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

• Conditions: Abortion Complication

• Registration Number: NCT04331847
• Lead Sponsor: Epicentre

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.

Study Timeline

• Study Start: 2019-09-03
• Study First Submitted: 2020-01-14
• Study First Submitted QC: 2020-03-31
• Study First Posted: 2020-04-02
• Primary Completion: 2021-03-15
• Status Verified: 2021-06
• Last Update Submitted: 2021-10-08
• Last Update Posted: 2021-10-11
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 2500

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
From the Quantitative observational descriptive study:	Between september 2019 and February 2021	Proportion of near-miss cases among all women presenting for abortion-related complications.

Secondary Outcome Measures

Name	Time	Method
Quantitative observational descriptive study: medical record review+quantitative interviews:	Between september 2019 and February 2021	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
Knowledge Attitude Practice and Behavior (KAPB) survey:	Between september 2019 and February 2021	Proportion of each knowledge, attitude and practice of health facility staff related to Post Abortion Care and Safe Abortion Care
Qualitative study (qualitative in-depth interviews):	Between september 2019 and February 2021	Description of conditions and factors that could contribute to the potentially life-threatening conditions and near-miss event.

Trial Locations

Locations (3)

Maternity center of the Hopital General de Référence; 🇨🇩 Masisi, Congo, The Democratic Republic of the

Castor Maternity Center; 🇨🇫 Bangui, Central African Republic

Maternity center of the general Jahun Hospital; 🇳🇬 Jahun, Nigeria