Perinatal Mortality Outcomes Through Household Infection Pathways (POTH)

June 27, 2026 updated by: Jade Benjamin-Chung, Stanford University

Effect of Cement Floors on Perinatal and Neonatal Mortality in Bangladesh: a Randomized Trial in Rural Bangladesh

The goal of this trial is to learn if replacing household soil floors with concrete floors can prevent deaths of infants around the time of birth, including stillbirths and deaths in the first month of life in rural Bangladesh. The primary question the study aims to answer is: Does residing in a home with a concrete vs. soil floor reduce the perinatal and neonatal morality in index children and their younger siblings up to 6 years post-installation of concrete floors?

Researchers will compare participants in households with concrete floors (intervention) vs. soil floors (comparison group) to see if concrete floors reduce the rate of perinatal death and child death up the 6 years post-intervention.

This study will extend an ongoing NIH-funded randomized trial in which households with soil floors where a pregnant woman resided were randomly chosen to receive a concrete floor intervention or to retain their existing soil floor. This study will track pregnancies, births, and deaths among infants born to pregnant mothers in the original study to measure effects of household concrete flooring up to 6 years after the concrete floors were installed.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study extends follow-up of an interventional, randomized controlled trial that enrolled 800 households in rural Bangladesh with soil floors where a pregnant woman resided and randomized them 1:1 to receive a concrete floor or keep their existing soil floor (Cement flooRs AnD chiLd hEalth (CRADLE), NCT05372068). The original trial installed concrete floors in the intervention arm during their pregnancy and will measure the primary endpoint when children born to enrolled pregnant women (i.e., index children) reach age 2 years. This study extends follow-up to up to 6 years after concrete floors were installed to measure perinatal and child mortality among all children born to CRADLE-enrolled mothers during the study period, including index children and children born in subsequent pregnancies. For subsequent pregnancies occurring during the study period, research staff will visit study homes in the perinatal period to ascertain birth outcomes and child deaths. For index children previously enrolled in the CRADLE trial, research staff will ascertain child deaths by phone once per year. For each death identified during the study period, research staff will perform verbal and social autopsy, and cause of death will be classified using the International Classification of Diseases, 11th Revision (ICD-11).

Study Type

Interventional

Enrollment (Estimated)

196

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bangladesh
      • Dhaka, Bangladesh
        • International Centre for Diarrhoeal Disease Research, Bangladesh
        • Principal Investigator:
          • Md. Mahbubur Rahman, MBBS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Prior enrollment in the CRADLE trial (NCT05372068), in either arm, and currently residing in the original CRADLE-enrolled household
  • Residence in Sirajganj or Tangail districts in Bangladesh
  • No major non-compliance (e.g., no removal of concrete floor in intervention arm or installation of concrete floor in control arm)
  • No plan to relocate within the study follow-up period
  • Incident pregnancy occurring after CRADLE trial enrollment, confirmed after 26 weeks gestation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Non-intervention
Experimental: Concrete household floor
Household soil floors will be replaced with concrete floors
Other: Concrete household floor
Household soil floors will be replaced with concrete floors

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Extended perinatal mortality rate
Time Frame: Up to 6 years post-intervention delivery in parent study
Total number of stillbirths (babies born following fetal deaths at 22 weeks or later gestation) and neonatal deaths within the first 28 days after birth divided by the number of total births (live births + stillbirths)
Up to 6 years post-intervention delivery in parent study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stillbirth rate
Time Frame: Up to 6 years post-intervention delivery in parent study
Total number of stillbirths (babies born following fetal deaths at 22 weeks or later gestation) divided by the number of total births (live births + stillbirths)
Up to 6 years post-intervention delivery in parent study
Early neonatal mortality rate
Time Frame: Up to 6 years post-intervention delivery in parent study
Total number of deaths occurring in the first 7 days of life divided by the number of live births
Up to 6 years post-intervention delivery in parent study
Neonatal mortality rate
Time Frame: Up to 6 years post-intervention delivery in parent study
Total number of deaths occurring in the first 28 days of life divided by the number of live births
Up to 6 years post-intervention delivery in parent study
Infant mortality rate
Time Frame: Up to 6 years post-intervention delivery in parent study
Total deaths prior to age 12 months among live births divided by total live births
Up to 6 years post-intervention delivery in parent study
Child mortality rate
Time Frame: Up to 6 years post-intervention delivery in parent study
Total deaths at any age among live births divided by total live births
Up to 6 years post-intervention delivery in parent study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

International Centre for Diarrhoeal Disease Research, Bangladesh
Thrasher Research Fund
North Carolina State University
Directorate General of Health Services, Bangladesh

Investigators

  • Principal Investigator: Jade Benjamin-Chung, PhD MPH, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

March 1, 2029

Study Completion (Estimated)

May 1, 2029

Study Registration Dates

First Submitted

May 27, 2026

First Submitted That Met QC Criteria

May 27, 2026

First Posted (Actual)

June 2, 2026

Study Record Updates

Last Update Posted (Actual)

July 1, 2026

Last Update Submitted That Met QC Criteria

June 27, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 86289
  • 03001 (Other Grant/Funding Number: Thrasher Foundation)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All human subjects data will be de-identified and published. Identifiers that will be removed include participant names, address, date of birth, and geocoordinates. All data will be made available at the individual level (outcomes, covariates) or household level (in the case of the household survey variables, i.e. wealth).

IPD Sharing Time Frame

De-identified data will be made publicly available within 2 years of the end of the study or at the time of publication, whichever is sooner.

IPD Sharing Access Criteria

To be determined

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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