Observational Mondkeypox Pregnancy Cohort

Launched by ROBERT COLEBUNDERS · May 29, 2024

Keywords

ClinConnect Summary

The PREGMPOX study is a research trial aiming to understand how the monkeypox virus (Mpox) affects pregnant women in South Kivu, Democratic Republic of the Congo. With an increase in Mpox cases among this group, the study will track both pregnant women who show symptoms and those who do not, over a two-year period. Researchers want to learn about how the virus might be transmitted from mother to baby and any potential health impacts, such as complications during pregnancy or effects on newborns. This information will help create better guidelines for managing monkeypox during pregnancy and may contribute to global health policies.

To participate in this study, women must be confirmed to be pregnant and living in the study area. They can be of any age and can either show symptoms of monkeypox, like fever or skin rashes, or be healthy but have been in contact with someone who has the virus. Participants will be monitored throughout their pregnancy, and their health outcomes will be documented. It’s important to note that women who choose to join the study must provide consent and will be carefully informed about what to expect and any risks involved. This study is not yet recruiting participants but is preparing to gather valuable data to support pregnant women facing monkeypox.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Pregnancy status: all women confirmed to be pregnant at the time of recruitment.
• • 2. 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).
• • 3. Geographical inclusion: residing within the catchment areas of the selected healthcare facilities in South Kivu to ensure that they are likely to continue receiving follow-up care at the participating sites throughout their pregnancy.
• 4. 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.
• • Exclusion Criteria:1. Non-consent: pregnant women who do not consent/or their parent-caregiver to participate in the study.
• • 2. Medical exclusions: women with pre-existing medical conditions that, as determined by clinical judgment, may either put them at risk due to participation in the study or could confound the study results (e.g., conditions that significantly alter immune response such as confirmed cancer).
• • 3. Plans to relocate: women who plan to move out of the geographical study area during the study period, which would interfere with follow-up.
• • 4. 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.
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