The Impact of Sulphadoxine-Pyrimethamine Use At Scale on Newborn Outcomes in Nigeria

NCT02758353 | Completed DMC

• 1 other identifier: JSI-MIPP-NG #1
• Study Type: interventional
• Target: 31,493
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Malaria; Stillbirths

Keywords

Malaria in Pregnancy; Nigeria; Sulfadoxine-Pyrimethamine; Scale up; Primary Health Care

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 7 months

Secondary Outcomes (4)

• Cost per Woman served with SP in Nigeria Naira

  Up to 7 months

• Cost per SP dose delivered in Nigeria Naira

  Up to 12 months

• Incidence of Stillbirths in stillbirths per 1000 term births

  Up to 7 months

• Head circumference of Newborn in millimeters

  Up to 7 months

Study Arms (1)

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.

Drug: Community distribution of SP

Interventions

Community distribution of SP DRUG

SP delivered at both the community and facility level by trained CBHVs in three LGAs.

Also known as: Community Distribution of SP to eligible participants

Community distribution of SP

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must be pregnant.
• Pregnant participants must have experienced quickening in course of gestation.
• Participants must reside in an intervention or a counterfactual LGA.

You may not qualify if:

• Non-pregnant residents in a counterfactual or an intervention LGA.
• Non-residents of counterfactual or intervention LGA.

Sponsors & Collaborators

• JSI Research & Training Institute, Inc.: lead
• Bill and Melinda Gates Foundation: collaborator
• Federal Ministry of Health, Nigeria: collaborator

Related Publications (12)

• WHO. World Malaria Report 2015 [Internet]. 2015. Available from: http://apps.who.int/iris/bitstream/10665/200018/1/9789241565158_eng.pdf?ua=1

  BACKGROUND

• 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.

  PMID: 20126256 BACKGROUND

• Partnership 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

• 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.

  PMID: 11094267 BACKGROUND

• Desai 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.

  PMID: 17251080 BACKGROUND

• Radeva-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.

  PMID: 25300703 BACKGROUND

• Blencowe 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.

  PMID: 26795602 BACKGROUND

• Villar 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.

  PMID: 25209487 BACKGROUND

• Menendez 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.

  PMID: 10823776 BACKGROUND

• McClure 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.

  PMID: 23490427 BACKGROUND

• WHO. 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

  BACKGROUND

• 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.

  PMID: 27814763 DERIVED

MeSH Terms

Conditions

Malaria; Stillbirth

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Fetal Death; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nosa G Orobaton, MD, DrPH

  John Snow, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Advisor, Global Health/Chief of Party

Study Record Dates

• First Submitted: April 26, 2016
• First Posted: May 2, 2016
• Study Start: April 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: May 2, 2016

Record last verified: 2016-04