Scolaris Content Display Scolaris Content Display

Cochrane Database of Systematic Reviews

Anestesia/analgesia para la extracción manual de la placenta retenida

Información

DOI:
https://doi.org/10.1002/14651858.CD013013.pub2Copiar DOI
Base de datos:
  1. Cochrane Database of Systematic Reviews
Versión publicada:
  1. 12 junio 2020see what's new
Tipo:
  1. Intervention
Etapa:
  1. Review
Grupo Editorial Cochrane:

  1. Grupo Cochrane de Embarazo y parto

Copyright:
  1. Copyright © 2020 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

Cifras del artículo

Altmetric:

Citado por:

Citado 0 veces por enlace Crossref Cited-by

Contraer

Autores

  • Kiattisak Kongwattanakul

    Correspondencia a: Department of Obstetrics and Gynaecology, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand

    [email protected]

    [email protected]

  • Nonthida Rojanapithayakorn

    Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand

  • Malinee Laopaiboon

    Department of Epidemiology and Biostatistics, Faculty of Public Health, Khon Kaen University, Khon Kaen, Thailand

  • Pisake Lumbiganon

    Department of Obstetrics and Gynaecology, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand

Contributions of authors

Kiattisak Kongwattanakul (KK) conceived the review question, drafted and finalised the protocol, assessed trial eligibility, extracted data, assessed risk of bias, evaluated certainty of evidence using GRADE for the 'Summary of findings' table, drafted and finalised the review.

Nonthida Rojanapithayakorn (NR) conceived the review question, revised the protocol, assessed trial eligibility, extracted data, assessed risk of bias, evaluated certainty of evidence using GRADE for the 'Summary of findings' table, and finalised the review.

Malinee Laopaiboon (ML) revised the protocol, revised and finalised the review.

Pisake Lumbiganon (PL) conceived the review question, revised and finalised the protocol, evaluated certainty of evidence using GRADE for the 'Summary of findings' table, revised and finalised the review.

Sources of support

Internal sources

  • Department of Obstetrics and Gynaecology, Faculty of Medicine, Khon Kaen University, Thailand

  • Department of Epidemiology and Biostatistics, Faculty of Public Health, Khon Kaen University, Thailand

  • Department of Anaesthesiology, Faculty of Medicine, Khon Kaen University, Thailand

External sources

  • No sources of support supplied

Declarations of interest

KK: none known

NR: none known

ML: none known

PL: none known

Acknowledgements

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

We acknowledge Chumnan Kietpeerakool's contribution to the published protocol for this review (Kongwattanakul 2018).

We thank Zarko Alfirevic, Ashraf Nabhan, and the Cochrane Pregnancy and Childbirth Group Consumer Panel, led by Janet Wale, for their helpful comments on the protocol and this review. 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

2020 Jun 12

Anaesthesia/analgesia for manual removal of retained placenta

Review

Kiattisak Kongwattanakul, Nonthida Rojanapithayakorn, Malinee Laopaiboon, Pisake Lumbiganon

https://doi.org/10.1002/14651858.CD013013.pub2

2018 Apr 20

Anaesthesia/analgesia for manual removal of retained placenta

Protocol

Kiattisak Kongwattanakul, Nonthida Rojanapithayakorn, Chumnan Kietpeerakool, Malinee Laopaiboon, Pisake Lumbiganon

https://doi.org/10.1002/14651858.CD013013

Differences between protocol and review

Types of outcome measures

1. Postpartum haemorrhage (blood loss of 500 mL or more) was included as one of the effectiveness outcomes and removed from the safety outcome.

2. In assessment of the quality of the evidence using the GRADE approach, we chose only seven outcomes from those presented in the methods.

Unit of analysis issues

In a future update of this review, we will consider the following issues regarding the unit of analysis.

Cluster‐randomised trials

We plan to include cluster‐randomised trials in the analyses along with individually‐randomised trials. We will adjust the standard errors of these trials according to the methods described in the Cochrane Handbook, using an estimate of the intracluster correlation co‐efficient (ICC) derived from the trial (if possible), from a similar trial, or from a study of a similar population (Higgins 2011). If we use ICCs from other sources, we will report this, and conduct sensitivity analyses to investigate the effect of variation in the ICC. If we identify both cluster‐randomised trials and individually‐randomised trials, we plan to synthesise the relevant information. We consider it reasonable to combine the results from both if there is little heterogeneity between the study designs, and if interaction between the effect of intervention and the choice of randomisation unit is considered to be unlikely (Higgins 2011). We plan to also acknowledge heterogeneity in randomisation units, and perform a sensitivity analysis to investigate the effects of the randomisation units.

Cross‐over trials

Studies employing a cross‐over design are not appropriate for the interventions that this review aims to evaluate and thus, will not be eligible for inclusion in this review.

