Breastmilk ExpressionEXPRESS-MOMNCT05516199
Antenatal Breastmilk Expression From Week 34 of Gestation
A study testing Antenatal breastmilk expression and Breastfeeding consultation in people with Breastmilk Expression and Collection, Breastmilk, run by Odense University Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastmilk Expression, Collection, Breastmilk, Breastfeeding
- What is being tested?
- Antenatal breastmilk expression and Breastfeeding consultation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- 31 Aug 2022to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Antenatal Breastmilk Expression From Week 34 of Gestation Safety in Pregnancy and Benefits for the Newborn Infant: A Pilot Randomized Study
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.
Read the detailed 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.
- Conditions
- Breastmilk Expression, Collection, Breastmilk, Breastfeeding, Healthy
- Being tested
- Antenatal breastmilk expression, Breastfeeding consultation
- Keywords
- Infant nutrition, Lactation, Breastmilk, Breastfeeding
- Medical subject headings
- Breast Milk Expression, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antenatal breastmilk expressionBehavioural
Stimulation of the breast by hand/handexpression of breastmilk during pregnancy from week 34
Breastfeeding consultationBehavioural
60 min standardized breastfeeding consultation with a trained midwife, with focus on practical breastfeeding skills
| Study group | Role | What they receive |
|---|---|---|
| Antenatal breastmilk expression | Experimental | Breastfeeding consultation with trained midwife in week 33 + antenatal breastmilk expression from week 34 Receives: Behavioral: Antenatal breastmilk expression; Behavioral: Breastfeeding consultation |
| Control | Other | Breastfeeding consultation with trained midwife in week 33 Receives: Behavioral: Breastfeeding consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an avarage of 1 year.
Secondary outcomes (5)
Number of weekly breastmilk expressions before birth
Number of weekly expressions in interventiongroup. Measured through the weekly push-messages.
Measured: Through study completion, an avarage of 1 year.
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.
Measured: 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
Measured through weekly self-reported push-messages in both groups
Measured: 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
Measured through the weekly self-reported push-messages in both groups
Measured: 1, 2, 4 and 8 weeks after birth
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
Measured: Through study completion, an avarage of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2022
- Study start31 Aug 2022
- Primary completion30 Sep 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Breastmilk ExpressionStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern Denmark
- Responsible party
- Principal investigator, Marie Bendix Simonsen, M.D., Odense University Hospital
- Investigators
- Marie B Simonsen, M.D, Principal investigator, OUH & SDU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05516199
- Sponsor's protocol ID
- OUH-HCA005
- Acronym
- EXPRESS-MOM
- Status last verified
- Jan 2024
- First submitted
- 11 Aug 2022
- Last updated
- 16 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 30982856Wagner 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.
PubMed 33656144Laine 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.
PubMed 33593367Victora 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.
PubMed 26869575Ballard 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.
PubMed 23178060Yu 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.
PubMed 30776448Underwood 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.
PubMed 23178065Parker 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.
PubMed 25659030Forster 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.
PubMed 28589894Lopez-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.
PubMed 28642112Lamba 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.
PubMed 26924904Foudil-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.
PubMed 33712049Casey 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.
PubMed 30891743Demirci 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.
PubMed 30950165Demirci 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.
PubMed 29544467
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antenatal Breastmilk Expression From Week 34 of Gestation Safety in Pregnancy and Benefits for the Newborn Infant: A Pilot Randomized Study
- ClinicalTrials.gov ID
- NCT05516199
- Acronym / sponsor ID
- EXPRESS-MOM / OUH-HCA005
- Conditions
- Breastmilk Expression, Collection, Breastmilk, Breastfeeding, Healthy
- Keywords
- Infant nutrition, Lactation, Breastmilk, Breastfeeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- University of Southern Denmark
- Study start
- 31 Aug 2022 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 25 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Antenatal breastmilk expression | Experimental | Behavioral: Antenatal breastmilk expression, Behavioral: Breastfeeding consultationBreastfeeding consultation with trained midwife in week 33 + antenatal breastmilk expression from week 34 |
| Control | Other | Behavioral: Breastfeeding consultationBreastfeeding consultation with trained midwife in week 33 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antenatal breastmilk expressionStimulation of the breast by hand/handexpression of breastmilk during pregnancy from week 34 | Behavioural | Antenatal breastmilk expression |
| Breastfeeding consultation60 min standardized breastfeeding consultation with a trained midwife, with focus on practical breastfeeding skills | Behavioural | Antenatal breastmilk expression, Control |
Primary outcome
Gestational age at birth in the two groups
Time frame: Through study completion, an avarage of 1 year.
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.
5 secondary outcomes
Number of weekly breastmilk expressions before birth
Time frame: Through study completion, an avarage of 1 year.
Amount of breastmilk expressed
Time frame: 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
Time frame: 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
Time frame: 1, 2, 4 and 8 weeks after birth
Adverse reactions from mother or fetus during first breastmilk expression
Time frame: Through study completion, an avarage of 1 year.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2024.
- Background: PubMed 30982856Ford 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.
- Background: PubMed 33656144Wagner 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.
- Background: PubMed 33593367Laine 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.
- Background: PubMed 26869575Victora 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.
- Background: PubMed 23178060Ballard 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.
- Background: PubMed 30776448Yu 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.
- Background: PubMed 23178065Underwood 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.
- Background: PubMed 25659030Parker 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.
- Background: PubMed 28589894Forster 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.
- Background: PubMed 28642112Lopez-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.
- Background: PubMed 26924904Lamba 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.
- Background: PubMed 33712049Foudil-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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie B Simonsen, M.D principal investigator
OUH & SDU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antenatal breastmilk expression and Breastfeeding consultation in people with Breastmilk Expression and Collection, Breastmilk, run by Odense University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gestational age at birth in the two groups (time frame: Through study completion, an avarage of 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05516199, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2024.