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Parto prematuro programado versus manejo expectante del feto con sospecha de compromiso a término para mejorar los desenlaces

Información

DOI:
https://doi.org/10.1002/14651858.CD009433.pub2Copiar DOI
Base de datos:
  1. Cochrane Database of Systematic Reviews
Versión publicada:
  1. 24 noviembre 2015see what's new
Tipo:
  1. Intervention
Etapa:
  1. Review
Grupo Editorial Cochrane:
  1. Grupo Cochrane de Embarazo y parto

Copyright:
  1. Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Autores

  • Diana M Bond

    Correspondencia a: RPA Newborn Care, Royal Prince Alfred Hospital; The Kolling Institute of Medicine, University of Sydney at the Royal North Shore Hospital, Sydney, Australia

    [email protected]

  • Adrienne Gordon

    Neonatology, Royal Prince Alfred Hospital, Sydney, Australia

  • Jon Hyett

    Department of High Risk Obstetrics, RPA Women and Babies, Royal Prince Alfred Hospital, Sydney, Australia

  • Bradley de Vries

    Department of High Risk Obstetrics, RPA Women and Babies, Royal Prince Alfred Hospital, Sydney, Australia

  • Angela E Carberry

    Sydney School of Public Health, University of Sydney, Sydney, Australia

  • Jonathan Morris

    The Kolling Institute of Medicine, University of Sydney, St Leonards, Australia

Contributions of authors

Diana Bond is guarantor for the review. Diana Bond and Dr Adrienne Gordon were responsible for the design, co‐ordination, research and writing of the review. All authors contributed with a clinical and methodological perspective as well as providing general advice for the review.

Sources of support

Internal sources

  • No sources of support supplied

External sources

  • Stillbirth Foundation, Australia.

  • 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

Diana Bond: We are grateful to the Stillbirth Foundation Australia for their generous funding to support the Sydney Stillbirth Study. SFA has had no input or influence regarding the publication of this review.

Angela Carberry: None known.

Adrienne Gordon: Diana bond is supported for her work on another project by a grant from the stillbirth foundation Australia. The charity was not involved with this review and we do not believe there is a conflict of interest.

Jon Hyett: None known.

Jonathan Morris: None known.

Bradley de Vries: I am employed by Royal Prince Alfred Hospital as a staff specialist obstetrician.

Acknowledgements

As part of the pre‐publication editorial process, this review has been commented on by three peers (an editor and two referees who are 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 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.

Helen West (HW) assisted with the production of the GRADE 'Summary of findings' table. HW is supported by the NIHR Cochrane Programme Grant Project: 13/89/05 – Pregnancy and childbirth systematic reviews to support clinical guidelines.

The authors would like to thank Kim Boers and Saskia le Cessie for provision of outcome data for those women randomised at 37 weeks or greater and Sverker Ek for responding to request for additional information.

Version history

Published

Title

Stage

Authors

Version

2015 Nov 24

Planned early delivery versus expectant management of the term suspected compromised baby for improving outcomes

Review

Diana M Bond, Adrienne Gordon, Jon Hyett, Bradley de Vries, Angela E Carberry, Jonathan Morris

https://doi.org/10.1002/14651858.CD009433.pub2

2011 Nov 09

Planned early delivery versus expectant management of the term suspected compromised baby for improving outcomes

Protocol

Diana M Bond, Adrienne Gordon, Jon Hyett, Bradley de Vries, Angela E Carberry, Jonathan Morris

https://doi.org/10.1002/14651858.CD009433

Differences between protocol and review

This review includes additional outcomes not pre‐specified in the protocol in order to include outcomes specified in the included studies. The additional outcomes are as follows.

  1. Gestational age ≥ 40 weeks

  2. Birthweight < 2.3 percentile (we have indicated in the review that we did a post hoc analysis of birthweight < 2.3 percentile and the reason why)

  3. Admission to intermediate care nursery

  4. Maternal hospital stay

This review also changed two maternal secondary outcomes.

