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Cochrane Database of Systematic Reviews

Monitorización uterina domiciliaria para la detección del trabajo de parto prematuro

Información

DOI:
https://doi.org/10.1002/14651858.CD006172.pub4Copiar DOI
Base de datos:
  1. Cochrane Database of Systematic Reviews
Versión publicada:
  1. 15 febrero 2017see what's new
Tipo:
  1. Intervention
Etapa:
  1. Review
Grupo Editorial Cochrane:
  1. Grupo Cochrane de Embarazo y parto

Copyright:
  1. Copyright © 2017 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Autores

  • Christine Urquhart

    Correspondencia a: Department of Information Studies, Aberystwyth University, Aberystwyth, UK

    [email protected]

  • Rosemary Currell

    Public Health Directorate, Suffolk NHS Primary Care Trust, Bramford, Ipswich, UK

  • Francoise Harlow

    Norfolk and Norwich University Hospital, Norwich, UK

  • Liz Callow

    University of Oxford, Oxford, UK

Contributions of authors

Rosemary Currell and Christine Urquhart jointly worked on the protocol, with assistance from Liz Callow for literature searching and development of the search strategy. Francoise Harlow advised on the protocol and commented on the draft review. The idea for the review emerged from a systematic review of telemedicine (for the Cochrane Effective Practice and Organisation of Care Group) which identified a discrete set of studies on home uterine monitoring that were more suitable for consideration as a separate review for the Cochrane Pregnancy and Childbirth Group. Both Rosemary Currell and Christine Urquhart were review authors on the telemedicine review.

Rosemary Currell and Christine Urquhart jointly worked on the 2014 and 2016 updates with contributions from Liz Callow (search strategy development) and Francoise Harlow (contribution to background).

Christine Urquhart is the contact author and guarantor for this review.

Sources of support

Internal sources

  • Aberystwyth University, UK.

External sources

  • UNDP‐UNFPA‐UNICEF‐WHO‐World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), Department of Reproductive Health and Research (RHR), World Health Organization, Switzerland.

    2014 update

  • National Institute for Health Research (NIHR), UKNIHR Cochrane Programme Grant Project: 13/89/05 – Pregnancy and childbirth systematic reviews to support clinical guidelines, UK.

Declarations of interest

Christine Urquhart was a co‐author with Rosemary Currell on a Cochrane Review of telemedicine for the EPOC group.

Rosemary Currell: University of Wales Swansea received a grant from the Welsh Office of Research and Development for work on the Cochrane Review of telemedicine (published 2000), from which the current review originated.

Francoise Harlow: none known.

Liz Callow: none known.

Acknowledgements

Therese Dowswell, for assistance with the editorial queries for the 2016 update.

Nancy Medley, for preparing the 'Summary of findings' table for the 2014 update. Nancy Medley's work was financially supported by the UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), Department of Reproductive Health and Research (RHR), World Health Organization. The named authors alone are responsible for the views expressed in this publication.

The review authors thank the Cochrane Pregnancy and Childbirth Group (Liverpool, UK) for their support, and the Cochrane Effective Practice and Organisation of Care Group for their earlier support in the telemedicine systematic review work that was the start of this particular review.

As part of the prepublication editorial process, the previous version of this review (Urquhart 2012) was commented on by three peers (an editor and two referees who are external to the editorial team) and the Group's Statistical Adviser.

This project was supported by the National Institute for Health Research, via Cochrane programme Grant 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

2017 Feb 15

Home uterine monitoring for detecting preterm labour

Review

Christine Urquhart, Rosemary Currell, Francoise Harlow, Liz Callow

https://doi.org/10.1002/14651858.CD006172.pub4

2015 Jan 06

Home uterine monitoring for detecting preterm labour

Review

Christine Urquhart, Rosemary Currell, Francoise Harlow, Liz Callow

https://doi.org/10.1002/14651858.CD006172.pub3

2012 May 16

Home uterine monitoring for detecting preterm labour

Review

Christine Urquhart, Rosemary Currell, Francoise Harlow, Liz Callow

https://doi.org/10.1002/14651858.CD006172.pub2

2006 Oct 18

Home uterine monitoring for detecting preterm labour

Protocol

Rosemary Currell, Christine Urquhart, Fran Harlow, Liz Callow

https://doi.org/10.1002/14651858.CD006172

Differences between protocol and review

We have updated the methods to reflect the latest Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011) and the Cochrane Pregnancy and Childbirth Group's methodological guidelines.

