Post Partum DepressionNCT03715218
Impact of Mothers Touch Program to Improve Maternal Health After Birth
A study testing Mothers Touch Program in people with Post Partum Depression and Quality of Life, run by NMP Medical Research Institute at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post Partum Depression, Quality of Life
- What is being tested?
- Mothers Touch Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteIndia
- Study dates
- 21 Jan 2018to 12 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Primigravida
- Healthy pregnancy
- Consent to participate
Who cannot join
- Mental Health diagnosis
- Severe depression or psychosis
- Substance abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Indian Postpartum Care: A-randomised Trial to Improve Maternal Health Six Weeks After Birth
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.
- Conditions
- Post Partum Depression, Quality of Life
- Being tested
- Mothers Touch Program, Usual Care Program
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mothers Touch ProgramOther
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 ProgramOther
Usual care group had advice, support and educational program delivered by midwife, or physicians.
| Study group | Role | What they receive |
|---|---|---|
| Mother Touch Program | Experimental | Post natal care provided by trained carer after the birth. 6 weeks of care included massage, special diet, physical and mental relaxations. Receives: Other: Mothers Touch Program |
| Usual care Program | Other | Usual care and supervision was provided as usual. Receives: Other: Usual Care Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Post-natal depression
Changes were assessed using Edinburgh Postnatal Depression scale
Measured: 6 weeks following child birth
Secondary outcomes (1)
Change in Quality of Life
Quality of life was measured using Short Form-36
Measured: 6 weeks following child birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2018
- Study start21 Jan 2018
- Primary completion15 May 2018
- Study completion12 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Partum DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- NMP Medical Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Warwick Research Services, Mothers Touch Foundation, India
- Responsible party
- Sponsor
- Investigators
- Rekha Chaudhari, Study chair, Mothers Touch Foundation, IndiaNeha Sharma, Principal investigator, Warwick Research ServicesSangram Birje, Study director, Mothers Touch Foundation, IndiaAparna Chaudhari, Study director, Mothers Touch Foundation, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03715218
- Sponsor's protocol ID
- NMP 0146
- Status last verified
- Oct 2018
- First submitted
- 19 Oct 2018
- Last updated
- 23 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 34286512
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Indian Postpartum Care: A-randomised Trial to Improve Maternal Health Six Weeks After Birth
- ClinicalTrials.gov ID
- NCT03715218
- Acronym / sponsor ID
- NMP 0146
- Conditions
- Post Partum Depression, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- NMP Medical Research InstituteUniversity, hospital or other
- Collaborators
- Warwick Research Services, Mothers Touch Foundation, India
- Study start
- 21 Jan 2018 (actual)
- Primary completion
- 15 May 2018 (actual)
- Study completion
- 12 Aug 2018 (actual)
- First posted
- 23 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mother Touch Program | Experimental | Other: Mothers Touch ProgramPost natal care provided by trained carer after the birth. 6 weeks of care included massage, special diet, physical and mental relaxations. |
| Usual care Program | Other | Other: Usual Care ProgramUsual care and supervision was provided as usual. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Primigravida
- Healthy pregnancy
- Consent to participate
Key exclusion criteria (3 listed)
- Mental Health diagnosis
- Severe depression or psychosis
- Substance abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mothers Touch ProgramMothers Touch Program with bed rest, Relaxation program to reduce stress, massage for mother and infant, gently physical exercise and special dietary program each week. | Other | Mother Touch Program |
| Usual Care ProgramUsual care group had advice, support and educational program delivered by midwife, or physicians. | Other | Usual care Program |
Primary outcome
Change in Post-natal depression
Time frame: 6 weeks following child birth
Changes were assessed using Edinburgh Postnatal Depression scale
1 secondary outcome
Change in Quality of Life
Time frame: 6 weeks following child birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2018.
- Derived from this study: PubMed 34286512Yonemoto 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rekha Chaudhari study chair
Mothers Touch Foundation, India
Neha Sharma principal investigator
Warwick Research Services
Sangram Birje study director
Mothers Touch Foundation, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mothers Touch Program in people with Post Partum Depression and Quality of Life, run by NMP Medical Research Institute at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Post-natal depression (time frame: 6 weeks following child birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03715218, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2018.