Malaria in PregnancyPhase 3NCT00730366
New Approaches to Improve Coverage and Compliance of Antimalarial Treatment for Pregnant Women in Rural Africa
A Phase 3 study testing sulfadoxine-pyrimethamine and Chloroquine in people with Malaria in Pregnancy, run by Institute of Tropical Medicine, Belgium at 1 site in Burkina Faso.
Trial summary
Malaria in pregnancy contributes substantially to maternal anaemia and low birth weight: effective malaria control in pregnancy could avoid about 10,000 maternal and up to 200,000 infant deaths every year. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Malaria in Pregnancy
- What is being tested?
- sulfadoxine-pyrimethamine and Chloroquine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,766 participants
- Where
- 1 siteBurkina Faso
- Study dates
- Mar 2004to Dec 2006
- Phase
- Phase 3
- 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
Who may be able to join
- Female
- First or second trimester of pregnancy
- First or second pregnancy
- Resident in the study area
Who cannot join
- Refuse to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: New Approaches to Improve Coverage and Compliance of Antimalarial Treatment for Pregnant Women in Rural Africa.
Malaria in pregnancy contributes substantially to maternal anaemia and low birth weight: effective malaria control in pregnancy could avoid about 10,000 maternal and up to 200,000 infant deaths every year. Intermittent preventive treatment with the drug sulfadoxine-pyrimethamine (IPTp-SP), administered at least twice during routine antenatal clinics, is recommended by the World Health Organization for areas of moderate to high malaria transmission, including Sub-Saharan Africa.
Studies carried out in Kenya and Malawi before 2004 had showed that two doses of IPTp-SP significantly reduce maternal anaemia, placental malaria parasitaemia and low birth weight. However, in countries where this strategy had been introduced as part of national policy, the coverage of the target population has varied widely, with estimates of 33-93% for uptake of one dose and 24-68% for two doses, and no country had reached the goal of 80% of pregnant women receiving at least 2 doses of IPTp. New approaches designed to improve IPTp coverage were therefore urgently needed.
This study was therefore set up in 2002, in order to evaluate the additional effect of a targeted promotional campaign on antenatal clinics utilization and on coverage and uptake of Intermittent preventive treatment with sulfadoxine-pyrimethamine in a rural health district in Burkina Faso; and to investigate the effectiveness of intermittent preventive treatment with the sulfadoxine-pyrimethamine compared with weekly chloroquine, in order to provide additional evidence to the Burkinabé Ministry of Health for an impending policy change.
Read the detailed description
Each year, about 50 million women living in malaria endemic regions become pregnant, more than half in sub-Saharan Africa. In areas of relatively stable transmission, where acquired immunity to Plasmodium falciparum limits infection and prevents severe disease in adults, women in their first and second pregnancy are the most vulnerable subjects, due to a higher risk of severe anaemia and a low birth weight (LBW) outcome, a leading cause of child mortality and poor growth and development.
Malaria in pregnancy and its adverse consequences can be prevented with suppressive antimalarial treatment or chemoprophylaxis. Weekly chloroquine (CQ) had been the basis for prevention for many years, but its application became limited over time, partly because of difficulties in coverage and compliance throughout pregnancy and partly because of increased parasite resistance to CQ in endemic areas. A new strategy for prevention based on insecticide-treated bed nets (ITNs) and use of intermittent preventive treatment in pregnancy (IPTp) was thus formulated, with IPTp being based on the administration of treatment doses of sulfadoxine-pyrimethamine (1500/75 mg; SP) to all pregnant women at pre-defined intervals and regardless of malaria infection. WHO elaborated new recommendations, based on the administration of SP two or three times at scheduled antenatal visits at least one month apart from the second trimester onwards. Evidence of the efficacy of IPTp with SP for preventing malaria infection and improving birth weight was reported from East Africa and West Africa.
However, the IPTp strategy assumes that most pregnant women attend antenatal clinics (ANC) at least twice during their pregnancy and at a time when SP can be administered under direct observation. Unfortunately, it appeared soon that late attendance to ANC and weak health services limit the effectiveness of this strategy; coverage with two or more SP doses varied widely (24-68%) and was well behind the goal of 80% proposed by the Roll Back Malaria Partnership. New approaches to increase IPTp coverage were urgently needed.
