Antenatal Breastmilk Expression From Week 34 of Gestation

NCT05516199 | Completed DMC

• 1 other identifier: OUH-HCA005
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

In this pilot study, the investigators aim to examine if antenatal breastmilk expression from week 34 of pregnancy is a safe and feasible procedure for the mother and fetus. Furthermore, the investigators want to evaluate breastfeeding rates.

Conditions

Breastmilk Expression; Collection, Breastmilk; Breastfeeding; Healthy

Keywords

Infant nutrition; Lactation; Breastmilk; Breastfeeding

Outcome Measures

Primary Outcomes (1)

• Gestational age at birth in the two groups

  Gestational age of infant at birth. Information will be found through medical records. In the weekly push-messages the women have to answer if they have been giving birth. If they click yes, investigators get a notification and find gestational age and baseline infant characteristics through medical records.

  Through study completion, an avarage of 1 year.

Secondary Outcomes (5)

• Number of weekly breastmilk expressions before birth

  Through study completion, an avarage of 1 year.

• Amount of breastmilk expressed

  Through out the study, an average of 1 year. Assesment when all women included have been giving birth.

• Breastfeeding rates 1, 2, 4 and 8 weeks after birth

  Through study completion, an avarage of 1 year.

• Number of exclusively breastfeeding versus partially breastfeeding women in each group at 1, 2, 4 and 8 weeks after birth

  1, 2, 4 and 8 weeks after birth

• Adverse reactions from mother or fetus during first breastmilk expression

  Through study completion, an avarage of 1 year.

Study Arms (2)

Antenatal breastmilk expression

EXPERIMENTAL

Breastfeeding consultation with trained midwife in week 33 + antenatal breastmilk expression from week 34

Behavioral: Antenatal breastmilk expression; Behavioral: Breastfeeding consultation

Control

OTHER

Breastfeeding consultation with trained midwife in week 33

Behavioral: Breastfeeding consultation

Interventions

Antenatal breastmilk expression BEHAVIORAL

Stimulation of the breast by hand/handexpression of breastmilk during pregnancy from week 34

Antenatal breastmilk expression

Breastfeeding consultation BEHAVIORAL

60 min standardized breastfeeding consultation with a trained midwife, with focus on practical breastfeeding skills

Antenatal breastmilk expression; Control

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: No. They have to be able to be pregnant
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy nulliparous women with no major chronic or pregnancy related diseases
• BMI \<27
• Danish speaking
• Singleton pregnancies
• Planning to exclusively breastfeed their infants and deliver at Odense University Hospital (Odense and Svendborg)

You may not qualify if:

• Suspected fetal intrauterine growth restriction or known major fetal anomaly
• Women at risk of preterm birth with one of the following diagnoses: Placenta previa, premature preterm rupture of membranes (PPROM) or previous cervical conization
• Women taking medications where breastfeeding is contraindicated
• Women with prior breast surgery: Breast reductive surgery or breast implants

Sponsors & Collaborators

• Odense University Hospital: lead
• University of Southern Denmark: collaborator

Study Sites (1)

Odense University Hospital

Odense, 5000, Denmark

Location

Related Publications (19)

• 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.

  PMID: 30982856 BACKGROUND

• 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.

  PMID: 33656144 BACKGROUND

• 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.

  PMID: 33593367 BACKGROUND

• 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.

  PMID: 26869575 BACKGROUND

• 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.

  PMID: 23178060 BACKGROUND

• 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.

  PMID: 30776448 BACKGROUND

• 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.

  PMID: 23178065 BACKGROUND

• 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.

  PMID: 25659030 BACKGROUND

• 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.

  PMID: 28589894 BACKGROUND

• 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.

  PMID: 28642112 BACKGROUND

• 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.

  PMID: 26924904 BACKGROUND

• 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.

  PMID: 33712049 BACKGROUND

• 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.

  PMID: 30891743 BACKGROUND

• 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.

  PMID: 30950165 BACKGROUND

• 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.

  PMID: 29544467 BACKGROUND

• 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.

  PMID: 23199299 BACKGROUND

• 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.

  PMID: 26928297 RESULT

• 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.

  PMID: 39748396 DERIVED

• 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.

  PMID: 39493541 DERIVED

MeSH Terms

Conditions

Breast Milk Expression; Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Marie B Simonsen, M.D

  OUH & SDU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: August 11, 2022
• First Posted: August 25, 2022
• Study Start: August 31, 2022
• Primary Completion: September 30, 2023
• Study Completion: November 30, 2023
• Last Updated: January 16, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Time Frame: Study protocol, SAP and ICF after protocol publication. CSR: After ended intervention and data collection
• Access Criteria: Write to principal investigator to request data. Data will be transferred to Rigsarkivet Denmark if possible with regard to GDP regulations.

Locations

DK (1)