RecruitingACTRN12621001250820

Effect of boosting breastmilk supply on maternal and infant health

Effect of evidence-based methods and measurement on breastfeeding duration and infant health.

Sponsor

The University of Western Australia - School of Molecular Sciences

Enrollment

180 participants

Start Date

Nov 18, 2021

Study Type

Interventional

Conditions

Low breastmilk production Diabetes Mellitus Obesity Hypertension Polycystic Ovary Syndrome Overweight Intrauterine Growth Restriction

Summary

The primary purpose of the study is to determine whether frequent milk removal and phone support across the first three weeks after birth improves both breastfeeding outcomes and maternal fetal health outcomes for women at high risk of low milk production. The study is a randomised control trial (RCT) with 180 participants. Women who are antenatally identified as being at high risk for lactation difficulties will be eligible for the trial. They may have one or a combination of the following health factors, overweight or obesity defined by pre-pregnancy BMI, pre-existing diabetes mellitus, gestational diabetes mellitus (GDM), polycystic ovarian syndrome (PCOS), intrauterine growth restriction (IUGR), pregnancy induced hypertension, preeclampsia and previous history of low unexplained breastmilk supply, The intervention arm (n=90) will receive individual education about frequent feeding and removal of milk from the breast after birth, provision of an electric hospital grade pump in late pregnancy for ease of access post birth and postpartum phone support from an IBCLC every days 3- 4 days for 3 weeks. In contrast, the control arm (n=90) will only receive individual education about frequent feeding and removal of milk from the breast after birth. The primary outcome of the trial is 24 hour milk production at 2 and 6 weeks postpartum. Other data to be compared between the two groups over the 12 months are: - Exclusivity and duration of breastmilk feeding - Incidence and duration of acute infant infections - Anthropometric data on the infants - Maternal physical and emotional health The study will also investigate changes in breastmilk composition associated with low breastmilk production at 1, 2 and 6 weeks. The study hypothesis is that women who are provided with regular telephone support to regularly remove milk through breastfeeding +/- pumping during the first 3 postnatal weeks, and are loaned an electric hospital grade breast pump, will have a higher milk production volume at 2 weeks and 6 weeks postpartum than those who do not receive regular telephone support and an electric hospital grade breast pump.

Eligibility

Sex: FemalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Some mothers are at higher risk of producing less breast milk after birth — including those who are overweight or obese, have diabetes or polycystic ovarian syndrome (PCOS), experienced pregnancy complications like gestational diabetes or preeclampsia, or had low milk supply in a previous pregnancy. This trial is testing whether providing extra support — specifically, lending a hospital-grade electric breast pump and offering regular phone check-ins from a specialist lactation consultant every few days for the first three weeks — helps these women produce more milk and breastfeed for longer. All participants will receive education about breastfeeding. The intervention group also gets the pump loan and ongoing phone support. Researchers will measure how much milk mothers produce at 2 and 6 weeks, and follow both mother and baby for 12 months tracking breastfeeding duration, baby infections, and maternal wellbeing. You may be eligible if you have at least one of the listed health factors and plan to breastfeed for at least six months. You must give birth at 37 weeks or later and be an English-speaking woman in the metropolitan area. Women with certain conditions like HIV, breast surgery history, multiple pregnancy, or conditions requiring medication incompatible with breastfeeding are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

The intervention study protocol includes: - Antenatal breastfeeding education to ensure frequent breastmilk removal postnatally to improve breastmilk production outcomes (De Carvalho, et al., 1982;

The intervention study protocol includes: - Antenatal breastfeeding education to ensure frequent breastmilk removal postnatally to improve breastmilk production outcomes (De Carvalho, et al., 1982; Yamauchi & Yamanouchi, 1990). Individual education will be provided in late pregnancy (36 weeks onwards) by a current International Board Certified Lactation Consultant with over 10 years experience. It will be conducted during a routine 60 minute antenatal appointment at one of the four One for Women rooms in suburban Perth . Breastmilk removal will be promoted within 2 hours of birth and at least 8 times in 24 hours in the first two weeks postpartum. i.e. every 2 - 4 hours, no more than one 5 hour interval. - If a participant is unable to directly breastfeed due to maternal or infant health issues or separation (neonatal nursery admission, mother very unwell, nipple pain, baby unable to latch or not feeding well) breastfeeds are to be replaced or supplemented with breast expression using a hospital grade pump. Participants in the intervention arm will be loaned a Medela Symphony pump, a hospital grade electric pump, in late pregnancy (i.e. from 36 weeks gestation ). This is to provide ease of access to a hospital grade pump if required after birth. It will be given at a One for Women antenatal appointment by either the attending Midwife, General Practitioner Obstetrician (GPO) or by the researcher an IBCLC. Detailed instructions via a hand-out will be given to participants with the pump, including when to use, how to use and how to clean the pump as well as on breastmilk storage and use. Any questions will be addressed at this time in addition participants will be given the contact e-mail address of the researcher (an IBCLC) to answer any further queries. - Participants in the intervention arm will receive phone support every 3 - 4 days for 3 weeks postpartum as evidence concludes that phone calls improve perceived quality of postnatal care (Dennis & Kingston, 2008). The phone calls will be provided by a current International Board Certified Lactation Consultant (IBCLC) with over 10 years experience in the field of lactation. These will be personalised to address any particular concerns or challenges the participant is experiencing and provide consistent evidence based advice. The phone calls will not have time constraints applied and each call may take up to 30 to 60 minutes. Intervention adherence will be assessed by participant data logging. De Carvalho, M., Robertson, S., Merkatz, R., & Klaus, M. (1982). Milk intake and frequency of feeding in breast fed infants. Early Human Development, 7(2), 155-163. Dennis, C., & Kingston, D. (2008). A systematic review of telephone support for women during pregnancy and the early postpartum period. Journal Obstetric Gynecological Neonatal Nursing, 37(3), 301-314. Yamauchi, Y., & Yamanouchi, I. (1990). Breast-feeding frequency during the first 24 hours after birth in full-term neonates. Pediatrics, 86(2), 171–175.