Malaria in PregnancyNCT03944317
Azithromycin (AZ) and Sulphadoxine-pyrimethamine (SP) for Malaria Prevention in Pregnant Women (IPT-AZ/IPT-SP)
A study testing Sulfadoxine pyrimethamine and Azithromycin in people with Malaria in Pregnancy and Pregnancy, run by Federal Medical Centre, Owo at 1 site in Nigeria.
Trial summary
AZITHROMYCIN VERSUS SULPHADOXINE-PYRIMETHAMINE FOR PROPHYLAXIS AGAINST MALARIA IN PREGNANCY IN OWO, SOUIHWESTERN NIGERIA: A RANDOMISED CONTROLLED TRIAL OBJECTIVE: This study is to compare the efficacy of Azithromycin versus sulphadoxine-pyrimethamine as options of chemoprophylaxis against malaria in pregnancy. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Malaria in Pregnancy, Pregnancy
- What is being tested?
- Sulfadoxine pyrimethamine and Azithromycin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteNigeria
- Study dates
- 1 Jun 2019to 31 Jan 2020
- Phase
- Interventional
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- booked pregnant women
- Consent for the study
- Availability for follow-up during the pregnancy by keeping the next ANC appointment
- Willingness to deliver at the study site
- Age ≥ 18years
- comply with use of IPT-SP or Azithromycin medication as required by the study
Who cannot join
- Women treated for malaria in the index pregnancy
- Women who are severely ill (have medical conditions requiring hospital admission)
- Women who report prior adverse drug reaction to sulpha-containing medications and Azithromycin
- Patients with multiple gestations, sickle cell disease, HIV, IUGR and APH
- Women who did not want to participate in the study
- Age <18years
Trial locations and contacts
1 site in 1 country.
Dr Eniowo Roland, FMCOG,FWACS contact
Nigeria1 site
FMCOWO
Owo, Ondo State, 341101
AHMED Ganiyu Olanipekun, MB;BS, 08063458440, ahmadexnatural@gmail.com
About this study
Official title: Randomized Controlled Trial of Azithromycin (AZ) and Sulphadoxine-pyrimethamine (SP) for Prophylaxis Against Malaria in Pregnancy (IPT)
AZITHROMYCIN VERSUS SULPHADOXINE-PYRIMETHAMINE FOR PROPHYLAXIS AGAINST MALARIA IN PREGNANCY IN OWO, SOUIHWESTERN NIGERIA: A RANDOMISED CONTROLLED TRIAL
OBJECTIVE: This study is to compare the efficacy of Azithromycin versus sulphadoxine-pyrimethamine as options of chemoprophylaxis against malaria in pregnancy.
METHOD: This is a randomized controlled trial with parallel assignment that will be conducted in the Obstetrics and Gynaecology department of the Federal Medical Centre. One hundred and sixty four (164) pregnant women who are eligible will be randomly allocated to 2 groups (A and B) of 84 each, using computer generated random numbers. Group A will receive sulfadoxine-pyrimethamine for malaria prophylaxis while Group B will receive azithromycin. All other aspects of antenatal care till delivery will be the same for all the women recruited. Maternal venous blood samples for malaria parasitaemia will be collected on recruitment and repeated at follow-up visits at any gestation there are symptoms of malaria; maternal peripheral blood film, placental and cord blood samples will be collected at delivery. All data will be documented in the data collection sheet. The results obtained will be subjected to statistical analysis using statistical package for social sciences (SPSS) version 21, Armonk, NY:IBM. The level of significance will be set at 5%. Outcomes will be compared across groups using Chi-square.
Read the detailed description
Study design and Patient recruitment
The design is a randomized comparative controlled study. Candidates for the study will be recruited from the antenatal booking clinic of our institution after being duly informed that participation is voluntary. Informed consent will be obtained after the purpose, procedure, benefits, discomfort, risks and precautions associated with the study have been dully explained to them. Due diligence will be taken in adequately responding to any question or concern raised about the study. It will fully be explained to them that their participation is entirely voluntary. Also, if they are unwilling at any point to participate, they will be completely at liberty to discontinue their participation in the study which will not in any away affect their further and adequate management in the hospital. It will be explained that their participation in the study will not have any negative impact on them and their unborn babies and it has no financial benefits but the outcomes of the study may contribute to improved antenatal care. However, if there is additional financial cost (though not immediately foreseen) to any patient outside the cost of routine ANC visit, the investigator shall arrange for modest compensation. Consented eligible pregnant woman will be recruited and those enrolled will be alloted into the two groups A and B of SP and Azithromycin respectively using a computer program (SPSS software version 21, Armonk, NY:IBM) generated sequence of numbers. Sequentially numbered sealed envelope containing either SP or AZ labelled will be allotted one after the other to participants. The personnel involved in the data collection and laboratory staff analyzing the samples will all not be aware of which group of patient is taking SP or Azithromycin while the doctors involved in administering the medication and the patients will be aware of which is being administered.