  1. Combined elective and emergency caesarean sections into one combined outcome

  2. Deleted 'mode of induction' as this referred to induced women only, so was not a randomised comparison

The methods have been updated to include the current standard methods of Cochrane Pregnancy and Childbirth, including methods for GRADE and the incorporation of a 'Summary of findings' table. The background has been edited.

We have added information relating to Types of participants to specify that we will include women presenting with oligohydramnios or polyhydramnios, and growth measurements consistent with fetal growth restriction.

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.

'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Figuras y tablas -
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.
Figuras y tablas -
Figure 3

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

Comparison 1 Planned early delivery versus expectant management, Outcome 1 Perinatal mortality.
Figuras y tablas -
Analysis 1.1

Comparison 1 Planned early delivery versus expectant management, Outcome 1 Perinatal mortality.

Comparison 1 Planned early delivery versus expectant management, Outcome 2 Major neonatal morbidity.
Figuras y tablas -
Analysis 1.2

Comparison 1 Planned early delivery versus expectant management, Outcome 2 Major neonatal morbidity.

Comparison 1 Planned early delivery versus expectant management, Outcome 3 Neurodevelopmental disability/impairment.
Figuras y tablas -
Analysis 1.3

Comparison 1 Planned early delivery versus expectant management, Outcome 3 Neurodevelopmental disability/impairment.

Comparison 1 Planned early delivery versus expectant management, Outcome 4 Maternal mortality.
Figuras y tablas -
Analysis 1.4

Comparison 1 Planned early delivery versus expectant management, Outcome 4 Maternal mortality.

Comparison 1 Planned early delivery versus expectant management, Outcome 5 Major maternal morbidity.
Figuras y tablas -
Analysis 1.5

Comparison 1 Planned early delivery versus expectant management, Outcome 5 Major maternal morbidity.

Comparison 1 Planned early delivery versus expectant management, Outcome 6 Neonatal seizures.
Figuras y tablas -
Analysis 1.6

Comparison 1 Planned early delivery versus expectant management, Outcome 6 Neonatal seizures.

Comparison 1 Planned early delivery versus expectant management, Outcome 7 Necrotising enterocolitis.
Figuras y tablas -
Analysis 1.7

Comparison 1 Planned early delivery versus expectant management, Outcome 7 Necrotising enterocolitis.

Comparison 1 Planned early delivery versus expectant management, Outcome 8 Respiratory distress syndrome.
Figuras y tablas -
Analysis 1.8

Comparison 1 Planned early delivery versus expectant management, Outcome 8 Respiratory distress syndrome.

Comparison 1 Planned early delivery versus expectant management, Outcome 9 Meconium aspiration.
Figuras y tablas -
Analysis 1.9

Comparison 1 Planned early delivery versus expectant management, Outcome 9 Meconium aspiration.

Comparison 1 Planned early delivery versus expectant management, Outcome 10 Gestational age at birth (days).
Figuras y tablas -
Analysis 1.10

Comparison 1 Planned early delivery versus expectant management, Outcome 10 Gestational age at birth (days).

Comparison 1 Planned early delivery versus expectant management, Outcome 11 Gestational age ≥ 40 weeks (not pre‐specified).
Figuras y tablas -
Analysis 1.11

Comparison 1 Planned early delivery versus expectant management, Outcome 11 Gestational age ≥ 40 weeks (not pre‐specified).

Comparison 1 Planned early delivery versus expectant management, Outcome 12 Apgar score < 7 at 5 minutes.
Figuras y tablas -
Analysis 1.12

Comparison 1 Planned early delivery versus expectant management, Outcome 12 Apgar score < 7 at 5 minutes.

Comparison 1 Planned early delivery versus expectant management, Outcome 13 Resuscitation required.
Figuras y tablas -
Analysis 1.13

Comparison 1 Planned early delivery versus expectant management, Outcome 13 Resuscitation required.

Comparison 1 Planned early delivery versus expectant management, Outcome 14 Requirement for mechanical ventilation.
Figuras y tablas -
Analysis 1.14

Comparison 1 Planned early delivery versus expectant management, Outcome 14 Requirement for mechanical ventilation.

