Abortion ComplicationAMoCoNCT04331847
Abortion-related Morbidity and Mortality in Conflict-affected and Fragile Settings Study
An observational study of Abortion Complication, run by Epicentre at 3 sites in 3 countries.
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… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Abortion Complication
- How many people
- 2,500 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 3 Sep 2019to Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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
- 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
Who cannot join
- 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)
- Participation to the interview as potentially harmwful to the woman according to her health care provider, Refusal to participate.
Show all 13Show fewer
- 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
- 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:
- Refusal to participate.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Central African Republic1 site
Castor Maternity Center
Bangui
Democratic Republic of the Congo1 site
Maternity center of the Hopital General de Référence
Masisi
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Abortion Complication
- Keywords
- Near-miss, Risks factors, Maternal health, Abortion, Maternal mortality
- Medical subject headings
- Maternal Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
From the Quantitative observational descriptive study:
Proportion of near-miss cases among all women presenting for abortion-related complications.
Measured: Between september 2019 and February 2021
Secondary outcomes (14)
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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Between september 2019 and February 2021
Quantitative observational descriptive study: medical record review+quantitative interviews:
Proportion of each induced abortion method used
Measured: 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
Measured: Between september 2019 and February 2021
Qualitative study (qualitative in-depth interviews):
Description of the woman pathway to care
Measured: Between september 2019 and February 2021
Qualitative study (qualitative in-depth interviews):
Description of perceptions and opinions about their own experience
Measured: 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.
Measured: 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
Measured: Between september 2019 and February 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2020
- Study start3 Sep 2019
- Primary completion15 Mar 2021
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abortion ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Epicentre
- Sponsor type
- University, hospital or other
- Collaborators
- Ipas, Guttmacher Institute, Medecins Sans Frontieres, Netherlands
- Responsible party
- Sponsor
- Investigators
- FETTERS Tamara, Study director, IpasPASQUIER Estelle, Study director, Epicentre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04331847
- Sponsor's protocol ID
- Elrha-R2HC
- Other IDs
- 509, 18110
- Acronym
- AMoCo
- Status last verified
- Jun 2021
- First submitted
- 14 Jan 2020
- Last updated
- 11 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A Memorandum of Understanding includes a chapter on data sharing agreement (DSA) between each of the partners (MSF-Epicentre/Ipas/Guttmacher) has been signed.
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AMoCo Study: Abortion-related Morbidity and Mortality in Conflict-affected and Fragile Settings Study
- ClinicalTrials.gov ID
- NCT04331847
- Acronym / sponsor ID
- AMoCo / Elrha-R2HC
- Conditions
- Abortion Complication
- Keywords
- Near-miss, Risks factors, Maternal health, Abortion, Maternal mortality
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- EpicentreUniversity, hospital or other
- Collaborators
- Ipas, Guttmacher Institute, Medecins Sans Frontieres, Netherlands
- Study start
- 3 Sep 2019 (actual)
- Primary completion
- 15 Mar 2021 (actual)
- Study completion
- Dec 2021 (estimated)
- First posted
- 2 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
- 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
Key exclusion criteria (13 listed)
- 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
- Inclusion criteria: all women included in the medical record review subcomponent and hospitalized (who stayed overnight or more)
- Participation to the interview as potentially harmwful to the woman according to her health care provider, Refusal to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
From the Quantitative observational descriptive study:
Time frame: Between september 2019 and February 2021
Proportion of near-miss cases among all women presenting for abortion-related complications.
14 secondary outcomes
Quantitative observational descriptive study: medical record review+quantitative interviews:
Time frame: Between september 2019 and February 2021
Quantitative observational descriptive study: medical record review+quantitative interviews:
Time frame: Between september 2019 and February 2021
Quantitative observational descriptive study: medical record review+quantitative interviews:
Time frame: Between september 2019 and February 2021
Quantitative observational descriptive study: medical record review+quantitative interviews:
Time frame: Between september 2019 and February 2021
Quantitative observational descriptive study: medical record review+quantitative interviews:
Time frame: Between september 2019 and February 2021
Quantitative observational descriptive study: medical record review+quantitative interviews:
Time frame: Between september 2019 and February 2021
Quantitative observational descriptive study: medical record review+quantitative interviews:
Time frame: Between september 2019 and February 2021
Quantitative observational descriptive study: medical record review+quantitative interviews:
Time frame: Between september 2019 and February 2021
Quantitative observational descriptive study: medical record review+quantitative interviews:
Time frame: Between september 2019 and February 2021
Quantitative observational descriptive study: medical record review+quantitative interviews:
Time frame: Between september 2019 and February 2021
Qualitative study (qualitative in-depth interviews):
Time frame: Between september 2019 and February 2021
Qualitative study (qualitative in-depth interviews):
Time frame: Between september 2019 and February 2021
Qualitative study (qualitative in-depth interviews):
Time frame: Between september 2019 and February 2021
Knowledge Attitude Practice and Behavior (KAPB) survey:
Time frame: Between september 2019 and February 2021
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2021.
- Individual participant dataSharing planned: Yes. A Memorandum of Understanding includes a chapter on data sharing agreement (DSA) between each of the partners (MSF-Epicentre/Ipas/Guttmacher) has been signed.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
FETTERS Tamara study director
Ipas
PASQUIER Estelle study director
Epicentre
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abortion Complication, run by Epicentre at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Central African Republic, Democratic Republic of the Congo, Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
From the Quantitative observational descriptive study: (time frame: Between september 2019 and February 2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2021.