Breastfeeding
Conditions
Keywords
antenatal milk expression, antenatal colostrum
Brief summary
The purpose of this randomized controlled trial is to examine the impact of a remotely-delivered antenatal milk expression (AME) intervention versus an attention control condition on breastfeeding outcomes among a sample of 280 nulliparous, non-diabetic women with pre-pregnancy body mass indices ≥ 25. AME involves milk expression and collection in the third pregnancy trimester and is theorized to address multiple barriers to breastfeeding among women with higher BMI, including impaired breastfeeding self-efficacy, insufficient milk supply (critical period endocrine modulation of milk volume), and early formula supplementation in the context of a medically complex birth (availability of banked antenatal milk). Participants will be enrolled in their third trimester of pregnancy and allocated into one of two study arms: 1) AME instruction delivered by remote, live International Board Certified Lactation Consultants via an innovative app-based telelactation platform; or 2) an attention control condition (video-based infant care education unrelated to infant feeding). Video-based education for both groups will occur in weekly study visits from 37 to 40 weeks gestation, with women in the intervention group continuing AME 1-2 times per day at home. Measured outcomes of interest will include short and long-term breastfeeding practices (e.g., breastfeeding duration, exclusivity) and participants' experiences with and perceptions of AME.
Detailed description
The purpose of the PREPARE Trial is to examine the impact of an antenatal milk expression (AME) intervention among women with pre-pregnancy BMI 25 or more on breastfeeding outcomes, including breastfeeding self-efficacy, breastfeeding duration and exclusivity, and perception of insufficient milk supply. Specifically, the investigators will: 1. Determine the effect of the AME intervention on short-term breastfeeding outcomes, including breastfeeding self-efficacy and exclusivity, to two weeks postpartum. 2. Explore the sustained effect of the AME intervention on longer-term breastfeeding duration and exclusivity over the first year postpartum. 3. Examine participants' experiences with and perceptions of AME.
Interventions
BEHAVIORALAME
Participants receive education on AME and feedback on technique with a remotely-based IBCLC via live streaming video.
BEHAVIORALVideo-based infant care education
Participants view a standard set of web-based streamed videos addressing evidence-based infant care, unrelated to feeding/breastfeeding.
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Statistician completing final analysis of data will be blinded to group assignment. An unbiased, third party will conduct qualitative interviews. Participants, obstetric providers in recruitment clinics, and lactation consultant interventionists will be blinded to outcomes of interest.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Pregnant women who: 1. have a pre-pregnancy BMI ≥ 25 2. are ≥ 18 years 3. are English-speaking 4. are 34 0/7-36 6/7 gestational weeks 5. are nulliparous 6. intend to/have interest in breastfeeding after birth 7. are having a singleton pregnancy 8. plan to receive prenatal care and deliver at select hospital/birth facility systems (access to EMR data)
Exclusion criteria
1. contraindications to breastfeeding as specified by the American Academy of Pediatrics 2. history of breast reduction surgery or radiation 3. indication for delivery by 37 weeks gestation 4. gestational or pre-existing diabetes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Breastfeeding Exclusivity | 2 weeks postpartum | Whether participant is feeding 100% breast milk at 2 weeks postpartum |
| Breastfeeding Self-efficacy | 2 weeks postpartum | Score on Breastfeeding Self-Efficacy Scale-SF (score range 14-70, with higher score represents better outcome) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Exclusively Breastfeeding at 6 Weeks Postpartum | 6 weeks postpartum | This variable derived from participant self-report survey emailed at 6 weeks postpartum. Responses for Breastfeeding Exclusivity were categorized as YES if the infant had been fed only their mother's own breast milk. Responses were categorized as NO if they had received anything other than only their mother's own breast milk (e.g., formula + their own milk, formula only). |
| Number of Participants Exclusively Breastfeeding at 12 Weeks Postpartum | 12 weeks postpartum | This variable derived from participant self-report survey emailed at 12 weeks postpartum. Responses for Breastfeeding Exclusivity were categorized as YES if the infant had been fed only their mother's own breast milk. Responses were categorized as NO if they had received anything other than only their mother's own breast milk (e.g., formula + their own milk, formula only). |
| Number of Participants Exclusively Breastfeeding at 6 Months Postpartum | 6 months postpartum | This variable derived from participant self-report survey emailed at 6 months postpartum. Responses for Breastfeeding Exclusivity were categorized as YES if the infant had been fed only their mother's own breast milk. Responses were categorized as NO if they had received anything other than only their mother's own breast milk (e.g., formula + their own milk, formula only). |
| Breastfeeding Exclusivity (Categorical) | 0-4 days postpartum | Categorical outcome indicating proportional range of breast milk feeds during postpartum/birth hospitalization (0-4 days postpartum) |
| Breastfeeding Self-efficacy | 6 weeks postpartrum | Scores on Breastfeeding Self-Efficacy Scale-SF(score range 14-70, with higher score represents better outcome) |
| Number of Participants Breastfeeding at Postpartum Hospitalization (0-4 Days Postpartum) | Postpartum hospitalization (0-4 days postpartum) | This variable was derived from the infant's feeding documentation via Electronic Medical Record. Responses were categorized as YES for Breastfeeding Duration if they answered that they were still feeding their own breast milk to their infant at each respective timepoint. Please note that responses were still classified as a YES if they were combination feeding (e.g., using their own breast milk along with formula, solids, etc.). Responses were categorized as NO if they had ceased to provide any of their own breast milk to their infant. |
| Number of Participants Breastfeeding at 2 Weeks Postpartum | 2 weeks postpartum | Participants were asked what their infant was currently being fed. Responses were categorized as YES for Breastfeeding Duration if they answered that they were still feeding their own breast milk to their infant at each respective timepoint. Please note that responses were still classified as a YES if they were combination feeding (e.g., using their own breast milk along with formula, solids, etc.). Responses were categorized as NO if they had ceased to provide any of their own breast milk to their infant. |
