Abortion Complication Clinical Trial
— AMoCoOfficial title:
AMoCo Study: Abortion-related Morbidity and Mortality in Conflict-affected and Fragile Settings Study
| Verified date | June 2021 |
| Source | Epicentre |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Active, not recruiting |
| Enrollment | 2500 |
| Est. completion date | December 2021 |
| Est. primary completion date | March 15, 2021 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | N/A and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Central African Republic | Castor Maternity Center | Bangui | |
| Congo, The Democratic Republic of the | Maternity center of the Hopital General de Référence | Masisi | |
| Nigeria | Maternity center of the general Jahun Hospital | Jahun |
| Lead Sponsor | Collaborator |
|---|---|
| Epicentre | Guttmacher Institute, Ipas, Medecins Sans Frontieres, Netherlands |
Central African Republic, Congo, The Democratic Republic of the, Nigeria,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | Quantitative observational descriptive study: medical record review+quantitative interviews: | Proportion of each induced abortion method used | Between september 2019 and February 2021 | |
| Secondary | 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 | |
| Secondary | Qualitative study (qualitative in-depth interviews): | Description of the woman pathway to care | Between september 2019 and February 2021 | |
| Secondary | Qualitative study (qualitative in-depth interviews): | Description of perceptions and opinions about their own experience | Between september 2019 and February 2021 | |
| Secondary | 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 | |
| Secondary | 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 |