Back to resultsImpact of Mothers Touch Program to Improve Maternal Health After Birth
Primary Purpose
Post Partum Depression, Quality of Life
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Mothers Touch Program
Usual Care Program
Sponsored by
About this trial
This is an interventional supportive care trial for Post Partum Depression
Eligibility Criteria
Inclusion Criteria:
- Primigravida
- Healthy pregnancy
- Consent to participate
Exclusion Criteria:
- Mental Health diagnosis
- Severe depression or psychosis
- Substance abuse
Sites / Locations
- NMP Medical Reserach Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Mother Touch Program
Usual care Program
Arm Description
Post natal care provided by trained carer after the birth. 6 weeks of care included massage, special diet, physical and mental relaxations.
Usual care and supervision was provided as usual.
Outcomes
Primary Outcome Measures
Change in Post-natal depression
Changes were assessed using Edinburgh Postnatal Depression scale
Secondary Outcome Measures
Change in Quality of Life
Quality of life was measured using Short Form-36
Full Information
NCT ID
NCT03715218
First Posted
October 19, 2018
Last Updated
October 19, 2018
Sponsor
NMP Medical Research Institute
Collaborators
Warwick Research Services, Mothers Touch Foundation, India
1. Study Identification
Unique Protocol Identification Number
NCT03715218
Brief Title
Impact of Mothers Touch Program to Improve Maternal Health After Birth
Official Title
Indian Postpartum Care: A-randomised Trial to Improve Maternal Health Six Weeks After Birth
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
January 21, 2018 (Actual)
Primary Completion Date
May 15, 2018 (Actual)
Study Completion Date
August 12, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NMP Medical Research Institute
Collaborators
Warwick Research Services, Mothers Touch Foundation, India
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Partum Depression, Quality of Life
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mother Touch Program
Arm Type
Experimental
Arm Description
Post natal care provided by trained carer after the birth. 6 weeks of care included massage, special diet, physical and mental relaxations.
Arm Title
Usual care Program
Arm Type
Other
Arm Description
Usual care and supervision was provided as usual.
Intervention Type
Other
Intervention Name(s)
Mothers Touch Program
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual Care Program
Intervention Description
Usual care group had advice, support and educational program delivered by midwife, or physicians.
Primary Outcome Measure Information:
Title
Change in Post-natal depression
Description
Changes were assessed using Edinburgh Postnatal Depression scale
Time Frame
6 weeks following child birth
Secondary Outcome Measure Information:
Title
Change in Quality of Life
Description
Quality of life was measured using Short Form-36
Time Frame
6 weeks following child birth
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Primigravida
Healthy pregnancy
Consent to participate
Exclusion Criteria:
Mental Health diagnosis
Severe depression or psychosis
Substance abuse
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rekha Chaudhari
Organizational Affiliation
Mothers Touch Foundation, India
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Neha Sharma
Organizational Affiliation
Warwick Research Services
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sangram Birje
Organizational Affiliation
Mothers Touch Foundation, India
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Aparna Chaudhari
Organizational Affiliation
Mothers Touch Foundation, India
Official's Role
Study Director
Facility Information:
Facility Name
NMP Medical Reserach Institute
City
Jaipur
State/Province
Rajasthan
Country
India
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34286512
Citation
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.
Results Reference
derived
Learn more about this trial
Impact of Mothers Touch Program to Improve Maternal Health After Birth
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