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Impact of Mothers Touch Program to Improve Maternal Health After Birth

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03715218
Recruitment Status : Completed
First Posted : October 23, 2018
Last Update Posted : October 23, 2018
Sponsor:
Collaborators:
Warwick Research Services
Mothers Touch Foundation, India
Information provided by (Responsible Party):
NMP Medical Research Institute

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.


Condition or disease Intervention/treatment Phase
Post Partum Depression Quality of Life Other: Mothers Touch Program Other: Usual Care Program Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Indian Postpartum Care: A-randomised Trial to Improve Maternal Health Six Weeks After Birth
Actual Study Start Date : January 21, 2018
Actual Primary Completion Date : May 15, 2018
Actual Study Completion Date : August 12, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mother Touch Program
Post natal care provided by trained carer after the birth. 6 weeks of care included massage, special diet, physical and mental relaxations.
Other: Mothers Touch Program
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 Program
Usual care and supervision was provided as usual.
Other: Usual Care Program
Usual care group had advice, support and educational program delivered by midwife, or physicians.




Primary Outcome Measures :
  1. Change in Post-natal depression [ Time Frame: 6 weeks following child birth ]
    Changes were assessed using Edinburgh Postnatal Depression scale


Secondary Outcome Measures :
  1. Change in Quality of Life [ Time Frame: 6 weeks following child birth ]
    Quality of life was measured using Short Form-36



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Primigravida
  • Healthy pregnancy
  • Consent to participate

Exclusion Criteria:

  • Mental Health diagnosis
  • Severe depression or psychosis
  • Substance abuse

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03715218


Locations
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India
NMP Medical Reserach Institute
Jaipur, Rajasthan, India
Sponsors and Collaborators
NMP Medical Research Institute
Warwick Research Services
Mothers Touch Foundation, India
Investigators
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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

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Responsible Party: NMP Medical Research Institute
ClinicalTrials.gov Identifier: NCT03715218    
Other Study ID Numbers: NMP 0146
First Posted: October 23, 2018    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depression, Postpartum
Puerperal Disorders
Pregnancy Complications
Depressive Disorder
Mood Disorders
Mental Disorders