Non HIV Infected Pregnant WomenPhase 4NCT00372632
IPT of Malaria With SP in Different Zones of Drug Resistance in Rwanda
A Phase 4 study testing Sulfadoxine-Pyrimethamine in people with Non HIV Infected Pregnant Women, run by Institute of Tropical Medicine, Belgium at 1 site in Rwanda.
Trial summary
The present study will address the question whether the use of IPT using SP in pregnancy is efficacious in Rwanda, where it is going to be used for the first time, in areas with high levels of SP resistance. Read more about this study
- Who is it for?
- Ages 21 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Non HIV Infected Pregnant Women
- What is being tested?
- Sulfadoxine-Pyrimethamine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,717 participants
- Where
- 1 siteRwanda
- Study dates
- Dec 2005to Apr 2008
- Phase
- Phase 4
- 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 21 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women between 16-28 weeks of gestation;
- Residence within the catchment's area of the health facility;
- Willing to deliver at the health facility;
- Willing to ; adhere to all requirements of the study;
- Willing to provide written informed consent;
- Aged 21 years and above
Who cannot join
- Severe anemia (Hb < 6 g/dL)
- History of allergic reactions to sulfa drugs;
- Taking other sulfa drugs as CTX;
- History of known pregnancy complications (e.g. breech presentation, severe pre-eclampsia, prior caesarian section);
- History or presence of major illnesses likely to influence pregnancy outcome including diabetes mellitus, severe renal or heart disease, or active tuberculosis, prior to randomization;
- Any significant illness that requires hospitalization;
- Intent to move out of the study catchment's area before delivery or deliver at relative's home out of the catchment's area;
- Prior enrollment in the study or concurrent enrollment in another study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intermittent Preventive Treatment of Malaria With Sulfadoxine-Pyrimethamine in Different Zones of Drug Resistance in Rwanda
The present study will address the question whether the use of IPT using SP in pregnancy is efficacious in Rwanda, where it is going to be used for the first time, in areas with high levels of SP resistance. While the implementation of the new policy will take place in areas at low SP resistance level, where we expect pregnant women and newborns to benefit from it, it is of paramount importance to clarify which is the real impact of IPT/SPin areas of high SP drug resistance and at what level of SP resistance this strategy is still efficacious. As bed nets are a part of the actual control strategy of malaria in pregnancy all women will receive a bed net at enrolment
Read the detailed description
The present study will address the question whether the use of IPT using SP in pregnancy is efficacious in Rwanda, where it is going to be used for the first time, in areas with high levels of SP resistance. While the implementation of the new policy will take place in areas at low SP resistance level, where we expect pregnant women and newborns to benefit from it, it is of paramount importance to clarify which is the real impact of IPT/SPin areas of high SP drug resistance and at what level of SP resistance this strategy is still efficacious. As bed nets are a part of the actual control strategy of malaria in pregnancy all women will receive a bed net at enrolment.
This will be a randomized blinded placebo controlled trial: women in the 16-28th week of gestation will be offered enrolment into the study and randomized to receive IPT/SP regimen or placebo once during the second and once in the third trimesters.
The study will be conducted in Mashesha (estimated SP drug resistance 20%, 12% in 2000), Kicukiro (40% SP resistance) and Rukara (60% SP resistance). In each of these sites there are about 1000 deliveries per year. According to DHMT data, over 75% of pregnant women attend antenatal clinics, usually booking between 15 and 25 weeks of gestation. Based on this study we expect to find placental malaria prevalence over 50% in all sites.
- Conditions
- Non HIV Infected Pregnant Women
- Being tested
- Sulfadoxine-Pyrimethamine, placebo
- Keywords
- Pregnancy malaria prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sulfadoxine-PyrimethamineDrug
Also called fansidar
The intervention group receives 1500mg of sulfadoxine and 75mg of pyrimethamine at enrollment and in the third trimester.
placeboDrug
The control group receives placebo similar in taste and appearance to to the experimental arm
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
| sulfadoxine-pyrimethamine | Experimental | Not described Receives: Drug: Sulfadoxine-Pyrimethamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
malaria infection will be defined as the presence of asexual stage parasites on thick smears made with maternal side placental blood and Maternal peripheral blood
Measured: maternal placental blood at delivery; maternal peripheral blood at monthly visits between 16 weeks of gestation and delivery
Secondary outcomes (10)
LBW = birth weight <2,500 grams
Measured: at delivery
Premature delivery = delivery prior to 37 weeks gestation
Measured: at delivery
Spontaneous miscarriage = any spontaneous abortion before the end of gestation
Measured: at delivery
Stillbirth
Measured: at delivery
Cord blood parasitaemia = presence of asexual stage parasites in thick smears
Measured: at delivery
Neonatal death = infant death within the first 28 days of life
Measured: 7days and 6 weeks after delivery
Maternal anemia = Hb <11.0 g/dL
Measured: at monthly visits between 16 weeks of gestation and delivery
Maternal severe anemia = Hb <6 g/dL
Measured: at monthly visits between 16 weeks of gestation and delivery
Symptomatic maternal malaria infection = axillary temperature 37.5°C and asexual parasitaemia
Measured: at monthly visits between 16 weeks of gestation and delivery
Severe maternal adverse reactions to SP = severe cutaneous reactions (e.g., erythema multiform, Stevens-Johnson syndrome, or toxic epidermal necrolysis)
Measured: at monthly visits between 16 weeks of gestation and delivery plus at day 7 and week 6 after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2006 (estimated)
- Study startDec 2005
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non HIV Infected Pregnant WomenStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,717 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Tropical Medicine, Belgium
- Sponsor type
- University, hospital or other
