Treatments for breast engorgement during lactation.

BACKGROUND: Breast engorgement is a painful condition affecting large numbers of women in the early postpartum period. It may lead to premature weaning, cracked nipples, mastitis and breast abscess. Various forms of treatment for engorgement have been studied but so far little evidence has been found on an effective intervention. OBJECTIVES: This is an update of a systematic review first published by Snowden et al. in 2001 and subsequently published in 2010. The objective of this update is to seek new information on the best forms of treatment for breast engorgement in lactating women. SEARCH METHODS: We identified studies for inclusion through the Cochrane Pregnancy and Childbirth Group's Trials Register (30 June 2015) and searched reference lists of retrieved studies. SELECTION CRITERIA: Randomised and quasi-randomised controlled trials. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trials for eligibility, extracted data and conducted 'Risk of bias' assessments. Where insufficient data were presented in trial reports, we attempted to contact study authors and obtain necessary information. We assessed the quality of the evidence using the GRADE approach. MAIN RESULTS: In total, we included 13 studies with 919 women. In 10 studies individual women were the unit of analysis and in three studies, individual breasts were the unit of analysis. Four out of 13 studies were funded by an agency with a commercial interest, two received charitable funding, and two were funded by government agencies.Trials examined interventions including non-medical treatments: cabbage leaves (three studies), acupuncture (two studies), ultrasound (one study), acupressure (one study), scraping therapy (Gua Sha) (one study), cold breast-packs and electromechanical massage (one study), and medical treatments: serrapeptase (one study), protease (one study) and subcutaneous oxytocin (one study). The studies were small and used different comparisons with only single studies contributing data to outcomes of this review. We were unable to pool results in meta-analysis and only seven studies provided outcome data that could be included in data and analysis. Non-medical No differences were observed in the one study comparing acupuncture with usual care (advice and oxytocin spray) (risk ratio (RR) 0.50, 95% confidence interval (CI) 0.13 to 1.92; one study; 140 women) in terms of cessation of breastfeeding. However, women in the acupuncture group were less likely to develop an abscess (RR 0.20, 95% CI 0.04 to 1.01; one study; 210 women), had less severe symptoms on day five (RR 0.84, 95% CI 0.70 to 0.99), and had a lower rate of pyrexia (RR 0.82, 95% CI 0.72 to 0.94) than women in the usual care group.In another study with 39 women comparing cabbage leaf extract with placebo, no differences were observed in breast pain (mean difference (MD) 0.40, 95% CI -0.67 to 1.47; low-quality evidence) or breast engorgement (MD 0.20, 95% CI -0.18 to 0.58; low-quality evidence). There was no difference between ultrasound and sham treatment in analgesic requirement (RR 0.98, 95% CI 0.63 to 1.51; one study; 45 women; low-quality evidence). A study comparing Gua-Sha therapy with hot packs and massage found a marked difference in breast engorgement (MD -2.42, 95% CI -2.98 to -1.86; one study; 54 women), breast pain (MD -2.01, 95% CI -2.60 to -1.42; one study; 54 women) and breast discomfort (MD -2.33, 95% CI -2.81 to -1.85; one study; 54 women) in favour of Gua-Sha therapy five minutes post-intervention, though both interventions significantly decreased breast temperature, engorgement, pain and discomfort at five and 30 minutes post-treatment.Results from individual trials that could not be included in data analysis suggested that there were no differences between room temperature and chilled cabbage leaves and between chilled cabbage leaves and gel packs, with all interventions producing some relief. Intermittent hot/cold packs applied for 20 minutes twice a day were found to be more effective than acupressure (P < 0.001). Acupuncture did not improve maternal satisfaction with breastfeeding. In another study, women who received breast-shaped cold packs were more likely to experience a reduction in pain intensity than women who received usual care; however, the differences between groups at baseline, and the failure to observe randomisation, make this study at high risk of bias. One study found a decrease in breast temperature (P = 0.03) following electromechanical massage and pumping in comparison to manual methods; however, the high level of attrition and alternating method of sequence generation place this study at high risk of bias. MedicalWomen treated with protease complex were less likely to have no improvement in pain (RR 0.17, 95% CI 0.04 to 0.74; one study; 59 women) and swelling (RR 0.34, 95% CI 0.15 to 0.79; one study; 59 women) on the fourth day of treatment and less likely to experience no overall change in their symptoms or worsening of symptoms (RR 0.26, 95% CI 0.12 to 0.56). It should be noted that it is more than 40 years since the study was carried out, and we are not aware that this preparation is used in current practice. Subcutaneous oxytocin provided no relief at all in symptoms at three days (RR 3.13, 95% CI 0.68 to 14.44; one study; 45 women).Serrapeptase was found to produce some relief in breast pain, induration and swelling, when compared to placebo, with a fewer number of women experiencing slight to no improvement in overallbreast engorgement, swelling and breast pain.Overall, the risk of bias of studies in the review is high. The overall quality as assessed using the GRADE approach was found to be low due to limitations in study design and the small number of women in the included studies, with only single studies providing data for analysis. AUTHORS' CONCLUSIONS: Although some interventions such as hot/cold packs, Gua-Sha (scraping therapy), acupuncture, cabbage leaves and proteolytic enzymes may be promising for the treatment of breast engorgement during lactation, there is insufficient evidence from published trials on any intervention to justify widespread implementation. More robust research is urgently needed on the treatment of breast engorgement.