This study, conceived in 2002 and carried out between 2004 and 2006, had therefore two different components: on one side, it investigated whether promoting regular and early antenatal attendance of pregnant women through community based health education would increase coverage and uptake of IPTp; on the other side, it investigated the effectiveness of IPTp-SP compared with weekly CQ, in order to provide additional evidence to the Burkinabé Ministry of Health for an impending policy change.
- Conditions
- Malaria in Pregnancy
- Being tested
- sulfadoxine-pyrimethamine, Chloroquine
- Keywords
- Malaria, Pregnancy, Intermittent Preventive Treatment
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sulfadoxine-pyrimethamineDrug
Also called IPTp-SP, SP, Fansidar
Sulfadoxine-pyrimethamine given as intermittent therapy, at the dosage of 1500/75 mg per administration (3 tablets), Twice during pregnancy
ChloroquineDrug
Also called CQ, Nivaquine
Chloroquine tablets 100 mg. First administration of 1500 mg given over three days, followed by weekly doses of 300 mg/week
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Experimental: IPTp-SP + promotion: Active Comparator Receives: Drug: sulfadoxine-pyrimethamine |
| 2 | Experimental | IPTp-SP alone (without promotion) Receives: Drug: sulfadoxine-pyrimethamine |
| 3 | Active comparator | Weekly CQ prophylaxis Receives: Drug: Chloroquine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Birth weight
Measured: At delivery
Secondary outcomes (3)
Anemia
Measured: At 32 weeks gestation and at delivery
Peripheral and placental parasitaemia
Measured: At 32 weeks gestation (peripheral) and at delivery (both)
Gestational age
Measured: At first antenatal visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2008 (estimated)
- Study startMar 2004
- Primary completionOct 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,766 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Tropical Medicine, Belgium
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ouagadougou, Burkina Faso, National Laboratory of Public Health,Burkina Faso, Liverpool School of Tropical Medicine, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Sheick Coulibaly Oumar Coulibaly, MD PhD, Study director, Directeur de la Biologie Médicale du Laboratoire National de Santé PubliqueUmberto D'Alessandro, MD, Study chair, Institute of Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00730366
- Sponsor's protocol ID
- DELIMAL
- Status last verified
- Sep 2010
- First submitted
- 5 Aug 2008
- Last updated
- 14 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Approaches to Improve Coverage and Compliance of Antimalarial Treatment for Pregnant Women in Rural Africa.
- ClinicalTrials.gov ID
- NCT00730366
- Acronym / sponsor ID
- DELIMAL
- Conditions
- Malaria in Pregnancy
- Keywords
- Malaria, Pregnancy, Intermittent Preventive Treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,766 participants (actual)
- Lead sponsor
- Institute of Tropical Medicine, BelgiumUniversity, hospital or other
- Collaborators
- University of Ouagadougou, Burkina Faso, National Laboratory of Public Health,Burkina Faso, Liverpool School of Tropical Medicine, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Study start
- Mar 2004
- Primary completion
- Oct 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 8 Aug 2008 (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.
Malaria in pregnancy contributes substantially to maternal anaemia and low birth weight: effective malaria control in pregnancy could avoid about 10,000 maternal and up to 200,000 infant deaths every year. Intermittent preventive treatment with the drug sulfadoxine-pyrimethamine (IPTp-SP), administered at least twice during routine antenatal clinics, is recommended by the World Health Organization for areas of moderate to high malaria transmission, including Sub-Saharan Africa.
Studies carried out in Kenya and Malawi before 2004 had showed that two doses of IPTp-SP significantly reduce maternal anaemia, placental malaria parasitaemia and low birth weight. However, in countries where this strategy had been introduced as part of national policy, the coverage of the target population has varied widely, with estimates of 33-93% for uptake of one dose and 24-68% for two doses, and no country had reached the goal of 80% of pregnant women receiving at least 2 doses of IPTp. New approaches designed to improve IPTp coverage were therefore urgently needed.