Comparison 1 Planned early delivery versus expectant management, Outcome 15 Birthweight < 10 centile.
Figuras y tablas -
Analysis 1.15

Comparison 1 Planned early delivery versus expectant management, Outcome 15 Birthweight < 10 centile.

Comparison 1 Planned early delivery versus expectant management, Outcome 16 Birthweight < 2.3 centile (not pre‐specified).
Figuras y tablas -
Analysis 1.16

Comparison 1 Planned early delivery versus expectant management, Outcome 16 Birthweight < 2.3 centile (not pre‐specified).

Comparison 1 Planned early delivery versus expectant management, Outcome 17 Admission to NICU.
Figuras y tablas -
Analysis 1.17

Comparison 1 Planned early delivery versus expectant management, Outcome 17 Admission to NICU.

Comparison 1 Planned early delivery versus expectant management, Outcome 18 Admission to intermediate care nursery (not pre‐specified).
Figuras y tablas -
Analysis 1.18

Comparison 1 Planned early delivery versus expectant management, Outcome 18 Admission to intermediate care nursery (not pre‐specified).

Comparison 1 Planned early delivery versus expectant management, Outcome 19 Length of stay in NICU/SCN (days).
Figuras y tablas -
Analysis 1.19

Comparison 1 Planned early delivery versus expectant management, Outcome 19 Length of stay in NICU/SCN (days).

Comparison 1 Planned early delivery versus expectant management, Outcome 20 Interval (days) between randomisation and delivery.
Figuras y tablas -
Analysis 1.20

Comparison 1 Planned early delivery versus expectant management, Outcome 20 Interval (days) between randomisation and delivery.

Comparison 1 Planned early delivery versus expectant management, Outcome 21 Neonatal sepsis.
Figuras y tablas -
Analysis 1.21

Comparison 1 Planned early delivery versus expectant management, Outcome 21 Neonatal sepsis.

Comparison 1 Planned early delivery versus expectant management, Outcome 22 Caesarean section.
Figuras y tablas -
Analysis 1.22

Comparison 1 Planned early delivery versus expectant management, Outcome 22 Caesarean section.

Comparison 1 Planned early delivery versus expectant management, Outcome 23 Placental abruption.
Figuras y tablas -
Analysis 1.23

Comparison 1 Planned early delivery versus expectant management, Outcome 23 Placental abruption.

Comparison 1 Planned early delivery versus expectant management, Outcome 24 Pre‐eclampsia.
Figuras y tablas -
Analysis 1.24

Comparison 1 Planned early delivery versus expectant management, Outcome 24 Pre‐eclampsia.

Comparison 1 Planned early delivery versus expectant management, Outcome 25 Induction of labour.
Figuras y tablas -
Analysis 1.25

Comparison 1 Planned early delivery versus expectant management, Outcome 25 Induction of labour.

Comparison 1 Planned early delivery versus expectant management, Outcome 26 Vaginal birth.
Figuras y tablas -
Analysis 1.26

Comparison 1 Planned early delivery versus expectant management, Outcome 26 Vaginal birth.

Comparison 1 Planned early delivery versus expectant management, Outcome 27 Assisted vaginal birth.
Figuras y tablas -
Analysis 1.27

Comparison 1 Planned early delivery versus expectant management, Outcome 27 Assisted vaginal birth.

Comparison 1 Planned early delivery versus expectant management, Outcome 28 Breastfeeding.
Figuras y tablas -
Analysis 1.28

Comparison 1 Planned early delivery versus expectant management, Outcome 28 Breastfeeding.

Comparison 1 Planned early delivery versus expectant management, Outcome 29 Breastfeeding (weeks).
Figuras y tablas -
Analysis 1.29

Comparison 1 Planned early delivery versus expectant management, Outcome 29 Breastfeeding (weeks).

Comparison 1 Planned early delivery versus expectant management, Outcome 30 Maternal hospital stay (days) (not pre‐specified).
Figuras y tablas -
Analysis 1.30

Comparison 1 Planned early delivery versus expectant management, Outcome 30 Maternal hospital stay (days) (not pre‐specified).

