NCT03703219

Brief Summary

The study investigates the effect of the Mothers Touch program on the psychological well-being of new mothers following 5 weeks of child birth. Mothers Touch Program is designed based on traditional Indian post-partum care given by trained carer in the family. Study was designed as cohort, including a randomised controlled trial.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 12, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 6, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 9, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 11, 2018

Completed
Last Updated

October 22, 2018

Status Verified

October 1, 2018

Enrollment Period

3 months

First QC Date

October 9, 2018

Last Update Submit

October 19, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Post Natal Depression

    Edinburgh Postnatal depression Scale

    6 weeks following child birth

Secondary Outcomes (3)

  • General well being

    6 weeks following child birth

  • Parent-Infant Relationship

    6 weeks following child birth

  • Maternal Confidence

    6 weeks following child birth

Study Arms (2)

Mother Touch Program

Forty days of rest period of the mother after delivery, Full body massage, diet and belly binding methods were administered by trained carer.

Other: Mothers Touch Program

Usual care Program

comparison cohort were followed in usual care under the supervision of health professionals.

Interventions

Combination of diet, massage, body binding methods along with 40 days of rest following the traditional way of delivering

Mother Touch Program

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Participants giving birth in pre selected 4 hospitals in India.

You may qualify if:

  • Healthy women giving birth for first time (primiparous)
  • Given informed consent
  • Accepts traditional home care

You may not qualify if:

  • Previous history of mental health condition
  • History drug or substance abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NMP Medical Reserach Institute

Jaipur, Rajasthan, India

Location

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental Disorders

Study Officials

  • Rekha Chaudhari

    Mothers Touch Foundation, India

    STUDY CHAIR
  • Neha Sharma

    Warwick Research Services

    PRINCIPAL INVESTIGATOR
  • Sangram Birje

    Mothers Touch Foundation, India

    STUDY DIRECTOR
  • Aparna Chaudhari

    Mothers Touch Foundation, India

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2018

First Posted

October 11, 2018

Study Start

April 12, 2018

Primary Completion

July 15, 2018

Study Completion

September 6, 2018

Last Updated

October 22, 2018

Record last verified: 2018-10

Locations