Advising women with diabetes in pregnancy to express breastmilk in late pregnancy (Diabetes and Antenatal Milk Expressing [DAME]): a multicentre, unblinded, randomised controlled trial
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 e...
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| Published in | The Lancet (British edition) Vol. 389; no. 10085; pp. 2204 - 2213 |
|---|---|
| Main Authors | , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
England
Elsevier Ltd
03.06.2017
Elsevier Limited |
| Subjects | |
| Online Access | Get full text |
| ISSN | 0140-6736 1474-547X 1474-547X |
| DOI | 10.1016/S0140-6736(17)31373-9 |
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| Abstract | 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.
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.
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).
There is no harm in advising women with diabetes in pregnancy at low risk of complications to express breastmilk from 36 weeks' gestation.
Australian National Health and Medical Research Council. |
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| AbstractList | 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.
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.
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).
There is no harm in advising women with diabetes in pregnancy at low risk of complications to express breastmilk from 36 weeks' gestation.
Australian National Health and Medical Research Council. 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.BACKGROUNDInfants 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.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.METHODSWe 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.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).FINDINGSBetween 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).There is no harm in advising women with diabetes in pregnancy at low risk of complications to express breastmilk from 36 weeks' gestation.INTERPRETATIONThere is no harm in advising women with diabetes in pregnancy at low risk of complications to express breastmilk from 36 weeks' gestation.Australian National Health and Medical Research Council.FUNDINGAustralian National Health and Medical Research Council. Summary 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. 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 expressingvs44 [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. |
| Author | McNamara, Catharine Amir, Lisa H Walker, Susan P Moorhead, Anita M Aylward, Amanda Gold, Lisa Opie, Gillian F Jacobs, Susan E East, Christine McEgan, Kerri M Ford, Rachael Forster, Della A Donath, Susan M Davis, Peter G |
| Author_xml | – sequence: 1 givenname: Della A surname: Forster fullname: Forster, Della A email: d.forster@latrobe.edu.au organization: Judith Lumley Centre, School of Nursing and Midwifery, La Trobe University, Melbourne, VIC, Australia – sequence: 2 givenname: Anita M surname: Moorhead fullname: Moorhead, Anita M organization: Judith Lumley Centre, School of Nursing and Midwifery, La Trobe University, Melbourne, VIC, Australia – sequence: 3 givenname: Susan E surname: Jacobs fullname: Jacobs, Susan E organization: Royal Women's Hospital, Parkville, VIC, Australia – sequence: 4 givenname: Peter G surname: Davis fullname: Davis, Peter G organization: Royal Women's Hospital, Parkville, VIC, Australia – sequence: 5 givenname: Susan P surname: Walker fullname: Walker, Susan P organization: Department of Obstetrics and Gynaecology, University of Melbourne, VIC, Australia – sequence: 6 givenname: Kerri M surname: McEgan fullname: McEgan, Kerri M organization: Mercy Hospital for Women, Heidelberg, VIC, Australia – sequence: 7 givenname: Gillian F surname: Opie fullname: Opie, Gillian F organization: Department of Obstetrics and Gynaecology, University of Melbourne, VIC, Australia – sequence: 8 givenname: Susan M surname: Donath fullname: Donath, Susan M organization: Clinical Epidemiology and Biostatistics Unit, Murdoch Childrens Research Institute, Parkville, VIC, Australia – sequence: 9 givenname: Lisa surname: Gold fullname: Gold, Lisa organization: School of Health and Social Development, Deakin University, Geelong, VIC, Australia – sequence: 10 givenname: Catharine surname: McNamara fullname: McNamara, Catharine organization: Mercy Hospital for Women, Heidelberg, VIC, Australia – sequence: 11 givenname: Amanda surname: Aylward fullname: Aylward, Amanda organization: Royal Women's Hospital, Parkville, VIC, Australia – sequence: 12 givenname: Christine surname: East fullname: East, Christine organization: School of Nursing and Midwifery, Monash University and Monash Health, Clayton, VIC, Australia – sequence: 13 givenname: Rachael surname: Ford fullname: Ford, Rachael organization: Royal Women's Hospital, Parkville, VIC, Australia – sequence: 14 givenname: Lisa H surname: Amir fullname: Amir, Lisa H organization: Judith Lumley Centre, School of Nursing and Midwifery, La Trobe University, Melbourne, VIC, Australia |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/28589894$$D View this record in MEDLINE/PubMed |
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| Copyright | 2017 Elsevier Ltd Elsevier Ltd Copyright © 2017 Elsevier Ltd. All rights reserved. Copyright Elsevier Limited Jun 3, 2017 2017. Elsevier Ltd |
