Breastfeeding outcomes at 3 months for women with diabetes in pregnancy: Findings from the Diabetes and Antenatal Milk Expressing randomized controlled trial.

BACKGROUND: Women with diabetes in pregnancy have decreased exclusivity and duration of breastfeeding compared with women without diabetes, and their infants are at increased risk of hypoglycemia. Clinicians often suggest pregnant women with diabetes to express breastmilk, and studies have reported increased breastfeeding exclusivity in the early postnatal period for patients who have expressed. Little is known about longer term outcomes. We investigated whether advising low-risk women with diabetes in pregnancy to express beginning at 36 weeks of pregnancy increased exclusivity and maintenance of breastfeeding at 3 months. METHODS: We conducted a multicenter, two-group, randomized controlled trial at six hospitals in Melbourne, Australia, between 2011 and 2015. Women were randomized to either standard maternity care or advised to hand express for 10 min twice daily, in addition to standard care. Women were telephoned at 12-13 weeks postpartum and asked a series of questions about feeding their baby, perceptions of their milk supply, and other health outcomes. RESULTS: Of 631 women in the study, data for 570 (90%) were analyzed at 12-13 weeks. After adjustment, we found no evidence that women allocated to antenatal expressing were more likely to be giving only breastmilk (aRR 1.07 [95% CI 0.92-1.22]) or any breastmilk (aRR 0.99 [95% CI 0.92-1.06]) at 12-13 weeks postpartum compared with women in the standard care group. CONCLUSION: While the practice of antenatal expression for low-risk women with diabetes during pregnancy is promising for increasing exclusivity of breastmilk feeding in hospital, at 12-13 weeks, there was no association with breastfeeding outcomes.

Study Protocol for a Stepped-Wedge Cluster (Nested) Randomized Controlled Trial of Antenatal Colostrum Expression (ACE) Instruction in First-Time Mothers: The ACE Study.

BACKGROUND: Although many mothers initiate breastfeeding, supplementation with human-milk substitutes (formula) during the birth hospitalization is common and has been associated with early breastfeeding cessation. Colostrum hand expressed in the last few weeks before birth, known as antenatal colostrum expression (ACE), can be used instead of human-milk substitutes. However, evidence is lacking on the efficacy of ACE on breastfeeding outcomes and in non-diabetic mothers. METHODS AND PLANNED ANALYSIS: This multicenter stepped-wedge cluster (nested) randomized controlled trial aims to recruit 945 nulliparous pregnant individuals. The trial is conducted in two phases. During Phase 1, control group participants are under standard care. During Phase 2, participants are randomized to ACE instruction via a pre-recorded online video or a one-on-one session with a midwife. Adjusted logistic regression analysis will be used to examine the relationship between ACE instruction and breastfeeding outcomes. RESEARCH AIMS AND QUESTIONS: Primary aim: (1) Does advising pregnant individuals to practice ACE and providing instruction improve exclusive breastfeeding rates at 4 months postpartum? Secondary research questions: (2) Do individuals who practice ACE have higher rates of exclusive breastfeeding during the initial hospital stay after birth? (3) Is teaching ACE via an online video non-inferior to one-on-one instruction from a midwife? (4) Does expressing colostrum in pregnancy influence time to secretory activation, or (5) result in any differences in the composition of postnatal colostrum? DISCUSSION: Trial findings have important implications for maternity practice, with the online video providing an easily accessible opportunity for ACE education as part of standard antenatal care.

'Is there any point in me doing this?' Views and experiences of women in the Diabetes and Antenatal Milk Expressing (DAME) trial.

The Diabetes and Antenatal Milk Expressing (DAME) randomised controlled trial (RCT) was conducted in 2011-2015, at six sites in Melbourne, Australia to explore the effect of advising women with diabetes in pregnancy to express breast milk from 36 weeks gestation. Infants whose mothers were randomised to express in pregnancy were more likely to be exclusively breast milk fed during their hospital stay, and there was no evidence of harm. This paper explores women's views and experiences of antenatal expressing. In this two-arm RCT, 635 women with diabetes in pregnancy who were otherwise of low medical risk were randomised at 36-37 weeks gestation to usual care (not expressing, n = 316), or the intervention, where women were advised to hand express for 10 min twice daily until birth (n = 319). Semistructured face-to-face interviews were conducted with 10 women who expressed antenatally. They were asked about their experiences of antenatal expressing, including how they felt about the overall experience, the amount of breast milk they expressed, making time to express, and their experience of breastfeeding. Thematic analysis of the in-depth interviews identified six themes: (1) learning and adapting expressing, (2) feelings and sensations associated with expressing, (3) support, (4) dis/empowerment, (5) health, and (6) the value of breast milk. Women had both positive and negative experiences of antenatal expressing. If health professionals are advising antenatal expressing to women, it is important they understand the range of outcomes and experiences.

