Pregnancy RelatedNCT04929301
Antenatal Milk Expression in Nulliparous Pregnant People
A study testing Antenatal milk expression and Education handouts in people with Pregnancy Related and Breast Feeding, run by University of Pittsburgh at 1 site in United States.
Trial summary
This was a pilot randomized trial to examine the feasibility and preliminary effectiveness of a structured antenatal milk expression (AME) educational intervention on breastfeeding outcomes within a sample of low-risk pregnant individuals without other children. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related, Breast Feeding, Milk Expression, Breast
- What is being tested?
- Antenatal milk expression and Education handouts
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Nov 2016to 9 Jul 2018
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pregnant with a single fetus
- 34-36 6/7 weeks pregnant (calculated from anticipated due date)
- No other living children and no prior breastfeeding experience
- Plan to breastfeed exclusively for at least 4 months
- At least 18 years old
- Plan to deliver baby at Magee-Womens Hospital of UPMC
- Healthy (no major medical or pregnancy condition which would constitute a high-risk pregnancy)
Who cannot join
- Women with contraindications to breastfeeding, as specified by American Academy of Pediatrics, including HIV+ status, human T-cell lymphotrophic virus, etc. HIV status will be assessed by history (maternal self-report of diagnosis).
- Conditions known to significantly adversely impact maternal milk supply (e.g., breast hypoplasia, history of breast reduction surgery, as assessed on screening form)
- Conditions which predispose to preterm labor or otherwise constitute a high-risk pregnancy as outlined by the National Institute of Child Health and Human Development including: breech presentation, vaginal bleeding during second or third pregnancy trimester (more than one episode, not related to possible cervical mechanical trauma from sexual intercourse or cervical exam), diagnosed or suspected developmental abnormalities in the fetus, less than 6 months between last birth and the beginning of current pregnancy, placenta previa, diabetes type I or II or gestational diabetes, preeclampsia (or hypertension with proteinuria), smoking, alcohol use, or illicit drug use during pregnancy, oligohydramnios/polyhydramnios, any previous second or third trimester pregnancy loss/miscarriage
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Magee Women's Hospital
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Feasibility and Acceptability of Antenatal Breast Milk Expression-a Pilot Randomized Trial in Nulliparous Pregnant People
This was a pilot randomized trial to examine the feasibility and preliminary effectiveness of a structured antenatal milk expression (AME) educational intervention on breastfeeding outcomes within a sample of low-risk pregnant individuals without other children. A convenience sample of 45 participants were enrolled and randomized to either the AME intervention or a control group receiving breastfeeding educational handouts. Both groups met with study staff at 37, 38, 39, and 40 weeks gestation to receive assigned intervention. AME participants practiced AME 1-2 times/day and recorded this in a diary. Data were collected from surveys, interviews, and electronic health record to 3-4 months postpartum.
Read the detailed description
Antenatal milk expression (AME) has emerged as a simple, inexpensive, novel method to increase maternal breastfeeding confidence, avoid early formula use, and increase proportion of mother's own milk (MOM) feeds-potentially leading to greater breastfeeding satisfaction, increased breastfeeding duration and exclusivity, and improved maternal-infant health outcomes. AME capitalizes on the production, and sometimes leaking, of milk-commencing during the second trimester of pregnancy by allowing women to collect and store milk for later use if needed and gain confidence in breastfeeding and their milk-making capabilities. AME may also "prime" the hormonal milk production process to create a larger postpartum milk supply. Pilot studies conducted with diabetic women demonstrate AME's safety, feasibility, and preliminary effectiveness in improving breastfeeding rates. AME has yet to be investigated in non-diabetic populations.
In the current study, investigators trialed our study procedures and milk collection and analysis methods, and examined the preliminary effectiveness of AME on breastfeeding outcomes among pregnant people without other biological children. Forty-five healthy, nulliparous women were enrolled and randomized to either a structured AME educational intervention or usual care/control group at Magee-Womens Hospital midwife practice at their 34-36 week prenatal appointment. The Principal Investigator (PI) or an research assistant (RA) met with all participants weekly from 37 weeks until delivery, during postpartum hospitalization, and at 1-2 weeks and 3-4 months postpartum. During visits, the PI/RA collected questionnaire data on maternal health and delivery, stress, depression, as well as outcomes of perceived milk supply and breastfeeding attitude, satisfaction, confidence, continuation and exclusivity. Those randomized to AME were taught the technique at the 37 week visit by a lactation consultant, with instructions to continue 1-2 times/day at home. AME was practiced and reinforced with the lactation consultant at each subsequent visit. Those in the control group received breastfeeding handouts at each prenatal visit. For those in the AME group, the PI/RA also collected a small milk sample at each prenatal visit, along with a written diary documenting AME at home. The PI/RA collected a milk sample from all participants at postpartum visits; samples are stored at University of Pittsburgh School of Nursing lab for subsequent analyses (TBD). The PI/RA conducted semi-structured interviews at 1-2 weeks postpartum with AME participants about their experiences with the intervention. Summary statistics were then calculated for feasibility and breastfeeding outcome data, with significance tests (ANOVA, chi-square) to determine group differences breastfeeding outcomes as applicable. Interview data were analyzed for major themes to refine the intervention for a larger trial.