In the protocol we stated that we intended to carry out the following subgroup analyses: singleton pregnancy; multiple pregnancy; gestational age at which home uterine activity monitoring (HUAM) began; type of HUAM used; reason HUAM was used. We planned to use the following outcomes: perinatal mortality and preterm birth less than 34 weeks. The studies provided only data on singleton pregnancy and multiple pregnancy, and only one study was involved. For this update, we added the following outcomes to the methods for subgroup analysis:

  1. preterm birth less than 37 weeks;

  2. respiratory distress syndrome;

  3. number of unscheduled antenatal visits.

Keywords

MeSH

PICO

Population
Intervention
Comparison
Outcome

El uso y la enseñanza del modelo PICO están muy extendidos en el ámbito de la atención sanitaria basada en la evidencia para formular preguntas y estrategias de búsqueda y para caracterizar estudios o metanálisis clínicos. PICO son las siglas en inglés de cuatro posibles componentes de una pregunta de investigación: paciente, población o problema; intervención; comparación; desenlace (outcome).

Para saber más sobre el uso del modelo PICO, puede consultar el Manual Cochrane.

Study flow diagram.
Figuras y tablas -
Figure 1

Study flow diagram.

Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.
Figuras y tablas -
Figure 2

Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.

Methodological quality summary: review authors' judgements about each methodological quality item for each included study.
Figuras y tablas -
Figure 3

Methodological quality summary: review authors' judgements about each methodological quality item for each included study.

Comparison 1 Home uterine monitoring versus standard care ‐ primary outcomes, Outcome 1 Perinatal mortality.
Figuras y tablas -
Analysis 1.1

Comparison 1 Home uterine monitoring versus standard care ‐ primary outcomes, Outcome 1 Perinatal mortality.

Comparison 1 Home uterine monitoring versus standard care ‐ primary outcomes, Outcome 2 Preterm birth < 34 weeks.
Figuras y tablas -
Analysis 1.2

Comparison 1 Home uterine monitoring versus standard care ‐ primary outcomes, Outcome 2 Preterm birth < 34 weeks.

Comparison 1 Home uterine monitoring versus standard care ‐ primary outcomes, Outcome 3 Preterm birth < 34 weeks (Subgroup analysis).
Figuras y tablas -
Analysis 1.3

Comparison 1 Home uterine monitoring versus standard care ‐ primary outcomes, Outcome 3 Preterm birth < 34 weeks (Subgroup analysis).

Comparison 2 Home uterine monitoring versus standard care (secondary outcomes ‐ infant), Outcome 1 Preterm birth < 37 weeks.
Figuras y tablas -
Analysis 2.1

Comparison 2 Home uterine monitoring versus standard care (secondary outcomes ‐ infant), Outcome 1 Preterm birth < 37 weeks.

Comparison 2 Home uterine monitoring versus standard care (secondary outcomes ‐ infant), Outcome 2 Preterm birth < 37 weeks (Subgroup analysis).
Figuras y tablas -
Analysis 2.2

Comparison 2 Home uterine monitoring versus standard care (secondary outcomes ‐ infant), Outcome 2 Preterm birth < 37 weeks (Subgroup analysis).

Comparison 2 Home uterine monitoring versus standard care (secondary outcomes ‐ infant), Outcome 3 Preterm birth < 32 weeks.
Figuras y tablas -
Analysis 2.3

Comparison 2 Home uterine monitoring versus standard care (secondary outcomes ‐ infant), Outcome 3 Preterm birth < 32 weeks.

Comparison 2 Home uterine monitoring versus standard care (secondary outcomes ‐ infant), Outcome 4 Use of antenatal corticosteroids.
Figuras y tablas -
Analysis 2.4

Comparison 2 Home uterine monitoring versus standard care (secondary outcomes ‐ infant), Outcome 4 Use of antenatal corticosteroids.

Comparison 2 Home uterine monitoring versus standard care (secondary outcomes ‐ infant), Outcome 5 Respiratory distress syndrome.
Figuras y tablas -
Analysis 2.5

Comparison 2 Home uterine monitoring versus standard care (secondary outcomes ‐ infant), Outcome 5 Respiratory distress syndrome.

Comparison 2 Home uterine monitoring versus standard care (secondary outcomes ‐ infant), Outcome 6 Use of mechanical ventilation.
Figuras y tablas -
Analysis 2.6

Comparison 2 Home uterine monitoring versus standard care (secondary outcomes ‐ infant), Outcome 6 Use of mechanical ventilation.

