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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Abortion Complication

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 Type: Observational
• Enrollment (Anticipated): 2500

Contacts and Locations

Study Locations

• Central African Republic
  • Bangui, Central African Republic
    • Castor Maternity Center
• Congo, The Democratic Republic of the
  • Masisi, Congo, The Democratic Republic of the
    • Maternity center of the Hopital General de Référence
• Nigeria
  • Jahun, Nigeria
    • Maternity center of the general Jahun Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

All women presenting to the wards of the study sites which see women presenting for PAC (emergency unit, gyn/obs units, ICU unit, PAC unit, etc. according to site).

The provider in charge of the service providing post-abortion care, in each study sites, will be the key-informant who will answer the rapid facility assessment questionnaire.

All health professionals involved in PAC and SAC services will be proposed to participate in the KAPB survey

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Quantitative observational descriptive study; among women presenting for abortion-related complications
Qualitative study; among women with a near-miss or a potentially life-threatening complication
Rapid health facility assessment with the health professional; in charge of Post-Abortion Care
Knowledge Attitudes, Practice and Behavior quantitative survey; among health care providers involved in the management of abortion-related complications

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
Quantitative observational descriptive study: medical record review+quantitative interviews:	Proportion of each induced abortion method used	Between september 2019 and February 2021
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
Qualitative study (qualitative in-depth interviews):	Description of the woman pathway to care	Between september 2019 and February 2021
Qualitative study (qualitative in-depth interviews):	Description of perceptions and opinions about their own experience	Between september 2019 and February 2021
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
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

Collaborators and Investigators

• Sponsor: Epicentre
• Collaborators: Medecins Sans Frontieres, Netherlands; Ipas; Guttmacher Institute
• Investigators: Study Director: FETTERS Tamara, Ipas; Study Director: PASQUIER Estelle, Epicentre

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 3, 2019
• Primary Completion (ACTUAL): March 15, 2021
• Study Completion (ANTICIPATED): December 1, 2021

Study Registration Dates

• First Submitted: January 14, 2020
• First Submitted That Met QC Criteria: March 31, 2020
• First Posted (ACTUAL): April 2, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 11, 2021
• Last Update Submitted That Met QC Criteria: October 8, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Abortion; Risks factors; Maternal health; Maternal mortality; Near-miss
• Other Study ID Numbers: Elrha-R2HC; 509 (Guttmatcher Institute); 18110 (OTHER: MSF ERB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: A Memorandum of Understanding includes a chapter on data sharing agreement (DSA) between each of the partners (MSF-Epicentre/Ipas/Guttmacher) has been signed.
• IPD Sharing Time Frame: From June 2020 to December 2021
• IPD Sharing Access Criteria: Partners of the study
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No