Aspirin (single dose) for perineal pain in the early postpartum period

Emily Shepherd; Rosalie M Grivell

doi:10.1002/14651858.CD012129.pub3

Cochrane Database of Systematic Reviews

Aspirin (single dose) for perineal pain in the early postpartum period

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DOI:

https://doi.org/10.1002/14651858.CD012129.pub3 Copiar DOI

Base de datos:

Cochrane Database of Systematic Reviews

Versión publicada:

24 julio 2020see what's new

Tipo:

Intervention

Etapa:

Review

Grupo Editorial Cochrane:

Grupo Cochrane de Embarazo y parto

Copyright:

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

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Contraer

Autores

Emily Shepherd

Correspondencia a: Robinson Research Institute, Discipline of Obstetrics and Gynaecology, Adelaide Medical School, The University of Adelaide, Adelaide, Australia

[email protected]

Women and Kids Theme, South Australian Health and Medical Research Institute, Adelaide, Australia
Rosalie M Grivell

Department of Obstetrics and Gynaecology, Flinders University and Flinders Medical Centre, Bedford Park, Australia

Contributions of authors

For this update, Emily Shepherd and Rosalie Grivell re‐assessed the studies awaiting classification. Emily Shepherd drafted the update, with input from Rosalie Grivell.

For the previous version of this review, Sujana Molakatalla and Emily Shepherd assessed studies for inclusion and exclusion; carried out data extraction, and assessed the risk of bias of the included trials. Emily Shepherd entered data into RevMan 5 and performed the analyses. Sujana Molakatalla drafted the review with input from both Emily Shepherd (editorial) and Rosalie Grivell (editorial and clinical).

Sources of support

Internal sources

South Australian Health and Medical Research Institute (SAHMRI), Women and Kids, Australia
Department of Obstetrics and Gynaecology, Flinders University and Flinders Medical Centre, Australia

External sources

No sources of support supplied

Declarations of interest

Emily Shepherd: none known

Rosalie M Grivell: none known

Acknowledgements

As part of the pre‐publication editorial process, 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 (2017) commented on this review.

This project was supported by the National Institute for Health Research (NIHR), 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 Evidence Synthesis Programme, the NIHR, National Health Service (NHS), or the Department of Health and Social Care.

We acknowledge the support from the Cochrane Pregnancy and Childbirth editorial team in Liverpool. We thank Sujana Molakatalla for her contribution as an author to previous versions of this review.

Version history

Published

Title

Stage

Authors

Version

2020 Jul 24

Aspirin (single dose) for perineal pain in the early postpartum period

Review

Emily Shepherd, Rosalie M Grivell

https://doi.org/10.1002/14651858.CD012129.pub3

2017 Feb 09

Aspirin (single dose) for perineal pain in the early postpartum period

Review

Sujana Molakatalla, Emily Shepherd, Rosalie M Grivell

https://doi.org/10.1002/14651858.CD012129.pub2

2016 Mar 21

Aspirin (single dose) for perineal pain in early postpartum period

Protocol

Sujana Molakatalla, Emily Shepherd, Rosalie M Grivell

https://doi.org/10.1002/14651858.CD012129

Differences between protocol and review

There are some differences between our published protocol (Molakatalla 2016), and this full review.

Methods, data collection, and analysis − assessment of pain − we clarified that our measure was 50% or greater pain relief (our protocol stated 50%). We also clarified equations used for measures of pain in the review.

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.

Figure 1

Study flow diagram

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Figure 2

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

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Figure 3

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

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Figure 4

Funnel plot of comparison: 1 Aspirin versus placebo for perineal pain, outcome: 1.1 Adequate pain relief as reported by the women

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Figure 5

Funnel plot of comparison: 1 Aspirin versus placebo for perineal pain, outcome: 1.2 Need for additional pain relief

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Figure 6

Funnel plot of comparison: 1 Aspirin versus placebo for perineal pain, outcome: 1.3 Maternal adverse effects

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Analysis 1.1

Comparison 1: Aspirin versus placebo for perineal pain, Outcome 1: Adequate pain relief as reported by the woman

