The Effect of Early Versus Traditional Follow-Up on Breastfeeding Rates at 6 Months

This study is a non-blinded randomized controlled trial with intent to treat analysis
intended to determine whether early (2-3 weeks postpartum-experimental arm) versus
traditional (6-8 weeks postpartum-control arm) follow up increases breastfeeding rates at 6
months' postpartum. For purposes of this study, breastfeeding will be defined as any breast
milk produced by the mother and fed to her infant (whether by placing the infant to the
breast or pumping/expressing milk and feeding it to the infant in another way). A literature
search failed to identify any study that evaluated benefits or shortcomings of an exclusive
short interval postpartum visit instead of the 6-8 week traditionally timed visit. Although
there may be practical reasons to delay postpartum follow up until 6-8 weeks after delivery,
there is no good data to support this, and it may remain the dominant practice due solely to
convention. Recent expert opinion has suggested that earlier postpartum follow up may be
more practical and provide an earlier or more convenient opportunity to provide assessment
and education to postpartum women [9]. Earlier follow up may present a more timely
opportunity to discuss family planning, breastfeeding, and screen for depression. Pierce
CountyWomen/Infants/Children Program (WIC) data indicates a 34% breastfeeding rate in the
military beneficiary population 6 months' postpartum (2012 data). Using a sample size of 166
in the exposure and non-exposure arms would allow for detection of a 50% increase in the
outcome of the exposure arm using a two-sided test with α = 0.05 and β = 0.20. A 50%
increase in the rate of breastfeeding 6 months' postpartum (from 34% to 51%) would be a
clinically significant increase that approximates the Surgeon General's 2020 goal of a 60.6%
rate of breastfeeding at 6 months. We assume at 30% dropout rate, and therefore, plan to
recruit a total of 346 patients to the study.

Potential enrollees will be evaluated, recruited, and enrolled using the process described
in 6.2.3(b). A screening and enrollment log will track all patients reviewed for eligibility
whether or not they met inclusion/exclusion criteria and, if so, whether participation in
the study was accepted or declined. Patients who agree to enroll will sign the required
study consent and complete the breastfeeding attrition prediction tool (BAPT). With the
subject's assistance, the enrolling investigator will complete the demographic sheet. Once
these items are complete, randomization will occur. Randomization will be via
computer-generated block randomization with block sizes of six. Randomization and blocking
will be performed using the RAND function in Excel. Randomization will be performed by the
study's collaborating staff, who will have no direct contact with the potential subjects.
Treatment "A" will represent follow up 2-3 weeks postpartum. Treatment "B" will represent
follow up at 6-8 weeks postpartum. The randomized assignments denoted as either "Treatment
A: 2-3 week follow up" or "Treatment B: 6-8 week follow up" will be placed on a card within
sequentially numbered, sealed, opaque envelopes by the collaborating staff. The
randomization process, card, and envelope preparation will all be completed by the
collaborating staff without any involvement of the study investigators. These sequentially
numbered and sealed envelopes will be secured on Labor and Delivery until the study
investigator allocates an envelope to the enrollee. Once a patient agrees to enrollment, the
required demographic and screening tools are completed and the study consent form signed,
the box containing the sequentially numbered and sealed envelopes will be opened by the
study investigator and the patient will be given the next envelope in the sequence. Prior to
opening the envelope, the study investigator will denote on the enrollment log the date of
subject enrollment and the sequence number of the envelope assigned to the subject. The
envelope number assigned to the subject will be their study number. The subject will then
open the assigned envelope to determine their treatment assignment, and the study
investigator will denote the study arm assignment on the enrollment log.

Once assigned to a treatment arm, the screening and enrollment log designating treatment
assignments will be used to coordinate with the clerk in the Ob/Gyn Clinic, who will contact
the subject to schedule postpartum follow up at the allotted interval. The scheduled
appointments will be with providers (nurse practitioners and nurse midwives) not associated
with the study. At the postpartum visit, the subject will complete and return the postpartum
questionnaire, along with the Edinburgh perinatal depression screen, which is standard
screening completed by all postpartum patients. Subjects demonstrating an elevated
depression screen will be followed and assessed according to previously approved
departmental protocol (MAMC Perinatal Screening Program Algorithm). Subjects who fail to
show up at the assigned follow up interval will be included in the 6-month postpartum
assessment. Subjects who return for follow up at intervals outside their assigned
appointment interval will also be contacted for the 6- month follow up and included in their
originally assigned group for data analysis (intent-to-treat).

