NCT01309321

Brief Summary

The purpose of this study is to determine if an intensive handwashing intervention administered to primiparous women during their pregnancy can increase maternal handwashing with soap at critical times.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for not_applicable sepsis

Timeline
Completed

Started Oct 2010

Typical duration for not_applicable sepsis

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

October 7, 2010

Completed
5 months until next milestone

First Posted

Study publicly available on registry

March 7, 2011

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

March 13, 2014

Status Verified

October 1, 2010

Enrollment Period

2.8 years

First QC Date

October 7, 2010

Last Update Submit

March 12, 2014

Conditions

SepsisUmbilical CordInfection

Keywords

PerinatalHandwashingNeonatalMorbidityMortalityPrimiparousHealth behaviorDeveloping countriesSepsisOmphalitisInfectious diseaseBangladesh

Outcome Measures

Primary Outcomes (4)

  • Proportion of critical events where neonatal caregivers wash their hands with soap as a measure of behavior change.

    1 month post-natal

  • Proportion of critical events where neonatal caregivers wash their hands with soap as a measure of behavior change.

    3 months post-natal

  • Daily reduction in household soap weight.

    2 weeks post-natal.

  • Daily reduction in household soap weight.

    1 month post-natal

Secondary Outcomes (3)

  • Incidence density of suspected sepsis in neonates

    1 month post natal

  • Incidence density of suspected omphalitis in neonates

    1 month post-natal

  • All cause neonatal mortality rate.

    1 month post-natal.

Study Arms (2)

Perinatal Handwashing Intervention Arm

EXPERIMENTAL
Behavioral: Perinatal Handwashing Promotion

Neonatal Health Promotion

ACTIVE COMPARATOR
Behavioral: Neonatal Health Promotion

Interventions

Perinatal Handwashing PromotionBEHAVIORAL

Pregnancy may serve as a unique opportunity to improve maternal handwashing behavior more deeply and sustainably than a handwashing promotion intervention at a different time. Primiparous women will receive an intensive handwashing promotion program delivered at 3 in-home visits between one month prenatal and 1 week post natal. The program will promote handwashing benefits, provide hardware to reduce barriers to handwashing, and educate mothers about the critical times for handwashing. Mothers will also receive an essential neonatal care package with information on clean delivery, hypothermia prevention, breastfeeding counseling, umbilical cord care, and identification of neonatal danger signs.

Perinatal Handwashing Intervention Arm
Neonatal Health PromotionBEHAVIORAL

Mothers will receive an essential neonatal care package with information on clean delivery, hypothermia prevention, breastfeeding counseling, umbilical cord care, and identification of neonatal danger signs.

Neonatal Health Promotion

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Primiparous women who plan to remain in the study area up to 1 months after birth

You may not qualify if:

  • Prior live birth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ICDDR,B

Matlab, Bangladesh

Location

MeSH Terms

Conditions

SepsisInfectionsHealth BehaviorCommunicable Diseases

Condition Hierarchy (Ancestors)

Systemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsBehaviorDisease Attributes

Study Officials

  • Sharifa Nasreen, MBBS, MPH

    International Centre for Diarrhoeal Disease Research, Bangladesh

    PRINCIPAL INVESTIGATOR

  • Pavani K. Ram, MD

    State University of New York at Buffalo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2010

First Posted

March 7, 2011

Study Start

October 1, 2010

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

March 13, 2014

Record last verified: 2010-10

Locations

BA(1)