NCT00656591

Brief Summary

An Evaluation of the Cost-Effectiveness of Community-Based Participatory Interventions for Pregnant Women in Nepal to Reduce Fetal \& Infant Mortality and to Improve Fetal Growth \& Cognitive Development in Infancy

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
192,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2005

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

December 22, 2006

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

April 11, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

April 11, 2008

Status Verified

April 1, 2008

Enrollment Period

3.8 years

First QC Date

December 22, 2006

Last Update Submit

April 7, 2008

Conditions

Child Mortality

Keywords

Child mortality, Nepal, Community, care practices

Outcome Measures

Primary Outcomes (1)

  • neonatal mortality rates

    2 years

Interventions

MethotrexateDRUG

Methotrexate

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

48 village development committee areas

You may qualify if:

  • mothers, community health volunteers

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

International Child Health, ICH

London, WC1N 1EH, United Kingdom

RECRUITING

MeSH Terms

Interventions

Methotrexate

Intervention Hierarchy (Ancestors)

AminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Anthony Costello, Dr

    Institute of Child Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 22, 2006

First Posted

April 11, 2008

Study Start

March 1, 2005

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

April 11, 2008

Record last verified: 2008-04

Locations

GB(1)