MalariaMIPP-NGNCT02758353
The Impact of Sulphadoxine-Pyrimethamine Use At Scale on Newborn Outcomes in Nigeria
A study testing Community distribution of SP in people with Malaria and Stillbirths, run by JSI Research & Training Institute, Inc..
Trial summary
The purpose of this study is to test the feasibility of the scale-up of sulphadoxine- pyrimethamine (SP) for the preventive treatment of malaria in pregnancy in three Local Government Areas (LGAs) in Sokoto State, Nigeria. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Malaria, Stillbirths
- What is being tested?
- Community distribution of SP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31,493 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Nov 2015
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Participants must be pregnant.
- Pregnant participants must have experienced quickening in course of gestation.
- Participants must reside in an intervention or a counterfactual LGA.
Who cannot join
- Non-pregnant residents in a counterfactual or an intervention LGA.
- Non-residents of counterfactual or intervention LGA.
About this study
Official title: Scaling up the Use of Sulphadoxine-Pyrimethamine for the Preventive Treatment of Malaria in Pregnancy: Results and Lessons on Scalability, Costs and Program From Three Local Government Areas in Sokoto State, Nigeria
The purpose of this study is to test the feasibility of the scale-up of sulphadoxine- pyrimethamine (SP) for the preventive treatment of malaria in pregnancy in three Local Government Areas (LGAs) in Sokoto State, Nigeria. The scale-up strategy tested included the introduction of community-based distribution of SP in addition to ongoing health facility distribution during antenatal care (ANC) visits. In addition, the study examined for the effect of SP use by participants during pregnancy on the head circumference of live newborns and on the odds of a baby being a stillborn. Finally, the investigators also sought to quantify the costs associated with program scale up SP to deliver at least three doses of SP per participant via a government operated distribution program.
Read the detailed description
Study Objectives
The study objectives were to:
- Examine scale-up mechanisms that enable increased SP coverage through community-based primary health care delivery, without reducing facility uptake of SP.
- Examine community acceptance of SP and the likelihood of long-term community-sustained demand.
- Document associations, if any, between increased SP coverage and improved intrauterine conditions for newborn, as measured by head circumference increments and declines in still birth rates.
- Estimate the costs of delivering SP at scale per woman for a three doses or higher regimen.
Study Location and Relevant Contextual Information
The study was undertaken in four LGAs: Dange Shuni Goronyo and Silame (combined 2015 population, according to official Sokoto State estimates = 661,606) LGAs which were purposively selected as intervention LGAs; and Yabo LGA, the fourth (2015 population, according to official Sokoto State estimates = 167,971), was purposively selected as the counterfactual LGA. The selection criteria were that all LGAs had a high prevalence of malaria in pregnancy and that at one LGA each in the intervention group, was selected from each of the State's three senatorial zones.
Sampling Size Considerations
Given the intention of the study to examine the prospects of scaling up an already existing program, to reach all eligible pregnant participants, no sampling regimen was included in this study.
Data Collection Procedures
The community-based health volunteer (CBHV) system has an inbuilt data collection system managed by a community drug keeper (CDK) and a supervising facility-based health worker to monitor distribution at the community level. Investigators used an outcome form to collect data. Data captured in the outcome form included the condition of the newborn and mother at birth, of the newborn at birth-live birth or stillbirth-at days 7, 14 and 28 postpartum. For this study, the investigators modified the outcome form to also capture the number of SP doses a participant received and date/month the participant got them. The modified outcome form also collected data on a pregnant participant's primipara status, ANC status, gestation in months at time of delivery, the state of newborns (live or stillborn), sex of the newborn and head circumference measurements.
Nominal cost and expense data in 2015 Nigerian Naira (NGN) directly related to community and facility distribution of SP in the intervention and counterfactual LGAs were obtained from project records and other sources. The cost estimates obtained are what it would cost the state government and LGAs as de facto providers of primary health care in Nigeria, to deliver SP-related services at both the community and facility level, including start-up costs. Six cost centers were included in the analyses: health facility, LGA technical administration, CBHV supervisors, ward development committees, CBHV, and logistics for SP distribution.
