Malaria in PregnancyNCT01120145
Assessment of Sulphadoxine-pyrimethamine for Intermittent Preventive Treatment of Malaria in Pregnancy in Malawi
An observational study of Malaria in Pregnancy, run by Centers for Disease Control and Prevention at 1 site in Malawi.
Trial summary
The purpose of this study is to determine the efficacy and effectiveness of sulphadoxine-pyrimethamine intermittent preventive treatment in pregnancy for reducing malaria-associated morbidity in pregnant women in Malawi. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Malaria in Pregnancy
- How many people
- 1,410 participants
- Where
- 1 siteMalawi
- Study dates
- Mar 2010to Jan 2011
- 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
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Therapeutic efficacy study: Asymptomatic parasitemic pregnant women at 16-26 weeks of gestation Birth outcomes study: Pregnant women presenting for delivery Characterizing molecular markers of SP resistance study: Parasitemic outpatients
Who may be able to join
- 16-26 weeks gestation based on last menstrual period (LMP) or quickening
- Axillary temperature <37.5 degrees Celsius
- Informed consent
- Singleton pregnancy
- SP IPTp history available
- Informed consent
- Outpatient attending selected health facility
- Informed consent
Who cannot join
- History of hypersensitivity reaction to SP or components of SP
- Axillary temperature ≥37.5 degrees C
- History of receipt of antimalarials in the past month
- Known HIV infection
- Birth outcomes study:
- Blood transfusion after the 16th gestational week
Show all 10Show fewer
- Receipt of antimalarials other than SP for IPTp after 16th gestational week
- Known HIV infection
- Characterizing molecular markers of SP resistance:
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Efficacy and Effectiveness of Sulphadoxine-pyrimethamine for Intermittent Preventive Treatment of Malaria in Pregnancy in Malawi
The purpose of this study is to determine the efficacy and effectiveness of sulphadoxine-pyrimethamine intermittent preventive treatment in pregnancy for reducing malaria-associated morbidity in pregnant women in Malawi.
Read the detailed description
Malaria infection in pregnancy is associated with severe maternal anemia, placental parasitemia, low birth weight, and increased perinatal mortality. Intermittent preventive treatment in pregnancy (IPTp) with sulphadoxine-pyrimethamine (SP) is recommended by the World Health Organization (WHO) for reducing the risks associated with malaria in pregnancy. Traditionally, the level of SP resistance has been assessed by monitoring its in vivo efficacy for treatment of uncomplicated malaria in children under five years of age. However, parasite resistance to SP has compromised its efficacy in young children, and SP is no the longer a first-line recommended treatment for malaria in most African countries. Although SP currently appears to remain effective for IPTp in pregnant women probably because they have more immunity than young children, it is important to monitor SP effectiveness in this population. Characterizing SP resistance through in vivo and molecular methods in pregnant women may be useful to predict whether to continue a policy of IPTp with SP.
There will be three parts to this study. To determine therapeutic efficacy of SP IPTp in pregnant women, a prospective in vivo study will be done in women who present for antenatal care (ANC). Women will receive SP IPTp according to national guidelines and will be followed for 42 days for clearance of peripheral parasitemia. To determine birth outcomes of women given SP IPTp, a retrospective cohort study will be performed assessing outcomes of women at delivery. Information on prior receipt of SP IPTp, peripheral and placental parasitemia at delivery, placental histology, maternal anemia, and birth weight will be collected. To characterize baseline resistance of SP in pregnant women and in the general population, parasites will be collected from both participating women and attendees at outpatient clinics to measure SP resistance markers.
The results of this study will be used by the Malawi national control program to evaluate current policy of using SP for IPTp. This study will also contribute towards an international effort led by WHO to align priorities and methodologies in gathering data on the efficacy of SP in IPTp in the face of increasing SP resistance, thus providing data to inform IPTp policy at the global level.
