Maternal Malaria During Pregnancy - Baby Not Yet DeliveredEPI-PAMNCT06162078
Malaria Burden in Pregnant Women and the Incidence of Pregnancy in a Cohort of Nulligravida
An observational study of Maternal Malaria During Pregnancy - Baby Not Yet Delivered, run by Groupe de Recherche Action en Sante at 1 site in Burkina Faso.
Trial summary
The overarching aims of this study are to longitudinally determine the occurrence of pregnancy in a cohort of nulligravida at the community level and to estimate the burden of malaria infection during the course of the pregnancy till delivery. Read more about this study
- Who is it for?
- Ages 15 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maternal Malaria During Pregnancy - Baby Not Yet Delivered
- How many people
- 2,390 participants
- Where
- 1 siteBurkina Faso
- Study dates
- 25 Aug 2023to Dec 2024
- How long will I take part?
- 9 Months
- 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 15 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: For subgroup 1: Fieldworkers will visit the households in the study area to identify and enroll women meeting the eligibility criteria. For subgroup 2: Paticipants will be enrolled by study staff stationed at the antenatal care clinic. Women attending the ANC visit at any gestational age will be screened and enrolled. For Subgroup 3: Participants will be recruited during any of the ANC visit as consenting process will not be feasible during the labour at delivery. They will be issued a sticker that will be affixed to the health card so that they could easily be recognized when they come for delivery.
Who may be able to join
- For subgroup 1
- Nulligravidae aged ≥ 15 years
- Residing within the study area and planning to stay for the study duration
- Signed or thumb-printed informed consent obtained from participant/participant legally acceptable representatives. An assent will be obtained from minors.
- For subgroups 2 and 3
- Primigravidae aged ≥ 15 years at the time of enrolment
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- Residing within the study area for the last three months
- Signed or thumb-printed informed consent obtained from participant/participant legally acceptable representatives. An assent will be obtained from minors.
- Additional criteria for subgroup 3 • Third trimester of gestational age
Who cannot join
- For subgroup 1 only
- Women of non-childbearing potential. Non-childbearing potential is defined as current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy or post-menopause.
- Women reporting established use of oral, injected or implanted hormonal contraceptives; intrauterine device or intrauterine system
- For all the subgroups
- Chronic use of i) immunosuppressive drugs, ii) or other immune modifying drugs within three months prior to enrolment in the study
- Known history of Human Immunodeficiency Virus (HIV) (No test will be done by the study)
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- Use of any other investigational or non-registered product (drug or vaccine) during the study period.
- Any previous participation in any malaria (vaccine) study.
- Any other condition or situation that would, in the opinion of the investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
Trial locations and contacts
1 site in 1 country.
Burkina Faso1 site, 1 recruiting
- Recruiting
GRAS-Banfora
Banfora, 10248
Alphonse Ouedraogo, PhD, +22670140811, a.ouedraogo@gras.bf
Jean Baptiste Yaro, PhD, +22670718842, j.yaro@gras.bf
About this study
Official title: A Baseline Epidemiological Study to Document the Malaria Burden in Pregnant Women and the Incidence of Pregnancy in a Cohort of Nulligravida to Targeted Futur Malaria Vaccine Candidate Efficacy in Pregnancy in Burkina Faso
The overarching aims of this study are to longitudinally determine the occurrence of pregnancy in a cohort of nulligravida at the community level and to estimate the burden of malaria infection during the course of the pregnancy till delivery.
Read the detailed description
Three subgroups will involve in the design of this study:
for subgroup 1, fieldworkers will visit the households in the study area to identify and enroll women meeting the eligibility criteria to involve in a nulligravida cohort aged ≥ 15 years. After consenting a fingerprick blood sample will be obtained for pregnancy testing, malaria blood smear, and VAR2CSA antibodies measurement. Enrolled women will be visited every trimester to check for pregnancy and malaria infection. The follow up of each participant will end upon a pregnancy test is positive or at month 9 after the enrolment.
Participants to subgroup 2 will be enrolled primigravidae aged ≥ 15 years by study staff stationed at the antenatal care clinic. Women attending the ANC visit at any gestational age will be screened and those meeting the eligibility criteria will undergo the study procedures which includes collecting demographic data, medical and pregnancy history. They will then be requested to donate a fingerprick blood sample for malaria infection and hemoglobin measurement. This will be a single timepoint evaluation.
Subgroup 3 participants will be recruited primigravidae aged ≥ 15 years during any of the ANC visit as consenting process will not be feasible during the labour at delivery. They will be issued a sticker that will be affixed to the health card so that they could easily be recognized when they come for delivery. At delivery, samples will be collected from fingerprick, cord blood and placenta for detecting malaria infection by microscopy and histopathology. Additional data will be collected on the neonate for secondary outcomes assessment.
