Abortion-related Morbidity and Mortality in Conflict-affe... | NCT04331847

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

NCT04331847

Sponsor

Epicentre

Status

Unknown status

Last Update Posted

Oct 11, 2021Actual

Enrollment

2,500Estimated

Phase

Not provided

Conditions

Abortion Complication

Interventions

Not provided

Countries

Central African Republic
Democratic Republic of the Congo
Nigeria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
509	Other Identifier	Guttmatcher Institute
18110	Other Identifier	MSF ERB

Status Module

Record Verification Date

Jun 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 3, 2019Actual

Primary Completion Date

Mar 15, 2021Actual

Completion Date

Dec 2021Estimated

First Submitted Date

Jan 14, 2020

First Submission Date that Met QC Criteria

Mar 31, 2020

First Posted Date

Apr 2, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 8, 2021

Last Update Posted Date

Oct 11, 2021Actual

Name	Class
Ipas	OTHER
Guttmacher Institute	OTHER
Medecins Sans Frontieres, Netherlands	OTHER

Description Module

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:

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.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

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 Outcomes

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:

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder 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

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
FETTERS Tamara	Ipas	Study Director
PASQUIER Estelle	Epicentre	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Castor Maternity Center		Bangui			Central African Republic
Maternity center of the Hopital General de Référence

ID	Term
D063129	Parental Death
D003643	Death
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms