Treatments for breast engorgement during lactation
Abstract
This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:
To identify the best forms of treatment for women who experience breast engorgement.
Background
The birth of the baby is an important event in any family. It is therefore important that for a mother to have a healthy baby, she gives her baby the best nutrition. Breast milk is the best food for babies as breastfed babies are healthier than formula‐fed babies (Chopra 2006). In recognition of the immense importance of breastfeeding, the Baby‐Friendly Hospital Initiative was launched by UNICEF/WHO in 1991 (Schubiger 1997). Breastfeeding results in decreased problems such as infections and other medical problems (Campbell 2000; Cunningham 2005). It has also been linked to enhancement of cognitive development, prevention of obesity, hypertension and insulin dependent diabetes mellitus (Leung 2005). It therefore lowers the rate of sickness episodes and consequently the rate of hospital admissions.
Correct breastfeeding technique goes a long way in ensuring successful breastfeeding. Incorrect technique may contribute to breast engorgement. Breast engorgement is the overfilling of breast milk that causes discomfort and pain to the mother whilst non‐infectious mastitis is inflammation of the breast due to milk duct blockage (Clarke 2007). Support to initiate breastfeeding and ongoing breastfeeding support is important because it has been shown that breastfeeding rates decrease with a decrease in breastfeeding support. Lack of support results in problems of establishment of breastfeeding, breast engorgement, sore or cracked nipples; usually due to poor technique (Stamp 2006). De Oliveira et al also demonstrated in their randomised controlled trial that there was no difference between women who were counselled once in hospital and those that were not counselled on breastfeeding. This suggests that ongoing support is crucial if breastfeeding is to be successful (De Oliveira 2006).
Breast engorgement occurs if the baby sucks less milk than the amount that the mother produces. Inadequate emptying of breasts results in problems such as breast engorgement, plugged milk duct, breast infection and insufficient milk supply (Giugliani 2004). Some health professionals compound this problem by discouraging women from breastfeeding when breast engorgement occurs. Lack of knowledge in managing this condition could be the reason for this inappropriate advice (Hillenbrand 2002). Primary engorgement occurs in the first few days after the baby is born, and it occurs when the mother's body is still trying to adjust to the amount of milk that the baby demands. Secondary engorgement occurs later, and it occurs when the mother is not feeding as frequently as she used to or the baby's demand has decreased. Augmentation mammoplasty has also lately been identified as a cause of breast engorgement when women who have had such operations are breastfeeding (Acarturk 2005).
Breast engorgement is an important public health topic in the era of HIV and AIDS. A separate Cochrane Review will address the question of the best way to avoid mother‐to‐child transmission of HIV infection post‐delivery (Tholandi 2003). In developing countries, the stigma associated with avoiding breastfeeding, the unavailability of resources (formula milk, clean water etc) and the fact that most women do not know their HIV status make it impossible to avoid breastfeeding. In cases where formula feeding is not possible, women usually opt for exclusive breastfeeding. In all breastfeeding women, breast engorgement should be prevented or treated, as it may discourage women to continue breastfeeding.
Many methods of treating breastfeeding engorgement have been introduced. It is not known which ones are highly effective compared to the others. It is important that this topic be reviewed as the review may have positive public health implications.
Objectives
To identify the best forms of treatment for women who experience breast engorgement.
Methods
Criteria for considering studies for this review
Types of studies
Randomised controlled trials and quasi‐randomised trials where treatments for breast engorgement are evaluated.
Types of participants
All women receiving any treatment for breast engorgement during breastfeeding.
Types of interventions
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Non‐medical forms of treatment, e.g. compression binders, support bra, fluid limitation, etc
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Medical treatments, e.g. ibuprofen
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Medical and non‐medical forms of treatment combined
Types of outcome measures
Primary outcomes
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Temporary cessation of breastfeeding
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Permanent cessation of breastfeeding
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Mastitis
Secondary outcomes
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Temperature higher than 38 degrees Celsius
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Maternal opinion of treatment
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Maternal acceptance of treatment
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Analgesic requirement
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Hospital admission
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Mother's confidence in continuing to breastfeed
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Breast abscess
Search methods for identification of studies
Electronic searches
We will contact the Trials Search Co‐ordinator to search the Cochrane Pregnancy and Childbirth Group's Trials Register.
The Cochrane Pregnancy and Childbirth Group's Trials Register is maintained by the Trials Search Co‐ordinator and contains trials identified from:
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quarterly searches of the Cochrane Central Register of Controlled Trials (CENTRAL);
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monthly searches of MEDLINE;
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handsearches of 30 journals and the proceedings of major conferences;
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weekly current awareness search of a further 37 journals.
Details of the search strategies for CENTRAL and MEDLINE, the list of handsearched journals and conference proceedings, and the list of journals reviewed via the current awareness service can be found in the 'Search strategies for identification of studies' section within the editorial information about the Cochrane Pregnancy and Childbirth Group.
Trials identified through the searching activities described above are given a code (or codes) depending on the topic. The codes are linked to review topics. The Trials Search Co‐ordinator searches the register for each review using these codes rather than keywords.
In addition, we will search CENTRAL (The Cochrane Library) using the search strategy: (breastfe* or lactation or lactating) and engorge*.
We will also consult breastfeeding associations.
We will not apply any language restrictions.
Data collection and analysis
Selection of studies
We will assess for inclusion all potential studies we identify as a result of search strategy. We will resolve any disagreements through discussion or, if required, consult the Pregnancy and Childbirth Group Editor for this review.
Assessment of methodological quality of included studies
We will assess the validity of each study using the criteria outlined in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2005). Methods used for generation of the randomisation sequence will be described for each trial.
(1) Selection bias
We will assign a quality score for each trial, using the following criteria:
(A) adequate concealment of allocation: such as telephone randomisation, consecutively numbered sealed opaque envelopes;
(B) unclear whether adequate concealment of allocation: such as list or table used, sealed envelopes, or study does not report any concealment approach;
(C) inadequate concealment of allocation: such as open list of random number tables, use of case record numbers, dates of birth or days of the week.
(2) Attrition bias
We will assess completeness to follow up using the following criteria:
(A) less than 5% loss of participants;
(B) 5% to 9.9% loss of participants;
(C) 10% to 19.9% loss of participants;
(D) more than 20% loss of participants.
Data extraction and management
We will design a form to extract data. Both authors will extract the data using the agreed form. We will resolve discrepancies through discussion. We will use the Review Manager software (RevMan 2003) to double enter all the data or a subsample. We will do sensitivity analysis for trial quality.
When information regarding any of the above is unclear, we will attempt to contact authors of the original reports to provide further details.
Measures of treatment effect
We will carry out statistical analysis using RevMan 2003. We will use fixed‐effect meta‐analysis for combining data in the absence of significant heterogeneity if trials are sufficiently similar.
Dichotomous data
For dichotomous data, we will present results as summary relative risk with 95% confidence intervals.
Continuous data
For continuous data, we will use the weighted mean difference if outcomes are measured in the same way between trials. We will use the standardised mean difference to combine trials that measure the same outcome, but use different methods. If there is evidence of skewness, this will be reported.
Unit of analysis issues
Cluster‐randomised trials
If we have cluster‐randomised trials, we will include them in the analyses along with individually randomised trials. Their sample sizes will be adjusted using the methods described in Gates 2005 using an estimate of the intracluster correlation co‐efficient (ICC) derived from the trial (if possible), or from another source. If ICCs from other sources are used, this will be reported and sensitivity analyses conducted 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 will consider it reasonable to combine the results from both if there is little heterogeneity between the study designs and the interaction between the effect of intervention and the choice of randomisation unit is considered to be unlikely. For more information on data analysis of cluster randomised trials we will consult Ukoumune 1999 and Rao 1992 and where further assistance is needed, we will consult statisticians. We will also acknowledge heterogeneity in the randomisation unit and perform a separate meta‐analysis; therefore the meta‐analysis will be performed in two parts as well.
Available case analysis
We will analyse data on all participants with available data in the group to which they are allocated, regardless of whether or not they received the allocated intervention. If in the original reports participants are not analysed in the group to which they were randomised, and there is sufficient information in the trial report, we will attempt to restore them to the correct group.
Assessment of heterogeneity
We will apply tests of heterogeneity between trials, if appropriate, using the I² statistic. If we identify high levels of heterogeneity among the trials (exceeding 50%), we will use random‐effects model and we will not conduct a meta‐analysis.
Subgroup analyses
We will conduct planned subgroup analyses classifying whole trials by interaction tests as described by Deeks 2001. A separate meta‐analysis will need to be conducted for participants in each subgroup.
We plan to carry out the following subgroup analyses:
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when breastfeeding was just initiated and when it was already established;
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medical treatments, non‐medical treatments and where these two forms are mixed or undefined.
Sensitivity analyses
We will carry out sensitivity analysis to explore the effect of trial quality assessed by concealment of allocation by excluding studies with clearly inadequate allocation of concealment (rated C).