Fetal movement counting for assessment of fetal wellbeing.

BACKGROUND: Fetal movement counting is a method by which a woman quantifies the movements she feels to assess the condition of her baby. The purpose is to try to reduce perinatal mortality by alerting caregivers when the baby might be compromised. This method may be used routinely, or only in women who are considered at increased risk of complications affecting the baby. Fetal movement counting may allow the clinician to make appropriate interventions in good time to improve outcomes. On the other hand, fetal movement counting may cause unnecessary anxiety to pregnant women, or elicit unnecessary interventions. OBJECTIVES: To assess outcomes of pregnancy where fetal movement counting was done routinely, selectively or was not done at all; and to compare different methods of fetal movement counting. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 May 2015) and reference lists of retrieved studies. SELECTION CRITERIA: Randomised controlled trials (RCTs) and cluster-RCTs where fetal movement counting was assessed as a method of monitoring fetal wellbeing. DATA COLLECTION AND ANALYSIS: Two review authors assessed studies for eligibility, assessed the methodological quality of included studies and independently extracted data from studies. Where possible the effects of interventions were compared using risk ratios (RR), and presented with 95% confidence intervals (CI). For some outcomes, the quality of the evidence was assessed using the GRADE approach. MAIN RESULTS: Five studies (71,458 women) were included in this review; 68,654 in one cluster-RCT. None of these five trials were assessed as having low risk of bias on all seven risk of bias criteria. All included studies except for one (which included high-risk women as participants) included women with uncomplicated pregnancies.Two studies compared fetal movement counting with standard care, as defined by trial authors. Two included studies compared two types of fetal movement counting; once a day fetal movement counting (Cardiff count-to-10) with more than once a day fetal movement counting methods. One study compared fetal movement counting with hormone assessment.(1) Routine fetal movement counting versus mixed or undefined fetal movement countingNo study reported on the primary outcome 'perinatal death or severe morbidity'. In one large cluster-RCT, there was no difference in mean stillbirth rates per cluster (standard mean difference (SMD) 0.23, 95% CI -0.61 to 1.07; participants = 52 clusters; studies = one, low quality evidence). The other study reported no fetal deaths. There was no difference in caesarean section rate between groups (RR 0.93, 95% CI 0.60 to 1.44; participants = 1076; studies = one,low quality evidence). Maternal anxiety was significantly reduced with routine fetal movement counting (SMD -0.22, 95% CI -0.35 to -0.10; participants = 1013; studies = one, moderate quality evidence). Maternal-fetal attachment was not significantly different (SMD -0.02, 95% CI -0.15 to 0.11; participants = 951; studies = one, low quality evidence). In one study antenatal admission after reporting of decreased fetal movements was increased (RR 2.72, 95% CI 1.34 to 5.52; participants = 123; studies = one). In another there was a trend to more antenatal admissions per cluster in the counting group than in the control group (SMD 0.38, 95% CI -0.17 to 0.93; participants = 52 clusters; studies = one, low quality evidence). Birthweight less than 10th centile was not significantly different between groups (RR 0.98, 95% CI 0.66 to 1.44; participants = 1073; studies = one, low quality evidence). The evidence was of low quality due to imprecise results and because of concerns regarding unclear risk of bias. (2) Formal fetal movement counting (Modified Cardiff method) versus hormone analysisThere was no difference between the groups in the incidence of caesarean section (RR 1.18, 95% CI 0.83 to 1.69; participants = 1191; studies = one). Women in the formal fetal movement counting group had significantly fewer hospital visits than those randomised to hormone analysis (RR 0.26, 95% CI 0.20 to 0.35), whereas there were fewer Apgar scores less than seven at five minutes for women randomised to hormone analysis (RR 1.72, 95% CI 1.01 to 2.93). No other outcomes reported showed statistically significant differences. 'Perinatal death or severe morbidity' was not reported. (3) Formal fetal movement counting once a day (count-to-10) versus formal fetal movement counting method where counting was done more than once a day (after meals)The incidence of caesarean section did not differ between the groups under this comparison (RR 2.33, 95% CI 0.61 to 8.99; participants = 1400; studies = one). Perinatal death or severe morbidity was not reported. Women were more compliant in using the count-to-10 method than they were with other fetal movement counting methods, citing less interruption with daily activities as one of the reasons (non-compliance RR 0.25, 95% CI 0.19 to 0.32).Except for one cluster-RCT, included studies were small and used different comparisons, making it difficult to measure the outcomes using meta-analyses. The nature of the intervention measured also did not allow blinding of participants and clinicians.. AUTHORS' CONCLUSIONS: This review does not provide sufficient evidence to influence practice. In particular, no trials compared fetal movement counting with no fetal movement counting. Only two studies compared routine fetal movements with standard antenatal care, as defined by trial authors. Indirect evidence from a large cluster-RCT suggested that more babies at risk of death were identified in the routine fetal monitoring group, but this did not translate to reduced perinatal mortality. Robust research by means of studies comparing particularly routine fetal movement counting with selective fetal movement counting is needed urgently, as it is a common practice to introduce fetal movement counting only when there is already suspected fetal compromise.

