual problems and relationship problems with partners. That all lead to poorer emotional and mental health and factors contributing isolation, exhaustion and physical health problems. 'Sava Mahina (6-week period) is a traditional practice for postpartum women in India, which include special diet, lifestyle and supportive care. The current multicenter randomized controlled trial (RCT) aims to evaluate outcomes of Indian postpartum care on women.
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 2018
Shorter than P25 for not_applicable
1 active site
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
Study Start
First participant enrolled
January 21, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 12, 2018
CompletedFirst Submitted
Initial submission to the registry
October 19, 2018
CompletedFirst Posted
Study publicly available on registry
October 23, 2018
CompletedOctober 23, 2018
October 1, 2018
4 months
October 19, 2018
October 19, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Post-natal depression
Changes were assessed using Edinburgh Postnatal Depression scale
6 weeks following child birth
Secondary Outcomes (1)
Change in Quality of Life
6 weeks following child birth
Study Arms (2)
Mother Touch Program
EXPERIMENTALPost natal care provided by trained carer after the birth. 6 weeks of care included massage, special diet, physical and mental relaxations.
Usual care Program
OTHERUsual care and supervision was provided as usual.
Interventions
Mothers Touch Program with bed rest, Relaxation program to reduce stress, massage for mother and infant, gently physical exercise and special dietary program each week.
Usual care group had advice, support and educational program delivered by midwife, or physicians.
Eligibility Criteria
You may qualify if:
- Primigravida
- Healthy pregnancy
- Consent to participate
You may not qualify if:
- Mental Health diagnosis
- Severe depression or psychosis
- Substance abuse
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NMP Medical Research Institutelead
- Warwick Research Servicescollaborator
- Mothers Touch Foundation, Indiacollaborator
Study Sites (1)
NMP Medical Reserach Institute
Jaipur, Rajasthan, India
Related Publications (1)
Yonemoto N, Nagai S, Mori R. Schedules for home visits in the early postpartum period. Cochrane Database Syst Rev. 2021 Jul 21;7(7):CD009326. doi: 10.1002/14651858.CD009326.pub4.
PMID: 34286512DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Rekha Chaudhari
Mothers Touch Foundation, India
- PRINCIPAL INVESTIGATOR
Neha Sharma
Warwick Research Services
- STUDY DIRECTOR
Sangram Birje
Mothers Touch Foundation, India
- STUDY DIRECTOR
Aparna Chaudhari
Mothers Touch Foundation, India
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 19, 2018
First Posted
October 23, 2018
Study Start
January 21, 2018
Primary Completion
May 15, 2018
Study Completion
August 12, 2018
Last Updated
October 23, 2018
Record last verified: 2018-10