When the patient is 5-6 months' postpartum, a study investigator will telephonically contact
the subject to obtain answers to the 6-month postpartum questionnaire. The questionnaire
will be reviewed by standardized script.

A multitude of factors influence breastfeeding success for mothers choosing to breastfeed.
Some of these factors include prior breastfeeding experience, maternal and fetal medical
complications, social support, attitudes, education, age, race, and other demographic
factors, as well as maternal-fetal proximity within the immediate postpartum period. To
minimize potential confounders and bias, we aim to enroll only primiparous mothers, as these
mothers are unlikely to have prior breastfeeding experience. Demographic information
collected will be used to perform subset analyses and evaluate the homogeneity of the two
study groups. The standardized assessment tools will be used to characterize maternal
attitudes and support for breastfeeding and will also be used for subset analysis. Some
neonates are unable to be with their mother immediately after birth due to a variety of
issues that may warrant observation in the Neonatal Intensive Care Unit (NICU) or, in some
cases, due to maternal illness. We will also exclude mothers whose infants are not
rooming-in with them continuously for the first 48 hours postpartum, as this may pose a
potential barrier to initiating breastfeeding. To ensure the study is generalizable, we will
include mothers with spontaneous or operative deliveries, as well as cesarean deliveries,
which constitute approximately 16% (nulliparous term singleton vertex cesarean birth rate at
our facility in 2012) of primiparous births at our facility, as long as the other
inclusion/exclusion criteria are met. Additionally, some patients may present for enhanced
follow up (in the case of a complicated delivery or postpartum complication) or acute visits
within the first 8 weeks' postpartum. These visits represent other opportunities outside the
typical postpartum follow up appointment for mothers to seek evaluation for breastfeeding
support or other concerns. We will collect data on the number and type of scheduled and
unscheduled provider encounters that occur within our medical system outside of the
scheduled postpartum follow up appointment. Furthermore, some subjects may fail to follow up
at the assigned interval. Data analysis will be via an intent-to-treat, therefore, subjects
assigned to one arm or the other who either fail to follow up at the assigned interval or
follow up more frequently will still be evaluated and assessed for the primary outcome.

1. Describe what will happen on this study that is EXPERIMENTAL: Subjects in the
experimental arm (2-3 week postpartum follow up) will have their postpartum appointment
at an earlier interval that what is current considered the standard of care. All study
participants will complete the BAPT. Demographic data will be obtained for each subject
prior to their discharge. All subjects will also complete a standardized postpartum
questionnaire at their scheduled postpartum visit (either 2-3 weeks or 6-8 weeks
depending on their arm of the study). All subjects will have a 6-month follow up via a
standardized/scripted phone survey.

2. Describe what will happen on this study that is STANDARD of CARE: The control arm of
the trial will be assigned to the traditional 6-8 week postpartum visit. All study
subjects will receive postpartum follow up care.

Inclusion Criteria:

- Age 18 or above at time of delivery

- Delivery of live born infant at estimated gestational age (EGA) ≥37wk

- Postpartum primiparous patients within the first 48 hours after delivery

- Patient intent to breastfeed

- Breastfeeding initiated within the first 48 hours of delivery and/or prior to
hospital discharge (whichever occurs first)

- Infant is continuously rooming in with mother from the time of delivery

- English-speaking

- Able to read and complete surveys

- No anticipated discharge from military system, Tricare benefits, or move planned in
the upcoming 6 months

- Willing to render informed consent

Exclusion Criteria:

- Patients delivered by the Family Medicine Department (relatively small number in our
population who are not followed postpartum by the Department of Obstetrics and
Gynecology)

- Any condition deemed by patient provider to be an absolute contraindication to
breastfeeding

- Maternal HIV/AIDS

- Planned use of radioactive or chemotherapeutic medications or medication for other
medical problems which is contraindicated for delivery

- Known fetal factor that would impair breastfeeding

- Fetal mid-facial defects

- Known fetal chromosomal abnormality

- Known fetal conditioning resulting in fetal hypotonia

- Labor and Delivery complications

- Maternal separation from infant during the first 48 hours postpartum (such as
maternal ICU admission, infant NICU admission)