A double-blind, randomized, placebo-controlled trial of misoprostol and routine uterotonics for the prevention of postpartum hemorrhage.

OBJECTIVE: To assess the effects of 400-µg sublingual misoprostol plus routine uterotonics on postpartum hemorrhage. METHODS: A double-blind, placebo-controlled, randomized study was performed. After delivery of the child, eligible women received routine uterotonics and were randomly allocated to receive 400-µg misoprostol or placebo sublingually. The primary outcome measure was blood loss of at least 500 mL within 1 hour of taking the trial tablets. RESULTS: In total, 672 women received misoprostol and 673 received placebo. The baseline data were similar for both groups. Misoprostol plus routine uterotonics reduced postpartum blood loss, but the effect was not significant for blood loss of at least 500 mL (relative risk [RR] 0.96; 95% confidence interval [CI], 0.63-1.45) or blood loss of at least 1000 mL (RR 0.50; 95% CI, 0.15-1.66). Misoprostol also reduced the need for non-routine oxytocin, manual removal of the placenta, and hysterectomy, but these differences were not significant either. Misoprostol was associated with pyrexia and moderate/severe shivering. There was no death in either group. CONCLUSION: Misoprostol plus routine uterotonics resulted in modest reductions of blood loss in the third stage of labor, but the effects did not reach statistical significance. Larger studies are recommended.

Administration of 400 µg of misoprostol to augment routine active management of the third stage of labor.

OBJECTIVE: To assess the effectiveness and safety of the administration of misoprostol, an orally active prostaglandin, in addition to routine uterotonic therapy as part of the active management of the third stage of labor. METHODS: The present study was a hospital-based, decentralized, multi-center, randomized, placebo-controlled, double-blind trial. We enrolled 1103 women (out of a target sample size of 1180) at 4 hospitals in South Africa, Uganda, and Nigeria. Participants received a sublingual dose of 400 µg of misoprostol or a placebo, in addition to standard active management of the third stage of labor, after vaginal birth. RESULTS: The baseline characteristics of the participants were comparable. The difference in the primary outcome of blood loss of 500 mL or more within 1 hour of randomization was not significant between the 2 groups (misoprostol 22/546 [4.0%] versus placebo 35/553 [6.3%]; relative risk, 0.64; 95% confidence interval, 0.38-1.07). Shivering and pyrexia occurred more frequently in the misoprostol group. No maternal deaths occurred. CONCLUSION: The present study did not confirm a beneficial effect of administering 400 µg of misoprostol, in addition to routine uterotonic therapy, during the third stage of labor, but was consistent with other trials showing a cumulative modest benefit. Where routine uterotonics are available for prophylactic use, any potential benefit of misoprostol might not outweigh the likelihood of adverse effects.

