Pregnancy Clinical Trial
Official title:
The Effect of Early (2-3 Week Postpartum) Versus Traditional (6-8 Week Postpartum) Follow-Up on Breastfeeding Rates at 6 Months
The study's purpose is to determine if early (2-3 week) versus traditional (6-8 week) postpartum follow up is associated with a higher rate of breastfeeding at 6 months. The study's hypothesis is that follow up at 2-3 weeks postpartum is associated with a higher rate of breastfeeding 6 months postpartum.
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.
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