Trial Outcomes & Findings for Prenatal Breast Pump Education of Mothers and Their Support Person (NCT NCT04006509)

NCT ID: NCT04006509

Last Updated: 2024-05-21

Results Overview

Time in hours until mothers pump at least 20 mL of milk in 2 consecutive pumping sessions

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 90 participants
• Primary outcome timeframe: Up to 96 Hours
• Results posted on: 2024-05-21

Participant Flow

Participant milestones

Measure	Antenatal Education Group Patients will receive a prenatally delivered lactation educational program. Prenatally Delivered Lactation Educational Program: The support person (SP) of mothers at risk for preterm birth will be educated on how to use a breast pump and instructions regarding breast milk expression and have a pump in their hospital room	Standard of Care Group Patients will receive standard of care and not a prenatally delivered lactation educational program.
Overall Study STARTED	49	25
Overall Study COMPLETED	36	25
Overall Study NOT COMPLETED	13	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Prenatal Breast Pump Education of Mothers and Their Support Person

Baseline characteristics by cohort

Measure	Antenatal Education Group n=36 Participants Patients will receive a prenatally delivered lactation educational program. Prenatally Delivered Lactation Educational Program: The support person (SP) of mothers at risk for preterm birth will be educated on how to use a breast pump and instructions regarding breast milk expression and have a pump in their hospital room	Standard of Care Group n=25 Participants Patients will receive standard of care and not a prenatally delivered lactation educational program.	Total n=61 Participants Total of all reporting groups
Age, Continuous	27.2 years STANDARD_DEVIATION 6.4 • n=5 Participants	29 years STANDARD_DEVIATION 6 • n=7 Participants	28 years STANDARD_DEVIATION 6.1 • n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants	25 Participants n=7 Participants	61 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	22 Participants n=5 Participants	14 Participants n=7 Participants	36 Participants n=5 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants	11 Participants n=7 Participants	24 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 96 Hours

Time in hours until mothers pump at least 20 mL of milk in 2 consecutive pumping sessions

Outcome measures

Measure	Antenatal Education Group n=36 Participants Patients will receive a prenatally delivered lactation educational program. Prenatally Delivered Lactation Educational Program: The support person (SP) of mothers at risk for preterm birth will be educated on how to use a breast pump and instructions regarding breast milk expression and have a pump in their hospital room	Standard of Care Group n=25 Participants Patients will receive standard of care and not a prenatally delivered lactation educational program.
Onset of Lactogenesis Stage II Through Volume Attainment	84.8 hours Interval 58.8 to 102.6	81 hours Interval 61.3 to 101.3

SECONDARY outcome

Timeframe: 0-24 hours postpartum

Volume of breast milk produced from 0-24 hours postpartum

Outcome measures

Measure	Antenatal Education Group n=36 Participants Patients will receive a prenatally delivered lactation educational program. Prenatally Delivered Lactation Educational Program: The support person (SP) of mothers at risk for preterm birth will be educated on how to use a breast pump and instructions regarding breast milk expression and have a pump in their hospital room	Standard of Care Group n=25 Participants Patients will receive standard of care and not a prenatally delivered lactation educational program.
Breast Milk Production on Day 1	15.3 mL Standard Deviation 16.5	24.3 mL Standard Deviation 28.1

SECONDARY outcome

Timeframe: first 24 hours after delivery

Time to mothers beginning to pump breasts after delivery

Outcome measures

Measure	Antenatal Education Group n=36 Participants Patients will receive a prenatally delivered lactation educational program. Prenatally Delivered Lactation Educational Program: The support person (SP) of mothers at risk for preterm birth will be educated on how to use a breast pump and instructions regarding breast milk expression and have a pump in their hospital room	Standard of Care Group n=25 Participants Patients will receive standard of care and not a prenatally delivered lactation educational program.
Time to Breast Pumping Initiation	4 Hours Standard Deviation 3.5	3.8 Hours Standard Deviation 3.4

SECONDARY outcome

Timeframe: Day 2 postpartum

Volume of breast milk produced on day 2 postpartum

Outcome measures

Measure	Antenatal Education Group n=36 Participants Patients will receive a prenatally delivered lactation educational program. Prenatally Delivered Lactation Educational Program: The support person (SP) of mothers at risk for preterm birth will be educated on how to use a breast pump and instructions regarding breast milk expression and have a pump in their hospital room	Standard of Care Group n=25 Participants Patients will receive standard of care and not a prenatally delivered lactation educational program.
Breast Milk Production Day 2	32.7 mL Standard Deviation 35.6	39.5 mL Standard Deviation 43.7