Summary of findings for the main comparison. Planned early delivery compared with expectant management for improving outcomes of the term suspected compromised baby

Planned early delivery compared with expectant management for improving outcomes of the term suspected compromised baby

Patient or population: pregnant women with a term suspected compromised baby
Settings: studies took place in The Netherlands and Sweden
Intervention: planned early delivery
Comparison: expectant management

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Expectant management

Planned early delivery

Perinatal mortality
(stillbirth ‐ death of fetus prior to birth; neonatal death ‐ death within the first 28 days of birth; or infant death ‐ death after the first 28 days)

See comment

See comment

Not estimable

459
(1 study)

⊕⊕⊕⊝
moderate1

Major neonatal morbidity
one or more of the following: hypoxic ischaemic encephalopathy (HIE) ‐ grade II or III, necrotising enterocolitis (NEC), need for ongoing ventilation, meconium aspiration syndrome, seizures, need for therapeutic hypothermia
Follow‐up: 0‐22 days

Study population

RR 0.15
(0.01 to 2.81)

459
(1 study)

⊕⊕⊝⊝
low2,3

13 per 1000

2 per 1000
(0 to 36)

Neurodevelopmental disability/impairment
CBCL, Ages and Stages Questionnaire
Follow‐up: mean 2 years

Study population

RR 2.04
(0.62 to 6.69)

459
(1 study)

⊕⊕⊝⊝
low2,3

17 per 1000

35 per 1000
(11 to 115)

Maternal mortality
Follow‐up: 0‐10 days

Study population

RR 3.07
(0.13 to 74.87)

459
(1 study)

⊕⊕⊝⊝
low2,3

0 per 1000

0 per 1000
(0 to 0)

Significant maternal morbidity
one or more of the following: significant postpartum haemorrhage requiring blood transfusion; maternal admission to intensive care unit; uterine rupture; hysterectomy

Study population

RR 0.92
(0.38 to 2.22)

459
(1 study)

⊕⊕⊝⊝
low2,3

43 per 1000

40 per 1000
(16 to 96)

Admission to NICU

Study population

RR 0.88
(0.35 to 2.23)

545
(3 studies)

⊕⊝⊝⊝
very low2,3,4

33 per 1000

29 per 1000
(11 to 73)

Moderate

26 per 1000

23 per 1000
(9 to 58)

Caesarean section

Study population

RR 1.02
(0.65 to 1.59)

546
(3 studies)

⊕⊕⊝⊝
low5,6

124 per 1000

126 per 1000
(80 to 197)

Moderate

154 per 1000

157 per 1000
(100 to 245)

*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; 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.

1 There were no events for this outcome.
2 Few total events (< 30).
3 Wide CI crossing line of no effect and RR > 25%.
4 Although all studies address outcome of NICU admission, 2 studies included additional outcome of intermediate nursery admission. Overall this may have compromised the total number of events comparatively.
5 One study did not give outcomes for elective C/S, only emergency C/S assessed.
6 Two out of three studies had wide CIs crossing the line of no effect.

CBCL: child behaviour checklist
NICU: neonatal intensive care unit

Figuras y tablas -
Summary of findings for the main comparison. Planned early delivery compared with expectant management for improving outcomes of the term suspected compromised baby
Comparison 1. Planned early delivery versus expectant management

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Perinatal mortality Show forest plot

1

459

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2 Major neonatal morbidity Show forest plot

1

459

Risk Ratio (M‐H, Fixed, 95% CI)

0.15 [0.01, 2.81]

3 Neurodevelopmental disability/impairment Show forest plot

1

459

Risk Ratio (M‐H, Fixed, 95% CI)

2.04 [0.62, 6.69]

4 Maternal mortality Show forest plot

1

459

Risk Ratio (M‐H, Fixed, 95% CI)

3.07 [0.13, 74.87]

5 Major maternal morbidity Show forest plot

1

459

Risk Ratio (M‐H, Fixed, 95% CI)