| Number of Participants Exclusively Breastfeeding During Postpartum Hospitalization | Postpartum hospitalization (0-4 days postpartum) | This variable was derived from the infant's feeding documentation via Electronic Medical Record. Responses for Breastfeeding Exclusivity were categorized as YES if the infant had been fed only their mother's own breast milk. Responses were categorized as NO if they had received anything other than only their mother's own breast milk (e.g., formula + their own milk, formula only). |
| Number of Participants Breastfeeding at 12 Weeks Postpartum | 12 weeks postpartum | Participants were asked what their infant was currently being fed. Responses were categorized as YES for Breastfeeding Duration if they answered that they were still feeding their own breast milk to their infant at each respective timepoint. Please note that responses were still classified as a YES if they were combination feeding (e.g., using their own breast milk along with formula, solids, etc.). Responses were categorized as NO if they had ceased to provide any of their own breast milk to their infant. |
| Number of Participants Breastfeeding at 6 Months Postpartum | 6 months postpartum | Participants were asked what their infant was currently being fed. Responses were categorized as YES for Breastfeeding Duration if they answered that they were still feeding their own breast milk to their infant at each respective timepoint. Please note that responses were still classified as a YES if they were combination feeding (e.g., using their own breast milk along with formula, solids, etc.). Responses were categorized as NO if they had ceased to provide any of their own breast milk to their infant. |
| Number of Participants Breastfeeding at 12 Months Postpartum | 12 months postpartum | Participants were asked what their infant was currently being fed. Responses were categorized as YES for Breastfeeding Duration if they answered that they were still feeding their own breast milk to their infant at each respective timepoint. Please note that responses were still classified as a YES if they were combination feeding (e.g., using their own breast milk along with formula, solids, etc.). Responses were categorized as NO if they had ceased to provide any of their own breast milk to their infant. |
| Onset of Lactogenesis II | 2 weeks postpartum | Recall of lactogenesis II in post-birth days |
| Perceived Milk Supply (Continuous) | 2 weeks postpartum | Score on PIBBS subscale of H & H Lactation Scale measuring perceived infant satisfaction with breast milk received (score range: 5-35, higher score is better outcome) |
| Perceived Milk Supply (Dichotomous) | 2 weeks postpartum | Endorsement of insufficient milk supply via investigator created item (dichotomous outcome) |
| Number of Participants Commenting on the Impact/Integration of AME During Pregnancy and Utilization of Antenatally Collected Milk During the Postpartum Period | 6 weeks postpartum | A subset of participants took place in a qualitative assessment via semi-structured interview. Numbers below represent the number of participants who endorsed each of the following categories during their interview: 1) discussing the impact of the study on their pregnancy/postpartum experience, 2) integration of AME into their daily life, and 3) utilization of antenatal milk during the postpartum period |
| Number of Participants Breastfeeding at 6 Weeks Postpartum | 6 weeks postpartum | Participants were asked what their infant was currently being fed. Responses were categorized as YES for Breastfeeding Duration if they answered that they were still feeding their own breast milk to their infant at each respective timepoint. Please note that responses were still classified as a YES if they were combination feeding (e.g., using their own breast milk along with formula, solids, etc.). Responses were categorized as NO if they had ceased to provide any of their own breast milk to their infant. |
| Number of Participants Exclusively Breastfeeding at 2 Weeks Postpartum | 2 weeks postpartum | This variable derived from participant self-report survey emailed at 2 weeks postpartum. Responses for Breastfeeding Exclusivity were categorized as YES if the infant had been fed only their mother's own breast milk. Responses were categorized as NO if they had received anything other than only their mother's own breast milk (e.g., formula + their own milk, formula only). |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled between September 23, 2020 and October 23, 2023. Recruitment occurred via electronic health record scans of prenatal practices involved in the study for patients who met basic eligibility criteria, who then received study advertisements, health system portal messages, and/or approaches by study staff at a prenatal visit. Other recruitment strategies included social media ads, a university research registry, study flyers at clinical sites, and magazine advertisements.
Pre-assignment details
Of 539 participants assessed for eligibility, 280 met eligibility criteria, agreed to participate, and were randomized to an interventionist group.
Participants by arm
| Arm | Count |
|---|---|
| Antenatal Milk Expression (AME) Intervention Group Weekly video interactions (weeks 37-40 of pregnancy) with International Board Certified Lactation Consultants (IBCLCs) to teach and reinforce antenatal milk expression. At-home practice of hand expression and collection of any expressed milk.
AME: Participants receive education on AME and feedback on technique with a remotely-based IBCLC via live streaming video. | 140 |
| Video-based Infant Care Education Control Group Weekly video education (weeks 37-40 of pregnancy) on various topics related to infant care (e.g., safe sleep, car seat safety, etc.).
Video-based infant care education: Participants view a standard set of web-based streamed videos addressing evidence-based infant care, unrelated to feeding/breastfeeding. | 140 |
| Total | 280 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Fetal demise | 0 | 1 |
| Overall Study | Lost to Follow-up | 10 | 4 |
| Overall Study | Protocol Violation | 1 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Antenatal Milk Expression (AME) Intervention Group | Video-based Infant Care Education Control Group | Total |
|---|---|---|---|
| Age, Continuous | 30 years STANDARD_DEVIATION 4.71 | 31.12 years STANDARD_DEVIATION 5.2 | 30.57 years STANDARD_DEVIATION 4.98 |
| Breastfeeding Self-Efficacy Scale (Short Form) Score Baseline | 45.57 units on a scale STANDARD_DEVIATION 8.04 | 46.16 units on a scale STANDARD_DEVIATION 8.43 | 45.87 units on a scale STANDARD_DEVIATION 8.23 |
| Education level Associates degree | 9 Participants | 5 Participants | 14 Participants |
| Education level Bachelor's degree | 43 Participants | 52 Participants | 95 Participants |
| Education level Completed occupational or vocational program | 6 Participants | 0 Participants | 6 Participants |
| Education level Graduated from high school/GED | 9 Participants | 13 Participants | 22 Participants |
| Education level Master's or doctoral degree | 55 Participants | 60 Participants | 115 Participants |
| Education level Some college, no degree | 15 Participants | 9 Participants | 24 Participants |
| Education level Unknown | 2 Participants | 1 Participants | 3 Participants |