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 |
|---|---|---|
| Subgroup 1, Household longitudinal survey of nulligravida cohort | fieldworkers will visit the households in the study area to identify and enroll women meeting the eligibility criteria. After consenting a fingerprick blood sample will be obtained for pregnancy testing and malaria blood smear, and VAR2CSA antibodies measurement. Enrolled women will be visited every trimester to check for pregnancy and malaria infection. The follow up of each participant will end upon a pregnancy test is positive or at month 9 after the enrolment. | |
| Subgroup 2, Single timepoint evaluation for primigravidae 1rst, 2nd and 3 rd trimester | Participants will be enrolled by study staff stationed at the antenatal care clinic. Women attending the ANC visit at any gestational age will be screened and those meeting the eligibility criteria will undergo the study procedures which includes collecting demographic data, medical and pregnancy history. They will then be requested to donate a fingerprick blood sample for malaria infection and hemoglobin measurement. | |
| Subgroup 3, Single timepoint evaluation at primigravidae delivery | participants will be recruited during any of the ANC visit as consenting process will not be feasible during the labour at delivery. They will be issued a sticker that will be affixed to the health card so that they could easily be recognized when they come for delivery. At delivery, samples will be collected from fingerprick, cord blood and placenta for detecting malaria infection by microscopy and histopathology. Additional data will be collected on the neonate for secondary outcomes assessment, adverse birth outcomes . |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of nulliparous with positive urine test
Proportion of nulliparous with positive urine pregnancy test at 3 months, 6 months and 9 months post enrolment
Measured: 9 months
P. falciparum infection in nulliparous attending the antenatal care visit
Prevalence of P. falciparum infection by microscopy and PCR (polymerase chain reaction) in nulliparous attending the antenatal care visit at the local health care facility
Measured: 9 months
Moderate and severe anemia during the last antenatal care visit
Proportion of pregnant women with moderate and severe anemia during the last antenatal care visit at the local health care facility
Measured: 9 months
P. falciparum infection at delivery
Prevalence of parasitemia at delivery (maternal and cord blood) by microscopy
Measured: 9 months
Placental infection
Proportion of women at delivery with histopathologically confirmed placental infection
Measured: 9 months
Secondary outcomes (2)
Adverse birth outcomes
Prevalence of adverse birth outcomes (spontaneous abortion, stillbirth, low birth weight (<2,500 g), preterm delivery (<37 weeks))
Measured: 9 months
Uptake IPTp-SP (Intermittent preventive treatment of malaria in pregnancy using sulfadoxine-pyrimethamine) during the pregnancy
Proportion of pregnant women receiving one, two, three and ≥ 3 doses of IPT-SP during the pregnancy
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start25 Aug 2023
- Primary completionAug 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal Malaria During Pregnancy - Baby Not Yet DeliveredStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 2,390 participants (estimated)
- Target duration
- 9 Months
Sponsor and investigators
- Lead sponsor
- Groupe de Recherche Action en Sante
- Sponsor type
- University, hospital or other
- Collaborators
- European Vaccine Initiative
- Responsible party
- Sponsor
- Investigators
- Alphonse OUEDRAOGO, MD, PhD, Principal investigator, Groupe de Recherche Action en Sante (GRAS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06162078
- Sponsor's protocol ID
- GRAS
- Acronym
- EPI-PAM
- Status last verified
- Dec 2023
- First submitted
- 25 Jul 2023
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Baseline Epidemiological Study to Document the Malaria Burden in Pregnant Women and the Incidence of Pregnancy in a Cohort of Nulligravida to Targeted Futur Malaria Vaccine Candidate Efficacy in Pregnancy in Burkina Faso
- ClinicalTrials.gov ID
- NCT06162078
- Acronym / sponsor ID
- EPI-PAM / GRAS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,390 participants (estimated)
- Lead sponsor
- Groupe de Recherche Action en SanteUniversity, hospital or other
- Collaborators
- European Vaccine Initiative
- Study start
- 25 Aug 2023 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 8 Dec 2023 (actual)
- 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.
The overarching aims of this study are to longitudinally determine the occurrence of pregnancy in a cohort of nulligravida at the community level and to estimate the burden of malaria infection during the course of the pregnancy till delivery.
Detailed description
Three subgroups will involve in the design of this study:
for subgroup 1, fieldworkers will visit the households in the study area to identify and enroll women meeting the eligibility criteria to involve in a nulligravida cohort aged ≥ 15 years. After consenting a fingerprick blood sample will be obtained for pregnancy testing, malaria blood smear, and VAR2CSA antibodies measurement. Enrolled women will be visited every trimester to check for pregnancy and malaria infection. The follow up of each participant will end upon a pregnancy test is positive or at month 9 after the enrolment.