Data Quality Procedures
Twelve teams of four data quality auditors, independent of other project staff, were recruited to track data quality obtained from communities. Each team comprised of three females and one supervisor. Over the life of the project, the teams visited all the participants recorded with at least one birth-that occurred during the project-in the 42 wards of the three intervention and one counterfactual LGAs. The data auditors also sought for and compiled information on omitted mothers and births. The auditors were expected to directly inquire of a participant-or an informed family member - in the event of a maternal death-if a CBHV and CBHV Supervisor visited, the status of newborns, alive or stillborn, and if head circumference was measured within seven days among live births. With participants' responses as the gold standard, births, status of births, and confirmed head circumference measurements were verified.
Statistical Analyses
Programmatic data was used to assess the coverage of SP doses during pregnancy in the intervention and counterfactual LGA's. Univariate and multivariate analyses were used by investigators to test associations between doses of SP and newborn head circumference and the odds of stillbirth. These analyses were conducted in Statistical Analysis System (SAS) v.9 and excel.
For cost data, the investigators calculated two ratios: cost per dose and cost per woman served, disaggregated by number of SP doses in the intervention and and counterfactual group. Analyses were conducted in Excel®.
- Conditions
- Malaria, Stillbirths
- Being tested
- Community distribution of SP
- Keywords
- Malaria in Pregnancy, Nigeria, Sulfadoxine-Pyrimethamine, Scale up, Primary Health Care
- Medical subject headings
- Malaria, Stillbirth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community distribution of SPDrug
Also called Community Distribution of SP to eligible participants
SP delivered at both the community and facility level by trained CBHVs in three LGAs.
| Study group | Role | What they receive |
|---|---|---|
| Community distribution of SP | Experimental | All the eligible pregnant women were reached with SP either at health clinic and/or at community/household level with sulphadoxine-pyrimethamine (SP). Alerts and reminders were sent to them by community-based health volunteers ahead of subsequent SP doses. Receives: Drug: Community distribution of SP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants that got SP coverage among all pregnant women
The percentage SP coverage among all pregnant participants and by number of SP doses ingested. The outcome form will be used to obtain an aggregate number of women that received SP. The total number of eligible women will be obtained from either an enumeration of eligible women in the intervention LGA, or by population estimation in the counterfactual LGA.
Measured: Up to 7 months
Secondary outcomes (4)
Cost per Woman served with SP in Nigeria Naira
This will be obtained from costing data produced by the study and the total number of participants served as derived from the outcome forms.
Measured: Up to 7 months
Cost per SP dose delivered in Nigeria Naira
This will be obtained from costing data produced by the study and the total number of SP doses given as derived from the outcome forms.
Measured: Up to 12 months
Incidence of Stillbirths in stillbirths per 1000 term births
Stillbirth is a delivery that occurred after 7 months of gestation in which a baby was birthed without any signs of life (no breathing, no movement, and no sound) as reported by a participant or an informed family member.
Measured: Up to 7 months
Head circumference of Newborn in millimeters
Head circumference of live newborns was measured within 7 days postpartum by CBHV. The information will be aggregated from individual outcome forms.
Measured: Up to 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2016 (estimated)
- Study startApr 2015
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31,493 participants (actual)
Sponsor and investigators
- Lead sponsor
- JSI Research & Training Institute, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, Federal Ministry of Health, Nigeria
- Responsible party
- Principal investigator, Nosa Orobaton, JSI Research & Training Institute, Inc.
- Investigators
- Nosa G Orobaton, MD, DrPH, Principal investigator, John Snow, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02758353
- Sponsor's protocol ID
- JSI-MIPP-NG #1
- Acronym
- MIPP-NG
- Status last verified
- Apr 2016
- First submitted
- 26 Apr 2016
- Last updated
- 2 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
WHO. World Malaria Report 2015 [Internet]. 2015. Available from: http://apps.who.int/iris/bitstream/10665/200018/1/9789241565158_eng.pdf?ua=1
Dellicour S, Tatem AJ, Guerra CA, Snow RW, ter Kuile FO. Quantifying the number of pregnancies at risk of malaria in 2007: a demographic study. PLoS Med. 2010 Jan 26;7(1):e1000221. doi: 10.1371/journal.pmed.1000221.