- Conditions
- Malaria in Pregnancy, Pregnancy
- Being tested
- Sulfadoxine pyrimethamine, Azithromycin
- Keywords
- IPTip, SP, AZ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sulfadoxine pyrimethamineDrug
Also called fansidar
SP 1500/75mg tablet orally once starting from 16 weeks, at least at four weekly interval until delivery.
AzithromycinDrug
Also called Zithromax
A total of 1500mg Azithromycin tablets taken orally as 500mg daily for three consecutive days starting starting from 16weeks of pregnancy and to be repeated once at least after 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Sulfadoxine pyrimethamine | Active comparator | SP 1500/75mg tablet orally once starting from 16 weeks, at least at four weekly interval until delivery. Receives: Drug: Sulfadoxine pyrimethamine |
| Azithromycin | Active comparator | A total of 1500mg Azithromycin tablets taken orally as 500mg daily for three consecutive days starting starting from 16weeks of pregnancy and to be repeated once at least after 4 weeks Receives: Drug: Azithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
malaria parasitaemia during pregnancy
number of pregnant women with maternal peripheral blood parasitaemia during pregnancy among pregnant women who use sulfadoxine pyrimethamine and azithromycin for malaria prevention in pregnancy
Measured: through study completion, an average of 6 months
Secondary outcomes (1)
malaria parasitaemia at the point of delivery
number of pregnant women with maternal peripheral blood and placental parasitaemia, number of new born with cord blood parasitaemia at birth among pregnant women who use sulfadoxine pyrimethamine and azithromycin for malaria prevention in pregnancy
Measured: at the time of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2019
- Study start1 Jun 2019 (estimated)
- Primary completion30 Nov 2019 (estimated)
- Study completion31 Jan 2020 (estimated)
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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- The design is a randomized comparative controlled study. Candidates for the study will be recruited from the antenatal booking clinic of our institution after being duly informed that participation is voluntary. Consented eligible pregnant woman will be recruited and those enrolled will be alloted into the two groups A and B of SP and Azithromycin respectively using a computer program (SPSS software version 21, Armonk, NY:IBM) generated sequence of numbers. Sequentially numbered sealed envelope containing either SP or AZ labelled will be allotted one after the other to participants. The personnel involved in the data collection and laboratory staff analyzing the samples will all not be aware of which group of patient is taking SP or Azithromycin while the doctors involved in administering the medication and the patients will be aware of which is being administered.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal Medical Centre, Owo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, AHMED Ganiyu Olanipekun, Federal Medical Centre, Owo
- Investigators
- Dr Aiyeyemi Adeyinka Joseph, MB;BS, FWACS, Study director, Head of Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03944317
- Sponsor's protocol ID
- FMCOWO
- Status last verified
- May 2019
- First submitted
- 25 Apr 2019
- Last updated
- 10 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Azithromycin (AZ) and Sulphadoxine-pyrimethamine (SP) for Prophylaxis Against Malaria in Pregnancy (IPT)
- ClinicalTrials.gov ID
- NCT03944317
- Acronym / sponsor ID
- FMCOWO
- Conditions
- Malaria in Pregnancy, Pregnancy
- Keywords
- IPTip, SP, AZ
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- Federal Medical Centre, OwoIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2019 (estimated)
- Primary completion
- 30 Nov 2019 (estimated)
- Study completion
- 31 Jan 2020 (estimated)
- First posted
- 9 May 2019 (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.
AZITHROMYCIN VERSUS SULPHADOXINE-PYRIMETHAMINE FOR PROPHYLAXIS AGAINST MALARIA IN PREGNANCY IN OWO, SOUIHWESTERN NIGERIA: A RANDOMISED CONTROLLED TRIAL
OBJECTIVE: This study is to compare the efficacy of Azithromycin versus sulphadoxine-pyrimethamine as options of chemoprophylaxis against malaria in pregnancy.
METHOD: This is a randomized controlled trial with parallel assignment that will be conducted in the Obstetrics and Gynaecology department of the Federal Medical Centre. One hundred and sixty four (164) pregnant women who are eligible will be randomly allocated to 2 groups (A and B) of 84 each, using computer generated random numbers. Group A will receive sulfadoxine-pyrimethamine for malaria prophylaxis while Group B will receive azithromycin. All other aspects of antenatal care till delivery will be the same for all the women recruited. Maternal venous blood samples for malaria parasitaemia will be collected on recruitment and repeated at follow-up visits at any gestation there are symptoms of malaria; maternal peripheral blood film, placental and cord blood samples will be collected at delivery. All data will be documented in the data collection sheet. The results obtained will be subjected to statistical analysis using statistical package for social sciences (SPSS) version 21, Armonk, NY:IBM. The level of significance will be set at 5%. Outcomes will be compared across groups using Chi-square.