Participants to subgroup 2 will be enrolled primigravidae aged ≥ 15 years by study staff stationed at the antenatal care clinic. Women attending the ANC visit at any gestational age will be screened and those meeting the eligibility criteria will undergo the study procedures which includes collecting demographic data, medical and pregnancy history. They will then be requested to donate a fingerprick blood sample for malaria infection and hemoglobin measurement. This will be a single timepoint evaluation.
Subgroup 3 participants will be recruited primigravidae aged ≥ 15 years during any of the ANC visit as consenting process will not be feasible during the labour at delivery. They will be issued a sticker that will be affixed to the health card so that they could easily be recognized when they come for delivery. At delivery, samples will be collected from fingerprick, cord blood and placenta for detecting malaria infection by microscopy and histopathology. Additional data will be collected on the neonate for secondary outcomes assessment.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 9 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Subgroup 1, Household longitudinal survey of nulligravida cohort | – | –fieldworkers will visit the households in the study area to identify and enroll women meeting the eligibility criteria. After consenting a fingerprick blood sample will be obtained for pregnancy testing and malaria blood smear, and VAR2CSA antibodies measurement. Enrolled women will be visited every trimester to check for pregnancy and malaria infection. The follow up of each participant will end upon a pregnancy test is positive or at month 9 after the enrolment. |
| Subgroup 2, Single timepoint evaluation for primigravidae 1rst, 2nd and 3 rd trimester | – | –Participants will be enrolled by study staff stationed at the antenatal care clinic. Women attending the ANC visit at any gestational age will be screened and those meeting the eligibility criteria will undergo the study procedures which includes collecting demographic data, medical and pregnancy history. They will then be requested to donate a fingerprick blood sample for malaria infection and hemoglobin measurement. |
| Subgroup 3, Single timepoint evaluation at primigravidae delivery | – | –participants will be recruited during any of the ANC visit as consenting process will not be feasible during the labour at delivery. They will be issued a sticker that will be affixed to the health card so that they could easily be recognized when they come for delivery. At delivery, samples will be collected from fingerprick, cord blood and placenta for detecting malaria infection by microscopy and histopathology. Additional data will be collected on the neonate for secondary outcomes assessment, adverse birth outcomes . |
Who may qualify
- Ages
- 15 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- For subgroup 1: Fieldworkers will visit the households in the study area to identify and enroll women meeting the eligibility criteria. For subgroup 2: Paticipants will be enrolled by study staff stationed at the antenatal care clinic. Women attending the ANC visit at any gestational age will be screened and enrolled. For Subgroup 3: Participants will be recruited during any of the ANC visit as consenting process will not be feasible during the labour at delivery. They will be issued a sticker that will be affixed to the health card so that they could easily be recognized when they come for delivery.
Key inclusion criteria (9 listed)
- For subgroup 1
- For subgroups 2 and 3
- Additional criteria for subgroup 3 • Third trimester of gestational age
Key exclusion criteria (9 listed)
- For subgroup 1 only
- For all the subgroups
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
Proportion of nulliparous with positive urine test
Time frame: 9 months
Proportion of nulliparous with positive urine pregnancy test at 3 months, 6 months and 9 months post enrolment
P. falciparum infection in nulliparous attending the antenatal care visit
Time frame: 9 months
Prevalence of P. falciparum infection by microscopy and PCR (polymerase chain reaction) in nulliparous attending the antenatal care visit at the local health care facility
Moderate and severe anemia during the last antenatal care visit
Time frame: 9 months
Proportion of pregnant women with moderate and severe anemia during the last antenatal care visit at the local health care facility
P. falciparum infection at delivery
Time frame: 9 months
Prevalence of parasitemia at delivery (maternal and cord blood) by microscopy
Placental infection
Time frame: 9 months
Proportion of women at delivery with histopathologically confirmed placental infection
2 secondary outcomes
Adverse birth outcomes
Time frame: 9 months
Uptake IPTp-SP (Intermittent preventive treatment of malaria in pregnancy using sulfadoxine-pyrimethamine) during the pregnancy
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Individual participant dataSharing planned: Yes
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.
Alphonse OUEDRAOGO, MD, PhD principal investigator
Groupe de Recherche Action en Sante (GRAS)
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 Maternal Malaria During Pregnancy - Baby Not Yet Delivered, run by Groupe de Recherche Action en Sante at 1 site in Burkina Faso.
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 9 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 19 Apr 2024. 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 Burkina Faso. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alphonse OUEDRAOGO, MD, PhD (+22670140811, a.ouedraogo@gras.bf), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of nulliparous with positive urine test (time frame: 9 months). The study lists 5 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 19 Apr 2024.