- Investigators
- Umberto D'Alessandro, MD,MSc, PHD, Study director, Institute of Tropical Medicine Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00372632
- Sponsor's protocol ID
- 05 34 5 520
- Status last verified
- Sep 2010
- First submitted
- 5 Sep 2006
- 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
- Intermittent Preventive Treatment of Malaria With Sulfadoxine-Pyrimethamine in Different Zones of Drug Resistance in Rwanda
- ClinicalTrials.gov ID
- NCT00372632
- Acronym / sponsor ID
- 05 34 5 520
- Conditions
- Non HIV Infected Pregnant Women
- Keywords
- Pregnancy malaria prevention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,717 participants (actual)
- Lead sponsor
- Institute of Tropical Medicine, BelgiumUniversity, hospital or other
- Study start
- Dec 2005
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 7 Sep 2006 (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 present study will address the question whether the use of IPT using SP in pregnancy is efficacious in Rwanda, where it is going to be used for the first time, in areas with high levels of SP resistance. While the implementation of the new policy will take place in areas at low SP resistance level, where we expect pregnant women and newborns to benefit from it, it is of paramount importance to clarify which is the real impact of IPT/SPin areas of high SP drug resistance and at what level of SP resistance this strategy is still efficacious. As bed nets are a part of the actual control strategy of malaria in pregnancy all women will receive a bed net at enrolment
Detailed description
The present study will address the question whether the use of IPT using SP in pregnancy is efficacious in Rwanda, where it is going to be used for the first time, in areas with high levels of SP resistance. While the implementation of the new policy will take place in areas at low SP resistance level, where we expect pregnant women and newborns to benefit from it, it is of paramount importance to clarify which is the real impact of IPT/SPin areas of high SP drug resistance and at what level of SP resistance this strategy is still efficacious. As bed nets are a part of the actual control strategy of malaria in pregnancy all women will receive a bed net at enrolment.
This will be a randomized blinded placebo controlled trial: women in the 16-28th week of gestation will be offered enrolment into the study and randomized to receive IPT/SP regimen or placebo once during the second and once in the third trimesters.
The study will be conducted in Mashesha (estimated SP drug resistance 20%, 12% in 2000), Kicukiro (40% SP resistance) and Rukara (60% SP resistance). In each of these sites there are about 1000 deliveries per year. According to DHMT data, over 75% of pregnant women attend antenatal clinics, usually booking between 15 and 25 weeks of gestation. Based on this study we expect to find placental malaria prevalence over 50% in all sites.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: placebo |
| sulfadoxine-pyrimethamine | Experimental | Drug: Sulfadoxine-Pyrimethamine |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Pregnant women between 16-28 weeks of gestation;
- Residence within the catchment's area of the health facility;
- Willing to deliver at the health facility;
- Willing to ; adhere to all requirements of the study;
- Willing to provide written informed consent;
Key exclusion criteria (8 listed)
- Severe anemia (Hb < 6 g/dL)
- History of allergic reactions to sulfa drugs;
- Taking other sulfa drugs as CTX;
- History of known pregnancy complications (e.g. breech presentation, severe pre-eclampsia, prior caesarian section);
- History or presence of major illnesses likely to influence pregnancy outcome including diabetes mellitus, severe renal or heart disease, or active tuberculosis, prior to randomization;
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: fansidarThe intervention group receives 1500mg of sulfadoxine and 75mg of pyrimethamine at enrollment and in the third trimester. | Drug | sulfadoxine-pyrimethamine |
| placeboThe control group receives placebo similar in taste and appearance to to the experimental arm | Drug | placebo |
Primary outcome
malaria infection will be defined as the presence of asexual stage parasites on thick smears made with maternal side placental blood and Maternal peripheral blood
Time frame: maternal placental blood at delivery; maternal peripheral blood at monthly visits between 16 weeks of gestation and delivery
10 secondary outcomes
LBW = birth weight <2,500 grams
Time frame: at delivery
Premature delivery = delivery prior to 37 weeks gestation
Time frame: at delivery
Spontaneous miscarriage = any spontaneous abortion before the end of gestation
Time frame: at delivery
Stillbirth
Time frame: at delivery
Cord blood parasitaemia = presence of asexual stage parasites in thick smears
Time frame: at delivery
Neonatal death = infant death within the first 28 days of life
Time frame: 7days and 6 weeks after delivery
Maternal anemia = Hb <11.0 g/dL
Time frame: at monthly visits between 16 weeks of gestation and delivery
Maternal severe anemia = Hb <6 g/dL
Time frame: at monthly visits between 16 weeks of gestation and delivery
Symptomatic maternal malaria infection = axillary temperature 37.5°C and asexual parasitaemia
Time frame: at monthly visits between 16 weeks of gestation and delivery
Severe maternal adverse reactions to SP = severe cutaneous reactions (e.g., erythema multiform, Stevens-Johnson syndrome, or toxic epidermal necrolysis)
Time frame: at monthly visits between 16 weeks of gestation and delivery plus at day 7 and week 6 after delivery
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.
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.
Umberto D'Alessandro, MD,MSc, PHD study director
Institute of Tropical Medicine Antwerp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sulfadoxine-Pyrimethamine in people with Non HIV Infected Pregnant Women, run by Institute of Tropical Medicine, Belgium at 1 site in Rwanda.
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 6 inclusion and 8 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 Rwanda. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
malaria infection will be defined as the presence of asexual stage parasites on thick smears made with maternal side placental blood and Maternal peripheral blood (time frame: maternal placental blood at delivery; maternal peripheral blood at monthly visits between 16 weeks of gestation and 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.