Impact of Mothers Touch Program to Improve Maternal Health After Birth

NCT ID: NCT03715218

Last Updated: 2018-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-21

Study Completion Date

2018-08-12

Brief Summary

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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.

Detailed Description

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Conditions

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Post Partum Depression Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Mothers Touch Program

Intervention Type 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

Usual care and supervision was provided as usual.

Group Type OTHER

Usual Care Program

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Usual Care Program

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Primigravida
* Healthy pregnancy
* Consent to participate

Exclusion Criteria

* Mental Health diagnosis
* Severe depression or psychosis
* Substance abuse
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Warwick Research Services

OTHER

Sponsor Role collaborator

Mothers Touch Foundation, India

UNKNOWN

Sponsor Role collaborator

NMP Medical Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rekha Chaudhari

Role: STUDY_CHAIR

Mothers Touch Foundation, India

Neha Sharma

Role: PRINCIPAL_INVESTIGATOR

Warwick Research Services

Sangram Birje

Role: STUDY_DIRECTOR

Mothers Touch Foundation, India

Aparna Chaudhari

Role: STUDY_DIRECTOR

Mothers Touch Foundation, India

Locations

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NMP Medical Reserach Institute

Jaipur, Rajasthan, India

Site Status

Countries

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India

References

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Yonemoto N, Nagai S, Mori R. Schedules for home visits in the early postpartum period. Cochrane Database Syst Rev. 2021 Jul 21;7(7):CD009326. doi: 10.1002/14651858.CD009326.pub4.

Reference Type DERIVED
PMID: 34286512 (View on PubMed)

Other Identifiers

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NMP 0146

Identifier Type: -

Identifier Source: org_study_id

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