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Guideline Summary
Guideline Title
The diagnosis and treatment of malaria in pregnancy.
Bibliographic Source(s)
Royal College of Obstetricians and Gynaecologists (RCOG). The diagnosis and treatment of malaria in pregnancy. London (UK): Royal College of Obstetricians and Gynaecologists (RCOG); 2010 Apr. 29 p. (Green-top guideline; no. 54B).  [81 references]
Guideline Status

This is the current release of the guideline.

FDA Warning/Regulatory Alert

Note from the National Guideline Clearinghouse: This guideline references a drug(s) for which important revised regulatory and/or warning information has been released.

  • August 1, 2013 – Acetaminophen External Web Site Policy: The U.S. Food and Drug Administration (FDA) notified healthcare professionals and patients that acetaminophen has been associated with a risk of rare but serious skin reactions. Acetaminophen is a common active ingredient to treat pain and reduce fever; it is included in many prescription and over-the-counter (OTC) products. These skin reactions, known as Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP), can be fatal. These reactions can occur with first-time use of acetaminophen or at any time while it is being taken. Other drugs used to treat fever and pain/body aches (e.g., non-steroidal anti-inflammatory drugs, or NSAIDS, such as ibuprofen and naproxen) also carry the risk of causing serious skin reactions, which is already described in the warnings section of their drug labels.

Scope

Disease/Condition(s)

Malaria in pregnancy

Guideline Category
Counseling
Diagnosis
Management
Treatment
Clinical Specialty
Family Practice
Infectious Diseases
Internal Medicine
Obstetrics and Gynecology
Intended Users
Advanced Practice Nurses
Nurses
Physician Assistants
Physicians
Guideline Objective(s)

To provide clinicians with up-to-date, evidence-based information on the diagnosis and treatment of malaria in pregnancy, in situations that are likely to be encountered in UK medical practice

Target Population

Pregnant women living in the UK with suspected or confirmed malaria

Interventions and Practices Considered

Diagnosis

  1. Microscopic diagnosis (microscopic examination of thick and thin blood films for parasites)
  2. Rapid detection tests

Management/Treatment

  1. Hospital admission
  2. Drug treatment for malaria (intravenous and oral) (artesunate, quinine, clindamycin, chloroquine, atovaquone-proguanil)
  3. Antipyretics for fever
  4. Screening for anemia
  5. Management plan for follow-up
  6. Management of pregnancy-related complications
    • Monitoring for hypoglycaemia
    • Clinical assessment of pulmonary oedema and acute respiratory distress
    • Slow transfusion or exchange transfusion for anaemia
    • Suspicion of secondary bacterial infection if patient becomes hypotensive
  7. Management of common obstetric problems with acute symptomatic malaria
    • Multidisciplinary approach to fetal compromise
    • Malaria treatment to prevent stillbirth and premature delivery
    • Tests for congenital malaria (placental histology and placenta, cord, and baby blood films)
    • Maternal counselling about vertical transmission of malaria

Note: Primaquine for treatment of malaria in pregnancy was discussed but not recommended.

Major Outcomes Considered
  • Sensitivity of diagnostic tests
  • Efficacy of drugs for treatment of malaria
  • Adverse effects of treatments for malaria
  • Maternal and fetal/neonate morbidity and mortality

Methodology

Methods Used to Collect/Select the Evidence
Hand-searches of Published Literature (Primary Sources)
Hand-searches of Published Literature (Secondary Sources)
Searches of Electronic Databases
Description of Methods Used to Collect/Select the Evidence

A literature search was performed using Medline (November 2009). Keywords used were 'severe malaria', 'uncomplicated malaria', 'burden malaria', 'congenital malaria', 'anaemia malaria', 'pregnancy', 'treatment', 'antimalarials', artesunate', 'artemether', 'artemether-lumefantrine', 'atovaquone-proguanil', 'chloroquine', 'clindamycin', 'dihydroartemisinin-piperaquine', 'mefloquine', 'quinine', 'primaquine', 'UK', 'epidemics', 'maternal mortality', 'pharmacokinetic' and 'pregnancy'. Reference lists of the articles identified were hand searched for additional articles. Other sources used in the development of this guideline included UK malaria treatment guidelines, published and online at the Health Protection Agency, international guidelines from the World Health Organization and websites covering malaria and pregnancy. Areas lacking evidence are highlighted and annotated as 'good practice points'. Articles on intermittent preventive treatment were specifically excluded, as this practice is not recommended in the UK.