Other unit of analyses issues

In studies with multiple arms, we will split the shared control group into two or more groups with a smaller sample size if the data could be combined in the same meta‐analysis, to avoid multiple counting as suggested in the Cochrane Handbook (Higgins 2011). If there are several relevant comparators in the same multi‐arm study, we will include each pair‐wise comparison separately, but with shared intervention groups divided out evenly among the study arms (Higgins 2011). For dichotomous outcomes, both the number of events and total number of participants will be divided up. For continuous outcomes, only the total number of participants will be divided, and the means and standard deviations will be left unchanged (Higgins 2011). When comparing more than two interventions, we may combine two intervention groups into a single group. For example, in cases that examine spinal, epidural, and general anaesthesia, we may combine spinal and epidural anaesthesia into a single ‘regional anaesthesia’ group to be compared with general anaesthesia. In such cases, we will employ the approach suggested in section 7.7.3.8 of the CochraneHandbook, entitled ‘Combining groups’ (Higgins 2011).

Dealing with missing data

In the review protocol, we stated that we would explore the impact of including studies with high levels of missing data in the overall assessment of treatment effect, using sensitivity analysis. However, we were unable to follow this plan, as we only included one trial in this review.

Assessment of heterogeneity

There was only one trial that met our inclusion criteria, therefore, assessment of heterogeneity was not necessary (see Differences between protocol and review). In future update of this review, we will assess statistical heterogeneity in each meta‐analysis using the Tau², I², and Chi² statistics. We will regard heterogeneity as substantial if an I² is greater than 30% and either a Tau² is greater than zero, or there is a low P value (less than 0.10) in the Chi² test for heterogeneity (Deeks 2001; Higgins 2003).

Assessment of reporting biases

As there was only one study that met our inclusion criteria, we were unable to construct funnel plots to determine the possibility of publication bias. In future updates of this review, If there are 10 or more studies in the meta‐analysis, we will investigate reporting biases (such as publication bias) using funnel plots. We will assess funnel plot asymmetry visually. If asymmetry is suggested by a visual assessment, we will perform exploratory analyses to investigate it (Sterne 2011).

Data synthesis

As there was only one study that met our inclusion criteria, we were unable to pool the results in meta‐analyses. In future updates, we will employ the following methods for data analysis. We will carry out statistical analysis using Review Manager 5 software (Review Manager 2014). We will use fixed‐effect meta‐analysis for combining data where it is reasonable to assume that studies are estimating the same underlying treatment effect, i.e. where trials are examining the same intervention, and the trials’ populations and methods are judged sufficiently similar. If there is clinical heterogeneity sufficient to expect that the underlying treatment effects differ between trials, or if substantial statistical heterogeneity is detected, we will use random‐effects meta‐analysis to produce an overall summary detailing, whether or not average treatment effect across trials can be considered clinically meaningful. The random‐effects summary will be treated as the average of the range of possible treatment effects, and we will discuss the clinical implications of treatment effects differing between trials. If the average treatment effect is not clinically meaningful, we will not combine trials. If we use random‐effects analyses, the results will be presented as the average treatment effect with 95% CIs, and the estimates of Tau² and I² (DerSimonian 1986).

Subgroup analysis and investigation of heterogeneity

We identified only one study that met our inclusion criteria. Subgroup analyses as mentioned in the review protocol was therefore not feasible. In future updates, if we identify substantial heterogeneity, we will investigate the heterogeneity using subgroup analyses. We will consider whether an overall summary is meaningful, and if it is, use random‐effects analysis to produce the pooled effects. We plan to carry out the following subgroup analyses.

  1. Type of intervention: general versus regional anaesthesia; general versus local anaesthesia; general versus systemic sedation or analgesia; regional versus local anaesthesia; regional versus systemic sedation or analgesia; local anaesthesia versus systemic sedation or analgesia; combined versus single anaesthesia or analgesia; combined A versus combined B anaesthesia or analgesia

  2. Type of operators for manual removal of the placenta: obstetricians versus other types of operator, i.e. midwife or general practitioner)

  3. Level of healthcare facility: primary versus secondary versus tertiary settings

We will use only the primary outcomes in subgroup analyses. We will assess subgroup differences using the interaction tests available within RevMan 5 (Review Manager 2014). We will report the results of subgroup analyses quoting the Chi² statistic and P value, and the interaction test I² value.

Sensitivity analysis

As there was only one that met our inclusion criteria, we were unable to perform sensitivity analysis. In future update of this review, if statistical heterogeneity is detected and there are sufficient trials included, we plan to carry out sensitivity analyses to explore the effect of risk of bias, as assessed by concealment of allocation, high attrition rates, or both. We will exclude studies with a high risk of bias from the analyses in order to assess whether this makes any difference to the overall results of the primary outcomes. In addition, we plan to perform sensitivity analysis to determine the impact of the randomisation units or ICC on the overall results of the primary outcomes.

