A randomised controlled trial to compare the effectiveness of icepacks and Epifoam with cooling maternity gel pads at alleviating postnatal perineal trauma

Mary Steen; Keith Cooper; Paul Marchant; Martin Griffiths‐Jones; James J. Walker

doi:10.1054/midw.1999.0188

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A randomised controlled trial to compare the effectiveness of icepacks and Epifoam with cooling maternity gel pads at alleviating postnatal perineal trauma

Mary Steen, Keith Cooper, Paul Marchant, Martin Griffiths‐Jones, James J. Walker

Elsevier BV (2000) • Volume 16, Issue 1, Pages 48-55

Empirical-ClinicalRCTPDF AvailableGrade Eligible⚠️ High Risk Flags⚠️ Moderate Risk Flags

Overall Assessment

Weak Methodological Quality

Assessment created by PaperScores Medical AI v0 on Dec 14, 2025

D-

38/100

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Quality Dimensions

Bias & Integrity

COI handling, outcome switching, selective reporting

D-35

Methods Rigour

Protocol clarity, sampling, controls

D45

External Validity

Generalisability, setting, population

D-35

Transparency & Reproducibility

Data/code/materials availability, preregistration

F20

Significance & Novelty

Contribution vs prior art; context if known

C-55

Statistical Validity

Models, assumptions, multiplicity, CI priority

D40

Integrity & Transparency

Integrity checks

P-hacking risk?

?

Review recommended

Signs of selective hypothesis testing or analysis choices that could inflate false positive rates.

Outcome switching?

?

Review recommended

Evidence that primary outcomes were changed during or after the study, potentially distorting results.

Conflict of interest?

?

Serious concern

Authors have financial or other relationships that could bias research findings.

Data integrity issues?

?

None suspected

Concerns about the accuracy, completeness, or authenticity of the reported data.

Open science signals

Research data

?

Not shared

Raw data used in the analyses is publicly available or accessible upon request.

Analysis code

?

Not shared

Code or scripts used to analyze the data are shared for reproducibility.

Study materials

?

Not shared

Protocols, questionnaires, and other materials are publicly available.

Premise

Primary Research Question

Are cooling maternity gel pads more effective than ice packs or Epifoam for postnatal perineal trauma?

Hypothesis

Gel pads reduce oedema, bruising and pain more than standard regimens.

Hypothesis is Falsifiable

✓Yes

Predefined outcomes measured at fixed timepoints allow refutation.

PICO Framework

Population✓Yes

Primigravidae, term, instrumental delivery, episiotomy, vicryl sutures.

Intervention✓Yes

Cooling maternity gel pads with specified preparation/application.

Comparison✓Yes

Standard care comparators: ice packs and Epifoam.

Outcome✓Yes

Perineal oedema, bruising, pain are clinically relevant.

Literature Positioning

Literature Review Balanced

Well covered

Prior trials and reviews on ice packs/Epifoam cited.

Evidence: References list

Research Gap Clearly Stated

Well covered

Effects on oedema/bruising not fully evaluated; new device to be tested.

Evidence: Introduction

Stated Contribution Clear

Well covered

RCT comparing gel pads vs ice packs and Epifoam for perineal trauma.

Evidence: Objective/Methods

Study Provenance

Peer reviewed venueFunding disclosedConflict disclosure provided5 affiliations listed

Authors & Affiliations

St James’s University Hospital, Leeds; Health Research Unit; Consultant Obstetrics & Gynaecology; University affiliations as listed.

Funding Statement

Elizabeth Clark Charitable Trust funded the trial.

Conflicts of Interest

No COI statement reported; authors developed the gel pads.

Peer Review

✓Published in Midwifery 2000;16(1):48–55.

Evidence: citation page

Methodological Assessment

Randomized Controlled TrialCONSORTRCT

14 applicable checklist items.

Yes 7 · No 3 · Unclear 4

Study Design & Protocol

✓

Power Analysis Reported

Power calc for oedema at 48h (5% alpha, 95% power).

Evidence: Methods: power calculation

✓

Randomisation Adequate

Computer programme randomised with equal chance to 3 groups.

Evidence: Methods: Randomisation

?

Allocation Concealment

Concealment process not described beyond computer allocation.

Evidence: Methods

✓

Blinding

Assessors blinded where possible; participants/providers not.

Evidence: Methods: Assessments

?

Blinding Adequate

Blinding compromised by visible interventions; ‘as far as possible’.

Evidence: Methods: Assessments

✓

Intervention Replicable

Protocols for preparation/application detailed for all arms.

Evidence: Methods: Treatment protocols

✓

Outcomes Pre-specified

Oedema, bruising, pain at prespecified timepoints.

Evidence: Methods

✗

Pre-registration Evidence

No registration or protocol publicly cited.

Evidence: Not reported

Analysis & Reporting

✗

Analysis Set Appropriate (ITT/mITT)

Post-randomisation exclusions/non-returns removed from analysis.

Evidence: Methods/Table 1

✗

Missing Data Handled Appropriately

Listwise exclusion of non-returns; no imputation.

Evidence: Methods: Statistical analysis

✓

Baseline Balance Acceptable

Baseline characteristics similar; no significant differences.

Evidence: Results/Table 1

?

Adherence Adequate

Repeat applications largely unsupervised; adherence not quantified.

Evidence: Methods: Treatment protocols

✓

Participant Flow Reported (CONSORT)

CONSORT-like counts: randomised 120; analysed 77; attrition detailed.

Evidence: Table 1

?

Harms Reported Adequately

Harms beyond wound healing not systematically reported.

Evidence: Methods/Results

Modules without applicable checklist items (8)

These designs were fully marked as not applicable but remain available for reference.

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Study Overview

Study Design

RCT

Primary classification used to evaluate this research.

Population

Primigravid women (20–35y) with instrumental delivery and episiotomy at a UK hospital, followed in hospital then at home.

Brief summary of who or what was studied.

Sample Size

120

Number of participants included in the study analyses.

Study Arms

3 arms

Total number of intervention or comparison groups.

Pre-registration

Not registered

Indicates whether the protocol or trial was registered before data collection.

Randomisation

Simple randomisation

How participants were allocated to groups: None (no randomisation), Simple (random order), Blocked (groups balanced in blocks), Stratified (balanced within subgroups), Adaptive (allocation adjusted based on previous enrollments).

Blinding

Single blind

Who was unaware of group assignments: None (everyone knew), Single blind (participants didn't know their group), Double blind (participants and researchers didn't know), Triple blind (also outcome assessors didn't know).

Analysis Set

mITT (modified intention-to-treat)

Which participants were included in analysis: ITT (all randomized, regardless of adherence), mITT (modified ITT, excluding some for valid reasons), Per protocol (only those who completed as planned), As treated (grouped by actual treatment received), Other (alternative approach).

Follow-up

Assessments <4h, 24h, 48h; pain at day 5; healing observed at days 5 & 10.

Duration of observation or follow-up for outcomes.

Loss to Follow-up

36%

Percentage of participants who did not complete follow-up.

Primary Outcome

Primary outcome was not pre-specified.

Reviewer Notes

Individually randomised 3-arm pragmatic RCT; participants unblinded; assessor blinding attempted; post-randomisation exclusions → mITT.

Publication Details

DOI

10.1054/midw.1999.0188

Published

March 1, 2000

Citations

70 citations

FWCI

1.72

External Resources

DOI Link OpenAlex

Disclaimer: This assessment is generated by AI and should not be the sole basis for clinical or research decisions. Always review the original paper and consult with domain experts.

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