PubMed 20126256Partnership RBM. Roll Back Malaria Annual Report 2013 [Internet]. [cited 2016 Feb 21]. Available from: http://www.rollbackmalaria.org/files/files/resources/RBM-Annual-Report- 2013(1).pdf
Onwujekwe O, Chima R, Okonkwo P. Economic burden of malaria illness on households versus that of all other illness episodes: a study in five malaria holo-endemic Nigerian communities. Health Policy. 2000 Nov 17;54(2):143-59. doi: 10.1016/s0168-8510(00)00105-6.
PubMed 11094267Desai M, ter Kuile FO, Nosten F, McGready R, Asamoa K, Brabin B, Newman RD. Epidemiology and burden of malaria in pregnancy. Lancet Infect Dis. 2007 Feb;7(2):93-104. doi: 10.1016/S1473-3099(07)70021-X.
PubMed 17251080Radeva-Petrova D, Kayentao K, ter Kuile FO, Sinclair D, Garner P. Drugs for preventing malaria in pregnant women in endemic areas: any drug regimen versus placebo or no treatment. Cochrane Database Syst Rev. 2014 Oct 10;2014(10):CD000169. doi: 10.1002/14651858.CD000169.pub3.
PubMed 25300703Blencowe H, Cousens S, Jassir FB, Say L, Chou D, Mathers C, Hogan D, Shiekh S, Qureshi ZU, You D, Lawn JE; Lancet Stillbirth Epidemiology Investigator Group. National, regional, and worldwide estimates of stillbirth rates in 2015, with trends from 2000: a systematic analysis. Lancet Glob Health. 2016 Feb;4(2):e98-e108. doi: 10.1016/S2214-109X(15)00275-2. Epub 2016 Jan 19.
PubMed 26795602Villar J, Cheikh Ismail L, Victora CG, Ohuma EO, Bertino E, Altman DG, Lambert A, Papageorghiou AT, Carvalho M, Jaffer YA, Gravett MG, Purwar M, Frederick IO, Noble AJ, Pang R, Barros FC, Chumlea C, Bhutta ZA, Kennedy SH; International Fetal and Newborn Growth Consortium for the 21st Century (INTERGROWTH-21st). International standards for newborn weight, length, and head circumference by gestational age and sex: the Newborn Cross-Sectional Study of the INTERGROWTH-21st Project. Lancet. 2014 Sep 6;384(9946):857-68. doi: 10.1016/S0140-6736(14)60932-6.
PubMed 25209487Menendez C, Ordi J, Ismail MR, Ventura PJ, Aponte JJ, Kahigwa E, Font F, Alonso PL. The impact of placental malaria on gestational age and birth weight. J Infect Dis. 2000 May;181(5):1740-5. doi: 10.1086/315449. Epub 2000 May 15.
PubMed 10823776McClure EM, Goldenberg RL, Dent AE, Meshnick SR. A systematic review of the impact of malaria prevention in pregnancy on low birth weight and maternal anemia. Int J Gynaecol Obstet. 2013 May;121(2):103-9. doi: 10.1016/j.ijgo.2012.12.014. Epub 2013 Mar 13.
PubMed 23490427WHO. Consensus Statement: Optimizing the Delivery of Malaria-inPregnancy Interventions [Internet]. 2013 [cited 2016 Feb 21]. Available from: http://www.pmi.gov/docs/default-source/default-document-library/toolscurricula/consensusreport_malariapregnancy.pdf?sfvrsn=4
Orobaton N, Austin AM, Abegunde D, Ibrahim M, Mohammed Z, Abdul-Azeez J, Ganiyu H, Nanbol Z, Fapohunda B, Beal K. Scaling-up the use of sulfadoxine-pyrimethamine for the preventive treatment of malaria in pregnancy: results and lessons on scalability, costs and programme impact from three local government areas in Sokoto State, Nigeria. Malar J. 2016 Nov 4;15(1):533. doi: 10.1186/s12936-016-1578-x.