Detailed description
Study design and Patient recruitment
The design is a randomized comparative controlled study. Candidates for the study will be recruited from the antenatal booking clinic of our institution after being duly informed that participation is voluntary. Informed consent will be obtained after the purpose, procedure, benefits, discomfort, risks and precautions associated with the study have been dully explained to them. Due diligence will be taken in adequately responding to any question or concern raised about the study. It will fully be explained to them that their participation is entirely voluntary. Also, if they are unwilling at any point to participate, they will be completely at liberty to discontinue their participation in the study which will not in any away affect their further and adequate management in the hospital. It will be explained that their participation in the study will not have any negative impact on them and their unborn babies and it has no financial benefits but the outcomes of the study may contribute to improved antenatal care. However, if there is additional financial cost (though not immediately foreseen) to any patient outside the cost of routine ANC visit, the investigator shall arrange for modest compensation. Consented eligible pregnant woman will be recruited and those enrolled will be alloted into the two groups A and B of SP and Azithromycin respectively using a computer program (SPSS software version 21, Armonk, NY:IBM) generated sequence of numbers. Sequentially numbered sealed envelope containing either SP or AZ labelled will be allotted one after the other to participants. The personnel involved in the data collection and laboratory staff analyzing the samples will all not be aware of which group of patient is taking SP or Azithromycin while the doctors involved in administering the medication and the patients will be aware of which is being administered.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The design is a randomized comparative controlled study. Candidates for the study will be recruited from the antenatal booking clinic of our institution after being duly informed that participation is voluntary. Consented eligible pregnant woman will be recruited and those enrolled will be alloted into the two groups A and B of SP and Azithromycin respectively using a computer program (SPSS software version 21, Armonk, NY:IBM) generated sequence of numbers. Sequentially numbered sealed envelope containing either SP or AZ labelled will be allotted one after the other to participants. The personnel involved in the data collection and laboratory staff analyzing the samples will all not be aware of which group of patient is taking SP or Azithromycin while the doctors involved in administering the medication and the patients will be aware of which is being administered.
| Arm | Type | Receives |
|---|---|---|
| Sulfadoxine pyrimethamine | Active comparator | Drug: Sulfadoxine pyrimethamineSP 1500/75mg tablet orally once starting from 16 weeks, at least at four weekly interval until delivery. |
| Azithromycin | Active comparator | Drug: AzithromycinA total of 1500mg Azithromycin tablets taken orally as 500mg daily for three consecutive days starting starting from 16weeks of pregnancy and to be repeated once at least after 4 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- booked pregnant women
- Consent for the study
- Availability for follow-up during the pregnancy by keeping the next ANC appointment
- Willingness to deliver at the study site
- Age ≥ 18years
Key exclusion criteria (6 listed)
- Women treated for malaria in the index pregnancy
- Women who are severely ill (have medical conditions requiring hospital admission)
- Women who report prior adverse drug reaction to sulpha-containing medications and Azithromycin
- Patients with multiple gestations, sickle cell disease, HIV, IUGR and APH
- Women who did not want to participate in the study
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: fansidarSP 1500/75mg tablet orally once starting from 16 weeks, at least at four weekly interval until delivery. | Drug | Sulfadoxine pyrimethamine |
| AzithromycinAlso: ZithromaxA total of 1500mg Azithromycin tablets taken orally as 500mg daily for three consecutive days starting starting from 16weeks of pregnancy and to be repeated once at least after 4 weeks | Drug | Azithromycin |
Primary outcome
malaria parasitaemia during pregnancy
Time frame: through study completion, an average of 6 months
number of pregnant women with maternal peripheral blood parasitaemia during pregnancy among pregnant women who use sulfadoxine pyrimethamine and azithromycin for malaria prevention in pregnancy
1 secondary outcome
malaria parasitaemia at the point of delivery
Time frame: at the time of delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2019.
- Individual participant dataSharing planned: No
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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.
Dr Eniowo Roland, FMCOG,FWACS contact
Dr Aiyeyemi Adeyinka Joseph, MB;BS, FWACS study director
Head of Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sulfadoxine pyrimethamine and Azithromycin in people with Malaria in Pregnancy and Pregnancy, run by Federal Medical Centre, Owo at 1 site in Nigeria.
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 6 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 10 May 2019. 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 Nigeria. 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 Dr Aiyeyemi Adeyinka Joseph, MB;BS, FWACS (08035057557, adeyinkaaiyeyemi1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
malaria parasitaemia during pregnancy (time frame: through study completion, an average of 6 months). 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 10 May 2019.