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

NCT06175520 | Unknown

• 1 other identifier: PR-21032
• Study Type: interventional
• Target: 2,500
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Preconception Care; Health System; Maternal Health; Family Planning; Adolescent Pregnancy

Outcome Measures

Primary Outcomes (4)

• Through baseline and end line questionnaire survey the study will assess the rate of knowledge and practices are increased in terms of modern FP methods among newlywed women

  To determine the improvement status of respondent's knowledge and uptake of family planning methods, the investigators anticipating 25% improvement from baseline to end line.

  "through study completion, an average of 1 and half years"

• Through baseline and end line questionnaire the study will assess the frequency of pregnancy related complications are reduced

  How much pregnancy related complications are reduced will be assessed among the women who received preconception care compared to who did not receive preconception care.

  "through study completion, an average of 1 and half years"

• Through baseline and end line questionnaire survey the study will assess the percentage of study participants have proper knowledge about skilled MNCH services

  How much knowledge for skilled MNCH care are increased will be measured from among the women who received preconception care and who did not receive preconception care. The investigators are anticipating 25% improvement from baseline to end line

  "through study completion, an average of 1 and half years"

• Through baseline and end line questionnaire survey the study will assess the proportion of recently delivered women utilized skilled ANC, DC, and PNC services

  To determine the Antenatal care (ANC), Delivery care (DC) and Postnatal care (PNC) uptake by skilled provider, the investigators will follow the criteria of Bangladesh Demographic and Health Survey (BDHS).

  "through study completion, an average of 1 and half years"

Secondary Outcomes (2)

• Through baseline and end line questionnaire survey the study will assess the rate of delaying first birth among the study participants'

  "through study completion, an average of 1 and half years"

• Through baseline and end line questionnaire survey the study will assess the rate of unintended pregnancy among the study participants'

  "through study completion, an average of 1 and half years"

Study Arms (2)

Preconception care (PCC) intervention

EXPERIMENTAL

There will be 12 clusters under the PCC intervention arm. Eligible participants (newlywed women) in PCC intervention areas will be followed up prospectively. The investigators will enroll around 2,500 participants residing in the study area and with no intention to relocate in the next 2 years. Under this arm, all the relevant healthcare providers and their line managers will be provided training on preconception care. Healthcare providers will enroll the participants using their couple registrars to provide preconception care.

Behavioral: Preconception care (PCC)

Comparison area

NO INTERVENTION

There will be 12 clusters under the comparison arm. Eligible participants will receive services through the existing health system.

Interventions

Preconception care (PCC) BEHAVIORAL

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.

Preconception care (PCC) intervention

Eligibility Criteria

• Age: 15 Years - 20 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Newlywed couples who are under 20 years of age

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead
• Directorate General of Family Planning, Minstry of Health and Family Welfare, Bangladesh: collaborator
• Directorate General of Health Services, Minstry of Health and Family Welfare, Bangladesh: collaborator
• UNFPA: collaborator
• FCDO: collaborator

Study Sites (1)

International Centre for Diarrhoeal Disease Research, Bangladesh

Dhaka, 1212, Bangladesh

Location

MeSH Terms

Conditions

Patient Acceptance of Health Care

Interventions

Preconception Care

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Maternal Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Women's Health Services

Study Officials

• Bidhan Krishna Sarker, MSS, MPH

  International Centre for Diarrhoeal Disease Research, Bangladesh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Under this model, eligible participants (newlywed married women) from each of the intervention clusters (union catchment area considered as a cluster) will be provided preconception care by community-based healthcare providers. To provide preconception care and counseling the investigators will involve different strategies which include counseling by the Marriage registrar, use of digital platforms to deliver messages, distribution of FP methods, PCC card, and MCH handbook intervention clusters. Overall the intervention components will be evaluated in parallel against a comparison group.

Study Record Dates

• First Submitted: November 8, 2023
• First Posted: December 19, 2023
• Study Start: October 1, 2021
• Primary Completion: December 31, 2024
• Study Completion: June 30, 2025
• Last Updated: December 19, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After completion of study activities, summary tables of study results will be available on www.clinicaltrials.gov.
• Access Criteria: Log in www.clinicaltrials.gov

Locations

BA (1)