Proactive Peer (Mother-to-Mother) Breastfeeding Support by Telephone (Ringing up About Breastfeeding Early [RUBY]): A Multicentre, Unblinded, Randomised Controlled Trial.

BACKGROUND: Breastfeeding rates are suboptimal internationally, and many infants are not receiving any breast milk at all by six months of age. Few interventions increase breastfeeding duration, particularly where there is relatively high initiation. The effect of proactive peer (mother-to-mother) support has been found to increase breastfeeding in some contexts but not others, but if it is shown to be effective would be a potentially sustainable model in many settings. We aimed to determine whether proactive telephone-based peer support during the postnatal period increases the proportion of infants being breastfed at six months of age. METHODS: RUBY (Ringing Up about Breastfeeding earlY) was a multicentre, two-arm un-blinded randomised controlled trial conducted in three hospitals in Victoria, Australia. First-time mothers intending to breastfeed were recruited after birth and prior to hospital discharge, and randomly assigned (1:1) to usual care or usual care plus proactive telephone-based breastfeeding support from a trained peer volunteer for up to six months postpartum. A computerised random number program generated block sizes of four or six distributed randomly, with stratification by site. Research midwives were masked to block size, but masking of allocation was not possible. The primary outcome was the proportion of infants receiving any breast milk at six months of age. Analyses were by intention to treat; data were collected and analysed masked to group. The trial is registered with ACTRN, number 12612001024831. FINDINGS: Women were recruited between Feb 14, 2013 and Dec 15, 2015 and randomly assigned to peer support (n = 574) or usual care (n = 578). Five were not in the primary analysis [5 post-randomisation exclusions]. Infants of women allocated to telephone-based peer support were more likely than those allocated to usual care to be receiving breast milk at six months of age (intervention 75%, usual care 69%; Adj. RR 1·10; 95% CI 1·02, 1·18). There were no adverse events. INTERPRETATION: Providing first time mothers with telephone-based support from a peer with at least six months personal breastfeeding experience is an effective intervention for increasing breastfeeding maintenance in settings with high breastfeeding initiation. FUNDING: The Felton Bequest, Australia, philanthropic donation and La Trobe University grant.

Advising women with diabetes in pregnancy to express breastmilk in late pregnancy (Diabetes and Antenatal Milk Expressing [DAME]): a multicentre, unblinded, randomised controlled trial.

BACKGROUND: Infants of women with diabetes in pregnancy are at increased risk of hypoglycaemia, admission to a neonatal intensive care unit (NICU), and not being exclusively breastfed. Many clinicians encourage women with diabetes in pregnancy to express and store breastmilk in late pregnancy, yet no evidence exists for this practice. We aimed to determine the safety and efficacy of antenatal expressing in women with diabetes in pregnancy. METHODS: We did a multicentre, two-group, unblinded, randomised controlled trial in six hospitals in Victoria, Australia. We recruited women with pre-existing or gestational diabetes in a singleton pregnancy from 34 to 37 weeks' gestation and randomly assigned them (1:1) to either expressing breastmilk twice per day from 36 weeks' gestation (antenatal expressing) or standard care (usual midwifery and obstetric care, supplemented by support from a diabetes educator). Randomisation was done with a computerised random number generator in blocks of size two and four, and was stratified by site, parity, and diabetes type. Investigators were masked to block size but masking of caregivers was not possible. The primary outcome was the proportion of infants admitted to the NICU. We did the analyses by intention to treat; the data were obtained and analysed masked to group allocation. This trial is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12611000217909. FINDINGS: Between June 6, 2011, and Oct 29, 2015, we recruited and randomly assigned 635 women: 319 to antenatal expressing and 316 to standard care. Three were not included in the primary analysis (one withdrawal from the standard care group, and one post-randomisation exclusion and one withdrawal from the antenatal expressing group). The proportion of infants admitted to the NICU did not differ between groups (46 [15%] of 317 assigned to antenatal expressing vs 44 [14%] of 315 assigned to standard care; adjusted relative risk 1·06, 95% CI 0·66 to 1·46). In the antenatal expressing group, the most common serious adverse event for infants was admission to the NICU for respiratory support (for three [<1%] of 317. In the standard care group, the most common serious adverse event for infants was moderate to severe encephalopathy with or without seizures (for three [<1%] of 315). INTERPRETATION: There is no harm in advising women with diabetes in pregnancy at low risk of complications to express breastmilk from 36 weeks' gestation. FUNDING: Australian National Health and Medical Research Council.