Number of Source Documents

Not stated

Methods Used to Assess the Quality and Strength of the Evidence
Weighting According to a Rating Scheme (Scheme Given)
Rating Scheme for the Strength of the Evidence

Classification of Evidence Levels

1++ High-quality meta-analyses, systematic reviews of randomised controlled trials or randomised controlled trials with a very low risk of bias

1+ Well-conducted meta-analyses, systematic reviews of randomised controlled trials or randomised controlled trials with a low risk of bias

1– Meta-analyses, systematic reviews of randomised controlled trials or randomised controlled trials with a high risk of bias

2++ High-quality systematic reviews of case–control or cohort studies or high-quality case–control or cohort studies with a very low risk of confounding, bias or chance and a high probability that the relationship is causal

2+ Well-conducted case–control or cohort studies with a low risk of confounding, bias or chance and a moderate probability that the relationship is causal

2– Case–control or cohort studies with a high risk of confounding, bias or chance and a significant risk that the relationship is not causal

3 Non-analytical studies; e.g., case reports, case series

4 Expert opinion

Methods Used to Analyze the Evidence
Review of Published Meta-Analyses
Systematic Review
Description of the Methods Used to Analyze the Evidence

Once the evidence has been collated for each clinical question it needs to be appraised and reviewed (refer to section 3 in "Development of RCOG Green-top guidelines: producing a clinical practice guideline" for information on the formulation of the clinical questions; see the "Availability of Companion Documents" field). For each question, the study type with least chance of bias should be used. If available, randomised controlled trials (RCTs) of suitable size and quality should be used in preference to observational data. This may vary depending on the outcome being examined.

The level of evidence and the grade of the recommendations used in this guideline originate from the guidance by the Scottish Intercollegiate Guidelines Network (SIGN) Grading Review Group, which incorporates formal assessment of the methodological quality, quantity, consistency, and applicability of the evidence base. The methods used to appraise individual study types are available from the SIGN Web site (www.sign.ac.uk/methodology/checklists.html External Web Site Policy). An objective appraisal of study quality is essential, but paired reviewing by guideline leads may be impractical because of resource constraints.

Once evidence has been collated and appraised, it can be graded. A judgement on the quality of the evidence will be necessary using the grading system (see the "Rating Scheme for the Strength of the Evidence" field). Where evidence is felt to warrant 'down-grading', for whatever reason, the rationale must be stated. Evidence judged to be of poor quality can be excluded. Any study with a high chance of bias (either 1– or 2–) will be excluded from the guideline and recommendations will not be based on this evidence. This prevents recommendations being based on poor-quality RCTs when higher-quality observational evidence is available.

Methods Used to Formulate the Recommendations
Expert Consensus
Informal Consensus
Description of Methods Used to Formulate the Recommendations

Guideline Development

The development of guidelines involves more than the collation and reviewing of evidence. Even with high-quality data from systematic reviews of randomised controlled trials, a value judgement is needed when comparing one therapy with another. This will therefore introduce the need for consensus.

Royal College of Obstetricians and Gynaecologists (RCOG) Green-top guidelines are drafted by nominated developers, in contrast to other guideline groups such as the National Institute for Health and Clinical Excellence (NICE) and the Scottish Intercollegiate Guidelines Network (SIGN), who use larger guideline development groups. Equally, in contrast to other guideline groups, the topics chosen for development as Green-top guidelines are concise enough to allow development by a smaller group of individuals.

In agreeing the precise wording of evidence-based guideline recommendations and in developing consensus-based 'good practice points', the Guidelines Committee (GC) will employ an informal consensus approach through group discussion. In line with current methodologies, the entire development process will follow strict guidance and be both transparent and robust. The RCOG acknowledges that formal consensus methods have been described but these require further evaluation in the context of clinical guideline development. It is envisaged that this will not detract from the rigor of the process but prevent undue delays in development.

Rating Scheme for the Strength of the Recommendations

Grades of Recommendations

A - At least one meta-analysis, systematic review or randomised controlled trial rated as 1++ and directly applicable to the target population; or

A systematic review of randomised controlled trials or a body of evidence consisting principally of studies rated as 1+ directly applicable to the target population and demonstrating overall consistency of results

B - A body of evidence including studies rated as 2++ directly applicable to the target population, and demonstrating overall consistency of results; or

Extrapolated evidence from studies rated as 1++ or 1+

C - A body of evidence including studies rated as 2+ directly applicable to the target population and demonstrating overall consistency of results; or

Extrapolated evidence from studies rated as 2++

D - Evidence level 3 or 4; or

Extrapolated evidence from studies rated as 2+

Good Practice Point - Recommended best practice based on the clinical experience of the guideline development group

Cost Analysis

A formal cost analysis was not performed and published cost analyses were not reviewed.

Method of Guideline Validation
External Peer Review
Internal Peer Review
Description of Method of Guideline Validation

Following discussion in the Guidelines Committee (GC), each Green-top guideline is formally peer reviewed. At the same time, the draft guideline is published on the Royal College of Obstetricians and Gynaecologists (RCOG) Web site for further peer discussion before final publication.

All comments will be collated by the RCOG and tabulated for consideration by the guideline leads. Each comment will require discussion. Where comments are rejected then justification will need to be made. Following this review, the document will be updated and the GC will then review the revised draft and the table of comments.

Once the GC signs-off on the guideline, it is submitted to the Standards Board for approval before final publication.

Recommendations

Major Recommendations

In addition to these evidence-based recommendations, the guideline development group also identifies points of best clinical practice in the original guideline document.

Classification of evidence levels (1++ to 4) and grades of recommendations (A-D) are defined at the end of the "Major Recommendations" field.

Diagnosis of Malaria in Pregnancy

How Should Malaria in Pregnancy Be Diagnosed?

A - Microscopic diagnosis allows species identification and estimation of parasitaemia, so that appropriate antimalarials can be prescribed.

C - Rapid detection tests may miss low parasitaemia, which is more likely in pregnant women, and rapid detections tests are relatively insensitive in Plasmodium vivax malaria.

C - In a febrile patient, three negative malaria smears 12–24 hours apart rules out the diagnosis of malaria.

Women who have taken prophylaxis may have their parasitaemia suppressed below the level of microscopic detection (total biomass 108 parasites) and details of prophylaxis (name, where it was bought – in case of fake drug – dosing and adherence) should be sought. Stop prophylaxis on admission to hospital. Pregnant women with a high background immune level may have negative peripheral blood thick films but parasites sequestered in the placenta (for example, a recently arrived woman from a high malaria-endemic country with an unexplained anaemia).

Other important prognostic factors that should be reported on a peripheral blood smear result are:

  • The presence and count of mature trophozoites and schizonts of P. falciparum
  • Finding malaria pigment in more than 5% of the polymorphonuclear leucocytes in the peripheral blood film.

How Is Malaria Infection Treated during Pregnancy?

B - Treat malaria in pregnancy as an emergency.

A - Admit pregnant women with uncomplicated malaria to hospital and pregnant women with severe and complicated malaria to an intensive care unit.

A - Intravenous artesunate is the treatment of choice for severe falciparum malaria. Use intravenous quinine if artesunate is not available.

B - Use quinine and clindamycin to treat uncomplicated P. falciparum (or mixed, such as P. falciparum and P. vivax).

A - Use chloroquine to treat P. vivax, P. ovale or P. malariae.

D - Primaquine should not be used in pregnancy.

B - Treat the fever with antipyretics.

A - Screen women with malaria for anaemia and treat appropriately.

B - Write a management plan for follow-up, to ensure detection of relapse.

Drug Treatment

Delay in diagnosis and treatment is associated with death from severe malaria. Use the treatment guidelines shown in the table below.

Table: U.K. Treatment Guidelines in Pregnancy

Severity Indication Drug and Dosage
Severe or complicated malariaa Any species (for specific cases after expert consultation; see Table 2 in the original guideline document) Artesunate IV 2.4 mg/kg at 0, 12, and 24 hours, then daily thereafter. When the patient is well enough to take oral medication she can be switched to oral artesunate 2 mg/kg (or IM artesunate 2.4 mg/kg) once daily, plus clindamycin. If oral artesunate is not available, use a 3-day course of Riamet® (GlaxoSmithKline [GSK]) or atovaquone-proguanil (Malarone®, Novartis) or a 7-day course of quinine and clindamycin at 450 mg 3 times a day 7 days.
  ALTERNATIVELY
Any species Quinine IV 20 mg/kg loading dose (no loading dose if patient already taking quinine or mefloquine) in 5% dextrose over 4 hours and then 10 mg/kg IV over 4 hours every 8 hours plus clindamycin IV 450 mg every 8 hours (maximum dose quinine 1.4 g). When the patient is well enough to take oral medication she can be switched to oral quinine 600 mg 3 times a day to complete 5–7 days and oral clindamycin 450 mg 3 times a day 7 days (an alternative rapid quinine-loading regimen is 7 mg/kg quinine dihydrochloride IV over 30 minutes using an infusion pump followed by 10 mg/kg over 4 hours).

Note: quinine dosing should be reduced to 12-hourly dosing if IV therapy extends more than 48 hours or if the patient has renal or hepatic dysfunction. Quinine is associated with severe and recurrent hypoglycaemia in late pregnancy.
Uncomplicated malariab P. falciparum Oral quinine 600 mg 8 hourly and oral clindamycin 450 mg 8 hourly for 7 days (can be given together)

or Riamet® 4 tablets/dose for weight >35 kg, twice daily for 3 days (with fat)

or atovaquone-proguanil (Malarone®) 4 standard tablets daily for 3 days
Vomiting but no signs of severe or complicated malaria Quinine 10 mg/kg dose IV in 5% dextrose over 4 hours every 8 hours plus IV clindamycin 450 mg every 8 hours. When the patient is well enough to take oral medication she can be switched to oral quinine 600 mg 3 times a day to complete 5–7 days and oral clindamycin can if needed be switched to 450 mg 3 times a day 7 days.
Non-falciparum malariac P. vivax, P. ovale, P. malariae Oral chloroquine (base) 600 mg followed by 300 mg 68 hours later. Then 300 mg on day 2 and again on day 3.
Resistant P. vivax As for uncomplicated malaria P. falciparum
Preventing relapse DURING pregnancy Chloroquine oral 300 mg weekly until delivery
Preventing relapse AFTER delivery Postpone until 3 months after delivery and G6PD testing
P. ovale Oral primaquine 15 mg single daily dose for 14 days
P. vivax Oral primaquine 30 mg single daily dose for 14 days
G6PD (mild) for P. vivax or P. ovale Primaquine oral 45–60 mg once a week for 8 weeks

a Severe and complicated malaria published evidence, see Appendix 3.1 in the original guideline document

b Uncomplicated malaria published evidence, see Appendix 3.2 in the original guideline document

c Non-falciparum malaria published evidence, see Appendix 3.3 in the original guideline document

IM = intramuscular, IV = intravenous, G6PD = glucose-6-phosphate dehydrogenase

Who Should Prescribe Treatment for Malaria Infection in Pregnancy?

In the UK, treatment prescription is limited to physicians. Treatment in pregnancy, particularly of severe and recurrent malaria, is best given with expert advice (see Table 2 in the original guideline document).

Where Should Treatment of Uncomplicated Malaria Infection Take Place?

In the UK, it is advisable to hospitalise all pregnant women with P. falciparum, as the clinical condition can deteriorate rapidly. Blood films are usually monitored every 24 hours but clinical deterioration is an indication for a repeat blood film.

While non-falciparum malaria can be managed on an outpatient basis, admission ensures compliance and any risk of vomiting or rapid deterioration is minimised and allows time for planning post-treatment prophylaxis.

What Happens if the Patient Vomits?

If the patient vomits, use an antiemetic. There are no studies of their efficacy in malaria but metoclopramide is considered safe, even in the first trimester. After the antiemetic has had time to take effect, repeat the dose. Repeat vomiting after antiemetic is an indication for parenteral therapy.

What Other Medication Should Be Provided Alongside Treatment of Uncomplicated Malaria Infection?

The fever of malaria has been associated with premature labour and fetal distress. Prompt treatment with antipyretics (paracetamol at the standard dose) is fundamental to the treatment of fever from malaria in pregnancy. Evidence for the efficacy of paracetamol arises mostly from studies in children. [Evidence level 1]

Does Pregnancy Affect the Efficacy of Malaria Treatments?

Treatments in pregnancy may have lower efficacy than in non-pregnant patients but this apparent effect could result from lowered concentrations of antimalarials in pregnancy. Women should be advised of the risk of recurrence and a suitable follow-up plan devised; for example, if symptoms or fever return, a repeat blood film is necessary. Alternatively, weekly screening by blood film can provide early detection and treatment of malaria.

How Should Recurrence Be Treated?

Unfortunately, the options for treatment of recurrent infection in pregnancy in the UK are limited but, if quinine and clindamycin has failed as first-line treatment, an alternative should be considered. Atovaquone-proguanil-artesunate and dihydroartemisinin-piperaquine have been used in pregnant women with multiple recurrent infections with good effect. Atovaquone-proguanil (Malarone®, GlaxoSmithKline) is available in the UK and was highly effective against uncomplicated P. falciparum malaria even when it was not combined with artesunate. Note that oral artesunate can be obtained from IDIS Pharma (see Table 2 in the original guideline document). The World Health Organization recommended regimen of 7 days of artesunate (2 mg/kg/day or 100 mg daily for 7 days) and clindamycin (450 mg three times daily for 7 days) could be given.

How Are Pregnancy-Related Complications of Severe Malaria Managed?

B - Monitor for hypoglycaemia regularly, as it can be profound and persistent in malaria in pregnancy and can be exacerbated by quinine.

B - Prevent mortality from pulmonary oedema and acute respiratory distress syndrome by clinical assessment of jugular venous or central venous pressure, aimed at keeping right arterial pressure less than 10 cm H2O.

B - Women who are severely anaemic should be transfused slowly, preferably with packed cells and intravenous frusemide 20 mg. Alternatively, exchange transfusion may be considered in centres where this can be performed safely.

C - Secondary bacterial infection should be suspected if the patient becomes hypotensive.

Severe malaria in pregnancy is a medical emergency and women should be treated in a high-dependency or intensive care unit, according to their condition and without delay. The World Health Organization's 2006 malaria treatment guidelines detail the treatment of severe malaria and do not need to be repeated here. Common clinical manifestations and management of severe malaria have been summarised in Table 3 in the original guideline document. While hypoglycaemia, pulmonary oedema, severe anaemia, and secondary bacterial infection can occur in severe malaria in non-pregnant patients, they are more common and severe in pregnant women.

Obstetric Management Specific to Malaria Infection in Pregnancy

Common Obstetric Problems with Acute Symptomatic Malaria

D - Preterm labour, fetal growth restriction, and fetal heart rate abnormalities can occur in malaria in pregnancy.

C - In severe malaria complicated by fetal compromise, a multidisciplinary team approach (intensive care specialist, infectious disease specialist, obstetrician, neonatologist) is required to plan optimal management of mother and baby.