Data collected in this study were used to revise our AME clinical teaching protocol, AME diaries, and establish standard operating procedures for milk collection and storage for an ongoing, larger randomized trial examining AME's effect on breastfeeding outcomes.
- Conditions
- Pregnancy Related, Breast Feeding, Milk Expression, Breast
- Being tested
- Antenatal milk expression, Education handouts
- Medical subject headings
- Breast Feeding, Breast Milk Expression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antenatal milk expressionOther
Hand-expression of breast milk in pregnancy
Education handoutsOther
Educational breastfeeding handouts
| Study group | Role | What they receive |
|---|---|---|
| AME Hand-Expression | Experimental | Participants in the antenatal milk expression (AME) group will learn hand-expression from a certified lactation consultant beginning at 37 weeks of pregnancy. At the same visit, the PI or RA will also provide oral and written instructions for AME at home, specifically instructing participants to do AME 1-2 times per day for no longer than 10 minutes. Receives: Other: Antenatal milk expression |
| Education | Active comparator | Participants in the education group will receive a weekly educational hand-out on varying breastfeeding topics (e.g., latch). Receives: Other: Education handouts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of individuals randomized
Number of individuals randomized divided by number of individuals screened
Measured: End date for study recruitment (approximately one year after beginning enrollment)
Proportion of participants completing study
Number of participants completing final study survey divided by number enrolled
Measured: End date for study data collection (approximately one year after beginning enrollment)
Secondary outcomes (9)
Breastfeeding confidence
between group differences in Breastfeeding Self-Efficacy Scale-SF (short form) scores (score range 14-70 with higher scores indicative of higher self-efficacy)
Measured: Enrollment, postpartum hospitalization: an average of 1-3 days postpartum, 1-2 weeks postpartum, 3-4 months postpartum
Perceived milk supply (single item)
Between group differences in perceived postpartum milk supply assessed as a single investigator-created item asking "Do you feel you make enough breast milk to satisfy your baby?" with answer options of "yes," "no," or "unsure" (no and unsure dichotomized to yes="no PIM" and no/unsure= "PIM")
Measured: During postpartum hospitalization: an average of 1-3 days postpartum, 1-2 weeks postpartum, 3-4 months postpartum
Perceived milk supply (scale score)
Between group differences in perceived postpartum milk supply assessed as a combined score on both the Perceived Infant Breastfeeding Satiety and Maternal-Infant Breastfeeding Satisfaction subscales (10 items total) within the H\&H Lactation Scale; possible scores range from 0-70, wherein lower scores represented lower breastfeeding satisfaction and lower confidence that one was making enough milk.
Measured: During postpartum hospitalization: an average of 1-3 days postpartum, 1-2 weeks postpartum, 3-4 months postpartum
In-hospital formula use
Between group differences in any formula feeds during birth hospitalization (yes/no) extracted from electronic health record
Measured: Discharge from birth hospital: an average of 1-3 days postpartum
Breastfeeding continuation
Between group differences in any breastmilk feeds (yes/no)
Measured: 1-2 weeks postpartum, 3-4 months postpartum
Breastfeeding exclusivity
Between group differences in only breast milk feeds (100% breast milk-yes/no)
Measured: 1-2 weeks postpartum, 3-4 months postpartum
Promoters and barriers to antenatal milk collection and storage
Qualitative interviews assessing participant perceptions related to collecting and storing antenatal milk
Measured: 1-2 weeks postpartum
Proportion of participants completing study visits
Number of participants completing each study visit divided by number enrolled
Measured: Study visits at 37, 38, 39, and 40 weeks of pregnancy
Proportion of participants engaging in AME
Number of participants engaging in AME during study visits and/or independently as documented in AME diary, divided by number of participants assigned to AME
Measured: End date for participant's pregnancy: an average of 40 gestational weeks with upper range to 42 gestational weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start21 Nov 2016
- Primary completion9 Jul 2018
- Study completion9 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- American Nurses Foundation
- Responsible party
- Principal investigator, Jill R. Demirci, PhD, RN, IBCLC, University of Pittsburgh
- Investigators
- Jill R Demirci, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04929301
- Sponsor's protocol ID
- STUDY20040354
- Status last verified
- Jun 2021
- First submitted
- 11 May 2021
- Last updated
- 18 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Demirci JR, Glasser M, Himes KP, Sereika SM. Structured antenatal milk expression education for nulliparous pregnant people: results of a pilot, randomized controlled trial in the United States. Int Breastfeed J. 2022 Jul 7;17(1):50. doi: 10.1186/s13006-022-00491-8.