Feeding infants directly at the breast during the postpartum hospital stay is associated with increased breastfeeding at 6 months postpartum: a prospective cohort study.

OBJECTIVE: To explore whether feeding only directly from the breast in the first 24-48 h of life increases the proportion of infants receiving any breast milk at 6 months. DESIGN: A prospective cohort study. SETTING: Three maternity hospitals in Melbourne, Australia. PARTICIPANTS: 1003 postpartum English-speaking women with a healthy singleton term infant, who intended to breast feed, were recruited between 2009 and 2011. Women were excluded if they or their infant were seriously ill. 92% (n=924) were followed up at 6 months postpartum. PRIMARY AND SECONDARY OUTCOME MEASURES: Main exposure variable - type of infant feeding in hospital up to time of study recruitment (24-48 h postpartum), categorised as 'fed directly at the breast only' or 'received at least some expressed breast milk (EBM) or infant formula'. Primary outcome - proportion of infants receiving any breast milk feeding at 6 months postpartum. Secondary outcomes - proportion of infants receiving only breast milk feeding at 6 months; breast milk feeding duration; and maternal characteristics associated with giving any breast milk at 6 months. RESULTS: Infants who had fed only at the breast prior to recruitment were more likely to be continuing to have any breast milk at 6 months than those who had received any EBM and/or infant formula (76% vs 59%; adjusted OR 1.76, 95% CI 1.24 to 2.48 (adjusted for parity, type of birth, breastfeeding intention, breastfeeding problems at recruitment, public/private status, epidural for labour or birth, maternal body mass index and education)). CONCLUSIONS: Healthy term infants that fed only directly at the breast 24-48 h after birth were more likely to be continuing to breast feed at 6 months than those who received any EBM and/or formula in the early postpartum period. Support and encouragement to initiate breastfeeding directly at the breast is important.

Safety and efficacy of antenatal milk expressing for women with diabetes in pregnancy: protocol for a randomised controlled trial.

INTRODUCTION: Many maternity providers recommend that women with diabetes in pregnancy express and store breast milk in late pregnancy so breast milk is available after birth, given (1) infants of these women are at increased risk of hypoglycaemia in the first 24 h of life; and (2) the delay in lactogenesis II compared with women without diabetes that increases their infant's risk of receiving infant formula. The Diabetes and Antenatal Milk Expressing (DAME) trial will establish whether advising women with diabetes in pregnancy (pre-existing or gestational) to express breast milk from 36 weeks gestation increases the proportion of infants who require admission to special or neonatal intensive care units (SCN/NICU) compared with infants of women receiving standard care. Secondary outcomes include birth gestation, breastfeeding outcomes and economic impact. METHODS AND ANALYSIS: Women will be recruited from 34 weeks gestation to a multicentre, two arm, unblinded randomised controlled trial. The intervention starts at 36 weeks. Randomisation will be stratified by site, parity and diabetes type. Women allocated to the intervention will be taught expressing and encouraged to hand express twice daily for 10 min and keep an expressing diary. The sample size of 658 (329 per group) will detect a 10% difference in proportion of babies admitted to SCN/NICU (85% power, α 0.05). Data are collected at recruitment (structured questionnaire), after birth (abstracted from medical record blinded to group), and 2 and 12 weeks postpartum (telephone interview). DATA ANALYSIS: the intervention group will be compared with the standard care group by intention to treat analysis, and the primary outcome compared using χ(2) and ORs. ETHICS AND DISSEMINATION: Research ethics approval will be obtained from participating sites. Results will be published in peer-reviewed journals and presented to clinicians, policymakers and study participants. TRIAL REGISTRATION NUMBER: Australian Controlled Trials Register ACTRN12611000217909.

