Impact of Mothers Touch Program to Improve Maternal Health After Birth

October 19, 2018 updated by: NMP Medical Research Institute

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Rajasthan
      • Jaipur, Rajasthan, India
        • NMP Medical Reserach Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Primigravida
  • Healthy pregnancy
  • Consent to participate

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Post-natal depression
Time Frame: 6 weeks following child birth
Changes were assessed using Edinburgh Postnatal Depression scale
6 weeks following child birth

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Quality of Life
Time Frame: 6 weeks following child birth
Quality of life was measured using Short Form-36
6 weeks following child birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NMP Medical Research Institute

Collaborators

Warwick Research Services
Mothers Touch Foundation, India

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 21, 2018

Primary Completion (Actual)

May 15, 2018

Study Completion (Actual)

August 12, 2018

Study Registration Dates

First Submitted

October 19, 2018

First Submitted That Met QC Criteria

October 19, 2018

First Posted (Actual)

October 23, 2018

Study Record Updates

Last Update Posted (Actual)

October 23, 2018

Last Update Submitted That Met QC Criteria

October 19, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMP 0146

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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