Treatments for breast engorgement during lactation.

BACKGROUND: Breast engorgement is a painful and unpleasant condition affecting large numbers of women in the early postpartum period. During a time when mothers are coping with the demands of a new baby it may be particularly distressing. Breast engorgement may inhibit the development of successful breastfeeding, lead to early breastfeeding cessation, and is associated with more serious illness, including breast infection. OBJECTIVES: To identify the best forms of treatment for women who experience breast engorgement. SEARCH STRATEGY: We identified studies for inclusion through the Cochrane Pregnancy and Childbirth Group's Trials Register (February 2010). SELECTION CRITERIA: Randomised and quasi-randomised controlled trials where treatments for breast engorgement were evaluated. DATA COLLECTION AND ANALYSIS: Two review authors assessed eligibility for inclusion and carried out data extraction. MAIN RESULTS: We included eight studies with 744 women. Trials examined a range of different treatments for breast engorgement: acupuncture (two studies), cabbage leaves (two studies), cold gel packs (one study), pharmacological treatments (two studies) and ultrasound (one study). For several interventions (ultrasound, cabbage leaves, and oxytocin) there was no statistically significant evidence that interventions were associated with a more rapid resolution of symptoms; in these studies women tended to have improvements in pain and other symptoms over time whether or not they received active treatment. There was evidence from one study that, compared with women receiving routine care, women receiving acupuncture had greater improvements in symptoms in the days following treatment, although there was no evidence of a difference between groups by six days, and the study did not have sufficient power to detect meaningful differences for other outcomes (such as breast abscess). A study examining protease complex reported findings favouring intervention groups although it is more than 40 years since the study was carried out, and we are not aware that this preparation is used in current practice. A study looking at cold packs suggested that the application of cold does not cause harm, and may be associated with improvements in symptoms, although differences between control and intervention groups at baseline mean that results are difficult to interpret. AUTHORS' CONCLUSIONS: Allthough some interventions may be promising, there is not sufficient evidence from trials on any intervention to justify widespread implementation. More research is needed on treatments for this painful and distressing condition.

Misoprostol for treating postpartum haemorrhage: a randomized controlled trial [ISRCTN72263357].

BACKGROUND: Postpartum haemorrhage remains an important cause of maternal death despite treatment with conventional therapy. Uncontrolled studies and one randomised comparison with conventional oxytocics have reported dramatic effects with high-dose misoprostol, usually given rectally, for treatment of postpartum haemorrhage, but this has not been evaluated in a placebo-controlled trial. METHODS: The study was conducted at East London Hospital Complex, Tembisa and Chris Hani Baragwanath Hospitals, South Africa. Routine active management of the third stage of labour was practised. Women with more than usual postpartum bleeding thought to be related to inadequate uterine contraction were invited to participate, and to sign informed consent. All routine treatment was given from a special 'Postpartum Haemorrhage Trolley'. In addition, participants who consented were enrolled by drawing the next in a series of randomised treatment packs containing either misoprostol 5 x 200 microg or similar placebo, which were given 1 orally, 2 sublingually and 2 rectally. RESULTS: With misoprostol there was a trend to reduced blood loss >/=500 ml in 1 hour after enrolment measured in a flat plastic 'fracture bedpan', the primary outcome (6/117 vs 11/120, relative risk 0.56; 95% confidence interval 0.21 to 1.46). There was no difference in mean blood loss or haemoglobin level on day 1 after birth < 6 g/dl or blood transfusion. Side-effects were increased, namely shivering (63/116 vs 30/118; 2.14, 1.50 to 3.04) and pyrexia > 38.5 degrees C (11/114 vs 2/118; 5.69, 1.29 to 25). In the misoprostol group 3 women underwent hysterectomy of whom 1 died, and there were 2 further maternal deaths. CONCLUSIONS: Because of a lower than expected incidence of the primary outcome in the placebo group, the study was underpowered. We could not confirm the dramatic effect of misoprostol reported in several unblinded studies, but the results do not exclude a clinically important effect. Larger studies are needed to assess substantive outcomes and risks before misoprostol enters routine use.