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Clinical Trials/NCT02886364
NCT02886364CompletedNot Applicable

Evaluation of the Adapted Safe Childbirth Checklist and Respectful Care in Rural Community Hospitals and Maternity Centers in Chiapas, Mexico: A Mixed Methods Convergent Intervention Study

Brigham and Women's Hospital0 sites575 target enrollmentStarted: September 1, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
575
Primary Endpoint
Adherence with evidence-based practices in the checklist

Study Overview

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. To evaluate the implementation of the adapted Safe Childbirth Checklist using quality of care indicators and the perspectives of providers and patients;
  2. To examine changes in the perceptions of disrespectful and respectful practices around childbirth among providers before and after a quality improvement program.
  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. 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

Detailed Description

This is a mixed methods convergent intervention study design. Quantitative and qualitative data will be collected and integrated to answer the specific aims above. There are 3 groups of people who will be approached to participate in this study:

  1. Obstetric providers at the maternity center in Revolución (approximately 7-15 people)
  2. Pregnant women who come to the maternity center or hospitals in Ángel Albino Corzo or Revolución to give birth from September 2016 - June 2017 (approximately 300 women, age >15 years old)
  3. Postpartum women who delivered in the maternity center or hospitals after September 2016 (approximately 30-40 women, age >15 years old) and their male partners (approximately 30-40 men, age >15 years old) who live in Partners In Health-affiliated communities

The quality improvement training program will center on coaching around the adapted Safe Childbirth Checklist. This document contains reminders for evidence-based practices during childbirth, and it has been adapted to the context in Mexico. Only standard of care practices will be taught and employed at the maternity center. The quality improvement program has no additional intervention that would change diagnoses or management during peripartum care.

Risks to subjects are minimized by ensuring privacy in all research encounters. Additionally, research staff will not provide any clinical care to subjects, thereby dissociating participation in research from receiving clinical care.

There are no anticipated harms to the participants of this study that would compromise their safety because our quality improvement program does not introduce a new diagnostic test or treatment modality. The only foreseeable risk is emotional distress from discussing a potentially traumatic birth experience, which could occur with both healthcare providers and patients. The research team will undergo sensitization training in identifying signs of distress that may arise during the survey, interview, or focus group. They will be instructed to provide the appropriate mental health referrals if necessary. Partners In Health has a growing mental health program that can provide appropriate clinical accompaniment if required.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
15 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

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

Arms & Interventions

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.

Intervention: Adapted Safe Childbirth Checklist (Behavioral)

Outcomes

Primary Outcomes

Adherence with evidence-based practices in the checklist

Time Frame: 10 months

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

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

Time Frame: 10 months

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

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

Time Frame: 10 months

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Daniel Palazuelos

Associate Physician

Brigham and Women's Hospital

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