Clinical trial NCT04331847: Abortion-related Morbidity and Mortality in Conflict-affected and Fragile Settings Study
Official title: AMoCo Study: Abortion-related Morbidity and Mortality in Conflict-affected and Fragile Settings Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Abortion Complication
Keywords: Near-miss
Risks factors
Maternal health
Abortion
Maternal mortality
Lead sponsor: Epicentre
Sponsor class: OTHER
Collaborators: name: Ipas
name: Guttmacher Institute
name: Medecins Sans Frontieres, Netherlands
First posted: 2020-04-02
Enrollment: 2500
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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

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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: From the Quantitative observational descriptive study:
timeFrame: Between september 2019 and February 2021
Secondary outcomes:
measure: Quantitative observational descriptive study: medical record review+quantitative interviews:
timeFrame: Between september 2019 and February 2021
measure: Quantitative observational descriptive study: medical record review+quantitative interviews:
timeFrame: Between september 2019 and February 2021
measure: Quantitative observational descriptive study: medical record review+quantitative interviews:
timeFrame: Between september 2019 and February 2021
measure: Quantitative observational descriptive study: medical record review+quantitative interviews:
timeFrame: Between september 2019 and February 2021
measure: Quantitative observational descriptive study: medical record review+quantitative interviews:
timeFrame: Between september 2019 and February 2021
measure: Quantitative observational descriptive study: medical record review+quantitative interviews:
timeFrame: Between september 2019 and February 2021
measure: Quantitative observational descriptive study: medical record review+quantitative interviews:
timeFrame: Between september 2019 and February 2021
measure: Quantitative observational descriptive study: medical record review+quantitative interviews:
timeFrame: Between september 2019 and February 2021
measure: Quantitative observational descriptive study: medical record review+quantitative interviews:
timeFrame: Between september 2019 and February 2021
measure: Quantitative observational descriptive study: medical record review+quantitative interviews:
timeFrame: Between september 2019 and February 2021
measure: Qualitative study (qualitative in-depth interviews):
timeFrame: Between september 2019 and February 2021
measure: Qualitative study (qualitative in-depth interviews):
timeFrame: Between september 2019 and February 2021
measure: Qualitative study (qualitative in-depth interviews):
timeFrame: Between september 2019 and February 2021
measure: Knowledge Attitude Practice and Behavior (KAPB) survey:
timeFrame: Between september 2019 and February 2021
Other outcomes:
Locations:
city: Bangui
country: Central African Republic
facility: Castor Maternity Center
city: Masisi
country: Congo, The Democratic Republic of the
facility: Maternity center of the Hopital General de Référence
city: Jahun
country: Nigeria
facility: Maternity center of the general Jahun Hospital
Study officials:
affiliation: Ipas
name: FETTERS Tamara
role: STUDY_DIRECTOR
affiliation: Epicentre
name: PASQUIER Estelle
role: STUDY_DIRECTOR
References: