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Diferentes regímenes terapéuticos de sulfato de magnesio para la tocólisis en pacientes en trabajo de parto prematuro

Information

DOI:
https://doi.org/10.1002/14651858.CD011200.pub2Copy DOI
Database:
  1. Cochrane Database of Systematic Reviews
Version published:
  1. 14 December 2015see what's new
Type:
  1. Intervention
Stage:
  1. Review
Cochrane Editorial Group:
  1. Cochrane Pregnancy and Childbirth Group

Copyright:
  1. Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Authors

  • Helen C McNamara

    Correspondence to: The Royal Women's Hospital, Melbourne, Australia

    [email protected]

  • Caroline A Crowther

    Liggins Institute, The University of Auckland, Auckland, New Zealand

    ARCH: Australian Research Centre for Health of Women and Babies, Robinson Research Institute, Discipline of Obstetrics and Gynaecology, The University of Adelaide, Adelaide, Australia

  • Julie Brown

    Liggins Institute, The University of Auckland, Auckland, New Zealand

Contributions of authors

Helen McNamara wrote the first draft of the review, with Julie Brown and Caroline Crowther making comments and contributing to subsequent drafts. Helen McNamara and Julie Brown assessed each study for inclusion and risk of bias, and extracted data for meta‐analysis. Caroline Crowther acted as the third author, resolving discrepancies where they arose.

Sources of support

Internal sources

  • No sources of support supplied

External sources

  • National Health and Medical Research Council, Australia.

Declarations of interest

Helen C McNamara: none known

Caroline A Crowther: none known

Julie Brown: none known

Acknowledgements

As part of the pre‐publication editorial process, this review has been commented on by two peers (an editor and referee who is external to the editorial team), a member of the Pregnancy and Childbirth Group's international panel of consumers and the Group's Statistical Adviser.

This project was supported by the National Institute for Health Research, via Cochrane Infrastructure funding to Cochrane Pregnancy and Childbirth. The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the Systematic Reviews Programme, NIHR, NHS or the Department of Health.

Version history

Published

Title

Stage

Authors

Version

2015 Dec 14

Different treatment regimens of magnesium sulphate for tocolysis in women in preterm labour

Review

Helen C McNamara, Caroline A Crowther, Julie Brown

https://doi.org/10.1002/14651858.CD011200.pub2

2014 Jul 07

Different treatment regimens for magnesium sulphate for tocolysis in women in preterm labour for improving health outcomes

Protocol

Helen C McNamara, Julie Brown, Caroline A Crowther

https://doi.org/10.1002/14651858.CD011200

Differences between protocol and review

Birth less than 48 hours after trial entry is no longer included as both a primary infant outcome and a secondary infant outcome. It is listed as a primary infant outcome only.

We have used the GRADE approach to assess the quality of the body of evidence and as detailed in 'summary of findings Table for the main comparison'.

Keywords

MeSH

PICOs

Population
Intervention
Comparison
Outcome

The PICO model is widely used and taught in evidence-based health care as a strategy for formulating questions and search strategies and for characterizing clinical studies or meta-analyses. PICO stands for four different potential components of a clinical question: Patient, Population or Problem; Intervention; Comparison; Outcome.

See more on using PICO in the Cochrane Handbook.

Study flow diagram.
Figures and Tables -
Figure 1

Study flow diagram.

'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Figures and Tables -
Figure 2

'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.
Figures and Tables -
Figure 3

'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.

Comparison 1 Magnesium sulphate high‐dose versus low‐dose regimen ‐ all included trials, Outcome 1 Fetal, neonatal and infant death.
Figures and Tables -
Analysis 1.1

Comparison 1 Magnesium sulphate high‐dose versus low‐dose regimen ‐ all included trials, Outcome 1 Fetal, neonatal and infant death.

Comparison 1 Magnesium sulphate high‐dose versus low‐dose regimen ‐ all included trials, Outcome 2 Fetal death.
Figures and Tables -
Analysis 1.2

Comparison 1 Magnesium sulphate high‐dose versus low‐dose regimen ‐ all included trials, Outcome 2 Fetal death.

Comparison 1 Magnesium sulphate high‐dose versus low‐dose regimen ‐ all included trials, Outcome 3 Neonatal death.
Figures and Tables -
Analysis 1.3

Comparison 1 Magnesium sulphate high‐dose versus low‐dose regimen ‐ all included trials, Outcome 3 Neonatal death.

Comparison 1 Magnesium sulphate high‐dose versus low‐dose regimen ‐ all included trials, Outcome 4 Respiratory distress syndrome.
Figures and Tables -
Analysis 1.4

Comparison 1 Magnesium sulphate high‐dose versus low‐dose regimen ‐ all included trials, Outcome 4 Respiratory distress syndrome.

Comparison 1 Magnesium sulphate high‐dose versus low‐dose regimen ‐ all included trials, Outcome 5 Hypocalcaemia, osteopenia or fracture.
Figures and Tables -
Analysis 1.5

Comparison 1 Magnesium sulphate high‐dose versus low‐dose regimen ‐ all included trials, Outcome 5 Hypocalcaemia, osteopenia or fracture.

Comparison 1 Magnesium sulphate high‐dose versus low‐dose regimen ‐ all included trials, Outcome 6 Mode of birth.
Figures and Tables -
Analysis 1.6

Comparison 1 Magnesium sulphate high‐dose versus low‐dose regimen ‐ all included trials, Outcome 6 Mode of birth.

Comparison 1 Magnesium sulphate high‐dose versus low‐dose regimen ‐ all included trials, Outcome 7 Pulmonary oedema.
Figures and Tables -
Analysis 1.7

Comparison 1 Magnesium sulphate high‐dose versus low‐dose regimen ‐ all included trials, Outcome 7 Pulmonary oedema.

Comparison 1 Magnesium sulphate high‐dose versus low‐dose regimen ‐ all included trials, Outcome 8 Self‐reported adverse effects.
Figures and Tables -
Analysis 1.8

Comparison 1 Magnesium sulphate high‐dose versus low‐dose regimen ‐ all included trials, Outcome 8 Self‐reported adverse effects.

Comparison 1 Magnesium sulphate high‐dose versus low‐dose regimen ‐ all included trials, Outcome 9 Admission to neonatal intensive care unit.
Figures and Tables -
Analysis 1.9

Comparison 1 Magnesium sulphate high‐dose versus low‐dose regimen ‐ all included trials, Outcome 9 Admission to neonatal intensive care unit.

Comparison 1 Magnesium sulphate high‐dose versus low‐dose regimen ‐ all included trials, Outcome 10 Length of stay neonatal intensive care unit (days).
Figures and Tables -
Analysis 1.10

Comparison 1 Magnesium sulphate high‐dose versus low‐dose regimen ‐ all included trials, Outcome 10 Length of stay neonatal intensive care unit (days).

Summary of findings for the main comparison. Different treatment regimens of magnesium sulphate for tocolysis in women in preterm labour

Different treatment regimens of magnesium sulphate for tocolysis in women in preterm labour

Patient or population: Women in preterm labour
Intervention: High‐dose magnesium sulphate
Comparison: Low‐dose magnesium sulphate

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

№ of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Risk with low‐dose (as defined by the trialist) magnesium sulphate

Risk with high‐dose (as defined by the trialist) magnesium sulphate

Fetal, neonatal and infant death

Study population

RR 0.43
(0.12 to 1.56)

100
(1 RCT)

⊕⊝⊝⊝
VERY LOW 1 2 3

140 per 1000

60 per 1000
(17 to 218)

Respiratory distress syndrome

Study population

RR 0.31
(0.11 to 0.88)

100
(1 RCT)

⊕⊕⊝⊝
LOW 1 3

260 per 1000

81 per 1000
(29 to 229)

*The risk in the intervention group (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

CI: Confidence interval; RR: Risk ratio; RCT: Randomised controlled trial.

GRADE Working Group grades of evidence
High quality: We are very confident that the true effect lies close to that of the estimate of the effect
Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect
Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect.

1 Evidence is based on a single trial

2 Evidence of wide confidence intervals crossing the line of no effect

3 No evidence of blinding of participants, personnel or outcome assessors

Figures and Tables -
Summary of findings for the main comparison. Different treatment regimens of magnesium sulphate for tocolysis in women in preterm labour
Comparison 1. Magnesium sulphate high‐dose versus low‐dose regimen ‐ all included trials

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Fetal, neonatal and infant death Show forest plot

1

100

Risk Ratio (M‐H, Fixed, 95% CI)

0.43 [0.12, 1.56]

2 Fetal death Show forest plot

1

100

Risk Ratio (M‐H, Fixed, 95% CI)

1.0 [0.06, 15.55]

3 Neonatal death Show forest plot

1

100

Risk Ratio (M‐H, Fixed, 95% CI)

0.33 [0.07, 1.57]

4 Respiratory distress syndrome Show forest plot

1

100

Risk Ratio (M‐H, Fixed, 95% CI)

0.31 [0.11, 0.88]

5 Hypocalcaemia, osteopenia or fracture Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

5.1 Hypocalcaemia

1

100

Risk Ratio (M‐H, Fixed, 95% CI)

0.33 [0.01, 7.99]

6 Mode of birth Show forest plot

2

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

6.1 Caesarean birth

2

248

Risk Ratio (M‐H, Fixed, 95% CI)

0.90 [0.59, 1.37]

7 Pulmonary oedema Show forest plot

1

148

Risk Ratio (M‐H, Fixed, 95% CI)

4.49 [0.22, 92.03]

8 Self‐reported adverse effects Show forest plot

2

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

8.1 Flushing

2

248

Risk Ratio (M‐H, Random, 95% CI)

1.64 [0.89, 3.03]

8.2 Headache

2

248

Risk Ratio (M‐H, Random, 95% CI)

1.78 [0.95, 3.31]

8.3 Nausea

1

100

Risk Ratio (M‐H, Random, 95% CI)

1.27 [0.73, 2.20]

9 Admission to neonatal intensive care unit Show forest plot

1

100

Risk Ratio (M‐H, Fixed, 95% CI)

0.46 [0.19, 1.12]

10 Length of stay neonatal intensive care unit (days) Show forest plot

1

100

Mean Difference (IV, Fixed, 95% CI)

‐3.10 [‐5.48, ‐0.72]

Figures and Tables -
Comparison 1. Magnesium sulphate high‐dose versus low‐dose regimen ‐ all included trials