NCT02886364

Brief Summary

The purpose of this mixed methods study is to evaluate the implementation of an adapted Safe Childbirth Checklist in a rural hospital in Chiapas, Mexico. The study aims are:

  1. 1.To evaluate the implementation of the adapted Safe Childbirth Checklist using quality of care indicators and the perspectives of providers and patients;
  2. 2.To examine changes in the perceptions of disrespectful and respectful practices around childbirth among providers before and after a quality improvement program.
  3. 3.To understand how postpartum women and their male partners perceive the care they received at the hospitals in Ángel Albino Corzo and Revolución with regard to disrespectful and respectful practices, and how, if at all, these experiences compare with prior birth experiences in other settings.
  4. 4.To examine trends in proportion of facility-based births in the catchment area of the hospital after the implementation of the adapted Safe Childbirth Checklist

Trial Health

100
On Track

Trial Health Score

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

Enrollment
575

participants targeted

Target at P75+ for not_applicable pregnancy

Timeline
Completed

Started Sep 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 1, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2017

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

November 4, 2024

Status Verified

November 1, 2024

Enrollment Period

10 months

First QC Date

August 28, 2016

Last Update Submit

November 1, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Perceptions of patient safety and quality of care from providers and patients

    Qualitative data will be collected through interviews of providers, postpartum women and their partners regarding their childbirth experiences in the district hospital where the adapted Safe Childbirth Checklist was implemented.

    10 months

  • Adherence with evidence-based practices in the checklist

    Quantitative data will be collected through key indicators in the checklist to capture uptake of best practices over time.

    10 months

  • Number of facility-based childbirths within Partners In Health-affiliated communities in the catchment area of hospital

    The proportions of facility-based births vs. home births will be compared pre- and post-implementation of the adapted Safe Childbirth Checklist.

    10 months

Study Arms (1)

Women delivered at AAC Hospital

OTHER

The intervention is only being implemented at the Ángel Albino Corzo Hospital due to limited funding. The site was selected by the Ministry of Health in Chiapas as a hospital that would benefit from improved quality of care around childbirth. There are no other arms in this study.

Behavioral: Adapted Safe Childbirth Checklist

Interventions

The World Health Organization has created and endorsed the WHO Safe Childbirth Checklist as a tool for improving quality of care around childbirth. This tool has been modified to the context in Mexico by another group of investigators at the National Institute of Public Health. Our team expanded the Mexican version of the WHO Safe Childbirth Checklist to include indicators around respectful maternity care.

Women delivered at AAC Hospital

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Women who delivered at Ángel Albino Corzo Hospital between September 2016 and June 2017
  • Women who live in Partners In Health-affiliated communities

You may not qualify if:

  • Index pregnancy that ended in miscarriage or stillbirth
  • Non-Spanish speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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
PRINCIPAL INVESTIGATOR
PI Title
Associate Physician

Study Record Dates

First Submitted

August 28, 2016

First Posted

September 1, 2016

Study Start

September 1, 2016

Primary Completion

June 30, 2017

Study Completion

May 1, 2018

Last Updated

November 4, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share