This study was therefore set up in 2002, in order to evaluate the additional effect of a targeted promotional campaign on antenatal clinics utilization and on coverage and uptake of Intermittent preventive treatment with sulfadoxine-pyrimethamine in a rural health district in Burkina Faso; and to investigate the effectiveness of intermittent preventive treatment with the sulfadoxine-pyrimethamine compared with weekly chloroquine, in order to provide additional evidence to the Burkinabé Ministry of Health for an impending policy change.
Detailed description
Each year, about 50 million women living in malaria endemic regions become pregnant, more than half in sub-Saharan Africa. In areas of relatively stable transmission, where acquired immunity to Plasmodium falciparum limits infection and prevents severe disease in adults, women in their first and second pregnancy are the most vulnerable subjects, due to a higher risk of severe anaemia and a low birth weight (LBW) outcome, a leading cause of child mortality and poor growth and development.
Malaria in pregnancy and its adverse consequences can be prevented with suppressive antimalarial treatment or chemoprophylaxis. Weekly chloroquine (CQ) had been the basis for prevention for many years, but its application became limited over time, partly because of difficulties in coverage and compliance throughout pregnancy and partly because of increased parasite resistance to CQ in endemic areas. A new strategy for prevention based on insecticide-treated bed nets (ITNs) and use of intermittent preventive treatment in pregnancy (IPTp) was thus formulated, with IPTp being based on the administration of treatment doses of sulfadoxine-pyrimethamine (1500/75 mg; SP) to all pregnant women at pre-defined intervals and regardless of malaria infection. WHO elaborated new recommendations, based on the administration of SP two or three times at scheduled antenatal visits at least one month apart from the second trimester onwards. Evidence of the efficacy of IPTp with SP for preventing malaria infection and improving birth weight was reported from East Africa and West Africa.
However, the IPTp strategy assumes that most pregnant women attend antenatal clinics (ANC) at least twice during their pregnancy and at a time when SP can be administered under direct observation. Unfortunately, it appeared soon that late attendance to ANC and weak health services limit the effectiveness of this strategy; coverage with two or more SP doses varied widely (24-68%) and was well behind the goal of 80% proposed by the Roll Back Malaria Partnership. New approaches to increase IPTp coverage were urgently needed.
This study, conceived in 2002 and carried out between 2004 and 2006, had therefore two different components: on one side, it investigated whether promoting regular and early antenatal attendance of pregnant women through community based health education would increase coverage and uptake of IPTp; on the other side, it investigated the effectiveness of IPTp-SP compared with weekly CQ, in order to provide additional evidence to the Burkinabé Ministry of Health for an impending policy change.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: sulfadoxine-pyrimethamineExperimental: IPTp-SP + promotion: Active Comparator |
| 2 | Experimental | Drug: sulfadoxine-pyrimethamineIPTp-SP alone (without promotion) |
| 3 | Active comparator | Drug: ChloroquineWeekly CQ prophylaxis |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Female
- First or second trimester of pregnancy
- First or second pregnancy
- Resident in the study area
Key exclusion criteria (1 listed)
- Refuse to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sulfadoxine-pyrimethamineAlso: IPTp-SP, SP, FansidarSulfadoxine-pyrimethamine given as intermittent therapy, at the dosage of 1500/75 mg per administration (3 tablets), Twice during pregnancy | Drug | 1, 2 |
| ChloroquineAlso: CQ, NivaquineChloroquine tablets 100 mg. First administration of 1500 mg given over three days, followed by weekly doses of 300 mg/week | Drug | 3 |
Primary outcome
Birth weight
Time frame: At delivery
3 secondary outcomes
Anemia
Time frame: At 32 weeks gestation and at delivery
Peripheral and placental parasitaemia
Time frame: At 32 weeks gestation (peripheral) and at delivery (both)
Gestational age
Time frame: At first antenatal visit
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 14 Sep 2010.
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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.
Sheick Coulibaly Oumar Coulibaly, MD PhD study director
Directeur de la Biologie Médicale du Laboratoire National de Santé Publique
Umberto D'Alessandro, MD study chair
Institute of Tropical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing sulfadoxine-pyrimethamine and Chloroquine in people with Malaria in Pregnancy, run by Institute of Tropical Medicine, Belgium 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 4 inclusion and 1 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 14 Sep 2010. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Birth weight (time frame: At delivery). 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 14 Sep 2010.