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MalariaPhase 4IPTp_ISTNCT01084213

Intermittent Preventive Treatment Versus Scheduled Screening and Treatment of Malaria in Pregnancy

A Phase 4 study testing Intermittent screening and treatment of malaria in pregnancy (IST) and SP-IPTp in people with Malaria and Pregnancy, run by London School of Hygiene and Tropical Medicine at 4 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The incidence of malaria, including the incidence in pregnant women, is declining in many African countries. Thus, there is a need to re-examine the efficacy and cost effectiveness of giving intermittent preventive treatment with sulphadoxine-pyrimethamine in pregnancy (SP-IPTp) on several occasions during pregnancy… Read more about this study

Who is it for?
Ages 16 to 45 years, women only
Conditions the study is for
Malaria, Pregnancy, Anaemia
What is being tested?
Intermittent screening and treatment of malaria in pregnancy (IST) and SP-IPTp
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5,354 participants
Where
4 sitesin 4 countries
Study dates
Jun 2010to Oct 2012
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 16 to 45 years
  • Women only
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Presence of a first or second pregnancy.
  • Gestation between 16 to 30 weeks inclusive at first booking as determined by symphysio-fundal measurements.
  • Provision of informed consent to join the trial.
  • Residence in the study area and intention to stay in the area for the duration of the pregnancy.

Who cannot join

  • Absence of informed consent.
  • An intention to leave the study area before delivery.
  • A history of sensitivity to sulphonamides.
  • Clinical AIDS or known HIV positivity.
  • Presence of any systemic illness likely to interfere with interpretation of the results of the trial.

Trial locations and contacts

4 sites in 4 countries.

4 sites in 4 countries

Burkina Faso1 site

  • Université de Ouagadougou

    Ouagadougou

Other trials in Burkina Faso

Ghana1 site

  • Navrongo Health Research Centre

    Navrongo

Other trials in Ghana

Mali1 site

  • Medical Research and Training Centre

    Bamako

Other trials in Mali

The Gambia1 site

  • Medical Research Council Laboratories

    Basse Santa Su

Other trials in The Gambia

About this study

Official title: A Trial of Intermittent Preventive Treatment With Sulfadoxine-pyrimethamine Versus Intermittent Screening and Treatment of Malaria in Pregnancy

The incidence of malaria, including the incidence in pregnant women, is declining in many African countries. Thus, there is a need to re-examine the efficacy and cost effectiveness of giving intermittent preventive treatment with sulphadoxine-pyrimethamine in pregnancy (SP-IPTp) on several occasions during pregnancy, an intervention that is threatened by increasing resistance to SP. Possible alternatives to SP-IPTp need to be explored. This applies especially to areas with highly seasonal malaria transmission where women are at risk for only a short period of the year.

The goal of this project is to determine whether in pregnant women who sleep under a long lasting insecticide treated bed net, screening and treatment at each scheduled antenatal clinic visit is as effective in protecting them from anaemia, low birth weight and placental infection as SP-IPTp.

Read more

Primigravidae and secundigravidae who present at antenatal clinics in study sites in four West African countries (Burkina Faso, Ghana, Mali and The Gambia) will be randomised to one of two groups. All women will be given a long lasting insecticide treated bed net on first presentation at the antenatal clinic. Women in group 1 (reference group) will receive SP-IPTp according to the current WHO guidelines. Those in group 2 will be screened with a rapid diagnostic test at each scheduled antenatal clinic visit and treated if parasitaemic. Approximately 5000 women will be recruited, 2500 in each group. Women will be encouraged to deliver in hospital where maternal haemoglobin and birth weight will be recorded and a placental sample obtained. Those who deliver at home will be visited within a week of delivery and maternal haemoglobin and infant weight recorded. Mothers and infants will be seen again six weeks after delivery. Also at delivery peripheral maternal blood sample will be obtained for the diagnosis of malaria using RDT, microscopy and PCR. The primary end points of the trial will be birth weight and anaemia at 38 weeks (+/-2 weeks) of gestation. The study is powered to show non-inferiority of group 2 compared to group 1. The costs and cost effectiveness of each intervention will be evaluated.

In the light of recent evidence suggesting that malaria infection during pregnancy, particularly in the last trimester may influence an infant's risk of malaria, we proposed to follow infants born to mothers recruited in the Navrongo site in Ghana who have received either IST or IPTp in pregnancy throughout the whole of their first year of life beyond the six weeks originally proposed. We have received approval for this from the ethic committees at Kwame Nkrumah University of Science and Technology, Ghana Health Service and Navrongo Health Research Centre. The aim is to obtain information on the incidence of both symptomatic and asymptomatic malaria infections in these infants during follow up of the infants.

