Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
NA
INTERVENTIONAL
2016-02-01
2018-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Perinatal Handwashing Intervention in Bangladesh
NCT01309321
Waterless Hand Cleansing With Chlorhexidine During the Perinatal Period
NCT01955317
Intervention Trial to Measure the Effect of Individual Prenatal Information Combined With Mobile Phones
NCT02084680
Healthy Baby Healthy Mother Toolkit
NCT06594419
Integrating Well-Woman and Well-Baby Care to Improve Parenting and Family Wellness
NCT00782028
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Control
Women will receive standard antenatal care but will not receive any additional handwashing promotion, soap, or handwashing device during their enrollment. At the end of data collection, handwashing with soap will be recommended to participants in the control arm and their families.
No interventions assigned to this group
Clinic
Handwashing promotion from healthcare workers at antenatal care clinic.
Clinic
Pregnant women will receive handwashing promotion from a trained facility-based health care worker during her regular antenatal visit at a healthcare clinic. To the extent feasible, everyone accompanying the pregnant woman will be invited to take part in the behavior change communication session. The participant will be provided with several bars of soap to take home and she will be encouraged to maintain a designated place for washing hands (with soap and water) at the home. A poster indicating the key events for handwashing with soap will be posted at the clinic and smaller posters will be given to the participant to post in her home. A system will be established to send regular SMS messages to the participant promote handwashing with soap during the neonatal period.
Clinic + home
Handwashing promotion from healthcare workers at antenatal care clinic and from community health volunteers at home visits.
Clinic + home
Women will receive all components of the clinic-based handwashing promotion in addition to handwashing promotion during 3-4 home visits before their expected delivery date and during the neonatal period from a community health volunteer. All household members present will be invited to join in the session, with emphasis on including all caregivers of the neonate.
Clinic + home + handwashing device
Handwashing promotion from healthcare workers at antenatal care clinic and from community health volunteers at home visits with provision of one handwashing device.
Clinic + home + handwashing device
Women will receive all components of the clinic + home-based handwashing promotion intervention in addition to one handwashing device (i.e. tap and basin to use as a handwashing station) during the first home visit by the community health volunteer. The community health volunteer will work with the woman and her family to identify the location where the neonate will be most of the time in order to position the handwashing station as close to the neonate as possible.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Clinic
Pregnant women will receive handwashing promotion from a trained facility-based health care worker during her regular antenatal visit at a healthcare clinic. To the extent feasible, everyone accompanying the pregnant woman will be invited to take part in the behavior change communication session. The participant will be provided with several bars of soap to take home and she will be encouraged to maintain a designated place for washing hands (with soap and water) at the home. A poster indicating the key events for handwashing with soap will be posted at the clinic and smaller posters will be given to the participant to post in her home. A system will be established to send regular SMS messages to the participant promote handwashing with soap during the neonatal period.
Clinic + home
Women will receive all components of the clinic-based handwashing promotion in addition to handwashing promotion during 3-4 home visits before their expected delivery date and during the neonatal period from a community health volunteer. All household members present will be invited to join in the session, with emphasis on including all caregivers of the neonate.
Clinic + home + handwashing device
Women will receive all components of the clinic + home-based handwashing promotion intervention in addition to one handwashing device (i.e. tap and basin to use as a handwashing station) during the first home visit by the community health volunteer. The community health volunteer will work with the woman and her family to identify the location where the neonate will be most of the time in order to position the handwashing station as close to the neonate as possible.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Seeking routine (non-emergency) care at a participating antenatal care clinic during the study period
* Between 30 and 36 weeks pregnant (calculated based on last known menstrual period) when they seek antenatal care
* Live within 30 minutes or 1-2 km one-way travel from the clinic
* Plan to remain in the study area for at least one month post-partum
* Willing to allow the field worker to visit her home following the antenatal care visit on the day of enrollment to conduct baseline assessments at the household
* Sought antenatal care from a qualified medical provider for the first time at or after 28 weeks gestation
Exclusion Criteria
* Excluded if enrolled in the formative research for this study
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Save the Children
OTHER
United States Agency for International Development (USAID)
FED
Unilever R&D
INDUSTRY
State University of New York at Buffalo
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pavani K. Ram, M.D.
Role: PRINCIPAL_INVESTIGATOR
State University of New York at Buffalo
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Government funded antenatal care clinics
Igembe North and Igembe South Subcounties, Meru County, Kenya
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ESRC P176/2015
Identifier Type: OTHER
Identifier Source: secondary_id
748140-1
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.