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

E

Epicentre

Status

Unknown

Conditions

Abortion Complication

Study type

Observational

Funder types

Other

Identifiers

NCT04331847
Elrha-R2HC
509
18110 (Other Identifier)

Details and patient eligibility

About

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.

Full description

Multi-sites mixed-methods study with 4 components:

  1. A quantitative observational descriptive study among women presenting for abortion-related complications to determine the frequency and severity of abortion-related complications including near-miss cases and death. Data will be collected through a medical records review and a quantitative survey among women presenting for abortion-related complications to determine the sociodemographic and clinical characteristics of the women with abortion-related complications, the type of abortion, the type and severity of complications and the clinical management received. It will also give insight into the characteristics of near-miss events following unsafe abortion.
  2. A qualitative study about women's experiences associated with a near-miss event (and potentially life threatening): their pathway of access to care including their decision-making process, their own perceptions and opinions and other factors or conditions that might contribute to the near-miss event (in-depth face to face interviews).
  3. A rapid health facility assessment with the health professional in charge of Post-Abortion Care will complement the assessment of the quality of management of complications
  4. A Knowledge Attitudes, Practice and Behavior quantitative survey among health care providers involved in the management of abortion-related complications will identify provider-associated factors that may contribute to near-miss events.

Enrollment

2,500 estimated patients

Sex

Female

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

MEDICAL RECORD REVIEW:

Inclusion Criteria:

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

Exclusion Criteria:

  • 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:

Inclusion criteria: all women included in the medical record review subcomponent and hospitalized (who stayed overnight or more)

Exclusion criteria:

Participation to the interview as potentially harmwful to the woman according to her health care provider, Refusal to participate.

QUALITATIVE INTERVIEW:

Inclusion criteria: Women eligible for the quantitative interview and who experienced at least 1 criterion of near-miss event or potentially life-threatening conditions

Exclusion criteria:

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:

Inclusion criteria:

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

Exclusion criteria:

Refusal to participate.

Trial design

2,500 participants in 4 patient groups

Quantitative observational descriptive study
Description:
among women presenting for abortion-related complications
Qualitative study
Description:
among women with a near-miss or a potentially life-threatening complication
Rapid health facility assessment with the health professional
Description:
in charge of Post-Abortion Care
Knowledge Attitudes, Practice and Behavior quantitative survey
Description:
among health care providers involved in the management of abortion-related complications

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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