PubMed 27814763
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scaling up the Use of Sulphadoxine-Pyrimethamine for the Preventive Treatment of Malaria in Pregnancy: Results and Lessons on Scalability, Costs and Program From Three Local Government Areas in Sokoto State, Nigeria
- ClinicalTrials.gov ID
- NCT02758353
- Acronym / sponsor ID
- MIPP-NG / JSI-MIPP-NG #1
- Conditions
- Malaria, Stillbirths
- Keywords
- Malaria in Pregnancy, Nigeria, Sulfadoxine-Pyrimethamine, Scale up, Primary Health Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31,493 participants (actual)
- Lead sponsor
- JSI Research & Training Institute, Inc.University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, Federal Ministry of Health, Nigeria
- Study start
- Apr 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 2 May 2016 (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 test the feasibility of the scale-up of sulphadoxine- pyrimethamine (SP) for the preventive treatment of malaria in pregnancy in three Local Government Areas (LGAs) in Sokoto State, Nigeria. The scale-up strategy tested included the introduction of community-based distribution of SP in addition to ongoing health facility distribution during antenatal care (ANC) visits. In addition, the study examined for the effect of SP use by participants during pregnancy on the head circumference of live newborns and on the odds of a baby being a stillborn. Finally, the investigators also sought to quantify the costs associated with program scale up SP to deliver at least three doses of SP per participant via a government operated distribution program.
Detailed description
Study Objectives
The study objectives were to:
- Examine scale-up mechanisms that enable increased SP coverage through community-based primary health care delivery, without reducing facility uptake of SP.
- Examine community acceptance of SP and the likelihood of long-term community-sustained demand.
- Document associations, if any, between increased SP coverage and improved intrauterine conditions for newborn, as measured by head circumference increments and declines in still birth rates.
- Estimate the costs of delivering SP at scale per woman for a three doses or higher regimen.
Study Location and Relevant Contextual Information
The study was undertaken in four LGAs: Dange Shuni Goronyo and Silame (combined 2015 population, according to official Sokoto State estimates = 661,606) LGAs which were purposively selected as intervention LGAs; and Yabo LGA, the fourth (2015 population, according to official Sokoto State estimates = 167,971), was purposively selected as the counterfactual LGA. The selection criteria were that all LGAs had a high prevalence of malaria in pregnancy and that at one LGA each in the intervention group, was selected from each of the State's three senatorial zones.
Sampling Size Considerations
Given the intention of the study to examine the prospects of scaling up an already existing program, to reach all eligible pregnant participants, no sampling regimen was included in this study.
Data Collection Procedures
The community-based health volunteer (CBHV) system has an inbuilt data collection system managed by a community drug keeper (CDK) and a supervising facility-based health worker to monitor distribution at the community level. Investigators used an outcome form to collect data. Data captured in the outcome form included the condition of the newborn and mother at birth, of the newborn at birth-live birth or stillbirth-at days 7, 14 and 28 postpartum. For this study, the investigators modified the outcome form to also capture the number of SP doses a participant received and date/month the participant got them. The modified outcome form also collected data on a pregnant participant's primipara status, ANC status, gestation in months at time of delivery, the state of newborns (live or stillborn), sex of the newborn and head circumference measurements.
Nominal cost and expense data in 2015 Nigerian Naira (NGN) directly related to community and facility distribution of SP in the intervention and counterfactual LGAs were obtained from project records and other sources. The cost estimates obtained are what it would cost the state government and LGAs as de facto providers of primary health care in Nigeria, to deliver SP-related services at both the community and facility level, including start-up costs. Six cost centers were included in the analyses: health facility, LGA technical administration, CBHV supervisors, ward development committees, CBHV, and logistics for SP distribution.
