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Clinical Trials/NCT03715218
NCT03715218
Completed
Not Applicable

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

NMP Medical Research Institute1 site in 1 country160 target enrollmentStarted: January 21, 2018Last updated:

Overview

Phase
Not Applicable
Status
Completed
Enrollment
160
Locations
1
Primary Endpoint
Change in Post-natal depression

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to 35 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Primigravida
  • Healthy pregnancy
  • Consent to participate

Exclusion Criteria

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

Outcomes

Primary Outcomes

Change in Post-natal depression

Time Frame: 6 weeks following child birth

Changes were assessed using Edinburgh Postnatal Depression scale

Secondary Outcomes

  • Change in Quality of Life(6 weeks following child birth)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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