Comparison 2 Home uterine monitoring versus standard care (secondary outcomes ‐ infant), Outcome 7 Admission to neonatal intensive care unit.
Figuras y tablas -
Analysis 2.7

Comparison 2 Home uterine monitoring versus standard care (secondary outcomes ‐ infant), Outcome 7 Admission to neonatal intensive care unit.

Comparison 2 Home uterine monitoring versus standard care (secondary outcomes ‐ infant), Outcome 8 Mode of delivery.
Figuras y tablas -
Analysis 2.8

Comparison 2 Home uterine monitoring versus standard care (secondary outcomes ‐ infant), Outcome 8 Mode of delivery.

Comparison 3 Home uterine monitoring versus standard care (secondary outcomes ‐ prenatal), Outcome 1 Number of antenatal visits (unscheduled).
Figuras y tablas -
Analysis 3.1

Comparison 3 Home uterine monitoring versus standard care (secondary outcomes ‐ prenatal), Outcome 1 Number of antenatal visits (unscheduled).

Comparison 3 Home uterine monitoring versus standard care (secondary outcomes ‐ prenatal), Outcome 2 Number of antenatal hospital admissions.
Figuras y tablas -
Analysis 3.2

Comparison 3 Home uterine monitoring versus standard care (secondary outcomes ‐ prenatal), Outcome 2 Number of antenatal hospital admissions.

Comparison 3 Home uterine monitoring versus standard care (secondary outcomes ‐ prenatal), Outcome 3 Number of antenatal visits (unscheduled) (Subgroup analysis).
Figuras y tablas -
Analysis 3.3

Comparison 3 Home uterine monitoring versus standard care (secondary outcomes ‐ prenatal), Outcome 3 Number of antenatal visits (unscheduled) (Subgroup analysis).

Comparison 3 Home uterine monitoring versus standard care (secondary outcomes ‐ prenatal), Outcome 4 Use of tocolysis.
Figuras y tablas -
Analysis 3.4

Comparison 3 Home uterine monitoring versus standard care (secondary outcomes ‐ prenatal), Outcome 4 Use of tocolysis.

Summary of findings for the main comparison. Home uterine monitoring for preventing preterm birth

Home uterine monitoring for preventing preterm birth

Patient or population: women undergoing home monitoring for preventing preterm birth versus women receiving standard care
Settings: trials took place in the USA and France
Intervention: home uterine monitoring

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of Participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Control

Home uterine monitoring

Perinatal mortality

Study population

RR 1.22
(0.86 to 1.72)

2589
(2 studies)

⊕⊕⊝⊝
low1,2

46 per 1000

56 per 1000
(39 to 79)

Preterm birth less than 34 weeks' gestation

Study population

RR 0.78
(0.62 to 0.99)

1596
(3 studies)

⊕⊕⊕⊕
high

Sensitivity analysis included 1 study at low risk of bias (1292 women) and did not show any difference in results

166 per 1000

130 per 1000
(103 to 165)

Antenatal hospital admissions

Study population

RR 0.91
(0.74 to 1.11)

1494
(3 studies)

⊕⊕⊝⊝
low2,3

186 per 1000

169 per 1000
(137 to 206)

Preterm birth less than 37 weeks' gestation

Study population

RR 0.85
(0.72 to 1.01)

4834
(8 studies)

⊕⊝⊝⊝
very low2,4,5

364 per 1000

310 per 1000
(262 to 368)

Admission to NICU

Study population

RR 0.77
(0.62 to 0.96)

2367
(5 studies)

⊕⊕⊕⊝
moderate3

Evidence not downgraded for moderate heterogeneity (I² = 32%)

290 per 1000

223 per 1000
(180 to 278)

Number of unscheduled antenatal visits

The mean number of days ranged across control groups from approximately 1 to 2 days

The mean number of days in the monitored group was approximately half a day higher

MD 0.48 (0.31 to 0.64)

1994
(2 studies)

⊕⊕⊕⊝
moderate1

Variation in protocol and healthcare delivery structures make it difficult to generalise from 1 large study contributing 65% of the weight for this outcome

Use of tocolysis

Study population

RR 1.21
(1.01 to 1.45)

4316
(7 studies)

⊕⊕⊝⊝
low4,6

This outcome may no longer be useful, due to changes in clinical practice. Sensitivity analysis including only 3 studies at low risk of bias (3749 women) did not show any clear difference in results.

188 per 1000

228 per 1000
(190 to 273)

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; MD: mean difference; RR: Risk ratio;

GRADE Working Group grades of evidence
High quality: further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: we are very uncertain about the estimate.