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| DOI | 10.1016/S0140-6736(17)31373-9 |
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| References | Mitanchez, Burguet, Simeoni (bib7) 2014; 164 Fenger-Gron, Fenger-Gron, Blunck, Schonemann-Rigel, Wielandt (bib19) 2015; 10 Tozier (bib17) 2013; 42 Nommsen-Rivers (bib23) 2016; 7 Soltani, Scott (bib26) 2012; 7 Aune, Norat, Romundstad, Vatten (bib18) 2014; 24 Murtaugh, Ostrom, Ferris, Reece (bib28) 1989; 3 Mitanchez, Yzydorczyk, Siddeek, Boubred, Benahmed, Simeoni (bib9) 2015; 29 Chapman, Pincombe, Harris, Fereday (bib14) 2013; 26 Rollins, Bhandari, Hajeebhoy (bib2) 2016; 387 Begg, Vos, Barker, Stanley, Lopez (bib3) 2008; 188 East, Dolan, Forster (bib10) 2014; 7 Schulz, Altman, Moher (bib29) 2010; 7 Forster, Jacobs, Amir (bib12) 2014; 4 Martens, Shafer, Dean (bib15) 2016; 128 (bib6) 2009 Ho, Yeung, Young (bib27) 2004; 89 Renfrew, Dyson, McCormick (bib22) 2010; 36 De Bortoli, Amir (bib24) 2016; 33 Ratner, Christophi, Metzger (bib5) 2008; 93 Hawkins, Casey (bib21) 2007; 34 Nucci, Virtanen, Sorkio (bib20) 2016 (bib4) 2010; 33 Cox (bib13) 2010; 18 Poston, Caleyachetty, Cnattingius (bib8) 2016; 4 Victora, Bahl, Barros (bib1) 2016; 387 Forster, McEgan, Ford (bib25) 2011; 27 Wszolek (bib30) 2015; 23 Forster, Amir, Moorhead (bib11) 2011; 27 Oza-Frank, Moreland, McNamara, Geraghty, Keim (bib16) 2016; 32 Tozier (10.1016/S0140-6736(17)31373-9_bib17) 2013; 42 Forster (10.1016/S0140-6736(17)31373-9_bib11) 2011; 27 Renfrew (10.1016/S0140-6736(17)31373-9_bib22) 2010; 36 (10.1016/S0140-6736(17)31373-9_bib6) 2009 Fenger-Gron (10.1016/S0140-6736(17)31373-9_bib19) 2015; 10 Mitanchez (10.1016/S0140-6736(17)31373-9_bib9) 2015; 29 Wszolek (10.1016/S0140-6736(17)31373-9_bib30) 2015; 23 Victora (10.1016/S0140-6736(17)31373-9_bib1) 2016; 387 De Bortoli (10.1016/S0140-6736(17)31373-9_bib24) 2016; 33 Begg (10.1016/S0140-6736(17)31373-9_bib3) 2008; 188 Chapman (10.1016/S0140-6736(17)31373-9_bib14) 2013; 26 Schulz (10.1016/S0140-6736(17)31373-9_bib29) 2010; 7 Ho (10.1016/S0140-6736(17)31373-9_bib27) 2004; 89 Poston (10.1016/S0140-6736(17)31373-9_bib8) 2016; 4 Murtaugh (10.1016/S0140-6736(17)31373-9_bib28) 1989; 3 Mitanchez (10.1016/S0140-6736(17)31373-9_bib7) 2014; 164 Hawkins (10.1016/S0140-6736(17)31373-9_bib21) 2007; 34 Oza-Frank (10.1016/S0140-6736(17)31373-9_bib16) 2016; 32 East (10.1016/S0140-6736(17)31373-9_bib10) 2014; 7 Forster (10.1016/S0140-6736(17)31373-9_bib12) 2014; 4 Forster (10.1016/S0140-6736(17)31373-9_bib25) 2011; 27 (10.1016/S0140-6736(17)31373-9_bib4) 2010; 33 Rollins (10.1016/S0140-6736(17)31373-9_bib2) 2016; 387 Cox (10.1016/S0140-6736(17)31373-9_bib13) 2010; 18 Nommsen-Rivers (10.1016/S0140-6736(17)31373-9_bib23) 2016; 7 Ratner (10.1016/S0140-6736(17)31373-9_bib5) 2008; 93 Soltani (10.1016/S0140-6736(17)31373-9_bib26) 2012; 7 Aune (10.1016/S0140-6736(17)31373-9_bib18) 2014; 24 Nucci (10.1016/S0140-6736(17)31373-9_bib20) 2016 Martens (10.1016/S0140-6736(17)31373-9_bib15) 2016; 128 28589882 - Lancet. 2017 Jun 3;389(10085):2167-2168 |
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An overview of the literature publication-title: Adv Nutr doi: 10.3945/an.115.011007 – volume: 4 start-page: 1025 year: 2016 ident: 10.1016/S0140-6736(17)31373-9_bib8 article-title: Preconceptional and maternal obesity: epidemiology and health consequences publication-title: Lancet Diabetes Endocrinol doi: 10.1016/S2213-8587(16)30217-0 – volume: 27 start-page: e301 year: 2011 ident: 10.1016/S0140-6736(17)31373-9_bib11 article-title: Is not testing a major change in clinical practice an ethical dilemma? publication-title: Midwifery doi: 10.1016/j.midw.2010.03.003 – volume: 387 start-page: 491 year: 2016 ident: 10.1016/S0140-6736(17)31373-9_bib2 article-title: Why invest, and what it will take to improve breastfeeding practices? publication-title: Lancet doi: 10.1016/S0140-6736(15)01044-2 – volume: 33 start-page: S62 issue: suppl 1 year: 2010 ident: 10.1016/S0140-6736(17)31373-9_bib4 article-title: Diagnosis and classification of diabetes mellitus publication-title: Diabetes Care – reference: 28589882 - Lancet. 2017 Jun 3;389(10085):2167-2168 |
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| Snippet | Infants of women with diabetes in pregnancy are at increased risk of hypoglycaemia, admission to a neonatal intensive care unit (NICU), and not being... Summary Background Infants of women with diabetes in pregnancy are at increased risk of hypoglycaemia, admission to a neonatal intensive care unit (NICU), and... |
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| SubjectTerms | Babies Breastfeeding & lactation Childbirth & labor Clinical trials Data processing Diabetes Diabetes mellitus Education Effectiveness Encephalopathy Evidence-based medicine Funding Gestation Gestational diabetes Health Hospitals Hypoglycemia Infants Intensive care Internal Medicine Masking Maternal & child health Medical research Milk Mothers Motivation Neonates Newborn babies Parity Pregnancy Pregnancy complications Prenatal care Random numbers Randomization Risk Safety Seizing Seizures Womens health |
| 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 |
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