The Effect of Early Versus Traditional Follow-Up on Breastfeeding Rates at 6 Months
Condition: Pregnancy; Breastfeeding; Contraception; Cervical Cancer; Postpartum Depression
MeSH terms: Uterine Cervical Neoplasms; Depression, Postpartum; Depression
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Postpartum follow up appointment 2-3 weeks after delivery; Postpartum follow up 6-8wk after delivery
Intervention type(s): Other; Other
Intervention description(s): experimental arm; control arm
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: postpartum appointment; breastfeeding; postpartum contraception; postpartum cervical cancer screening; postpartum depression screening