Ringing Up about Breastfeeding: a randomised controlled trial exploring early telephone peer support for breastfeeding (RUBY) - trial protocol.

BACKGROUND: The risks of not breastfeeding for mother and infant are well established, yet in Australia, although most women initiate breastfeeding many discontinue breastfeeding altogether and few women exclusively breastfeed to six months as recommended by the World Health Organization and Australian health authorities. We aim to determine whether proactive telephone peer support during the postnatal period increases the proportion of infants who are breastfed at six months, replicating a trial previously found to be effective in Canada. DESIGN/METHODS: A two arm randomised controlled trial will be conducted, recruiting primiparous women who have recently given birth to a live baby, are proficient in English and are breastfeeding or intending to breastfeed. Women will be recruited in the postnatal wards of three hospitals in Melbourne, Australia and will be randomised to peer support or to 'usual' care. All women recruited to the trial will receive usual hospital postnatal care and infant feeding support. For the intervention group, peers will make two telephone calls within the first ten days postpartum, then weekly telephone calls until week twelve, with continued contact until six months postpartum. Primary aim: to determine whether postnatal telephone peer support increases the proportion of infants who are breastfed for at least six months. HYPOTHESIS: that telephone peer support in the postnatal period will increase the proportion of infants receiving any breast milk at six months by 10% compared with usual care (from 46% to 56%).Outcome data will be analysed by intention to treat. A supplementary multivariate analysis will be undertaken if there are any baseline differences in the characteristics of women in the two groups which might be associated with the primary outcomes. DISCUSSION: The costs and health burdens of not breastfeeding fall disproportionately and increasingly on disadvantaged groups. We have therefore deliberately chosen trial sites which have a high proportion of women from disadvantaged backgrounds. This will be the first Australian randomised controlled trial to test the effectiveness and cost effectiveness of proactive peer telephone support for breastfeeding. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry ACTRN12612001024831.

Accreditation of midwife lactation consultants to perform infant tongue-tie release.

Infants with a tongue-tie or ankyloglossia have a short lingual frenulum, which can lead to problems with breastfeeding: attachment difficulties, nipple pain and damage, poor weight gain and eventually a reduction in milk supply. Trained clinicians can release the frenulum (frenotomy) in infants having difficulty with breastfeeding. Although traditionally performed by medical practitioners, we argue that this simple procedure is within the scope of practice of other clinicians. This paper outlines the process of setting up and maintaining credentialing for midwife lactation consultants (International Board Certified Lactation Consultants (IBCLCs)) to assess infant tongue-ties and perform frenotomy when appropriate at a tertiary maternity hospital. Since 2005, 11 midwives/IBCLCs have been credentialed to perform frenotomies at The Breastfeeding Education and Support Services at The Royal Women's Hospital in Melbourne, Australia. We believe that nurses/midwives/lactation consultants working in other settings could be trained to perform frenotomies, thus enabling faster resolution of breastfeeding problems.

A prospective study of fluconazole treatment for breast and nipple thrush.

BACKGROUND: Breastfeeding women with continuous burning nipple pain, often associated with post-feed radiating breast pain, may be diagnosed with nipple and breast Candida (thrush) infection. This project examined the efficacy of the three fuconazole capsule regime (one 150 mg capsule alternate days) and explored factors associated with longer courses of fluconazole. METHODS: Women diagnosed with nipple and breast Candida and treated with oral fuconazole at a tertiary hospital (n = 96) were followed up until pain resolution. RESULTS: Women took between 1 and 29 fluconazole capsules, mean = 7.3, median = 6. The number of capsules was not related to socio-demographic or health characteristics of mothers or babies; women with more severe breast pain were more likely to take > 3 capsules than women with less severe breast pain. Only minor side-effects were reported. DISCUSSION: Most women require more than three capsules of fluconazole, but two-thirds of women will require six or less.