| Employed at enrollment No | 16 Participants | 20 Participants | 36 Participants |
| Employed at enrollment Unknown/unreported | 2 Participants | 1 Participants | 3 Participants |
| Employed at enrollment Yes, but on leave until after baby's birth | 6 Participants | 4 Participants | 10 Participants |
| Employed at enrollment Yes, with reduced hours | 9 Participants | 14 Participants | 23 Participants |
| Employed at enrollment Yes, with the same number of hours as before pregnancy | 106 Participants | 101 Participants | 207 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 5 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 133 Participants | 134 Participants | 267 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 3 Participants |
| Infant Feeding Intentions Scale Score at enrollment | 10.59 units on a scale STANDARD_DEVIATION 2.07 | 10.40 units on a scale STANDARD_DEVIATION 2.02 | 10.49 units on a scale STANDARD_DEVIATION 2.04 |
| Iowa Infant Feeding Attitude Scale | 44.42 units on a scale STANDARD_DEVIATION 4.26 | 44.19 units on a scale STANDARD_DEVIATION 4.26 | 44.30 units on a scale STANDARD_DEVIATION 4.25 |
| Married Living with a partner | 21 Participants | 20 Participants | 41 Participants |
| Married Married | 105 Participants | 106 Participants | 211 Participants |
| Married Single or separated | 13 Participants | 14 Participants | 27 Participants |
| Pre-pregnancy BMI BMI 25.0-29.99 | 77 Participants | 76 Participants | 153 Participants |
| Pre-pregnancy BMI BMI ≥ 30.0 | 62 Participants | 64 Participants | 126 Participants |
| Pre-pregnancy BMI (Continuous) | 31.1 lbs/in^2 STANDARD_DEVIATION 5.69 | 30.8 lbs/in^2 STANDARD_DEVIATION 5.87 | 31.0 lbs/in^2 STANDARD_DEVIATION 5.77 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 9 Participants | 15 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 18 Participants | 28 Participants |
| Race (NIH/OMB) More than one race | 7 Participants | 5 Participants | 12 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) White | 111 Participants | 106 Participants | 217 Participants |
| Region of Enrollment United States | 140 Participants | 140 Participants | 280 Participants |
| Sex: Female, Male Female | 140 Participants | 140 Participants | 280 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Special Supplemental Program for Women, Infants, and Children (WIC) recipient No, not a current recipient | 121 Participants | 125 Participants | 246 Participants |
| Special Supplemental Program for Women, Infants, and Children (WIC) recipient Unreported/unknown | 2 Participants | 1 Participants | 3 Participants |
| Special Supplemental Program for Women, Infants, and Children (WIC) recipient Yes, current recipient | 16 Participants | 14 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 139 | 0 / 139 |
| other Total, other adverse events | 113 / 139 | 74 / 139 |
| serious Total, serious adverse events | 71 / 139 | 66 / 139 |
Outcome results
Primary
Breastfeeding Exclusivity
Whether participant is feeding 100% breast milk at 2 weeks postpartum
Time frame: 2 weeks postpartum
Population: Only includes participants with breastfeeding data available at 2 weeks postpartum (i.e., participants who completed breastfeeding survey item(s) at 2 weeks); note that some participants do not have 2 week breastfeeding data or 2 week survey data, but went on to complete the study by completing subsequent study timepoints
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Antenatal Milk Expression (AME) Intervention Group | Breastfeeding Exclusivity | 67 Participants |
| Video-based Infant Care Education Control Group | Breastfeeding Exclusivity | 84 Participants |
p-value: 0.12Chi-squared
p-value: 0.047495% CI: [0.352, 0.9907]Regression, Logistic
Primary
Breastfeeding Self-efficacy
Score on Breastfeeding Self-Efficacy Scale-SF (score range 14-70, with higher score represents better outcome)
Time frame: 2 weeks postpartum
Population: Please note that this indicates the number of participants who completed the BSES-SF in its entirety at this timepoint. Some participants may not have completed this portion of the survey due to 1) not completing a survey at this timepoint, or 2) reporting breastfeeding discontinuation at this timepoint, rendering this survey not applicable to their current experiences.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Antenatal Milk Expression (AME) Intervention Group | Breastfeeding Self-efficacy | 48.8 score on a scale | Standard Deviation 13.8 |
| Video-based Infant Care Education Control Group | Breastfeeding Self-efficacy | 47.7 score on a scale | Standard Deviation 11.9 |
p-value: 0.5201t-test, 1 sided
p-value: 0.917895% CI: [-2.5299, 2.8098]Regression, Linear
Secondary
Breastfeeding Exclusivity (Categorical)
Categorical outcome indicating proportional range of breast milk feeds in past week
Time frame: 6 months postpartum
Population: Please note that this indicates the number of participants who are represented here reflect only those who had still been active in the study at this point, exclusive of participants that had withdrawn (either by self or study staff) or did not complete a survey at this timepoint (either due to breastfeeding cessation at a prior timepoint or failure to complete the survey).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Antenatal Milk Expression (AME) Intervention Group | Breastfeeding Exclusivity (Categorical) | 0% breast milk | 13 Participants |
| Antenatal Milk Expression (AME) Intervention Group | Breastfeeding Exclusivity (Categorical) | 1-74% breast milk | 23 Participants |
| Antenatal Milk Expression (AME) Intervention Group | Breastfeeding Exclusivity (Categorical) | 75-99% breast milk | 38 Participants |
| Antenatal Milk Expression (AME) Intervention Group | Breastfeeding Exclusivity (Categorical) | 100% breast milk. | 20 Participants |
| Video-based Infant Care Education Control Group | Breastfeeding Exclusivity (Categorical) | 100% breast milk. | 22 Participants |
| Video-based Infant Care Education Control Group | Breastfeeding Exclusivity (Categorical) | 0% breast milk | 11 Participants |
| Video-based Infant Care Education Control Group | Breastfeeding Exclusivity (Categorical) | 75-99% breast milk | 40 Participants |
| Video-based Infant Care Education Control Group | Breastfeeding Exclusivity (Categorical) | 1-74% breast milk | 28 Participants |
p-value: 0.9071Chi-squared
p-value: 0.932895% CI: [0.7751, 1.2084]Regression, Logistic
Secondary
Breastfeeding Exclusivity (Categorical)
Categorical outcome indicating proportional range of breast milk feeds in past week
Time frame: 12 weeks postpartum
Population: Please note that this indicates the number of participants who are represented here reflect only those who had still been active in the study at this point, exclusive of participants that had withdrawn (either by self or study staff) or did not complete a survey at this timepoint (either due to breastfeeding cessation at a prior timepoint or failure to complete the survey).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Antenatal Milk Expression (AME) Intervention Group | Breastfeeding Exclusivity (Categorical) | 0% breast milk | 8 Participants |