Data Quality Procedures
Twelve teams of four data quality auditors, independent of other project staff, were recruited to track data quality obtained from communities. Each team comprised of three females and one supervisor. Over the life of the project, the teams visited all the participants recorded with at least one birth-that occurred during the project-in the 42 wards of the three intervention and one counterfactual LGAs. The data auditors also sought for and compiled information on omitted mothers and births. The auditors were expected to directly inquire of a participant-or an informed family member - in the event of a maternal death-if a CBHV and CBHV Supervisor visited, the status of newborns, alive or stillborn, and if head circumference was measured within seven days among live births. With participants' responses as the gold standard, births, status of births, and confirmed head circumference measurements were verified.
Statistical Analyses
Programmatic data was used to assess the coverage of SP doses during pregnancy in the intervention and counterfactual LGA's. Univariate and multivariate analyses were used by investigators to test associations between doses of SP and newborn head circumference and the odds of stillbirth. These analyses were conducted in Statistical Analysis System (SAS) v.9 and excel.
For cost data, the investigators calculated two ratios: cost per dose and cost per woman served, disaggregated by number of SP doses in the intervention and and counterfactual group. Analyses were conducted in Excel®.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Community distribution of SP | Experimental | Drug: Community distribution of SPAll the eligible pregnant women were reached with SP either at health clinic and/or at community/household level with sulphadoxine-pyrimethamine (SP). Alerts and reminders were sent to them by community-based health volunteers ahead of subsequent SP doses. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Participants must be pregnant.
- Pregnant participants must have experienced quickening in course of gestation.
- Participants must reside in an intervention or a counterfactual LGA.
Key exclusion criteria (2 listed)
- Non-pregnant residents in a counterfactual or an intervention LGA.
- Non-residents of counterfactual or intervention LGA.
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 |
|---|---|---|
| Community distribution of SPAlso: Community Distribution of SP to eligible participantsSP delivered at both the community and facility level by trained CBHVs in three LGAs. | Drug | Community distribution of SP |
Primary outcome
Percentage of participants that got SP coverage among all pregnant women
Time frame: Up to 7 months
The percentage SP coverage among all pregnant participants and by number of SP doses ingested. The outcome form will be used to obtain an aggregate number of women that received SP. The total number of eligible women will be obtained from either an enumeration of eligible women in the intervention LGA, or by population estimation in the counterfactual LGA.
4 secondary outcomes
Cost per Woman served with SP in Nigeria Naira
Time frame: Up to 7 months
Cost per SP dose delivered in Nigeria Naira
Time frame: Up to 12 months
Incidence of Stillbirths in stillbirths per 1000 term births
Time frame: Up to 7 months
Head circumference of Newborn in millimeters
Time frame: Up to 7 months
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 2 May 2016.
- BackgroundWHO. World Malaria Report 2015 [Internet]. 2015. Available from: http://apps.who.int/iris/bitstream/10665/200018/1/9789241565158_eng.pdf?ua=1
- Background: PubMed 20126256Dellicour S, Tatem AJ, Guerra CA, Snow RW, ter Kuile FO. Quantifying the number of pregnancies at risk of malaria in 2007: a demographic study. PLoS Med. 2010 Jan 26;7(1):e1000221. doi: 10.1371/journal.pmed.1000221.
- BackgroundPartnership RBM. Roll Back Malaria Annual Report 2013 [Internet]. [cited 2016 Feb 21]. Available from: http://www.rollbackmalaria.org/files/files/resources/RBM-Annual-Report- 2013(1).pdf
- Background: PubMed 11094267Onwujekwe O, Chima R, Okonkwo P. Economic burden of malaria illness on households versus that of all other illness episodes: a study in five malaria holo-endemic Nigerian communities. Health Policy. 2000 Nov 17;54(2):143-59. doi: 10.1016/s0168-8510(00)00105-6.
