Antenatal Breastmilk Expression From Week 34 of Gestation

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Breastmilk Expression, Collection, Breastmilk, Breastfeeding, Healthy

Intervention / Treatment
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* Behavioral: Antenatal breastmilk expression
* Behavioral: Breastfeeding consultation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Antenatal breastmilk expression<br>Breastfeeding consultation with trained midwife in week 33 + antenatal breastmilk expression from week 34 | Behavioral: Antenatal breastmilk expression<br>* Stimulation of the breast by hand/handexpression of breastmilk during pregnancy from week 34<br>Behavioral: Breastfeeding consultation<br>* 60 min standardized breastfeeding consultation with a trained midwife, with focus on practical breastfeeding skills<br>|
| Other: Control<br>Breastfeeding consultation with trained midwife in week 33 | Behavioral: Breastfeeding consultation<br>* 60 min standardized breastfeeding consultation with a trained midwife, with focus on practical breastfeeding skills<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 
| 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. | 
| 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 | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infant nutrition, Lactation, Breastmilk, Breastfeeding