Antenatal Breastmilk Expression From Week 34 of Gestation (EXPRESS-MOM)

January 11, 2024 updated by: Marie Bendix Simonsen, M.D., Odense University Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Denmark
      • Odense, Denmark, 5000
        • Odense University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, an avarage of 1 year.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of weekly breastmilk expressions before birth
Time Frame: Through study completion, an avarage of 1 year.
Number of weekly expressions in interventiongroup. Measured through the weekly push-messages.
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.
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
Time Frame: Through study completion, an avarage of 1 year.
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
Time Frame: 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
Time Frame: Through study completion, an avarage of 1 year.
Contractions and/or fetal stimulation during the first breastmilk expression during pregnancy, assessed with CTG
Through study completion, an avarage of 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Odense University Hospital

Collaborators

University of Southern Denmark

Investigators

  • Principal Investigator: Marie B Simonsen, M.D, OUH & SDU

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 31, 2022

Primary Completion (Actual)

September 30, 2023

Study Completion (Actual)

November 30, 2023

Study Registration Dates

First Submitted

August 11, 2022

First Submitted That Met QC Criteria

August 23, 2022

First Posted (Actual)

August 25, 2022

Study Record Updates

Last Update Posted (Actual)

January 16, 2024

Last Update Submitted That Met QC Criteria

January 11, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • OUH-HCA005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

Study protocol, SAP and ICF after protocol publication. CSR: After ended intervention and data collection

IPD Sharing Access Criteria

Write to principal investigator to request data. Data will be transferred to Rigsarkivet Denmark if possible with regard to GDP regulations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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