Keywords

MeSH

Medical Subject Headings (MeSH) Keywords

Medical Subject Headings Check Words

Female; Humans; Pregnancy;

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

Ir a la figura de la revisiónAbrir en una pestaña nueva

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

Figuras y tablas -
Figure 2

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

Ir a la figura de la revisiónAbrir en una pestaña nueva

Comparison 1: Paracervical block versus intravenous analgesia, Outcome 1: Postpartum haemorrhage (blood loss ≥ 500 mL)

Figuras y tablas -
Analysis 1.1

Comparison 1: Paracervical block versus intravenous analgesia, Outcome 1: Postpartum haemorrhage (blood loss ≥ 500 mL)

Ir a la figura de la revisiónAbrir en una pestaña nueva

Comparison 1: Paracervical block versus intravenous analgesia, Outcome 2: Provider's satisfaction with the procedure

Figuras y tablas -
Analysis 1.2

Comparison 1: Paracervical block versus intravenous analgesia, Outcome 2: Provider's satisfaction with the procedure

Ir a la figura de la revisiónAbrir en una pestaña nueva

Comparison 1: Paracervical block versus intravenous analgesia, Outcome 3: Woman's satisfaction with the procedure

Figuras y tablas -
Analysis 1.3

Comparison 1: Paracervical block versus intravenous analgesia, Outcome 3: Woman's satisfaction with the procedure

Ir a la figura de la revisiónAbrir en una pestaña nueva
Summary of findings 1. Paracervical block compared to intravenous diazepam/pethidine analgesia for manual removal of retained placenta

Paracervical block compared to intravenous diazepam and pethidine analgesia during manual removal of retained placenta

Patient or population: women with persistent or prolonged retention of placenta
Setting: general hospital, Papua New Guinea
Intervention: paracervical block
Comparison: intravenous pethidine and diazepam analgesia

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

№ of participants
(studies)

Certainty of the evidence
(GRADE)

Comments

Risk with intravenous pethidine and diazepam

Risk with paracervical block

Pain intensity

study did not measure this outcome

Adverse events

study did not measure this outcome

Postpartum haemorrhage (blood loss ≥ 500 mL)

Study population

not estimable

30
(1 RCT)

⊕⊝⊝⊝
Very lowa,b

None of the women lost ≥ 500 mL blood

0 per 1000

0 per 1000
(0 to 0)

Requirement of additional analgesia or general anaesthesia

study did not measure this outcome

Serious maternal morbidity

study did not measure this outcome

Providers' satisfaction with the procedure

Study population

RR 1.50
(0.71 to 3.16)

30
(1 RCT)

⊕⊝⊝⊝
Very lowa,c

400 per 1000

600 per 1000
(284 to 1000)

Women's satisfaction with the procedure

Study population

RR 0.82
(0.49 to 1.37)

30
(1 RCT)

⊕⊝⊝⊝
Very lowa,c

733 per 1000

601 per 1000
(359 to 1000)

*The risk in the intervention group (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 certainty: We are very confident that the true effect lies close to that of the estimate of the effect
Moderate certainty: 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 certainty: Our confidence in the effect estimate is limited; the true effect may be substantially different from the estimate of the effect
Very low certainty: We have very little confidence in the effect estimate; the true effect is likely to be substantially different from the estimate of effect

aDowngraded ‐2 for very serious limitations in study design (risk of bias) – high risk of bias for performance and detection bias; and unclear risk of selection bias and reporting bias.
bDowngraded ‐2 for very serious imprecision – results based on one small study involving 30 women and zero events. cDowngraded ‐2 for very serious imprecision – results based on one small study involving 30 women, wide confidence interval crossing the line of no effect.

Figuras y tablas -
Summary of findings 1. Paracervical block compared to intravenous diazepam/pethidine analgesia for manual removal of retained placenta
Ir a la tabla de la revisión
Comparison 1. Paracervical block versus intravenous analgesia

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1.1 Postpartum haemorrhage (blood loss ≥ 500 mL) Show forest plot

1

30

Risk Ratio (IV, Fixed, 95% CI)

Not estimable

1.2 Provider's satisfaction with the procedure Show forest plot

1

30

Risk Ratio (IV, Fixed, 95% CI)

1.50 [0.71, 3.16]

1.3 Woman's satisfaction with the procedure Show forest plot

1

30

Risk Ratio (IV, Fixed, 95% CI)

0.82 [0.49, 1.37]
Figuras y tablas -
Comparison 1. Paracervical block versus intravenous analgesia
Ir a la tabla de la revisión