B - Stillbirth and premature delivery in malaria in pregnancy are best prevented with prompt and effective antimalarial treatment.

A - Uncomplicated malaria in pregnancy is not a reason for induction of labour.

C - Pharmacological thromboprophylaxis should be weighed up against the risk of haemorrhage and should be withheld if the platelet count is falling or less than 100, indicating thrombocytopaenia.

D - Peripartum malaria is an indication for placental histology and placenta, cord and baby blood films to detect congenital malaria at an early stage.

C - Inform women of the risk of vertical transmission and, in the presence of positive placental blood films, that fever in the infant could indicate malaria; a blood film from the baby is required for confirmation.

Commonsense obstetrics applies to the management of the adverse effects of malaria in pregnancy. Efficacious and prompt treatment of malaria in the woman reduces the systemic effects of parasitaemia and reduces the adverse effects on the fetus, such as fetal distress.

In severe malaria, cardiotocograph monitoring may reveal fetal tachycardia, bradycardia or late decelerations in relation to uterine contractions, indicating fetal distress, particularly in the presence of fever. Paracetamol 1 g every 4–6 hours (to a maximum of 4 g/day) is safe and effective and should be prescribed. Maternal hypoglycaemia should be excluded as the cause of fetal distress, particularly if treatment is with quinine. Tocolytic therapy and prophylactic steroid therapy at the usual obstetric doses should be considered if there are no contraindications. [Evidence level 4]

In women with severe malaria, obstetric advice should be sought at an early stage. The paediatrician should be alerted and the mother's blood glucose checked frequently, particularly when intravenous quinine is administered. Fetal distress is common and has been related to malaria fever. Standard obstetric principles apply: the life of the woman comes first. There are no formal studies but instrumental birth in the second stage of labour in the presence of maternal or fetal distress is indicated, if there are no contraindications. In severe malaria, the role of early caesarean section for the viable fetus is unproven. [Evidence level 3]

What Is the Risk of Vertical Transmission of Malaria Infection to the Baby?

B - Vertical transmission to the fetus can occur particularly when there is infection at the time of birth and the placenta and cord are blood film positive for malaria (see Appendix 2 in the original guideline document).

D - All neonates whose mothers developed malaria in pregnancy should be screened for malaria with standard microscopy of thick and thin blood films at birth and weekly blood films for 28 days.

Definitions:

Grades of Recommendations

A - At least one meta-analysis, systematic review or randomised controlled trial rated as 1++ and directly applicable to the target population; or

A systematic review of randomised controlled trials or a body of evidence consisting principally of studies rated as 1+ directly applicable to the target population and demonstrating overall consistency of results

B - A body of evidence including studies rated as 2++ directly applicable to the target population, and demonstrating overall consistency of results; or

Extrapolated evidence from studies rated as 1++ or 1+

C - A body of evidence including studies rated as 2+ directly applicable to the target population and demonstrating overall consistency of results; or

Extrapolated evidence from studies rated as 2++

D - Evidence level 3 or 4; or

Extrapolated evidence from studies rated as 2+

Good Practice Point - Recommended best practice based on the clinical experience of the guideline development group

Classification of Evidence Levels

1++ High-quality meta-analyses, systematic reviews of randomised controlled trials or randomised controlled trials with a very low risk of bias

1+ Well-conducted meta-analyses, systematic reviews of randomised controlled trials or randomised controlled trials with a low risk of bias

1– Meta-analyses, systematic reviews of randomised controlled trials or randomised controlled trials with a high risk of bias

2++ High-quality systematic reviews of case–control or cohort studies or high-quality case–control or cohort studies with a very low risk of confounding, bias or chance and a high probability that the relationship is causal

2+ Well-conducted case–control or cohort studies with a low risk of confounding, bias or chance and a moderate probability that the relationship is causal

2– Case–control or cohort studies with a high risk of confounding, bias or chance and a significant risk that the relationship is not causal

3 Non-analytical studies; e.g., case reports, case series

4 Expert opinion

Clinical Algorithm(s)

An algorithm is provided in Appendix 1 of the original guideline document for initial rapid diagnosis, assessment, and treatment of malaria in pregnancy.

