Antenatal Breastmilk Expression From Week 34 of Gestation

Healthy Clinical Trial

— EXPRESS-MOM  

Official title:

Antenatal Breastmilk Expression From Week 34 of Gestation Safety in Pregnancy and Benefits for the Newborn Infant: A Pilot Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05516199
• Other study ID #: OUH-HCA005
• Status: Completed
• Phase: N/A
• Start date: August 31, 2022
• Est. completion date: November 30, 2023

Study information

• Verified date: January 2024
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

In a randomized pilot study, 60 healthy pregnant women will be randomized either to antenatal breastmilk expression from week 34+0 until delivery or no antenatal breastmilk expression. Furthermore, all participants will have an individual breastfeeding consultation with a trained midwife in week 33 of pregnancy. At the consultation, the intervention group will also be taught how to perform antenatal expression by hand and store any expressed breastmilk correctly. All women included in this study will receive standard care.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Healthy nulliparous women with no major chronic or pregnancy related diseases

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:

1. Suspected fetal intrauterine growth restriction or known major fetal anomaly

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

Related Conditions & MeSH terms

• Breastfeeding
• Healthy

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
Denmark	Odense University Hospital	Odense

Sponsors (2)

Lead Sponsor	Collaborator
Odense University Hospital	University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (17)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Yu X, Li J, Lin X, Luan D. Association between Delayed Lactogenesis ? 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. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of weekly breastmilk expressions before birth	Number of weekly expressions in interventiongroup. Measured through the weekly push-messages.	Through study completion, an avarage of 1 year.
Secondary	Amount of breastmilk expressed	How many women will be capable of expressing any milk before birth in intervention group, and how many ml. Volume is measured by each women using a container with a mL scale and reported through weekly self reported push-messages.	Through out the study, an average of 1 year. Assesment when all women included have been giving birth.
Secondary	Breastfeeding rates 1, 2, 4 and 8 weeks after birth	Measured through weekly self-reported push-messages in both groups	Through study completion, an avarage of 1 year.
Secondary	Number of exclusively breastfeeding versus partially breastfeeding women in each group at 1, 2, 4 and 8 weeks after birth	Measured through the weekly self-reported push-messages in both groups	1, 2, 4 and 8 weeks after birth
Secondary	Adverse reactions from mother or fetus during first breastmilk expression	Contractions and/or fetal stimulation during the first breastmilk expression during pregnancy, assessed with CTG	Through study completion, an avarage of 1 year.