Antenatal Breastmilk Expression From Week 34 of Gestation
NCT ID: NCT05516199
Last Updated: 2024-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2022-08-31
2023-11-30
Brief Summary
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Detailed Description
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To detect signs of uterine contractions or fetal reaction in relation to stimulation of the breast, a cardiotocography (CTG) will be performed before, during and after the first expression in the intervention group. If the CTG is normal the women can perform breastmilk expression by hand 5 minutes at each breast two times per day until birth, and collect and store any expressed milk.
During the intervention and 8 weeks after birth the participating women will receive weekly push-messages through an application on their smartphone. The messages include short questions about the handexpression of milk in pregnancy as well as regarding feeding of the infant after birth. At the end of the study the mothers will be invited for an interview to investigate their experience with the procedure, but this is an independent study and therefore not a part of this protocol.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Antenatal breastmilk expression
Breastfeeding consultation with trained midwife in week 33 + antenatal breastmilk expression from week 34
Antenatal breastmilk expression
Stimulation of the breast by hand/handexpression of breastmilk during pregnancy from week 34
Breastfeeding consultation
60 min standardized breastfeeding consultation with a trained midwife, with focus on practical breastfeeding skills
Control
Breastfeeding consultation with trained midwife in week 33
Breastfeeding consultation
60 min standardized breastfeeding consultation with a trained midwife, with focus on practical breastfeeding skills
Interventions
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Antenatal breastmilk expression
Stimulation of the breast by hand/handexpression of breastmilk during pregnancy from week 34
Breastfeeding consultation
60 min standardized breastfeeding consultation with a trained midwife, with focus on practical breastfeeding skills
Eligibility Criteria
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Inclusion Criteria
2. BMI \<27
3. Danish speaking
4. Singleton pregnancies
5. Planning to exclusively breastfeed their infants and deliver at Odense University Hospital (Odense and Svendborg)
Exclusion Criteria
2. Women at risk of preterm birth with one of the following diagnoses: Placenta previa, premature preterm rupture of membranes (PPROM) or previous cervical conization
3. Women taking medications where breastfeeding is contraindicated
4. Women with prior breast surgery: Breast reductive surgery or breast implants
18 Years
45 Years
FEMALE
Yes
Sponsors
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University of Southern Denmark
OTHER
Odense University Hospital
OTHER
Responsible Party
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Marie Bendix Simonsen, M.D.
Principal Investigator
Principal Investigators
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Marie B Simonsen, M.D
Role: PRINCIPAL_INVESTIGATOR
OUH & SDU
Locations
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Odense University Hospital
Odense, , Denmark
Countries
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References
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Ford SL, Lohmann P, Preidis GA, Gordon PS, O'Donnell A, Hagan J, Venkatachalam A, Balderas M, Luna RA, Hair AB. Improved feeding tolerance and growth are linked to increased gut microbial community diversity in very-low-birth-weight infants fed mother's own milk compared with donor breast milk. Am J Clin Nutr. 2019 Apr 1;109(4):1088-1097. doi: 10.1093/ajcn/nqz006.
Wagner KJP, Rossi CE, Hinnig PF, Alves MA, Retondario A, Vasconcelos FAG. ASSOCIATION BETWEEN BREASTFEEDING AND OVERWEIGHT/OBESITY IN SCHOOLCHILDREN AGED 7-14 YEARS. Rev Paul Pediatr. 2021 Feb 24;39:e2020076. doi: 10.1590/1984-0462/2021/39/2020076. eCollection 2021.
Laine MK, Kautiainen H, Gissler M, Pennanen P, Eriksson JG. Impact of gestational diabetes mellitus on the duration of breastfeeding in primiparous women: an observational cohort study. Int Breastfeed J. 2021 Feb 16;16(1):19. doi: 10.1186/s13006-021-00369-1.
Victora CG, Bahl R, Barros AJ, Franca GV, Horton S, Krasevec J, Murch S, Sankar MJ, Walker N, Rollins NC; Lancet Breastfeeding Series Group. Breastfeeding in the 21st century: epidemiology, mechanisms, and lifelong effect. Lancet. 2016 Jan 30;387(10017):475-90. doi: 10.1016/S0140-6736(15)01024-7.
Ballard O, Morrow AL. Human milk composition: nutrients and bioactive factors. Pediatr Clin North Am. 2013 Feb;60(1):49-74. doi: 10.1016/j.pcl.2012.10.002.
