Abortion-related Morbidity and Mortality in Conflict-affected and Fragile Settings Study

NCT04331847 | Unknown

• 3 other identifiers: Elrha-R2HC50918110
• Study Type: observational
• Target: 2,500
• Locations: 3 countries
• Sites: 3

Brief Summary

To describe and estimate the burden of abortion-related complications, particularly near-miss complications and deaths, and their associated factors among women presenting for abortion-related complications in health facilities supported by Médecins Sans Frontières (MSF) in African fragile and/or conflict-affected settings.

Conditions

Abortion Complication

Keywords

Near-miss; Risks factors; Maternal health; Abortion; Maternal mortality

Outcome Measures

Primary Outcomes (1)

• From the Quantitative observational descriptive study:

  Proportion of near-miss cases among all women presenting for abortion-related complications.

  Between september 2019 and February 2021

Secondary Outcomes (14)

• Quantitative observational descriptive study: medical record review+quantitative interviews:

  Between september 2019 and February 2021

• Quantitative observational descriptive study: medical record review+quantitative interviews:

  Between september 2019 and February 2021

• Quantitative observational descriptive study: medical record review+quantitative interviews:

  Between september 2019 and February 2021

• Quantitative observational descriptive study: medical record review+quantitative interviews:

  Between september 2019 and February 2021

• Quantitative observational descriptive study: medical record review+quantitative interviews:

  Between september 2019 and February 2021

Study Arms (4)

Quantitative observational descriptive study

among women presenting for abortion-related complications

Qualitative study

among women with a near-miss or a potentially life-threatening complication

Rapid health facility assessment with the health professional

in charge of Post-Abortion Care

Knowledge Attitudes, Practice and Behavior quantitative survey

among health care providers involved in the management of abortion-related complications

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All women presenting to the wards of the study sites which see women presenting for PAC (emergency unit, gyn/obs units, ICU unit, PAC unit, etc. according to site). The provider in charge of the service providing post-abortion care, in each study sites, will be the key-informant who will answer the rapid facility assessment questionnaire. All health professionals involved in PAC and SAC services will be proposed to participate in the KAPB survey

You may qualify if:

• Women
• with any signs or symptoms of abortion-related complications, i.e. any signs or symptoms of complications of spontaneous or induced abortion, whatever the abortion stage: inevitable, missed, incomplete, complete abortion .
• Or with a presentation primary diagnosis of ectopic pregnancy or molar pregnancy

You may not qualify if:

• Threatened abortion (defined as vaginal bleeding with a closed cervix after having excluded the diagnosis of ectopic pregnancy or molar pregnancy)
• History of abortion-related complications and presenting for an unrelated issue
• Refusal to participate
• QUANTITATIVE INTERVIEW:
• Participation to the interview as potentially harmwful to the woman according to her health care provider, Refusal to participate.
• QUALITATIVE INTERVIEW:
• Participation to the interview as potentially harmwful to the woman according to her health care provider, Refusal to participate.
• RAPID FACILITY ASSESSMENT:
• Key-informant: the provider in charge of the service providing post-abortion care
• KAPB SURVEY:
• Health professionals (i.e. doctors, midwives, clinical officers, medical officers, nurses, aidmidwives, aid-nurses) involved in PAC and SAC services in the study site health facility Literate
• Refusal to participate.

Sponsors & Collaborators

• Epicentre: lead
• Ipas: collaborator
• Guttmacher Institute: collaborator
• Medecins Sans Frontieres, Netherlands: collaborator

Study Sites (3)

Castor Maternity Center

Bangui, Central African Republic

Location

Maternity center of the Hopital General de Référence

Masisi, Democratic Republic of the Congo

Location

Maternity center of the general Jahun Hospital

Jahun, Nigeria

Location

MeSH Terms

Conditions

Maternal Death

Condition Hierarchy (Ancestors)

Parental Death; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• FETTERS Tamara

  Ipas

  STUDY DIRECTOR

• PASQUIER Estelle

  Epicentre

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2020
• First Posted: April 2, 2020
• Study Start: September 3, 2019
• Primary Completion: March 15, 2021
• Study Completion: December 1, 2021
• Last Updated: October 11, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: From June 2020 to December 2021
• Access Criteria: Partners of the study

Locations

DE (1); NG (1); CE (1)