- Background: PubMed 17251080Desai M, ter Kuile FO, Nosten F, McGready R, Asamoa K, Brabin B, Newman RD. Epidemiology and burden of malaria in pregnancy. Lancet Infect Dis. 2007 Feb;7(2):93-104. doi: 10.1016/S1473-3099(07)70021-X.
- Background: PubMed 25300703Radeva-Petrova D, Kayentao K, ter Kuile FO, Sinclair D, Garner P. Drugs for preventing malaria in pregnant women in endemic areas: any drug regimen versus placebo or no treatment. Cochrane Database Syst Rev. 2014 Oct 10;2014(10):CD000169. doi: 10.1002/14651858.CD000169.pub3.
- Background: PubMed 26795602Blencowe H, Cousens S, Jassir FB, Say L, Chou D, Mathers C, Hogan D, Shiekh S, Qureshi ZU, You D, Lawn JE; Lancet Stillbirth Epidemiology Investigator Group. National, regional, and worldwide estimates of stillbirth rates in 2015, with trends from 2000: a systematic analysis. Lancet Glob Health. 2016 Feb;4(2):e98-e108. doi: 10.1016/S2214-109X(15)00275-2. Epub 2016 Jan 19.
- Background: PubMed 25209487Villar J, Cheikh Ismail L, Victora CG, Ohuma EO, Bertino E, Altman DG, Lambert A, Papageorghiou AT, Carvalho M, Jaffer YA, Gravett MG, Purwar M, Frederick IO, Noble AJ, Pang R, Barros FC, Chumlea C, Bhutta ZA, Kennedy SH; International Fetal and Newborn Growth Consortium for the 21st Century (INTERGROWTH-21st). International standards for newborn weight, length, and head circumference by gestational age and sex: the Newborn Cross-Sectional Study of the INTERGROWTH-21st Project. Lancet. 2014 Sep 6;384(9946):857-68. doi: 10.1016/S0140-6736(14)60932-6.
- Background: PubMed 10823776Menendez C, Ordi J, Ismail MR, Ventura PJ, Aponte JJ, Kahigwa E, Font F, Alonso PL. The impact of placental malaria on gestational age and birth weight. J Infect Dis. 2000 May;181(5):1740-5. doi: 10.1086/315449. Epub 2000 May 15.
- Background: PubMed 23490427McClure EM, Goldenberg RL, Dent AE, Meshnick SR. A systematic review of the impact of malaria prevention in pregnancy on low birth weight and maternal anemia. Int J Gynaecol Obstet. 2013 May;121(2):103-9. doi: 10.1016/j.ijgo.2012.12.014. Epub 2013 Mar 13.
- BackgroundWHO. Consensus Statement: Optimizing the Delivery of Malaria-inPregnancy Interventions [Internet]. 2013 [cited 2016 Feb 21]. Available from: http://www.pmi.gov/docs/default-source/default-document-library/toolscurricula/consensusreport_malariapregnancy.pdf?sfvrsn=4
- Derived from this study: PubMed 27814763Orobaton N, Austin AM, Abegunde D, Ibrahim M, Mohammed Z, Abdul-Azeez J, Ganiyu H, Nanbol Z, Fapohunda B, Beal K. Scaling-up the use of sulfadoxine-pyrimethamine for the preventive treatment of malaria in pregnancy: results and lessons on scalability, costs and programme impact from three local government areas in Sokoto State, Nigeria. Malar J. 2016 Nov 4;15(1):533. doi: 10.1186/s12936-016-1578-x.
- Individual participant dataSharing planned: Undecided
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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.
Nosa G Orobaton, MD, DrPH principal investigator
John Snow, Inc.
Questions about this trial
What is this clinical trial studying?
A study testing Community distribution of SP in people with Malaria and Stillbirths, run by JSI Research & Training Institute, Inc..
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 3 inclusion and 2 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 2 May 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Percentage of participants that got SP coverage among all pregnant women (time frame: Up to 7 months). 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 NCT02758353, which also lists 12 linked publications.
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 2 May 2016.