- Conditions
- Malaria in Pregnancy
- Keywords
- Malaria, Pregnancy, Sulphadoxine-pyrimethamine
- Medical subject headings
- Malaria
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 |
|---|---|---|
| Therapeutic efficacy study | Asymptomatic parasitemic pregnant women at 16-26 weeks of gestation will be enrolled into the study and followed weekly for 42 days after the receipt of sulphadoxine-pyrimethamine intermittent preventive treatment in pregnancy to assess the clearance of parasitemia. | |
| Birth outcomes study | Women presenting for delivery will be enrolled and assessed for a history of sulphadoxine-pyrimethamine intermittent preventive treatment in pregnancy and evidence of malaria infection by placental histology, maternal peripheral parasitemia, maternal anemia and infant cord blood parasitemia. | |
| Characterizing molecular markers of SP resistance | Parasitemic outpatients attending the health facility will be tested for parasite molecular markers of sulphadoxine-pyrimethamine resistance. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Therapeutic efficacy study: Development of fever or symptoms of severe malaria (defined by WHO) and parasitemia at any time after the first dose of SP during the 42 day follow up period
Measured: 42 days
Birth outcomes study: Evidence of malaria infection based on placental histology at the time of delivery
Measured: At time of birth
Characterizing molecular markers of SP resistance: Prevalence of molecular markers of sulphadoxine-pyrimethamine resistance at the time of health facility visit
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2010 (estimated)
- Study startMar 2010
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malaria in PregnancyStudies 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
- Cohort
- Enrolment
- 1,410 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- Kamuzu University of Health Sciences
- Investigators
- Jacek Skarbinski, MD, Principal investigator, Malaria Branch, Centers for Disease Control and PreventionDon Mathanga, MD, PhD, Principal investigator, Kamuzu University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01120145
- Sponsor's protocol ID
- CDC-CGH-5756
- Status last verified
- Feb 2013
- First submitted
- 5 May 2010
- Last updated
- 6 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Gutman J, Mwandama D, Wiegand RE, Abdallah J, Iriemenam NC, Shi YP, Mathanga DP, Skarbinski J. In vivo efficacy of sulphadoxine-pyrimethamine for the treatment of asymptomatic parasitaemia in pregnant women in Machinga District, Malawi. Malar J. 2015 May 13;14:197. doi: 10.1186/s12936-015-0710-7.
PubMed 25962439
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Efficacy and Effectiveness of Sulphadoxine-pyrimethamine for Intermittent Preventive Treatment of Malaria in Pregnancy in Malawi
- ClinicalTrials.gov ID
- NCT01120145
- Acronym / sponsor ID
- CDC-CGH-5756
- Conditions
- Malaria in Pregnancy
- Keywords
- Malaria, Pregnancy, Sulphadoxine-pyrimethamine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,410 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- Kamuzu University of Health Sciences
- Study start
- Mar 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 10 May 2010 (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.
The purpose of this study is to determine the efficacy and effectiveness of sulphadoxine-pyrimethamine intermittent preventive treatment in pregnancy for reducing malaria-associated morbidity in pregnant women in Malawi.
Detailed description
Malaria infection in pregnancy is associated with severe maternal anemia, placental parasitemia, low birth weight, and increased perinatal mortality. Intermittent preventive treatment in pregnancy (IPTp) with sulphadoxine-pyrimethamine (SP) is recommended by the World Health Organization (WHO) for reducing the risks associated with malaria in pregnancy. Traditionally, the level of SP resistance has been assessed by monitoring its in vivo efficacy for treatment of uncomplicated malaria in children under five years of age. However, parasite resistance to SP has compromised its efficacy in young children, and SP is no the longer a first-line recommended treatment for malaria in most African countries. Although SP currently appears to remain effective for IPTp in pregnant women probably because they have more immunity than young children, it is important to monitor SP effectiveness in this population. Characterizing SP resistance through in vivo and molecular methods in pregnant women may be useful to predict whether to continue a policy of IPTp with SP.