PubMed 35799299
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of Antenatal Breast Milk Expression-a Pilot Randomized Trial in Nulliparous Pregnant People
- ClinicalTrials.gov ID
- NCT04929301
- Acronym / sponsor ID
- STUDY20040354
- Conditions
- Pregnancy Related, Breast Feeding, Milk Expression, Breast
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- American Nurses Foundation
- Study start
- 21 Nov 2016 (actual)
- Primary completion
- 9 Jul 2018 (actual)
- Study completion
- 9 Jul 2018 (actual)
- First posted
- 18 Jun 2021 (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.
This was a pilot randomized trial to examine the feasibility and preliminary effectiveness of a structured antenatal milk expression (AME) educational intervention on breastfeeding outcomes within a sample of low-risk pregnant individuals without other children. A convenience sample of 45 participants were enrolled and randomized to either the AME intervention or a control group receiving breastfeeding educational handouts. Both groups met with study staff at 37, 38, 39, and 40 weeks gestation to receive assigned intervention. AME participants practiced AME 1-2 times/day and recorded this in a diary. Data were collected from surveys, interviews, and electronic health record to 3-4 months postpartum.
Detailed description
Antenatal milk expression (AME) has emerged as a simple, inexpensive, novel method to increase maternal breastfeeding confidence, avoid early formula use, and increase proportion of mother's own milk (MOM) feeds-potentially leading to greater breastfeeding satisfaction, increased breastfeeding duration and exclusivity, and improved maternal-infant health outcomes. AME capitalizes on the production, and sometimes leaking, of milk-commencing during the second trimester of pregnancy by allowing women to collect and store milk for later use if needed and gain confidence in breastfeeding and their milk-making capabilities. AME may also "prime" the hormonal milk production process to create a larger postpartum milk supply. Pilot studies conducted with diabetic women demonstrate AME's safety, feasibility, and preliminary effectiveness in improving breastfeeding rates. AME has yet to be investigated in non-diabetic populations.
In the current study, investigators trialed our study procedures and milk collection and analysis methods, and examined the preliminary effectiveness of AME on breastfeeding outcomes among pregnant people without other biological children. Forty-five healthy, nulliparous women were enrolled and randomized to either a structured AME educational intervention or usual care/control group at Magee-Womens Hospital midwife practice at their 34-36 week prenatal appointment. The Principal Investigator (PI) or an research assistant (RA) met with all participants weekly from 37 weeks until delivery, during postpartum hospitalization, and at 1-2 weeks and 3-4 months postpartum. During visits, the PI/RA collected questionnaire data on maternal health and delivery, stress, depression, as well as outcomes of perceived milk supply and breastfeeding attitude, satisfaction, confidence, continuation and exclusivity. Those randomized to AME were taught the technique at the 37 week visit by a lactation consultant, with instructions to continue 1-2 times/day at home. AME was practiced and reinforced with the lactation consultant at each subsequent visit. Those in the control group received breastfeeding handouts at each prenatal visit. For those in the AME group, the PI/RA also collected a small milk sample at each prenatal visit, along with a written diary documenting AME at home. The PI/RA collected a milk sample from all participants at postpartum visits; samples are stored at University of Pittsburgh School of Nursing lab for subsequent analyses (TBD). The PI/RA conducted semi-structured interviews at 1-2 weeks postpartum with AME participants about their experiences with the intervention. Summary statistics were then calculated for feasibility and breastfeeding outcome data, with significance tests (ANOVA, chi-square) to determine group differences breastfeeding outcomes as applicable. Interview data were analyzed for major themes to refine the intervention for a larger trial.
