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OpenTrials
Completed

NCT Number: NCT03715218

Impact of Mothers Touch Program to Improve Maternal Health 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.

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Key information

Conditions

Post Partum Depression Depression, Postpartum Depressive Disorder Female Urogenital Diseases and Pregnancy Complications Mental Disorders Mood Disorders Pregnancy Complications Puerperal Disorders Quality of Life Urogenital Diseases

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

NMP Medical Reserach Institute

Jaipur, Rajasthan, India

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Primigravida
  • Healthy pregnancy
  • Consent to participate

Exclusion criteria

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

Treatment and study plan

Mothers Touch Program

Other

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

Other

Usual care group had advice, support and educational program delivered by midwife, or physicians.

Primary outcomes

  1. Change in Post-natal depression

    Time frame: 6 weeks following child birth

    Changes were assessed using Edinburgh Postnatal Depression scale

Secondary outcomes

  1. Change in Quality of Life

    Time frame: 6 weeks following child birth

    Quality of life was measured using Short Form-36

Sponsors and collaborators

Lead sponsor

NMP Medical Research Institute

Other

Collaborators

  • Mothers Touch Foundation, India
  • Warwick Research Services

Registry information

Official study title

Indian Postpartum Care: A-randomised Trial to Improve Maternal Health Six Weeks After Birth

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Oct 23, 2018
Registry last updated
Oct 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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