Impact of Mothers Touch Program to Improve Maternal Health After Birth

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03715218
• Other study ID #: NMP 0146
• Status: Completed
• Phase: N/A
• Start date: January 21, 2018
• Est. completion date: August 12, 2018

Study information

• Verified date: October 2018
• Source: NMP Medical Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: August 12, 2018
• Est. primary completion date: May 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Primigravida

• Healthy pregnancy

• Consent to participate

Exclusion Criteria:

• Mental Health diagnosis

• Severe depression or psychosis

• Substance abuse

Related Conditions & MeSH terms

• Depression, Postpartum
• Post Partum Depression
• Quality of Life

Intervention

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

Locations

Country	Name	City	State
India	NMP Medical Reserach Institute	Jaipur	Rajasthan

Sponsors (3)

Lead Sponsor	Collaborator
NMP Medical Research Institute	Mothers Touch Foundation, India, Warwick Research Services

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Post-natal depression	Changes were assessed using Edinburgh Postnatal Depression scale	6 weeks following child birth
Secondary	Change in Quality of Life	Quality of life was measured using Short Form-36	6 weeks following child birth