Data collected in this study were used to revise our AME clinical teaching protocol, AME diaries, and establish standard operating procedures for milk collection and storage for an ongoing, larger randomized trial examining AME's effect on breastfeeding outcomes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AME Hand-Expression | Experimental | Other: Antenatal milk expressionParticipants in the antenatal milk expression (AME) group will learn hand-expression from a certified lactation consultant beginning at 37 weeks of pregnancy. At the same visit, the PI or RA will also provide oral and written instructions for AME at home, specifically instructing participants to do AME 1-2 times per day for no longer than 10 minutes. |
| Education | Active comparator | Other: Education handoutsParticipants in the education group will receive a weekly educational hand-out on varying breastfeeding topics (e.g., latch). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Pregnant with a single fetus
- 34-36 6/7 weeks pregnant (calculated from anticipated due date)
- No other living children and no prior breastfeeding experience
- Plan to breastfeed exclusively for at least 4 months
- At least 18 years old
Key exclusion criteria (3 listed)
- Women with contraindications to breastfeeding, as specified by American Academy of Pediatrics, including HIV+ status, human T-cell lymphotrophic virus, etc. HIV status will be assessed by history (maternal self-report of diagnosis).
- Conditions known to significantly adversely impact maternal milk supply (e.g., breast hypoplasia, history of breast reduction surgery, as assessed on screening form)
- Conditions which predispose to preterm labor or otherwise constitute a high-risk pregnancy as outlined by the National Institute of Child Health and Human Development including: breech presentation, vaginal bleeding during second or third pregnancy trimester (more than one episode, not related to possible cervical mechanical trauma from sexual intercourse or cervical exam), diagnosed or suspected developmental abnormalities in the fetus, less than 6 months between last birth and the beginning of current pregnancy, placenta previa, diabetes type I or II or gestational diabetes, preeclampsia (or hypertension with proteinuria), smoking, alcohol use, or illicit drug use during pregnancy, oligohydramnios/polyhydramnios, any previous second or third trimester pregnancy loss/miscarriage
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 milk expressionHand-expression of breast milk in pregnancy | Other | AME Hand-Expression |
| Education handoutsEducational breastfeeding handouts | Other | Education |
Primary outcome
Proportion of individuals randomized
Time frame: End date for study recruitment (approximately one year after beginning enrollment)
Number of individuals randomized divided by number of individuals screened
Proportion of participants completing study
Time frame: End date for study data collection (approximately one year after beginning enrollment)
Number of participants completing final study survey divided by number enrolled
9 secondary outcomes
Breastfeeding confidence
Time frame: Enrollment, postpartum hospitalization: an average of 1-3 days postpartum, 1-2 weeks postpartum, 3-4 months postpartum
Perceived milk supply (single item)
Time frame: During postpartum hospitalization: an average of 1-3 days postpartum, 1-2 weeks postpartum, 3-4 months postpartum
Perceived milk supply (scale score)
Time frame: During postpartum hospitalization: an average of 1-3 days postpartum, 1-2 weeks postpartum, 3-4 months postpartum
In-hospital formula use
Time frame: Discharge from birth hospital: an average of 1-3 days postpartum
Breastfeeding continuation
Time frame: 1-2 weeks postpartum, 3-4 months postpartum
Breastfeeding exclusivity
Time frame: 1-2 weeks postpartum, 3-4 months postpartum
Promoters and barriers to antenatal milk collection and storage
Time frame: 1-2 weeks postpartum
Proportion of participants completing study visits
Time frame: Study visits at 37, 38, 39, and 40 weeks of pregnancy
Proportion of participants engaging in AME
Time frame: End date for participant's pregnancy: an average of 40 gestational weeks with upper range to 42 gestational weeks
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 18 Jun 2021.
- Derived from this study: PubMed 35799299Demirci JR, Glasser M, Himes KP, Sereika SM. Structured antenatal milk expression education for nulliparous pregnant people: results of a pilot, randomized controlled trial in the United States. Int Breastfeed J. 2022 Jul 7;17(1):50. doi: 10.1186/s13006-022-00491-8.
- Individual participant dataSharing planned: No
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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.
Jill R Demirci, PhD principal investigator
University of Pittsburgh
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 milk expression and Education handouts in people with Pregnancy Related and Breast Feeding, run by University of Pittsburgh at 1 site in United States.
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 7 inclusion and 3 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 18 Jun 2021. 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 United States. 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?
Proportion of individuals randomized (time frame: End date for study recruitment (approximately one year after beginning enrollment)). The study lists 2 primary outcomes in all. 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 NCT04929301, which also lists 1 linked publication.
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 18 Jun 2021.