Evidence Supporting the Recommendations

Type of Evidence Supporting the Recommendations

The type of supporting evidence is identified and graded for each recommendation (see "Major Recommendations" field).

Benefits/Harms of Implementing the Guideline Recommendations

Potential Benefits

Appropriate diagnosis and treatment of malaria in pregnancy

Potential Harms
  • Quinine is associated with severe and recurrent hypoglycaemia in late pregnancy. Hypoglycaemia is commonly asymptomatic, although it may be associated with fetal bradycardia and other signs of fetal distress. In the most severely ill women, it is associated with lactic acidosis and high mortality. In patients who have been given quinine, abnormal behaviour, sweating and sudden loss of consciousness are the usual manifestations. The hypoglycaemia of quinine is caused by hyperinsulinaemia and remains the most common and important adverse effect of this drug. The hypoglycaemia may be profound, recurrent and intractable in pregnancy and regular monitoring of glucose is required while under quinine treatment. It may present late in the disease when the patient appears to be recovering.
  • The 7-day course of quinine has significant adverse effects, principally cinchonism, which includes tinnitus, headache, nausea, diarrhoea, altered auditory acuity and blurred vision. This can lead to non-compliance, which frequently leads to failure.
  • Vomiting is a known adverse effect of quinine.

Contraindications

Contraindications

Primaquine is contraindicated in pregnancy, as it could induce haemolysis and methaemo-globinaemia in the fetus. Therefore, radical cure in pregnancy is not recommended until after delivery.

Qualifying Statements

Qualifying Statements
  • These recommendations are not intended to dictate an exclusive course of management or treatment. They must be evaluated with reference to individual patient needs, resources and limitations unique to the institution and variations in local populations. It is hoped that this process of local ownership will help to incorporate these guidelines into routine practice. Attention is drawn to areas of clinical uncertainty where further research may be indicated.
  • The Royal College of Obstetricians and Gynaecologists (RCOG) produces guidelines as an educational aid to good clinical practice. They present recognised methods and techniques of clinical practice, based on published evidence, for consideration by obstetricians and gynaecologists and other relevant health professionals. The ultimate judgement regarding a particular clinical procedure or treatment plan must be made by the doctor or other attendant in the light of clinical data presented by the patient and the diagnostic and treatment options available within the appropriate health series.
  • This means that RCOG Guidelines are unlike protocols or guidelines issued by employers, as they are not intended to be prescriptive directions defining a single course of management. Departure from the local prescriptive protocols or guidelines should be fully documented in the patient's case notes at the time the relevant decision is taken. Once adapted for local use, these guidelines no longer represent the views of the RCOG.
  • There is no published evidence of treatment efficacy for malaria in pregnant women in the UK or any other non-endemic country. There are no randomised controlled trials of antimalarials in the first trimester of pregnancy. The evidence for best treatment in pregnancy is gained from endemic areas and is not supported by the availability of drugs or licensing regulations within the UK. Treatment response in UK pregnant women can only be extrapolated from, and is likely to be worse than, treatment responses in semi-immune women. Treatment responses are likely to be closest to those observed in areas of low and unstable malaria transmission, where malaria in pregnancy is usually symptomatic. Data on malaria in pregnancy, especially epidemic malaria, where the severe effects on pregnant women were recorded, is historical. In this guideline, the best available evidence for treatment in pregnancy is published in parallel with UK treatment guidelines, with comments on the guidelines. Availability of drugs within the UK can change and this guideline promotes the use of evidence-based prescription choices in this vulnerable group.
  • Overall, 13 randomised controlled trials on the treatment of uncomplicated Plasmodium falciparum in pregnancy were completed in the past 20 years in eight different countries (Africa and Asia) and have included 2254 women from high and low transmission areas and a total of 16 different antimalarial drug regimens. Seventy-seven percent (10/13) of the trials followed the women post-treatment until delivery but 46% (6/13) attempted to evaluate the infants at 1 year of life. A 2009 Cochrane meta-analysis concluded that data on uncomplicated malaria in pregnancy were scant and, while some combinations appeared effective, data on safety were lacking.