| Antenatal Milk Expression (AME) Intervention Group | Breastfeeding Exclusivity (Categorical) | 1-74% breast milk | 18 Participants |
| Antenatal Milk Expression (AME) Intervention Group | Breastfeeding Exclusivity (Categorical) | 75-99% breast milk | 10 Participants |
| Antenatal Milk Expression (AME) Intervention Group | Breastfeeding Exclusivity (Categorical) | 100% breast milk | 68 Participants |
| Video-based Infant Care Education Control Group | Breastfeeding Exclusivity (Categorical) | 100% breast milk | 70 Participants |
| Video-based Infant Care Education Control Group | Breastfeeding Exclusivity (Categorical) | 0% breast milk | 8 Participants |
| Video-based Infant Care Education Control Group | Breastfeeding Exclusivity (Categorical) | 75-99% breast milk | 17 Participants |
| Video-based Infant Care Education Control Group | Breastfeeding Exclusivity (Categorical) | 1-74% breast milk | 16 Participants |
p-value: 0.6291Chi-squared
p-value: 0.542695% CI: [0.8745, 1.3931]Regression, Logistic
Secondary
Breastfeeding Exclusivity (Categorical)
Categorical outcome indicating proportional range of breast milk feeds in past week
Time frame: 6 weeks postpartum
Population: Please note that this indicates the number of participants who are represented here reflect only those who had still been active in the study at this point, exclusive of participants that had withdrawn (either by self or study staff) or did not complete a survey at this timepoint (either due to breastfeeding cessation at a prior timepoint or failure to complete the survey).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Antenatal Milk Expression (AME) Intervention Group | Breastfeeding Exclusivity (Categorical) | 0% breast milk | 15 Participants |
| Antenatal Milk Expression (AME) Intervention Group | Breastfeeding Exclusivity (Categorical) | 1-75% breast milk | 28 Participants |
| Antenatal Milk Expression (AME) Intervention Group | Breastfeeding Exclusivity (Categorical) | 75-99% breast milk | 16 Participants |
| Antenatal Milk Expression (AME) Intervention Group | Breastfeeding Exclusivity (Categorical) | 100% breast milk | 64 Participants |
| Video-based Infant Care Education Control Group | Breastfeeding Exclusivity (Categorical) | 100% breast milk | 73 Participants |
| Video-based Infant Care Education Control Group | Breastfeeding Exclusivity (Categorical) | 0% breast milk | 15 Participants |
| Video-based Infant Care Education Control Group | Breastfeeding Exclusivity (Categorical) | 75-99% breast milk | 14 Participants |
| Video-based Infant Care Education Control Group | Breastfeeding Exclusivity (Categorical) | 1-75% breast milk | 20 Participants |
p-value: 0.5613Chi-squared
p-value: 0.217395% CI: [0.4206, 1.2178]Regression, Logistic
Secondary
Breastfeeding Exclusivity (Categorical)
Categorical outcome indicating proportional range of breast milk feeds during postpartum/birth hospitalization (0-4 days postpartum)
Time frame: 0-4 days postpartum
Population: Data not collected from the EHR for the study due to reliability concerns
Secondary
Breastfeeding Exclusivity (Categorical)
Categorical outcome indicating proportional range of breast milk feeds since infant was born
Time frame: 2 weeks
Population: Please note that this indicates the number of participants who are represented here reflect only those who had still been active in the study at this point, exclusive of participants that had withdrawn (either by self or study staff) or did not complete a survey at this timepoint.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Antenatal Milk Expression (AME) Intervention Group | Breastfeeding Exclusivity (Categorical) | 0% breast milk | 0 Participants |
| Antenatal Milk Expression (AME) Intervention Group | Breastfeeding Exclusivity (Categorical) | 1-74% breast milk | 31 Participants |
| Antenatal Milk Expression (AME) Intervention Group | Breastfeeding Exclusivity (Categorical) | 75-99% breast milk | 45 Participants |
| Antenatal Milk Expression (AME) Intervention Group | Breastfeeding Exclusivity (Categorical) | 100% breast milk | 45 Participants |
| Video-based Infant Care Education Control Group | Breastfeeding Exclusivity (Categorical) | 100% breast milk | 46 Participants |
| Video-based Infant Care Education Control Group | Breastfeeding Exclusivity (Categorical) | 0% breast milk | 0 Participants |
| Video-based Infant Care Education Control Group | Breastfeeding Exclusivity (Categorical) | 75-99% breast milk | 56 Participants |
| Video-based Infant Care Education Control Group | Breastfeeding Exclusivity (Categorical) | 1-74% breast milk | 25 Participants |
p-value: 0.4258Chi-squared
p-value: 0.624695% CI: [0.5523, 1.4283]Regression, Logistic
Secondary
Breastfeeding Self-efficacy
Scores on Breastfeeding Self-Efficacy Scale-SF(score range 14-70, with higher score represents better outcome)
Time frame: 12 weeks postpartum
Population: Please note that this indicates the number of participants who completed the BSES-SF in its entirety at this timepoint. Some participants may not have completed this portion of the survey due to 1) not completing a survey at this timepoint, or 2) reporting breastfeeding discontinuation at this timepoint, rendering this survey not applicable to their current experience.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Antenatal Milk Expression (AME) Intervention Group | Breastfeeding Self-efficacy | 52.6 score on a scale | Standard Deviation 13.9 |
| Video-based Infant Care Education Control Group | Breastfeeding Self-efficacy | 49.7 score on a scale | Standard Deviation 14.3 |
p-value: 0.386195% CI: [-1.5771, 4.0594]Regression, Linear
Secondary
Breastfeeding Self-efficacy
Scores on Breastfeeding Self-Efficacy Scale-SF(score range 14-70, with higher score represents better outcome)
Time frame: 6 weeks postpartrum
Population: Please note that this indicates the number of participants who completed the BSES-SF in its entirety at this timepoint. Some participants may not have completed this portion of the survey due to 1) not completing a survey at this timepoint, or 2) reporting breastfeeding discontinuation at this timepoint, rendering this survey not applicable to their current experience.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Antenatal Milk Expression (AME) Intervention Group | Breastfeeding Self-efficacy | 49.7 score on a scale | Standard Deviation 14.3 |
| Video-based Infant Care Education Control Group | Breastfeeding Self-efficacy | 48.8 score on a scale | Standard Deviation 13.1 |
p-value: 0.554895% CI: [-1.9161, 3.5588]Regression, Linear
Secondary
Number of Participants Breastfeeding at 12 Months Postpartum
Participants were asked what their infant was currently being fed. Responses were categorized as YES for Breastfeeding Duration if they answered that they were still feeding their own breast milk to their infant at each respective timepoint. Please note that responses were still classified as a YES if they were combination feeding (e.g., using their own breast milk along with formula, solids, etc.). Responses were categorized as NO if they had ceased to provide any of their own breast milk to their infant.
