Observational Mondkeypox Pregnancy Cohort

NCT06442501 | Not Yet Recruiting

• 1 other identifier: University of Antwerp
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

PREGMPOXCO study addresses the escalating Mpox virus (MPXV) infections among pregnant women in South Kivu, DRC following a novel MPXV sub-lineage, predominantly transmitted through heterosexual contact, stressing critical gaps in our understanding of MPXV's impact on pregnant populations. To better understand this altered transmission pattern of MPXV and its impact on this vulnerable population, PREGMPOX will employ both passive and active surveillance techniques to methodologically capture MPXV incidence among pregnant women over two years, integrating data from routine antenatal care and targeted community outreach to timely assess the MPXV's effects on maternal and neonatal health. In sentinel study sites in hot spot areas, the incidence of mpox among pregnant women will be investigated and potential transmission routes determined. MPXV(+) pregnant women will be asked to participate in a cohort study where they will be followed until delivery to document pregnancy outcomes (e.g.: miscarriage, stillbirths, preterm deliveries, neonatal mpox), maternal immune response, virus abundance and pathological changes in the placenta. This will help to determine specific risk factors and modes and frequencies of vertical transmission to the unborn, and generate a list of clinical and immunological predictors for adverse outcomes for pregnant women and neonates. Data on MVA-BN exposure will also be captured to report on its real world effectiveness. As a prerequisite to evaluate the safety of the MVA-BN vaccine and tecovirimat treatment in pregnant women according to the new DRC guidelines, we will establish a comprehensive register of adverse pregnancy outcomes, using a pharmacovigilance model to monitor and analyse adverse events following immunization and treatment. The results of our multidisciplinary studies will be crucial for developing guidelines and recommendations to manage mpox more effectively during pregnancy, and for potentially influencing global health policies.

Conditions

Monkey Pox

Outcome Measures

Primary Outcomes (1)

• pregnancy outcome

  health of the mother and child

  at delivery

Study Arms (2)

MPXV infected pregnant women

MPXV infected pregnant women

Other: routine care

Not MPXV infected pregnant women

Not MPXV infected pregnant women

Other: routine care

Interventions

routine care OTHER

routine care

MPXV infected pregnant women; Not MPXV infected pregnant women

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women in the South Kivu province of the DRC at risk for mpox

You may qualify if:

• \. Pregnancy status: all women confirmed to be pregnant at the time of recruitment.
• \. Age: women of all age (ascent to be asked for non-legal age to allow for the pair mother-child to benefit with earlier diagnosis and other befit the study might offer).
• \. Symptomatic and asymptomatic participation:
• Symptomatic: pregnant women presenting with symptoms suggestive of mpox, such as fever, rash/skin lesion, or lymphadenopathy.
• Asymptomatic: pregnant women attending routine antenatal visits who do not exhibit symptoms but are screened as part of the study's surveillance efforts or who report a confirmed case of mpox in the household/or among closed contacts 5. Consent: women who provide written informed consent to participate in the study, having understood the purpose, procedures, potential risks, and benefits of the study.

You may not qualify if:

• \. Plans to relocate: women who plan to move out of the geographical study area during the study period, which would interfere with follow-up.
• \. Participation in other studies: women currently participating in other clinical trials that might interfere with the results of this study, especially trials involving new experimental treatments for mpox or other infectious diseases.

Sponsors & Collaborators

• Robert Colebunders: lead
• Patrick Kototo: collaborator

Biospecimen

Retention: SAMPLES WITH DNA

skin and mucosal swabs, blood, placenta

MeSH Terms

Conditions

Mpox, Monkeypox

Condition Hierarchy (Ancestors)

Poxviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Primate Diseases; Animal Diseases; Rodent Diseases

Central Study Contacts

Robert Colebunders, MD, PhD

CONTACT

0486920149; robert.colebunders@uantwerpen.be

Joseph Siewe Fodjo, MD, PhD

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: May 29, 2024
• First Posted: June 4, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: June 4, 2024

Record last verified: 2024-05