NCT06466512

Brief Summary

Background (brief):

  1. 1.Burden: Maternal and neonatal mortality continue to be a serious public health problem in Bangladesh. Facility-based healthcare services reduce the probability of preventable causes of maternal and neonatal death. Community clinics (CCs) are located closer to the community than other healthcare facilities are. However, only 2.8% of all CCs are ready to provide antenatal care (ANC) and 2.4% of these facilities are ready to provide delivery services. Despite the wide acceptance of midwifery care for ANC and delivery services, they are posted only up to the Upazila Health Complexes and at selected Union Health and Family Welfare Centers.
  2. 2.Knowledge gap: There is a dearth of evidence on whether the utilisation of ANC, normal vaginal delivery, and postnatal care (PNC) services can be increased if midwives are assigned to CCs to provide these services.
  3. 3.Relevance: Midwives were trained to provide antenatal and postnatal care, conduct normal deliveries, and manage CC-specific pregnancy-related complications. Midwives are posted up to union-level facilities, and the Government of Bangladesh has a strategic plan to enable selective community clinics for normal delivery services in addition to antenatal and postnatal care.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2024

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

June 9, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 20, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2026

Completed
Last Updated

June 20, 2024

Status Verified

May 1, 2024

Enrollment Period

1.5 years

First QC Date

June 9, 2024

Last Update Submit

June 13, 2024

Conditions

Keywords

Midwife, community clinic, maternal health, newborn health, feasibility

Outcome Measures

Primary Outcomes (1)

  • Fesibility of the midwifery-embodied community clinic model

    We will measure feasibility using qualitative method of data collection. We will conduct in-depth interviews and key-informant interviews to understand the extent to which the midwifery-led care in the primary level of healthcare facility (community clinic) can be introduced

    Immediately after the intervention

Secondary Outcomes (5)

  • Acceptability of midwifery-embodied community clinic model

    Immediately after the intervention

  • Appropriateness of midwifery-embodied community clinic model

    Immediately after the intervention

  • Fidelity of midwifery-embodied community clinic model

    Immediately after the intervention

  • Barriers and enablers of midwifery-embodied community clinic model

    Immediately after the intervention

  • Proportion of women and newborns with a history of birth in last one year received maternal and newborn healthcare

    Immediately after the intervention

Study Arms (1)

Implementation

EXPERIMENTAL

Pregnant women, women who needs to delivery done, and recently delivered women to received ANC, delivery, and postnatal care

Behavioral: Midwifery-embodied care

Interventions

The midwife will provide ANC, delivery and PNC. The Community Healthcare Provider, Health Assistants will act as auxillary staff. Local transports will be integrated into the system. Coordination committee will see through that the interventions are carried out properly.

Implementation

Eligibility Criteria

Age10 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Pregnant women or have a history of childbirth within one year of the survey period
  • The participants must be living in the catchment areas of the Delua and Sonapur Community Clinics of Narua and Nawabpur unions of the Baliakandi sub-district of Rajbari district
  • Healthcare providers of the selected community clinics (midwife, CHCP, HA, and FWA)
  • UH\&FPO, and focal person of the community group and community support group
  • Policymakers from Maternal Health Programme, MNC\&AH, DGHS and Maternal Health, DGFP
  • Technical experts of the Obstetrical and Gynaecological Society of Bangladesh (OGSB)

You may not qualify if:

  • \. Respondents who will not give consent to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Maternal Death

Condition Hierarchy (Ancestors)

Parental DeathDeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2024

First Posted

June 20, 2024

Study Start

August 1, 2024

Primary Completion

January 31, 2026

Study Completion

January 31, 2026

Last Updated

June 20, 2024

Record last verified: 2024-05