Time frame: 12 months postpartum
Population: Please note that this indicates the number of participants who are represented here reflect only those who had still been active in the study at this point, exclusive of participants that had withdrawn (either by self or study staff) or did not complete a survey at this timepoint (either due to breastfeeding cessation at a prior timepoint or failure to complete the survey).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Antenatal Milk Expression (AME) Intervention Group | Number of Participants Breastfeeding at 12 Months Postpartum | Yes | 50 Participants |
| Antenatal Milk Expression (AME) Intervention Group | Number of Participants Breastfeeding at 12 Months Postpartum | No | 33 Participants |
| Video-based Infant Care Education Control Group | Number of Participants Breastfeeding at 12 Months Postpartum | Yes | 51 Participants |
| Video-based Infant Care Education Control Group | Number of Participants Breastfeeding at 12 Months Postpartum | No | 40 Participants |
p-value: 0.496895% CI: [0.6534, 2.4041]Regression, Logistic
Secondary
Number of Participants Breastfeeding at 12 Weeks Postpartum
Participants were asked what their infant was currently being fed. Responses were categorized as YES for Breastfeeding Duration if they answered that they were still feeding their own breast milk to their infant at each respective timepoint. Please note that responses were still classified as a YES if they were combination feeding (e.g., using their own breast milk along with formula, solids, etc.). Responses were categorized as NO if they had ceased to provide any of their own breast milk to their infant.
Time frame: 12 weeks postpartum
Population: Please note that this indicates the number of participants who are represented here reflect only those who had still been active in the study at this point, exclusive of participants that had withdrawn (either by self or study staff) or did not complete a survey at this timepoint (either due to breastfeeding cessation at a prior timepoint or failure to complete the survey).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Antenatal Milk Expression (AME) Intervention Group | Number of Participants Breastfeeding at 12 Weeks Postpartum | Yes | 96 Participants |
| Antenatal Milk Expression (AME) Intervention Group | Number of Participants Breastfeeding at 12 Weeks Postpartum | No | 8 Participants |
| Video-based Infant Care Education Control Group | Number of Participants Breastfeeding at 12 Weeks Postpartum | Yes | 103 Participants |
| Video-based Infant Care Education Control Group | Number of Participants Breastfeeding at 12 Weeks Postpartum | No | 8 Participants |
p-value: 0.817595% CI: [0.3882, 3.3161]Regression, Logistic
Secondary
Number of Participants Breastfeeding at 2 Weeks Postpartum
Participants were asked what their infant was currently being fed. Responses were categorized as YES for Breastfeeding Duration if they answered that they were still feeding their own breast milk to their infant at each respective timepoint. Please note that responses were still classified as a YES if they were combination feeding (e.g., using their own breast milk along with formula, solids, etc.). Responses were categorized as NO if they had ceased to provide any of their own breast milk to their infant.
Time frame: 2 weeks postpartum
Population: Please note that this indicates the number of participants who are represented here reflect only those who had still been active in the study at this point, exclusive of participants that had withdrawn (either by self or study staff) or did not complete a survey at this timepoint.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Antenatal Milk Expression (AME) Intervention Group | Number of Participants Breastfeeding at 2 Weeks Postpartum | Yes | 121 Participants |
| Antenatal Milk Expression (AME) Intervention Group | Number of Participants Breastfeeding at 2 Weeks Postpartum | No | 10 Participants |
| Video-based Infant Care Education Control Group | Number of Participants Breastfeeding at 2 Weeks Postpartum | Yes | 127 Participants |
| Video-based Infant Care Education Control Group | Number of Participants Breastfeeding at 2 Weeks Postpartum | No | 10 Participants |
p-value: 1Chi-squared
p-value: 0.916395% CI: [0.3669, 2.4621]Regression, Logistic
Secondary
Number of Participants Breastfeeding at 6 Months Postpartum
Participants were asked what their infant was currently being fed. Responses were categorized as YES for Breastfeeding Duration if they answered that they were still feeding their own breast milk to their infant at each respective timepoint. Please note that responses were still classified as a YES if they were combination feeding (e.g., using their own breast milk along with formula, solids, etc.). Responses were categorized as NO if they had ceased to provide any of their own breast milk to their infant.
Time frame: 6 months postpartum
Population: Please note that this indicates the number of participants who are represented here reflect only those who had still been active in the study at this point, exclusive of participants that had withdrawn (either by self or study staff) or did not complete a survey at this timepoint (either due to breastfeeding cessation at a prior timepoint or failure to complete the survey).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Antenatal Milk Expression (AME) Intervention Group | Number of Participants Breastfeeding at 6 Months Postpartum | Yes | 81 Participants |
| Antenatal Milk Expression (AME) Intervention Group | Number of Participants Breastfeeding at 6 Months Postpartum | No | 13 Participants |
| Video-based Infant Care Education Control Group | Number of Participants Breastfeeding at 6 Months Postpartum | Yes | 90 Participants |
| Video-based Infant Care Education Control Group | Number of Participants Breastfeeding at 6 Months Postpartum | No | 11 Participants |
p-value: 0.43495% CI: [0.2813, 1.7241]Regression, Logistic
Secondary
Number of Participants Breastfeeding at 6 Weeks Postpartum
Participants were asked what their infant was currently being fed. Responses were categorized as YES for Breastfeeding Duration if they answered that they were still feeding their own breast milk to their infant at each respective timepoint. Please note that responses were still classified as a YES if they were combination feeding (e.g., using their own breast milk along with formula, solids, etc.). Responses were categorized as NO if they had ceased to provide any of their own breast milk to their infant.