0.92 [0.38, 2.22]

6 Neonatal seizures Show forest plot

1

336

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

7 Necrotising enterocolitis Show forest plot

1

333

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

8 Respiratory distress syndrome Show forest plot

1

333

Risk Ratio (M‐H, Fixed, 95% CI)

0.33 [0.01, 7.98]

9 Meconium aspiration Show forest plot

1

459

Risk Ratio (M‐H, Fixed, 95% CI)

0.34 [0.01, 8.32]

10 Gestational age at birth (days) Show forest plot

1

459

Mean Difference (IV, Fixed, 95% CI)

‐9.5 [‐10.82, ‐8.18]

11 Gestational age ≥ 40 weeks (not pre‐specified) Show forest plot

1

33

Risk Ratio (M‐H, Fixed, 95% CI)

0.10 [0.01, 0.67]

12 Apgar score < 7 at 5 minutes Show forest plot

3

546

Risk Ratio (M‐H, Fixed, 95% CI)

2.56 [0.50, 13.04]

13 Resuscitation required Show forest plot

1

459

Risk Ratio (M‐H, Fixed, 95% CI)

0.11 [0.01, 2.10]

14 Requirement for mechanical ventilation Show forest plot

1

337

Risk Ratio (M‐H, Fixed, 95% CI)

0.20 [0.01, 4.11]

15 Birthweight < 10 centile Show forest plot

2

491

Risk Ratio (M‐H, Fixed, 95% CI)

0.98 [0.88, 1.10]

16 Birthweight < 2.3 centile (not pre‐specified) Show forest plot

2

491

Risk Ratio (M‐H, Fixed, 95% CI)

0.51 [0.36, 0.73]

17 Admission to NICU Show forest plot

3

545

Risk Ratio (M‐H, Fixed, 95% CI)

0.88 [0.35, 2.23]

18 Admission to intermediate care nursery (not pre‐specified) Show forest plot

2

491

Risk Ratio (M‐H, Fixed, 95% CI)

1.28 [1.02, 1.61]

19 Length of stay in NICU/SCN (days) Show forest plot

1

459

Mean Difference (IV, Fixed, 95% CI)

0.0 [‐1.28, 1.28]

20 Interval (days) between randomisation and delivery Show forest plot

1

459

Mean Difference (IV, Fixed, 95% CI)

‐8.68 [‐10.04, ‐7.32]

21 Neonatal sepsis Show forest plot

2

366

Risk Ratio (M‐H, Fixed, 95% CI)

3.18 [0.14, 72.75]

22 Caesarean section Show forest plot

3

546

Risk Ratio (M‐H, Fixed, 95% CI)

1.02 [0.65, 1.59]

23 Placental abruption Show forest plot

1

459

Risk Ratio (M‐H, Fixed, 95% CI)

3.07 [0.13, 74.87]

24 Pre‐eclampsia Show forest plot

1

459

Risk Ratio (M‐H, Fixed, 95% CI)

0.63 [0.27, 1.49]

25 Induction of labour Show forest plot

1

459

Risk Ratio (M‐H, Fixed, 95% CI)

2.05 [1.78, 2.37]

26 Vaginal birth Show forest plot

3

546

Risk Ratio (M‐H, Fixed, 95% CI)

0.98 [0.90, 1.07]

27 Assisted vaginal birth Show forest plot

3

546

Risk Ratio (M‐H, Fixed, 95% CI)

1.19 [0.69, 2.04]

28 Breastfeeding Show forest plot

1

218

Risk Ratio (M‐H, Fixed, 95% CI)

1.09 [0.85, 1.40]

29 Breastfeeding (weeks) Show forest plot

1

124

Mean Difference (IV, Fixed, 95% CI)

1.74 [‐3.37, 6.85]

30 Maternal hospital stay (days) (not pre‐specified) Show forest plot

1

33

Mean Difference (IV, Fixed, 95% CI)

1.0 [0.68, 1.32]

Figuras y tablas -
Comparison 1. Planned early delivery versus expectant management