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

Abortion Complication Clinical Trial

— AMoCo  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04331847
• Other study ID #: Elrha-R2HC
• Secondary ID: 50918110
• Status: Active, not recruiting
• Start date: September 3, 2019
• Est. completion date: December 2021

Study information

• Verified date: June 2021
• Source: Epicentre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Abortion Complication

Locations

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

Sponsors (4)

Lead Sponsor	Collaborator
Epicentre	Guttmacher Institute, Ipas, Medecins Sans Frontieres, Netherlands

Countries where clinical trial is conducted

Central African Republic,  Congo, The Democratic Republic of the,  Nigeria, 

Outcome

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