The study will provide information to national malaria control programmes on whether there are alternative, safe and effective methods to the SP IPTp regimen for reducing the burden of malaria in pregnancy.

Being tested
Intermittent screening and treatment of malaria in pregnancy (IST), SP-IPTp
Keywords
Low birth weight, Placenta malaria, Anaemia, Intermittent preventive treatment, Intermittent screening and treatment, Rapid diagnostic test
Medical subject headings
Malaria, Anemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intermittent screening and treatment of malaria in pregnancy (IST)Drug

    Also called Coartem

    Scheduled intermittent screening of study women using rapid diagnostic test and treatment of those who are RDT positive during ante-natal clinic visits in the 2nd and 3rd trimester with arthemether lumefantrine.

  • SP-IPTpDrug

    Also called SP

    Study women will receive at least two doses of Sulfadoxine Pyrimethamine during their pregnancy, one at each of the recommended ante-natal visits during the 2nd and 3rd trimester.

Study groups in NCT01084213
Study groupRoleWhat they receive
IPTp with SPActive comparatorStudy women will receive at least two doses of SP during their pregnancy, one at each of the recommended ante-natal visits during the 2nd and 3rd trimester.
Receives: Drug: SP-IPTp
IST using RDTsExperimentalScheduled intermittent screening using rapid diagnostic tests and treatment of those who are RDT positive during ante-natal clinic visits in the 2nd and 3rd trimester.
Receives: Drug: Intermittent screening and treatment of malaria in pregnancy (IST)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prevalence of low birth weight

    Measured: 6 - 18 months

  2. Prevalence of third trimester anaemia

    Measured: 3 - 12 months

  3. Prevalence of placenta malaria

    Measured: 6 - 18 months

Secondary outcomes (9)

  1. Prevalence of anaemia at the time of delivery or shortly afterwards.

    Measured: 6 - 18 months

  2. Prevalence of peripheral blood parasitaemia

    Measured: 6 - 18 months

  3. Episodes of clinical malaria during the course of the pregnancy.

    Measured: 1 year

  4. Serious adverse events in the mother.

    Measured: 6 - 18 months

  5. Adverse outcome of pregnancy - abortions, still births and neonatal deaths.

    Measured: 6 - 18 months

  6. Occurrence of congenital abnormalities.

    Measured: 6 - 18 months

  7. Feasibility and costs of each approach to the control of malaria in pregnancy.

    Measured: 1 year

  8. Cost per cases of maternal anaemia (severe and non-severe) and peripheral malaria averted.

    Measured: 1 year

  9. Acceptability of each approach by pregnant women and antenatal clinic staff.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2010 (estimated)
  2. Study startJun 2010
  3. Primary completionJul 2012
  4. Study completionOct 2012

Resources

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
5,354 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01084213
Sponsor's protocol ID
MiPcMA05
Acronym
IPTp_IST
Status last verified
Apr 2014
First submitted
3 Mar 2010
Last updated
11 Apr 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Berry I, Walker P, Tagbor H, Bojang K, Coulibaly SO, Kayentao K, Williams J, Oduro A, Milligan P, Chandramohan D, Greenwood B, Cairns M. Seasonal Dynamics of Malaria in Pregnancy in West Africa: Evidence for Carriage of Infections Acquired Before Pregnancy Until First Contact with Antenatal Care. Am J Trop Med Hyg. 2018 Feb;98(2):534-542. doi: 10.4269/ajtmh.17-0620. Epub 2017 Nov 30.

    PubMed 29210351

  • Tagbor H, Cairns M, Bojang K, Coulibaly SO, Kayentao K, Williams J, Abubakar I, Akor F, Mohammed K, Bationo R, Dabira E, Soulama A, Djimde M, Guirou E, Awine T, Quaye S, Njie F, Ordi J, Doumbo O, Hodgson A, Oduro A, Meshnick S, Taylor S, Magnussen P, ter Kuile F, Woukeu A, Milligan P, Chandramohan D, Greenwood B. A Non-Inferiority, Individually Randomized Trial of Intermittent Screening and Treatment versus Intermittent Preventive Treatment in the Control of Malaria in Pregnancy. PLoS One. 2015 Aug 10;10(8):e0132247. doi: 10.1371/journal.pone.0132247. eCollection 2015.

    PubMed 26258474

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Intermittent screening and treatment of malaria in pregnancy (IST) and SP-IPTp in people with Malaria and Pregnancy, run by London School of Hygiene and Tropical Medicine at 4 sites in 4 countries.

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 5 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 11 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Burkina Faso, Ghana, Mali, The Gambia. 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 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?

Prevalence of low birth weight (time frame: 6 - 18 months). The study lists 3 primary outcomes in all. 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 NCT01084213, which also lists 2 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 11 Apr 2014.

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