Time frame: 6 weeks postpartum
Population: Please note that this indicates the number of participants who are represented here reflect only those who had still been active in the study at this point, exclusive of participants that had withdrawn (either by self or study staff) or did not complete a survey at this timepoint (either due to breastfeeding cessation at a prior timepoint or failure to complete the survey).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Antenatal Milk Expression (AME) Intervention Group | Number of Participants Breastfeeding at 6 Weeks Postpartum | Yes | 108 Participants |
| Antenatal Milk Expression (AME) Intervention Group | Number of Participants Breastfeeding at 6 Weeks Postpartum | No | 15 Participants |
| Video-based Infant Care Education Control Group | Number of Participants Breastfeeding at 6 Weeks Postpartum | Yes | 107 Participants |
| Video-based Infant Care Education Control Group | Number of Participants Breastfeeding at 6 Weeks Postpartum | No | 15 Participants |
p-value: 0.803195% CI: [0.4937, 2.4882]Regression, Logistic
Secondary
Number of Participants Breastfeeding at Postpartum Hospitalization (0-4 Days Postpartum)
This variable was derived from the infant's feeding documentation via Electronic Medical Record. Responses were categorized as YES for Breastfeeding Duration if they answered that they were still feeding their own breast milk to their infant at each respective timepoint. Please note that responses were still classified as a YES if they were combination feeding (e.g., using their own breast milk along with formula, solids, etc.). Responses were categorized as NO if they had ceased to provide any of their own breast milk to their infant.
Time frame: Postpartum hospitalization (0-4 days postpartum)
Population: Please note that this indicates the number of participants who are represented here reflect only those who had still been active in the study at this point, exclusive of participants that had withdrawn (either by self or study staff).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Antenatal Milk Expression (AME) Intervention Group | Number of Participants Breastfeeding at Postpartum Hospitalization (0-4 Days Postpartum) | Yes | 138 Participants |
| Antenatal Milk Expression (AME) Intervention Group | Number of Participants Breastfeeding at Postpartum Hospitalization (0-4 Days Postpartum) | No | 0 Participants |
| Video-based Infant Care Education Control Group | Number of Participants Breastfeeding at Postpartum Hospitalization (0-4 Days Postpartum) | Yes | 136 Participants |
| Video-based Infant Care Education Control Group | Number of Participants Breastfeeding at Postpartum Hospitalization (0-4 Days Postpartum) | No | 2 Participants |
p-value: 0.4779t-test, 1 sided
Secondary
Number of Participants Commenting on the Impact/Integration of AME During Pregnancy and Utilization of Antenatally Collected Milk During the Postpartum Period
A subset of participants took place in a qualitative assessment via semi-structured interview. Numbers below represent the number of participants who endorsed each of the following categories during their interview: 1) discussing the impact of the study on their pregnancy/postpartum experience, 2) integration of AME into their daily life, and 3) utilization of antenatal milk during the postpartum period
Time frame: 6 weeks postpartum
Population: Please note that this indicates the number of participants who were invited, agreed to participate, and completed a qualitative interview at 6 weeks postpartum.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Antenatal Milk Expression (AME) Intervention Group | Number of Participants Commenting on the Impact/Integration of AME During Pregnancy and Utilization of Antenatally Collected Milk During the Postpartum Period | Impact of/motivation for AME | 11 Participants |
| Antenatal Milk Expression (AME) Intervention Group | Number of Participants Commenting on the Impact/Integration of AME During Pregnancy and Utilization of Antenatally Collected Milk During the Postpartum Period | Integration of AME into daily life | 26 Participants |
| Antenatal Milk Expression (AME) Intervention Group | Number of Participants Commenting on the Impact/Integration of AME During Pregnancy and Utilization of Antenatally Collected Milk During the Postpartum Period | Utilization of milk collected antenatally | 11 Participants |
| Video-based Infant Care Education Control Group | Number of Participants Commenting on the Impact/Integration of AME During Pregnancy and Utilization of Antenatally Collected Milk During the Postpartum Period | Impact of/motivation for AME | 15 Participants |
| Video-based Infant Care Education Control Group | Number of Participants Commenting on the Impact/Integration of AME During Pregnancy and Utilization of Antenatally Collected Milk During the Postpartum Period | Integration of AME into daily life | 0 Participants |
| Video-based Infant Care Education Control Group | Number of Participants Commenting on the Impact/Integration of AME During Pregnancy and Utilization of Antenatally Collected Milk During the Postpartum Period | Utilization of milk collected antenatally | 0 Participants |
Secondary
Number of Participants Exclusively Breastfeeding at 12 Weeks Postpartum
This variable derived from participant self-report survey emailed at 12 weeks postpartum. Responses for Breastfeeding Exclusivity were categorized as YES if the infant had been fed only their mother's own breast milk. Responses were categorized as NO if they had received anything other than only their mother's own breast milk (e.g., formula + their own milk, formula only).
Time frame: 12 weeks postpartum
Population: Please note that this indicates the number of participants who are represented here reflect only those who had still been active in the study at this point, exclusive of participants that had withdrawn (either by self or study staff) or did not complete a survey at this timepoint (either due to breastfeeding cessation at a prior timepoint or failure to complete the survey).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Antenatal Milk Expression (AME) Intervention Group | Number of Participants Exclusively Breastfeeding at 12 Weeks Postpartum | Exclusively breastfeeding | 67 Participants |
| Antenatal Milk Expression (AME) Intervention Group | Number of Participants Exclusively Breastfeeding at 12 Weeks Postpartum | Not exclusively breastfeeding | 37 Participants |
| Video-based Infant Care Education Control Group | Number of Participants Exclusively Breastfeeding at 12 Weeks Postpartum | Exclusively breastfeeding | 69 Participants |
| Video-based Infant Care Education Control Group | Number of Participants Exclusively Breastfeeding at 12 Weeks Postpartum | Not exclusively breastfeeding | 42 Participants |
p-value: 0.520995% CI: [0.4192, 1.216]Regression, Logistic
Secondary
Number of Participants Exclusively Breastfeeding at 2 Weeks Postpartum
This variable derived from participant self-report survey emailed at 2 weeks postpartum. Responses for Breastfeeding Exclusivity were categorized as YES if the infant had been fed only their mother's own breast milk. Responses were categorized as NO if they had received anything other than only their mother's own breast milk (e.g., formula + their own milk, formula only).