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Analysis 1.2

Comparison 1: Aspirin versus placebo for perineal pain, Outcome 2: Need for additional pain relief

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Analysis 1.3

Comparison 1: Aspirin versus placebo for perineal pain, Outcome 3: Maternal adverse effects

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Analysis 2.1

Comparison 2: 300 mg aspirin versus 600 mg aspirin for perineal pain, Outcome 1: Adequate pain relief as reported by the woman

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Analysis 2.2

Comparison 2: 300 mg aspirin versus 600 mg aspirin for perineal pain, Outcome 2: Need for additional pain relief

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Analysis 2.3

Comparison 2: 300 mg aspirin versus 600 mg aspirin for perineal pain, Outcome 3: Maternal adverse effects

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Analysis 3.1

Comparison 3: 600 mg aspirin versus 1200 mg aspirin for perineal pain, Outcome 1: Adequate pain relief as reported by the woman

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Analysis 3.2

Comparison 3: 600 mg aspirin versus 1200 mg aspirin for perineal pain, Outcome 2: Need for additional pain relief

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Analysis 3.3

Comparison 3: 600 mg aspirin versus 1200 mg aspirin for perineal pain, Outcome 3: Maternal adverse effects

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Analysis 4.1

Comparison 4: 300 mg aspirin versus 1200 mg aspirin for perineal pain, Outcome 1: Adequate pain relief as reported by the woman

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Analysis 4.2

Comparison 4: 300 mg aspirin versus 1200 mg aspirin for perineal pain, Outcome 2: Need for additional pain relief

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Analysis 4.3

Comparison 4: 300 mg aspirin versus 1200 mg aspirin for perineal pain, Outcome 3: Maternal adverse effects

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Summary of findings 1. Aspirin compared with placebo for perineal pain in the early postpartum period

Aspirin compared with placebo for perineal pain in the early postpartum period
Patient or population: women with perineal pain in the early postpartum period Settings: hospitals in USA, Venezuela, Belgium, Canada, India Intervention: aspirin (single dose) Comparison: placebo
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of participants (studies)	Certainty of the evidence (GRADE)	Comments
Outcomes	Assumed risk for placebo	Corresponding risk for aspirin	Relative effect (95% CI)	No of participants (studies)	Certainty of the evidence (GRADE)	Comments
Adequate pain relief as reported by the woman (4 to 8 hours)	Study population		RR 2.03 (1.69 to 2.42)	1001 (13 RCTs)	⊕⊕⊝⊝ low^a
	253 per 1000	513 per 1000 (427 to 612)	RR 2.03 (1.69 to 2.42)	1001 (13 RCTs)	⊕⊕⊝⊝ low^a
Need for additional pain relief (4 to 8 hours)	Study population		RR 0.25 (0.17 to 0.37)	744 (10 RCTs)	⊕⊝⊝⊝ very low^a,b
Need for additional pain relief (4 to 8 hours)	267 per 1000	67 per 1000 (45 to 99)	RR 0.25 (0.17 to 0.37)	744 (10 RCTs)	⊕⊝⊝⊝ very low^a,b
Maternal adverse effects (4 to 8 hours)	Study population		RR 1.08 (0.57 to 2.06)	1067 (14 RCTs)	⊕⊝⊝⊝ very low^a,c
Maternal adverse effects (4 to 8 hours)	27 per 1000	29 per 1000 (15 to 55)	RR 1.08 (0.57 to 2.06)	1067 (14 RCTs)	⊕⊝⊝⊝ very low^a,c
Neonatal adverse effects				(0 RCTs)		Not reported by any of the included RCTs
Perineal pain at six weeks postpartum				(0 RCTs)		Not reported by any of the included RCTs
The corresponding risk* (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; RCT: randomised controlled trial; RR: risk ratio
GRADE Working Group grades of evidence High certainty: Further research is very unlikely to change our confidence in the estimate of effect. Moderate certainty: Further research is likely to have an important impact on our confidence in the estimate of effect, and may change the estimate. Low certainty: 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 certainty: We are very uncertain about the estimate.
^aWe downgraded 2 levels for very serious limitations in study design: most of the trials contributing data were at unclear risk of selection bias ^bWe downgraded 1 level for serious limitations in publication bias: visual inspection of funnel plot indicates likely publication bias ^cWe downgraded 1 level for serious limitations in imprecision: there were few events and wide 95% CI around the pooled estimate that includes no effect

