NCT04331847Unknown不适用
AMoCo Study: Abortion-related Morbidity and Mortality in Conflict-affected and Fragile Settings Study
适应症
试验速览
- 阶段
- 不适用
- 发起方
- Epicentre
- 入组人数
- 2,500
- 试验地点
- 3
- 主要终点
- From the Quantitative observational descriptive study:
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
From the Quantitative observational descriptive study:
时间窗: Between september 2019 and February 2021
Proportion of near-miss cases among all women presenting for abortion-related complications.
次要结局
- Quantitative observational descriptive study: medical record review+quantitative interviews:(Between september 2019 and February 2021)
- Knowledge Attitude Practice and Behavior (KAPB) survey:(Between september 2019 and February 2021)
- Qualitative study (qualitative in-depth interviews):(Between september 2019 and February 2021)
研究者
研究点 (3)
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