Plasmodium and Other Parasites in Pregnant Women and Children Around Margibi and Montserrado Coun… (NCT03719599) | Clinical Trial Compass
CompletedNot Applicable
Plasmodium and Other Parasites in Pregnant Women and Children Around Margibi and Montserrado Counties, Liberia
Liberia1,264 participantsStarted 2019-10-01
Plain-language summary
Background:
The disease malaria affects many people in Liberia and other parts of Africa. It is caused by germs that are spread by mosquito bites. It may be mild but can be serious or can lead to death if not diagnosed and treated. Children younger than 5 years old and pregnant women are most at risk of malaria. Worms also infect many people in Liberia. They can be caused by mosquito bites or by touching soil or still water. Worm infections can be mild or serious. Doctors in Liberia and their NIH partners want to learn more about these diseases in women and children.
Objective:
To measure how much malaria and worm infections there are in pregnant women and children in two counties of Liberia.
Eligibility:
Pregnant women ages 18 and older and children ages 6 12 months seeking routine care at C.H. Rennie Hospital or the Duport Road Health Center
Design:
Participants will be screened with questions about their health or their child s health.
Participants will be asked further questions about their health and about their home life.
Participants will give a small amount of blood by finger prick. This will be tested to see if they have malaria or some types of worms, and for research studies.
Participants who are sick from malaria will be treated at a study clinic. Treatment will follow standards of the Liberia and/or the World Health Organization.
Who can participate
Age range
6 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* INCLUSION CRITERIA:
* For pregnant women, a study participant must satisfy the following criteria to be enrolled in this study:
* Pregnant woman \>=18 years of age reporting for routine care at the center without acute illness or abnormal vital signs (e.g.fever, SBP \> 160, OR DBP \> 110) per standard clinic procedures
* The study participant understands the study and gives informed consent for participation
* Willingness to share a positive test result for malaria or helminths with the C.H. Rennie Hospital or the Duport Road Health Center so treatment can be initiated if necessary
* For children, a study participant must satisfy the following criteria to be enrolled in this study:
* Children 6-12 months of age at time of visit presenting for routine care at the center without acute illness or abnormal vital signs (e.g. fever) per standard clinic procedures
* The parent or guardian understands the study and gives informed consent for participation of their child
* Willingness of parent/guardian to share a positive test result for malaria or helminths with the C.H. Rennie Hospital or the Duport Road Health Center so treatment can be initiated if necessary
EXCLUSION CRITERIA:
* For women, prior enrollment in the study during the same pregnancy
* For children, prior enrollment in the study
* Conditions that in the judgment of the Principal Investigator or Clinical Investigators could adversely impact the safety of the study participant, including conditions tha…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Measurement of the frequency of P. falciparum parasitemia as defined by rapid diagnostic tests and/or blood smears
Timeframe: Seasonal and year of sample collection
Trial details
NCT IDNCT03719599
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)