Summary of findings 1. Aspirin compared with placebo for perineal pain in the early postpartum period

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Comparison 1. Aspirin versus placebo for perineal pain

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1.1 Adequate pain relief as reported by the woman Show forest plot	13	1001	Risk Ratio (M‐H, Fixed, 95% CI)	2.03 [1.69, 2.42]

1.1.1 300 mg aspirin	1	53	Risk Ratio (M‐H, Fixed, 95% CI)	2.60 [0.36, 18.88]
1.1.2 500 mg to 650 mg aspirin	11	800	Risk Ratio (M‐H, Fixed, 95% CI)	1.98 [1.64, 2.39]
1.1.3 900 mg aspirin	1	40	Risk Ratio (M‐H, Fixed, 95% CI)	1.83 [0.84, 3.99]
1.1.4 1200 mg aspirin	3	108	Risk Ratio (M‐H, Fixed, 95% CI)	2.75 [1.25, 6.06]
1.2 Need for additional pain relief Show forest plot	10	744	Risk Ratio (M‐H, Fixed, 95% CI)	0.25 [0.17, 0.37]

1.2.1 300 mg aspirin	1	53	Risk Ratio (M‐H, Fixed, 95% CI)	0.16 [0.03, 0.79]
1.2.2 500 mg to 650 mg aspirin	9	569	Risk Ratio (M‐H, Fixed, 95% CI)	0.27 [0.17, 0.41]
1.2.3 900 mg aspirin	1	40	Risk Ratio (M‐H, Fixed, 95% CI)	0.14 [0.01, 2.60]
1.2.4 1200 mg aspirin	2	82	Risk Ratio (M‐H, Fixed, 95% CI)	0.20 [0.06, 0.70]
1.3 Maternal adverse effects Show forest plot	14	1067	Risk Ratio (M‐H, Fixed, 95% CI)	1.08 [0.57, 2.06]

1.3.1 300 mg aspirin	1	53	Risk Ratio (M‐H, Fixed, 95% CI)	Not estimable
1.3.2 500 mg to 650 mg aspirin	13	892	Risk Ratio (M‐H, Fixed, 95% CI)	1.13 [0.51, 2.53]
1.3.3 900 mg aspirin	1	40	Risk Ratio (M‐H, Fixed, 95% CI)	2.50 [0.55, 11.41]
1.3.4 1200 mg aspirin	2	82	Risk Ratio (M‐H, Fixed, 95% CI)	0.10 [0.01, 1.80]

Comparison 1. Aspirin versus placebo for perineal pain

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Comparison 2. 300 mg aspirin versus 600 mg aspirin for perineal pain

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
2.1 Adequate pain relief as reported by the woman Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

2.2 Need for additional pain relief Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

2.3 Maternal adverse effects Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

Comparison 2. 300 mg aspirin versus 600 mg aspirin for perineal pain

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Comparison 3. 600 mg aspirin versus 1200 mg aspirin for perineal pain

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
3.1 Adequate pain relief as reported by the woman Show forest plot	2	121	Risk Ratio (M‐H, Fixed, 95% CI)	0.85 [0.52, 1.39]

3.2 Need for additional pain relief Show forest plot	2	121	Risk Ratio (M‐H, Fixed, 95% CI)	1.32 [0.30, 5.68]

3.3 Maternal adverse effects Show forest plot	2	121	Risk Ratio (M‐H, Fixed, 95% CI)	3.00 [0.13, 69.52]

Comparison 3. 600 mg aspirin versus 1200 mg aspirin for perineal pain

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Comparison 4. 300 mg aspirin versus 1200 mg aspirin for perineal pain

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
4.1 Adequate pain relief as reported by the woman Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

4.2 Need for additional pain relief Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

4.3 Maternal adverse effects Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

Comparison 4. 300 mg aspirin versus 1200 mg aspirin for perineal pain

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Aspirin (single dose) for perineal pain in the early postpartum period

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