There will be three parts to this study. To determine therapeutic efficacy of SP IPTp in pregnant women, a prospective in vivo study will be done in women who present for antenatal care (ANC). Women will receive SP IPTp according to national guidelines and will be followed for 42 days for clearance of peripheral parasitemia. To determine birth outcomes of women given SP IPTp, a retrospective cohort study will be performed assessing outcomes of women at delivery. Information on prior receipt of SP IPTp, peripheral and placental parasitemia at delivery, placental histology, maternal anemia, and birth weight will be collected. To characterize baseline resistance of SP in pregnant women and in the general population, parasites will be collected from both participating women and attendees at outpatient clinics to measure SP resistance markers.
The results of this study will be used by the Malawi national control program to evaluate current policy of using SP for IPTp. This study will also contribute towards an international effort led by WHO to align priorities and methodologies in gathering data on the efficacy of SP in IPTp in the face of increasing SP resistance, thus providing data to inform IPTp policy at the global level.
Study design
- Observational model
- Cohort
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Therapeutic efficacy study | – | –Asymptomatic parasitemic pregnant women at 16-26 weeks of gestation will be enrolled into the study and followed weekly for 42 days after the receipt of sulphadoxine-pyrimethamine intermittent preventive treatment in pregnancy to assess the clearance of parasitemia. |
| Birth outcomes study | – | –Women presenting for delivery will be enrolled and assessed for a history of sulphadoxine-pyrimethamine intermittent preventive treatment in pregnancy and evidence of malaria infection by placental histology, maternal peripheral parasitemia, maternal anemia and infant cord blood parasitemia. |
| Characterizing molecular markers of SP resistance | – | –Parasitemic outpatients attending the health facility will be tested for parasite molecular markers of sulphadoxine-pyrimethamine resistance. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Therapeutic efficacy study: Asymptomatic parasitemic pregnant women at 16-26 weeks of gestation Birth outcomes study: Pregnant women presenting for delivery Characterizing molecular markers of SP resistance study: Parasitemic outpatients
Key inclusion criteria (8 listed)
- 16-26 weeks gestation based on last menstrual period (LMP) or quickening
- Axillary temperature <37.5 degrees Celsius
- Informed consent
- Singleton pregnancy
- SP IPTp history available
Key exclusion criteria (10 listed)
- History of hypersensitivity reaction to SP or components of SP
- Axillary temperature ≥37.5 degrees C
- History of receipt of antimalarials in the past month
- Known HIV infection
- Blood transfusion after the 16th gestational week
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
Therapeutic efficacy study: Development of fever or symptoms of severe malaria (defined by WHO) and parasitemia at any time after the first dose of SP during the 42 day follow up period
Time frame: 42 days
Birth outcomes study: Evidence of malaria infection based on placental histology at the time of delivery
Time frame: At time of birth
Characterizing molecular markers of SP resistance: Prevalence of molecular markers of sulphadoxine-pyrimethamine resistance at the time of health facility visit
Time frame: Day 1
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 6 Feb 2013.
- Derived from this study: PubMed 25962439Gutman J, Mwandama D, Wiegand RE, Abdallah J, Iriemenam NC, Shi YP, Mathanga DP, Skarbinski J. In vivo efficacy of sulphadoxine-pyrimethamine for the treatment of asymptomatic parasitaemia in pregnant women in Machinga District, Malawi. Malar J. 2015 May 13;14:197. doi: 10.1186/s12936-015-0710-7.
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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.
Jacek Skarbinski, MD principal investigator
Malaria Branch, Centers for Disease Control and Prevention
Don Mathanga, MD, PhD principal investigator
Kamuzu University of Health Sciences
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 in Pregnancy, run by Centers for Disease Control and Prevention at 1 site in Malawi.
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 8 inclusion and 10 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 6 Feb 2013. 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 Malawi. 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?
Therapeutic efficacy study: Development of fever or symptoms of severe malaria (defined by WHO) and parasitemia at any time after the first dose of SP during the 42 day follow up period (time frame: 42 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01120145, which also lists 1 linked publication.
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 6 Feb 2013.