SECONDARY outcome

Timeframe: 3 days postpartum

Volume of milk produced on Day 3 postpartum

Outcome measures

Measure	Antenatal Education Group n=36 Participants Patients will receive a prenatally delivered lactation educational program. Prenatally Delivered Lactation Educational Program: The support person (SP) of mothers at risk for preterm birth will be educated on how to use a breast pump and instructions regarding breast milk expression and have a pump in their hospital room	Standard of Care Group n=24 Participants Patients will receive standard of care and not a prenatally delivered lactation educational program.
Milk Production Day 3	55.88 mL Standard Deviation 57.9	59.7 mL Standard Deviation 58

SECONDARY outcome

Timeframe: Day 4 postpartum

Volume of breast milk produced on Day 4 postpartum

Outcome measures

Measure	Antenatal Education Group n=36 Participants Patients will receive a prenatally delivered lactation educational program. Prenatally Delivered Lactation Educational Program: The support person (SP) of mothers at risk for preterm birth will be educated on how to use a breast pump and instructions regarding breast milk expression and have a pump in their hospital room	Standard of Care Group n=24 Participants Patients will receive standard of care and not a prenatally delivered lactation educational program.
Breast Milk Production Day 4	101.8 mL Standard Deviation 126.6	97.4 mL Standard Deviation 87.2

SECONDARY outcome

Timeframe: Day 5 postpartum

Volume of breast milk produced on Day 5 postpartum

Outcome measures

Measure	Antenatal Education Group n=36 Participants Patients will receive a prenatally delivered lactation educational program. Prenatally Delivered Lactation Educational Program: The support person (SP) of mothers at risk for preterm birth will be educated on how to use a breast pump and instructions regarding breast milk expression and have a pump in their hospital room	Standard of Care Group n=25 Participants Patients will receive standard of care and not a prenatally delivered lactation educational program.
Breast Milk Production on Day 5	149.9 mL Standard Deviation 167.4	138.5 mL Standard Deviation 113.2

SECONDARY outcome

Timeframe: Day 6 postpartum

Volume of breast milk produced on Day 6 postpartum

Outcome measures

Measure	Antenatal Education Group n=36 Participants Patients will receive a prenatally delivered lactation educational program. Prenatally Delivered Lactation Educational Program: The support person (SP) of mothers at risk for preterm birth will be educated on how to use a breast pump and instructions regarding breast milk expression and have a pump in their hospital room	Standard of Care Group n=25 Participants Patients will receive standard of care and not a prenatally delivered lactation educational program.
Breast Milk Production Day 6	245.3 mL Standard Deviation 317.9	266.8 mL Standard Deviation 300.1

SECONDARY outcome

Timeframe: Day 7 postpartum

Volume of milk produced on Day 7 postpartum

Outcome measures

Measure	Antenatal Education Group n=36 Participants Patients will receive a prenatally delivered lactation educational program. Prenatally Delivered Lactation Educational Program: The support person (SP) of mothers at risk for preterm birth will be educated on how to use a breast pump and instructions regarding breast milk expression and have a pump in their hospital room	Standard of Care Group n=24 Participants Patients will receive standard of care and not a prenatally delivered lactation educational program.
Breast Milk Production Day 7	345 mL Standard Deviation 558.4	361.9 mL Standard Deviation 342.3

SECONDARY outcome

Timeframe: Day 14 postpartum

Volume of breast milk produced on Day 14 postpartum

Outcome measures

Measure	Antenatal Education Group n=36 Participants Patients will receive a prenatally delivered lactation educational program. Prenatally Delivered Lactation Educational Program: The support person (SP) of mothers at risk for preterm birth will be educated on how to use a breast pump and instructions regarding breast milk expression and have a pump in their hospital room	Standard of Care Group n=25 Participants Patients will receive standard of care and not a prenatally delivered lactation educational program.
Breast Milk Production Day 14	431 mL Standard Deviation 416.7	428 mL Standard Deviation 349.9

SECONDARY outcome

Timeframe: 21 days postpartum

Volume of breast milk produced on Day 21 postpartum

Outcome measures

Measure	Antenatal Education Group n=29 Participants Patients will receive a prenatally delivered lactation educational program. Prenatally Delivered Lactation Educational Program: The support person (SP) of mothers at risk for preterm birth will be educated on how to use a breast pump and instructions regarding breast milk expression and have a pump in their hospital room	Standard of Care Group n=17 Participants Patients will receive standard of care and not a prenatally delivered lactation educational program.
Breast Milk Production Day 21	725 mL Standard Deviation 1070.1	573.9 mL Standard Deviation 402.1

Adverse Events

Antenatal Education Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard of Care Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Leslie A. Parker

University of Florida

Phone: 352 273 6384

Email: parkela@ufl.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place