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临床试验/NCT04331847
NCT04331847Unknown不适用

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

Epicentre3 个研究点 分布在 3 个国家目标入组 2,500 人开始时间: 2019年9月3日最近更新:
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:

  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.

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

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

发起方
Epicentre
申办方类型
Other
责任方
Sponsor

研究点 (3)

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