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Title: | Advising women with diabetes in pregnancy to express breastmilk in late pregnancy (Diabetes and Antenatal Milk Expressing [DAME]): a multicentre, unblinded, randomised controlled trial. | Authors: | Moorhead A.M.;Davis P.G.;Walker S.P.;McEgan K.M.;Opie G.F.;Donath S.M.;Gold L.;McNamara C.;Aylward A.;East C. ;Ford R.;Amir L.H.;Forster D.A.;Jacobs S.E. | Institution: | (Forster, Moorhead, Amir) Judith Lumley Centre, School of Nursing and Midwifery, La Trobe University, Melbourne, VIC, Australia (Forster, Moorhead, Jacobs, Davis, Aylward, Ford, Amir) Royal Women's Hospital, Parkville, VIC, Australia (Jacobs, Davis, Walker, Opie) Department of Obstetrics and Gynaecology, University of Melbourne, VIC, Australia (Donath) Clinical Epidemiology and Biostatistics Unit, Murdoch Childrens Research Institute, Parkville, VIC, Australia (Jacobs) Clinical Sciences, Murdoch Childrens Research Institute, Parkville, VIC, Australia (Walker, McEgan, Opie, McNamara) Mercy Hospital for Women, Heidelberg, VIC, Australia (Gold) School of Health and Social Development, Deakin University, Geelong, VIC, Australia (East) School of Nursing and Midwifery, Monash University and Monash Health, Clayton, VIC, Australia | Issue Date: | 29-Jun-2017 | Copyright year: | 2017 | Publisher: | Lancet Publishing Group Lancet Publishing Group (E-mail: cususerv@lancet.com) |
Place of publication: | United Kingdom | Publication information: | The Lancet. 389 (10085) (pp 2204-2213), 2017. Date of Publication: 03 Jun 2017. | Journal: | The Lancet | Abstract: | 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.Copyright © 2017 Elsevier Ltd | DOI: | http://monash.idm.oclc.org/login?url=http://dx.doi.org/10.1016/S0140-6736%2817%2931373-9 | Link to associated publication: | Click here for full text options | PubMed URL: | 28589894 [http://www.ncbi.nlm.nih.gov/pubmed/?term=28589894] | ISSN: | 0140-6736 | URI: | https://repository.monashhealth.org/monashhealthjspui/handle/1/27378 | Type: | Article | Subjects: | newborn jaundice obstetric analgesia patient safety postnatal depression *pregnancy diabetes mellitus/dt [Drug Therapy] prematurity priority journal program efficacy randomized controlled trial respiratory distress risk factor seizure/co [Complication] *third trimester pregnancy uterus contraction vagina bleeding analgesic agent/dt [Drug Therapy] analgesic agent/ei [Epidural Drug Administration] diazoxide glucagon glucose/iv [Intravenous Drug Administration] hydrocortisone insulin/dt [Drug Therapy] metformin/dt [Drug Therapy] non insulin dependent diabetes mellitus/dt [Drug Therapy] adult article artificial milk assisted ventilation brain disease/co [Complication] *breast milk expression breech presentation cesarean section controlled study diabetes control disease severity female follow up hospitalization human hypoglycemia hypothermia infant insulin dependent diabetes mellitus/dt [Drug Therapy] insulin treatment labor pain/dt [Drug Therapy] low birth weight macrosomia major clinical study multicenter study neonatal weight loss newborn infection human hypoglycemia hypothermia infant insulin dependent diabetes mellitus / drug therapy insulin treatment labor pain / drug therapy low birth weight macrosomia major clinical study multicenter study neonatal weight loss newborn infection newborn jaundice non insulin dependent diabetes mellitus / drug therapy obstetric analgesia patient safety postnatal depression *pregnancy diabetes mellitus / *drug therapy prematurity priority journal program efficacy randomized controlled trial respiratory distress risk factor seizure / complication *third trimester pregnancy *breast milk expression vagina bleeding brain disease / complication assisted ventilation artificial milk Article adult uterus contraction breech presentation cesarean section controlled study diabetes control disease severity female follow up hospitalization |
Type of Clinical Study or Trial: | Randomised controlled trial |
Appears in Collections: | Articles |
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