Introduction of Preconception Care Through Public Health System for Improving MNCH&FP

NCT06175520 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2500

Last updated 2023-12-19

No results posted yet for this study

Summary

The goal of this study is to test the feasibility and acceptability of introducing preconception care into the public health system targeting newlywed couples in increasing the uptake of maternal, neonatal health, and family planning services. The Investigators will follow a cluster randomized controlled trial design to implement this study. Twenty-four of the 30 clusters will be selected based on similar characteristics, then will be randomized into intervention and control arms prior to enrollment of the study participants. Therefore, there will be 12 clusters under each arm. Eligible participants from both arms will be surveyed at baseline and 3, 6, 9, 12, 15, 18, 21- and 24-month follow-ups. So, all the newly married couples both in intervention and comparison areas will be followed up prospectively and periodically. The Investigators will introduce preconception care to the existing government health system to ensure healthy pregnancy as well as to improve maternal, child, and adolescent health. For this study, The Investigators propose a package of preconception care interventions such as: screening for nutrition conditions, tobacco use, genetic condition, environmental health, infertility/ sub-fertility, family planning counseling and services, infectious diseases, and Vaccinations.

Conditions

  • Feasibility
  • Acceptability of Health Care

Interventions

BEHAVIORAL

Preconception care (PCC)

The investigators will introduce PCC through the existing public health system. At the community level facility, healthcare providers will screen the women for some specific health problems and provide necessary supplements. Healthcare providers will screen for health problems such as- infectious diseases (e.g., Tuberculosis), Hypertension, Anaemia, Diabetes Mellitus, Thyroid problems, Sexually Transmitted Infection/Reproductive Tract Infection/Urinary Tract Infection, Nutritional status (e.g., Body mass index), Thalassemia symptoms, Thyroid symptoms, severe Dysmenorrhea, Immunization status, and Symptoms of acute Hepatitis B Virus infection, etc. The provider will also consider age, menstrual history, and reproductive history during preconception screening. If the provider finds any abnormality from the screening test which is a risk for a woman to become pregnant and for her newborn; the woman will be provided proper counseling, treatment, and referral to the appropriate facility.

Sponsors & Collaborators

  • International Centre for Diarrhoeal Disease Research, Bangladesh

    lead OTHER
  • Directorate General of Family Planning, Minstry of Health and Family Welfare, Bangladesh

    collaborator UNKNOWN
  • Directorate General of Health Services, Minstry of Health and Family Welfare, Bangladesh

    collaborator UNKNOWN
  • UNFPA

    collaborator UNKNOWN
  • FCDO

    collaborator UNKNOWN

Principal Investigators

  • Bidhan Krishna Sarker, MSS, MPH · International Centre for Diarrhoeal Disease Research, Bangladesh

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
15 Years
Max Age
20 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-01
Primary Completion
2024-12-31
Completion
2025-06-30

Countries

  • Bangladesh

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06175520 on ClinicalTrials.gov