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

Study Overview
=================
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: 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. 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). 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 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.

Official Title
-----------------
AMoCo Study: Abortion-related Morbidity and Mortality in Conflict-affected and Fragile Settings Study

Conditions
-----------------
Abortion Complication

Participation Criteria
=================
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.
Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Quantitative observational descriptive study<br>among women presenting for abortion-related complications | |
| Qualitative study<br>among women with a near-miss or a potentially life-threatening complication | |
| Rapid health facility assessment with the health professional<br>in charge of Post-Abortion Care | |
| Knowledge Attitudes, Practice and Behavior quantitative survey<br>among health care providers involved in the management of abortion-related complications | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantitative observational descriptive study: medical record review+quantitative interviews: | Facility-based abortion-related complications ratio per annum for the following denominators: live births, all admissions and deliveries | Between september 2019 and February 2021 | 
| Quantitative observational descriptive study: medical record review+quantitative interviews: | Facility-based abortion-related near-miss ratio per annum for the following denominators: live births, abortion-related admissions, all admissions and deliveries | Between september 2019 and February 2021 | 
| Quantitative observational descriptive study: medical record review+quantitative interviews: | Facility-based abortion-related mortality ratio per annum for the following denominators: live births, abortion-related admissions, all admissions and deliveries | Between september 2019 and February 2021 | 
| Quantitative observational descriptive study: medical record review+quantitative interviews: | Facility-based abortion-related severe maternal outcome ratio: the number of women with severe abortion-related maternal outcome (near-miss + death) per 1000 live births (LB) | Between september 2019 and February 2021 | 
| Quantitative observational descriptive study: medical record review+quantitative interviews: | Facility-based abortion-related near-miss mortality ratio: ratio between abortion-related near- miss cases and abortion-related deaths | Between september 2019 and February 2021 | 
| Quantitative observational descriptive study: medical record review+quantitative interviews: | Facility-based abortion-related mortality index : number of abortion-related maternal deaths divided by the number of women with abortion-related severe maternal outcome expressed as a percentage | Between september 2019 and February 2021 | 
| Quantitative observational descriptive study: medical record review+quantitative interviews: | Proportional morbidity: proportion of each type of abortion-related complication among all complications | Between september 2019 and February 2021 | 
| Quantitative observational descriptive study: medical record review+quantitative interviews: | Proportion of women disclosing or presenting signs of induced abortion attempt | Between september 2019 and February 2021 | 
| Quantitative observational descriptive study: medical record review+quantitative interviews: | Proportion of each induced abortion method used | Between september 2019 and February 2021 | 
| Quantitative observational descriptive study: medical record review+quantitative interviews: | Risk factors (socio-demographic characteristics, obstetrical history, induced abortion, displacement/exposure to conflict, exposure to violence, delay in accessing care) associated with abortion related near-miss events | Between september 2019 and February 2021 | 
| Qualitative study (qualitative in-depth interviews): | Description of the woman pathway to care | Between september 2019 and February 2021 | 
| Qualitative study (qualitative in-depth interviews): | Description of perceptions and opinions about their own experience | Between september 2019 and February 2021 | 
| Qualitative study (qualitative in-depth interviews): | Description of conditions and factors that could contribute to the potentially life-threatening conditions and near-miss event. | Between september 2019 and February 2021 | 
| Knowledge Attitude Practice and Behavior (KAPB) survey: | Proportion of each knowledge, attitude and practice of health facility staff related to Post Abortion Care and Safe Abortion Care | Between september 2019 and February 2021 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Near-miss, Risks factors, Maternal health, Abortion, Maternal mortality