Yu X, Li J, Lin X, Luan D. Association between Delayed Lactogenesis Ⅱ and Early Milk Volume among Mothers of Preterm Infants. Asian Nurs Res (Korean Soc Nurs Sci). 2019 May;13(2):93-98. doi: 10.1016/j.anr.2019.02.001. Epub 2019 Feb 16.
Underwood MA. Human milk for the premature infant. Pediatr Clin North Am. 2013 Feb;60(1):189-207. doi: 10.1016/j.pcl.2012.09.008. Epub 2012 Oct 18.
Parker LA, Sullivan S, Krueger C, Mueller M. Association of timing of initiation of breastmilk expression on milk volume and timing of lactogenesis stage II among mothers of very low-birth-weight infants. Breastfeed Med. 2015 Mar;10(2):84-91. doi: 10.1089/bfm.2014.0089. Epub 2015 Feb 6.
Forster DA, Moorhead AM, Jacobs SE, Davis PG, Walker SP, McEgan KM, Opie GF, Donath SM, Gold L, McNamara C, Aylward A, East C, Ford R, Amir LH. Advising women with diabetes in pregnancy to express breastmilk in late pregnancy (Diabetes and Antenatal Milk Expressing [DAME]): a multicentre, unblinded, randomised controlled trial. Lancet. 2017 Jun 3;389(10085):2204-2213. doi: 10.1016/S0140-6736(17)31373-9.
Lopez-Fernandez G, Barrios M, Goberna-Tricas J, Gomez-Benito J. Breastfeeding during pregnancy: A systematic review. Women Birth. 2017 Dec;30(6):e292-e300. doi: 10.1016/j.wombi.2017.05.008. Epub 2017 Jun 19.
Lamba S, Chopra S, Negi M. Effect of Antenatal Breast Milk Expression at Term Pregnancy to Improve Post Natal Lactational Performance. J Obstet Gynaecol India. 2016 Feb;66(1):30-4. doi: 10.1007/s13224-014-0648-7. Epub 2015 Jan 20.
Foudil-Bey I, Murphy MSQ, Dunn S, Keely EJ, El-Chaar D. Evaluating antenatal breastmilk expression outcomes: a scoping review. Int Breastfeed J. 2021 Mar 12;16(1):25. doi: 10.1186/s13006-021-00371-7.
Casey JRR, Banks J, Braniff K, Buettner P, Heal C. The effects of expressing antenatal colostrum in women with diabetes in pregnancy: A retrospective cohort study. Aust N Z J Obstet Gynaecol. 2019 Dec;59(6):811-818. doi: 10.1111/ajo.12966. Epub 2019 Mar 19.
Demirci JR, Glasser M, Fichner J, Caplan E, Himes KP. "It gave me so much confidence": First-time U.S. mothers' experiences with antenatal milk expression. Matern Child Nutr. 2019 Oct;15(4):e12824. doi: 10.1111/mcn.12824. Epub 2019 May 23.
Demirci J, Schmella M, Glasser M, Bodnar L, Himes KP. Delayed Lactogenesis II and potential utility of antenatal milk expression in women developing late-onset preeclampsia: a case series. BMC Pregnancy Childbirth. 2018 Mar 15;18(1):68. doi: 10.1186/s12884-018-1693-5.
Soltani H, Scott AM. Antenatal breast expression in women with diabetes: outcomes from a retrospective cohort study. Int Breastfeed J. 2012 Dec 1;7(1):18. doi: 10.1186/1746-4358-7-18.
Bruun S, Wedderkopp N, Molgaard C, Kyhl HB, Zachariassen G, Husby S. Using text messaging to obtain weekly data on infant feeding in a Danish birth cohort resulted in high participation rates. Acta Paediatr. 2016 Jun;105(6):648-54. doi: 10.1111/apa.13382. Epub 2016 Apr 13.
Simonsen MB, Bentzen SB, Moller S, Holm KG, Vinter CA, Zachariassen G. Safety of antenatal breastmilk expression from week 34 of pregnancy: a randomized controlled pilot study (The Express-MOM study). Matern Health Neonatol Perinatol. 2025 Jan 3;11(1):2. doi: 10.1186/s40748-024-00197-1.
Bentzen SB, Simonsen MB, Zachariassen G, Vinter CA, Garne Holm K. Women's bodily experience of antenatal breastmilk expression from 34 weeks of gestation: Qualitative results from the Express-MOM study. Eur J Midwifery. 2024 Nov 1;8. doi: 10.18332/ejm/193601. eCollection 2024.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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OUH-HCA005
Identifier Type: -
Identifier Source: org_study_id
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