MalariaNCT02974608
Impact of Malaria on Pregnant Women in Ouelessebougou, Mali
An observational study of Malaria, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Mali.
Trial summary
Background: Malaria is a serious disease. It is passed by infected mosquitoes. In many parts of Africa, malaria continues to be the main cause of death in young children and pregnant women. Researchers want to find out more about how malaria affects pregnant women and their babies. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Malaria
- How many people
- 7,691 participants
- Where
- 1 siteMali
- Study dates
- 15 Feb 2017to 21 Apr 2022
- 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: Study population from which the cohorts will be selected live in selected villages surrounding the districts of Ouelessebougou, Mali
Who may be able to join
- A study participant must satisfy the following criteria to be enrolled in this study:
- Pregnant women and their newborn cohort: Pregnant women of any age and pregnancy stage and their newborns residing in the study area
- women of child-bearing age cohort: women who are not under contraception or breastfeeding for less than 12 months and planning to become pregnant, and their newborn once they become pregnant
- Children between the ages of 0-10 years residing in the study area
- The study participant or parent/guardian understands the study and is able to provide informed consent for themselves and/or their child.
Who cannot join
- Temporary residence in the study area
- Conditions that in the judgment of the investigator could impair the ability of the participants to understand the study or comply with the study procedures.
Trial locations and contacts
1 site in 1 country.
Mali1 site
Ouelessebougou Clinical Research Center (Malaria Research and Training Center)
Bamako
About this study
Official title: Demographic Surveillance to Monitor Impact of Malaria on Pregnant Women in Ouelessebougou, Mali
Background:
Malaria is a serious disease. It is passed by infected mosquitoes. In many parts of Africa, malaria continues to be the main cause of death in young children and pregnant women. Researchers want to find out more about how malaria affects pregnant women and their babies.
Read more
Objectives:
To study the rate of miscarriage and stillbirth during the second and third trimesters among women in a certain district in Mali. To study rates of malaria infection over time among pregnant women and children in this area.
Eligibility:
Pregnant women of any age and pregnancy stage and their newborns. They must live in Ouelessebougou, Mali. Children up to 10 years old who live there.
Design:
Information about the study will be shared at community meetings, during visits to the health centers, and during census updates.
Participants will read and sign a consent form.
Pregnant women will be screened to see if they are eligible. They may have a urine test. They may have an ultrasound to date their pregnancy. Ultrasound uses sound waves to take pictures of the body.
Women will be enrolled in the study after they have their babies.
Participants may have a physical exam.
Some participants will provide a finger/heel prick blood sample.
Participants will complete a questionnaire. They will be asked about:
Medical history
Antimalarial and other interventions
Socioeconomic status
Their pregnancy
Previous pregnancies
Health of their newborn...
Read the detailed description
Placental malaria (PM) leads to poor outcomes for pregnant women and their babies, and is caused by Plasmodium falciparum sequestration in the intervillous spaces of the placenta and ensuing inflammation. Severe maternal anemia, low birth weight (LBW) delivery and fetal loss are common sequelae. Malaria-related LBW alone is estimated to cause 62,000-363,000 infant deaths in Africa each year. To reduce poor pregnancy outcomes associated with malaria infection, WHO recommends monthly anti-malarial treatment with sulfadoxine pyrimethamine (SP) during the second and third trimester and the use of insecticide-treated bed nets. However, in East and Southern Africa, SP has lost its efficacy due to the spread of drug-resistant parasites. Therefore, an effective vaccine for PM is needed. Although the ideal vaccine will be given to adolescent girls prior to becoming pregnant, at this early stage of pregnancy malaria vaccine development, it is unknown if a boosting dose may be needed during pregnancy.
Before testing new interventions to improve pregnancy outcomes, it is important to obtain baseline information on pregnancy outcomes in the target population. In our recent longitudinal study of 1,885 pregnant women in Mali, in which women were closely followed during pregnancy (including malaria prevention and treatment), 2.9%, 2.4% and 6% of pregnancies ended in miscarriage, stillbirth, and preterm delivery, respectively.
The primary goal of the study is to assess pregnancy outcomes in women in the community with access to the WHO recommended standard of care. In the first part of the study, all women presenting for an antenatal visit at Ouelessebougou health centers will be recruited into the study. In the second part of the study, non-pregnant women will be enrolled and followed to capture data on pregnancy outcomes including early pregnancy losses. Pregnancy outcome information will be collected after the birth of the child or after pregnancy termination (i.e. miscarriage/stillbirth). Primary and secondary endpoints will be analyzed using appropriate statistical methods, including possible confounders, to determine the prevalence and factors associated with poor pregnancy outcomes.
- Conditions
- Malaria
- Keywords
- Placental, Fetal Loss, Observational, Antenatal, Infection, Natural History
- Medical subject headings
- Malaria, Infections
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 |
|---|---|---|
| Children 0-10 years | Children living in selected villages surrounding the district of Ouelessebougou | |
| Pregnant Women + Newborns | Pregnant women of any age and their newborn children | |
| Women of Child Bearing Age Potential | Non-pregnant women of child-bearing age |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of malaria infection
Rates of malaria infections
Measured: Semi-annual
Assess the rate of fetal loss during the 2nd and 3rd trimesters
Rates of fetal losses
Measured: Annual
Secondary outcomes (2)
Assess the prevalence rate of SP resistant parasites
Rate of SP resistant parasites (in vivo and molecular markers)
Measured: Annual
Assess the rate of pre-term and low birth weight deliveries
Number of pre-term deliveries, low birthweight deliveries, neonatal mortality
Measured: Annual
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2016 (estimated)
- Study start15 Feb 2017
- Primary completion20 Oct 2021
- Study completion21 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalariaStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 7,691 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Michal Fried, Ph.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02974608
- Sponsor's protocol ID
- 999917018
- Other IDs
- 17-I-N018
- Status last verified
- 21 Mar 2023
- First submitted
- 23 Nov 2016
- Last updated
- 23 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Demographic Surveillance to Monitor Impact of Malaria on Pregnant Women in Ouelessebougou, Mali
- ClinicalTrials.gov ID
- NCT02974608
- Acronym / sponsor ID
- 999917018
- Conditions
- Malaria
- Keywords
- Placental, Fetal Loss, Observational, Antenatal, Infection, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,691 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 15 Feb 2017 (actual)
- Primary completion
- 20 Oct 2021 (actual)
- Study completion
- 21 Apr 2022 (actual)
- First posted
- 28 Nov 2016 (estimated)
- 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.