Time frame: 2 weeks postpartum
Population: Please note that this indicates the number of participants who are represented here reflect only those who had still been active in the study at this point, exclusive of participants that had withdrawn (either by self or study staff) or did not complete a survey at this timepoint.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Antenatal Milk Expression (AME) Intervention Group | Number of Participants Exclusively Breastfeeding at 2 Weeks Postpartum | Exclusively breastfeeding | 45 Participants |
| Antenatal Milk Expression (AME) Intervention Group | Number of Participants Exclusively Breastfeeding at 2 Weeks Postpartum | Not exclusively breastfeeding | 76 Participants |
| Video-based Infant Care Education Control Group | Number of Participants Exclusively Breastfeeding at 2 Weeks Postpartum | Exclusively breastfeeding | 46 Participants |
| Video-based Infant Care Education Control Group | Number of Participants Exclusively Breastfeeding at 2 Weeks Postpartum | Not exclusively breastfeeding | 81 Participants |
p-value: 0.9788Chi-squared
p-value: 0.911995% CI: [0.603, 1.7067]Regression, Logistic
Secondary
Number of Participants Exclusively Breastfeeding at 6 Months Postpartum
This variable derived from participant self-report survey emailed at 6 months postpartum. Responses for Breastfeeding Exclusivity were categorized as YES if the infant had been fed only their mother's own breast milk. Responses were categorized as NO if they had received anything other than only their mother's own breast milk (e.g., formula + their own milk, formula only).
Time frame: 6 months postpartum
Population: Please note that this indicates the number of participants who are represented here reflect only those who had still been active in the study at this point, exclusive of participants that had withdrawn (either by self or study staff) or did not complete a survey at this timepoint (either due to breastfeeding cessation at a prior timepoint or failure to complete the survey).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Antenatal Milk Expression (AME) Intervention Group | Number of Participants Exclusively Breastfeeding at 6 Months Postpartum | Exclusively breastfeeding | 0 Participants |
| Antenatal Milk Expression (AME) Intervention Group | Number of Participants Exclusively Breastfeeding at 6 Months Postpartum | Not exclusively breastfeeding | 94 Participants |
| Video-based Infant Care Education Control Group | Number of Participants Exclusively Breastfeeding at 6 Months Postpartum | Exclusively breastfeeding | 2 Participants |
| Video-based Infant Care Education Control Group | Number of Participants Exclusively Breastfeeding at 6 Months Postpartum | Not exclusively breastfeeding | 99 Participants |
Secondary
Number of Participants Exclusively Breastfeeding at 6 Weeks Postpartum
This variable derived from participant self-report survey emailed at 6 weeks postpartum. Responses for Breastfeeding Exclusivity were categorized as YES if the infant had been fed only their mother's own breast milk. Responses were categorized as NO if they had received anything other than only their mother's own breast milk (e.g., formula + their own milk, formula only).
Time frame: 6 weeks postpartum
Population: Please note that this indicates the number of participants who are represented here reflect only those who had still been active in the study at this point, exclusive of participants that had withdrawn (either by self or study staff) or did not complete a survey at this timepoint (either due to breastfeeding cessation at a prior timepoint or failure to complete the survey).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Antenatal Milk Expression (AME) Intervention Group | Number of Participants Exclusively Breastfeeding at 6 Weeks Postpartum | Exclusively breastfeeding | 64 Participants |
| Antenatal Milk Expression (AME) Intervention Group | Number of Participants Exclusively Breastfeeding at 6 Weeks Postpartum | Not exclusively breastfeeding | 59 Participants |
| Video-based Infant Care Education Control Group | Number of Participants Exclusively Breastfeeding at 6 Weeks Postpartum | Exclusively breastfeeding | 73 Participants |
| Video-based Infant Care Education Control Group | Number of Participants Exclusively Breastfeeding at 6 Weeks Postpartum | Not exclusively breastfeeding | 49 Participants |
p-value: 0.217395% CI: [0.4192, 1.216]Regression, Logistic
Secondary
Number of Participants Exclusively Breastfeeding During Postpartum Hospitalization
This variable was derived from the infant's feeding documentation via Electronic Medical Record. Responses for Breastfeeding Exclusivity were categorized as YES if the infant had been fed only their mother's own breast milk. Responses were categorized as NO if they had received anything other than only their mother's own breast milk (e.g., formula + their own milk, formula only).
Time frame: Postpartum hospitalization (0-4 days postpartum)
Population: Please note that this indicates the number of participants who are represented here reflect only those who had still been active in the study at this point, exclusive of participants that had withdrawn (either by self or study staff).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Antenatal Milk Expression (AME) Intervention Group | Number of Participants Exclusively Breastfeeding During Postpartum Hospitalization | Exclusively breastfeeding | 79 Participants |
| Antenatal Milk Expression (AME) Intervention Group | Number of Participants Exclusively Breastfeeding During Postpartum Hospitalization | Not exclusively breastfeeding | 59 Participants |
| Video-based Infant Care Education Control Group | Number of Participants Exclusively Breastfeeding During Postpartum Hospitalization | Exclusively breastfeeding | 76 Participants |
| Video-based Infant Care Education Control Group | Number of Participants Exclusively Breastfeeding During Postpartum Hospitalization | Not exclusively breastfeeding | 61 Participants |
p-value: 0.8614t-test, 1 sided
p-value: 0.783695% CI: [0.6364, 1.8216]Regression, Logistic
Secondary
Onset of Lactogenesis II
Recall of lactogenesis II in post-birth days
Time frame: 2 weeks postpartum
Population: Please note that this indicates the number of participants who are represented here reflect only those who had still been active in the study at this point, exclusive of participants that had withdrawn (either by self or study staff) or did not complete a survey at this timepoint.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Antenatal Milk Expression (AME) Intervention Group | Onset of Lactogenesis II | 1 day or less | 5 Participants |
| Antenatal Milk Expression (AME) Intervention Group | Onset of Lactogenesis II | 2 days | 16 Participants |
| Antenatal Milk Expression (AME) Intervention Group | Onset of Lactogenesis II | 3 days | 40 Participants |
| Antenatal Milk Expression (AME) Intervention Group | Onset of Lactogenesis II | 4 days | 32 Participants |
| Antenatal Milk Expression (AME) Intervention Group | Onset of Lactogenesis II | More than 4 days | 33 Participants |
| Antenatal Milk Expression (AME) Intervention Group | Onset of Lactogenesis II | Never | 2 Participants |