1All studies contributing data with design limitations (‐1).
2Wide confidence interval crossing the line of no effect (‐1).
3Most studies with design limitations (‐1). Outcome not blinded in 2 studies.
4Most studies with design limitations (‐1).
5Statistical heterogeneity (I2 = 68%) (‐1).
6Statistical heterogeneity (I2 = 62%) (‐1).

Figuras y tablas -
Summary of findings for the main comparison. Home uterine monitoring for preventing preterm birth
Table 1. Methodological quality of trials

Methodological item

Adequate

Inadequate

Generation of random sequence

Computer‐generated sequence, random‐number tables, lot drawing, coin‐tossing, shuffling cards, throwing dice

Case number, date of birth, date of admission, alternation

Concealment of allocation

Central randomisation, coded drug boxes, sequentially‐sealed opaque envelopes

Open allocation sequence, any procedure based on inadequate generation

Figuras y tablas -
Table 1. Methodological quality of trials
Comparison 1. Home uterine monitoring versus standard care ‐ primary outcomes

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Perinatal mortality Show forest plot

2

2589

Risk Ratio (M‐H, Fixed, 95% CI)

1.22 [0.86, 1.72]

2 Preterm birth < 34 weeks Show forest plot

3

1596

Risk Ratio (M‐H, Fixed, 95% CI)

0.78 [0.62, 0.99]

3 Preterm birth < 34 weeks (Subgroup analysis) Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

3.1 Singleton gestations

1

138

Risk Ratio (M‐H, Fixed, 95% CI)

1.12 [0.55, 2.27]

3.2 Twin gestations

1

109

Risk Ratio (M‐H, Fixed, 95% CI)

0.55 [0.26, 1.17]

Figuras y tablas -
Comparison 1. Home uterine monitoring versus standard care ‐ primary outcomes
Comparison 2. Home uterine monitoring versus standard care (secondary outcomes ‐ infant)

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Preterm birth < 37 weeks Show forest plot

8

4834

Risk Ratio (M‐H, Random, 95% CI)

0.85 [0.72, 1.01]

2 Preterm birth < 37 weeks (Subgroup analysis) Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

2.1 Singleton gestations

1

2422

Risk Ratio (M‐H, Fixed, 95% CI)

0.95 [0.62, 1.45]

2.2 Twin gestations

1

844

Risk Ratio (M‐H, Fixed, 95% CI)

0.96 [0.71, 1.30]

3 Preterm birth < 32 weeks Show forest plot

3

2550

Risk Ratio (M‐H, Random, 95% CI)

0.76 [0.31, 1.85]

4 Use of antenatal corticosteroids Show forest plot

1

162

Risk Ratio (M‐H, Fixed, 95% CI)

1.01 [0.82, 1.25]

5 Respiratory distress syndrome Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

5.1 Singleton gestations

1

38

Risk Ratio (M‐H, Fixed, 95% CI)

1.25 [0.40, 3.95]

5.2 Twin gestations

1

86

Risk Ratio (M‐H, Fixed, 95% CI)

0.38 [0.13, 1.12]

6 Use of mechanical ventilation Show forest plot

2

539

Risk Ratio (M‐H, Random, 95% CI)

0.31 [0.04, 2.38]

7 Admission to neonatal intensive care unit Show forest plot

5

2367

Risk Ratio (M‐H, Random, 95% CI)

0.77 [0.62, 0.96]

8 Mode of delivery Show forest plot

1

162

Risk Ratio (M‐H, Fixed, 95% CI)

0.98 [0.36, 2.66]

Figuras y tablas -
Comparison 2. Home uterine monitoring versus standard care (secondary outcomes ‐ infant)
Comparison 3. Home uterine monitoring versus standard care (secondary outcomes ‐ prenatal)

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Number of antenatal visits (unscheduled) Show forest plot

2

1994

Mean Difference (IV, Fixed, 95% CI)

0.48 [0.31, 0.64]

2 Number of antenatal hospital admissions Show forest plot

3

1494

Risk Ratio (M‐H, Fixed, 95% CI)

0.91 [0.74, 1.11]

3 Number of antenatal visits (unscheduled) (Subgroup analysis) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

3.1 Singleton gestations

1

1060

Mean Difference (IV, Fixed, 95% CI)

0.40 [0.15, 0.65]

3.2 Twin gestations

1

564

Mean Difference (IV, Fixed, 95% CI)

0.60 [0.24, 0.96]

4 Use of tocolysis Show forest plot

7

4316

Risk Ratio (M‐H, Random, 95% CI)

1.21 [1.01, 1.45]

Figuras y tablas -
Comparison 3. Home uterine monitoring versus standard care (secondary outcomes ‐ prenatal)