Background:
Malaria is a serious disease. It is passed by infected mosquitoes. In many parts of Africa, malaria continues to be the main cause of death in young children and pregnant women. Researchers want to find out more about how malaria affects pregnant women and their babies.
Objectives:
To study the rate of miscarriage and stillbirth during the second and third trimesters among women in a certain district in Mali. To study rates of malaria infection over time among pregnant women and children in this area.
Eligibility:
Pregnant women of any age and pregnancy stage and their newborns. They must live in Ouelessebougou, Mali. Children up to 10 years old who live there.
Design:
Information about the study will be shared at community meetings, during visits to the health centers, and during census updates.
Participants will read and sign a consent form.
Pregnant women will be screened to see if they are eligible. They may have a urine test. They may have an ultrasound to date their pregnancy. Ultrasound uses sound waves to take pictures of the body.
Women will be enrolled in the study after they have their babies.
Participants may have a physical exam.
Some participants will provide a finger/heel prick blood sample.
Participants will complete a questionnaire. They will be asked about:
Medical history
Antimalarial and other interventions
Socioeconomic status
Their pregnancy
Previous pregnancies
Health of their newborn...
Detailed description
Placental malaria (PM) leads to poor outcomes for pregnant women and their babies, and is caused by Plasmodium falciparum sequestration in the intervillous spaces of the placenta and ensuing inflammation. Severe maternal anemia, low birth weight (LBW) delivery and fetal loss are common sequelae. Malaria-related LBW alone is estimated to cause 62,000-363,000 infant deaths in Africa each year. To reduce poor pregnancy outcomes associated with malaria infection, WHO recommends monthly anti-malarial treatment with sulfadoxine pyrimethamine (SP) during the second and third trimester and the use of insecticide-treated bed nets. However, in East and Southern Africa, SP has lost its efficacy due to the spread of drug-resistant parasites. Therefore, an effective vaccine for PM is needed. Although the ideal vaccine will be given to adolescent girls prior to becoming pregnant, at this early stage of pregnancy malaria vaccine development, it is unknown if a boosting dose may be needed during pregnancy.
Before testing new interventions to improve pregnancy outcomes, it is important to obtain baseline information on pregnancy outcomes in the target population. In our recent longitudinal study of 1,885 pregnant women in Mali, in which women were closely followed during pregnancy (including malaria prevention and treatment), 2.9%, 2.4% and 6% of pregnancies ended in miscarriage, stillbirth, and preterm delivery, respectively.
The primary goal of the study is to assess pregnancy outcomes in women in the community with access to the WHO recommended standard of care. In the first part of the study, all women presenting for an antenatal visit at Ouelessebougou health centers will be recruited into the study. In the second part of the study, non-pregnant women will be enrolled and followed to capture data on pregnancy outcomes including early pregnancy losses. Pregnancy outcome information will be collected after the birth of the child or after pregnancy termination (i.e. miscarriage/stillbirth). Primary and secondary endpoints will be analyzed using appropriate statistical methods, including possible confounders, to determine the prevalence and factors associated with poor pregnancy outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Children 0-10 years | – | –Children living in selected villages surrounding the district of Ouelessebougou |
| Pregnant Women + Newborns | – | –Pregnant women of any age and their newborn children |
| Women of Child Bearing Age Potential | – | –Non-pregnant women of child-bearing age |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Study population from which the cohorts will be selected live in selected villages surrounding the districts of Ouelessebougou, Mali
Key inclusion criteria (5 listed)
- Pregnant women and their newborn cohort: Pregnant women of any age and pregnancy stage and their newborns residing in the study area
- women of child-bearing age cohort: women who are not under contraception or breastfeeding for less than 12 months and planning to become pregnant, and their newborn once they become pregnant
- Children between the ages of 0-10 years residing in the study area
- The study participant or parent/guardian understands the study and is able to provide informed consent for themselves and/or their child.
Key exclusion criteria (2 listed)
- Temporary residence in the study area
- Conditions that in the judgment of the investigator could impair the ability of the participants to understand the study or comply with the study procedures.
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
Prevalence of malaria infection
Time frame: Semi-annual
Rates of malaria infections
Assess the rate of fetal loss during the 2nd and 3rd trimesters
Time frame: Annual
Rates of fetal losses
2 secondary outcomes
Assess the prevalence rate of SP resistant parasites
Time frame: Annual
Assess the rate of pre-term and low birth weight deliveries
Time frame: Annual
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
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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.
Michal Fried, Ph.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malaria, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Mali.
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 5 inclusion and 2 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: finished, as of the sponsor's last update on 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mali. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Prevalence of malaria infection (time frame: Semi-annual). The study lists 2 primary outcomes in all. 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 23 Mar 2023.