| Video-based Infant Care Education Control Group | Onset of Lactogenesis II | More than 4 days | 31 Participants |
| Video-based Infant Care Education Control Group | Onset of Lactogenesis II | 1 day or less | 5 Participants |
| Video-based Infant Care Education Control Group | Onset of Lactogenesis II | 4 days | 40 Participants |
| Video-based Infant Care Education Control Group | Onset of Lactogenesis II | 2 days | 15 Participants |
| Video-based Infant Care Education Control Group | Onset of Lactogenesis II | Never | 4 Participants |
| Video-based Infant Care Education Control Group | Onset of Lactogenesis II | 3 days | 38 Participants |
p-value: 0.900595% CI: [0.659, 1.6062]Regression, Logistic
Secondary
Perceived Milk Supply (Continuous)
Score on PIBBS subscale of H & H Lactation Scale measuring perceived infant satisfaction with breast milk received (score range: 5-35, higher score is better outcome)
Time frame: 6 weeks postpartum
Population: Please note that this indicates the number of participants who completed the H\&H Lactation Scale in its entirety at this timepoint. Some participants may not have completed this portion of the survey due to 1) not completing a survey at this timepoint, or 2) reporting breastfeeding discontinuation at this timepoint, rendering this survey not applicable to their current experience.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Antenatal Milk Expression (AME) Intervention Group | Perceived Milk Supply (Continuous) | 26.7 score on a scale | Standard Deviation 8.11 |
| Video-based Infant Care Education Control Group | Perceived Milk Supply (Continuous) | 28.6 score on a scale | Standard Deviation 6.89 |
p-value: 0.0795% CI: [-3.9475, 0.1559]Regression, Linear
Secondary
Perceived Milk Supply (Continuous)
Score on PIBBS subscale of H & H Lactation Scale measuring perceived infant satisfaction with breast milk received (score range: 5-35, higher score is better outcome)
Time frame: 12 weeks postpartum
Population: Please note that this indicates the number of participants who completed the H\&H Lactation Scale in its entirety at this timepoint. Some participants may not have completed this portion of the survey due to 1) not completing a survey at this timepoint, or 2) reporting breastfeeding discontinuation at this timepoint, rendering this survey not applicable to their current experience.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Antenatal Milk Expression (AME) Intervention Group | Perceived Milk Supply (Continuous) | 26.7 score on a scale | Standard Deviation 8.11 |
| Video-based Infant Care Education Control Group | Perceived Milk Supply (Continuous) | 29.6 score on a scale | Standard Deviation 6.67 |
p-value: 0.629995% CI: [-2.574, 1.562]Regression, Linear
Secondary
Perceived Milk Supply (Continuous)
Score on PIBBS subscale of H & H Lactation Scale measuring perceived infant satisfaction with breast milk received (score range: 5-35, higher score is better outcome)
Time frame: 2 weeks postpartum
Population: Please note that this indicates the number of participants who completed the H\&H Lactation Scale in its entirety at this timepoint. Some participants may not have completed this portion of the survey due to 1) not completing a survey at this timepoint, or 2) reporting breastfeeding discontinuation at this timepoint, rendering this survey not applicable to their current experience.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Antenatal Milk Expression (AME) Intervention Group | Perceived Milk Supply (Continuous) | 26.5 score on a scale | Standard Deviation 7.92 |
| Video-based Infant Care Education Control Group | Perceived Milk Supply (Continuous) | 27.7 score on a scale | Standard Deviation 6.69 |
p-value: 0.12795% CI: [-3.2052, 0.4015]Regression, Linear
Secondary
Perceived Milk Supply (Dichotomous)
Endorsement of insufficient milk supply via investigator created item (dichotomous outcome)
Time frame: 2 weeks postpartum
Population: Please note that this indicates the number of participants who are represented here reflect only those who had still been active in the study at this point, exclusive of participants that had withdrawn (either by self or study staff) or did not complete a survey at this timepoint.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Antenatal Milk Expression (AME) Intervention Group | Perceived Milk Supply (Dichotomous) | Perceived as insufficient | 32 Participants |
| Antenatal Milk Expression (AME) Intervention Group | Perceived Milk Supply (Dichotomous) | Perceived as sufficient | 89 Participants |
| Video-based Infant Care Education Control Group | Perceived Milk Supply (Dichotomous) | Perceived as insufficient | 28 Participants |
| Video-based Infant Care Education Control Group | Perceived Milk Supply (Dichotomous) | Perceived as sufficient | 99 Participants |
p-value: 0.383595% CI: [0.4029, 1.4138]Regression, Logistic
Secondary
Perceived Milk Supply (Dichotomous)
Endorsement of insufficient milk supply via investigator created item (dichotomous outcome)
Time frame: 6 weeks postpartum
Population: Please note that this indicates the number of participants who are represented here reflect only those who had still been active in the study at this point, exclusive of participants that had withdrawn (either by self or study staff) or did not complete a survey at this timepoint (either due to breastfeeding cessation at a prior timepoint or failure to complete the survey).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Antenatal Milk Expression (AME) Intervention Group | Perceived Milk Supply (Dichotomous) | Perceived as insufficient | 31 Participants |
| Antenatal Milk Expression (AME) Intervention Group | Perceived Milk Supply (Dichotomous) | Perceived as sufficient | 77 Participants |
| Video-based Infant Care Education Control Group | Perceived Milk Supply (Dichotomous) | Perceived as insufficient | 26 Participants |
| Video-based Infant Care Education Control Group | Perceived Milk Supply (Dichotomous) | Perceived as sufficient | 81 Participants |
p-value: 0.45995% CI: [0.409, 1.4912]Regression, Logistic
Secondary
Perceived Milk Supply (Dichotomous)
Endorsement of insufficient milk supply via investigator created item (dichotomous outcome)
Time frame: 12 weeks postpartum
Population: Please note that this indicates the number of participants who are represented here reflect only those who had still been active in the study at this point, exclusive of participants that had withdrawn (either by self or study staff) or did not complete a survey at this timepoint (either due to breastfeeding cessation at a prior timepoint or failure to complete the survey).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Antenatal Milk Expression (AME) Intervention Group | Perceived Milk Supply (Dichotomous) | Perceived as insufficient | 22 Participants |
| Antenatal Milk Expression (AME) Intervention Group | Perceived Milk Supply (Dichotomous) | Perceived as sufficient | 74 Participants |
| Video-based Infant Care Education Control Group | Perceived Milk Supply (Dichotomous) | Perceived as insufficient | 22 Participants |
| Video-based Infant Care Education Control Group | Perceived Milk Supply (Dichotomous) | Perceived as sufficient | 81 Participants |
p-value: 0.849995% CI: [0.458, 1.9039]Regression, Logistic