Implementation of the Guideline

Description of Implementation Strategy

An implementation strategy was not provided.

Implementation Tools
Clinical Algorithm
Resources
For information about availability, see the Availability of Companion Documents and Patient Resources fields below.

Institute of Medicine (IOM) National Healthcare Quality Report Categories

IOM Care Need
Getting Better
Living with Illness
IOM Domain
Effectiveness
Patient-centeredness
Timeliness

Identifying Information and Availability

Bibliographic Source(s)
Royal College of Obstetricians and Gynaecologists (RCOG). The diagnosis and treatment of malaria in pregnancy. London (UK): Royal College of Obstetricians and Gynaecologists (RCOG); 2010 Apr. 29 p. (Green-top guideline; no. 54B).  [81 references]
Adaptation

Not applicable: The guideline was not adapted from another source.

Date Released
2010 Apr
Guideline Developer(s)
Royal College of Obstetricians and Gynaecologists - Medical Specialty Society
Source(s) of Funding

Royal College of Obstetricians and Gynaecologists

Guideline Committee

Guidelines Committee

Composition of Group That Authored the Guideline

Authors: Dr R McGready, PhD, Dip, RANZCOG, Mae Sot, Thailand; Dr EA Ashley, PhD, London; Professor F Nosten, MD, PhD, Mae Sot, Thailand; Dr M Rijken, MD, PhD, Mae Sot, Thailand; A Dundorp, MD, PhD, Bangkok, Thailand

Peer reviewers: Dr A Diaf, MRCOG, Birmingham; RCOG Consumers' Forum; Mr SA Walkinshaw, MRCOG, Liverpool; Dr C Whitty, FRCP, London; the Advisory Committee on Malaria Prevention in UK Travellers: Dr BA Bannister, FRCP, London; Dr D Lalloo, FRCP, Liverpool; Professor P Chiodini, FRCP, London

Guidelines Committee lead peer reviewers: Dr ALM David, MRCOG, London, and Professor F McAuliffe, FRCOG, Dublin

Financial Disclosures/Conflicts of Interest

Guideline authors are required to complete a "declaration of interests" form.

Guideline Status

This is the current release of the guideline.

Guideline Availability
Availability of Companion Documents

The following are available:

  • Development of RCOG Green-top guidelines: policies and processes. Clinical Governance Advice No 1a. 2006 Nov. Available from the Royal College of Obstetricians and Gynaecologists (RCOG) Web site External Web Site Policy.
  • Development of RCOG Green-top guidelines: producing a scope. Clinical Governance Advice No 1b. 2006 Nov. Available from the RCOG Web site External Web Site Policy.
  • Development of RCOG Green-top guidelines: producing a clinical practice guideline. Clinical Governance Advice No 1c. 2006 Nov. Available from the RCOG Web site External Web Site Policy.
  • Development of RCOG Green-top guidelines: consensus methods for adaptation of Green-top guidelines. Governance Advice No. 1d. 2010 Feb. Available from the RCOG Web site External Web Site Policy.

Appendix II of the original guideline document External Web Site Policy contains a brief overview for preparing a blood film for malaria and taking a section of placenta for histopathology.

Patient Resources

None available

NGC Status

This NGC summary was completed by ECRI Institute on June 16, 2011. The information was verified by the guideline developer on July 22, 2011. This summary was updated by ECRI Institute on August 2, 2013 following the U.S. Food and Drug Administration advisory on Mefloquine Hydrochloride. This summary was updated by ECRI Institute on October 28, 2013 following the U.S. Food and Drug Administration advisory on Acetaminophen.

Copyright Statement

This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions.

Disclaimer

NGC Disclaimer

The National Guideline Clearinghouse™ (NGC) does not develop, produce, approve, or endorse the guidelines represented on this site.

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