ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02221895
Recruitment Status : Recruiting
First Posted : August 21, 2014
Last Update Posted : November 3, 2016
Sponsor:
Information provided by (Responsible Party):
Madigan Army Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Pregnancy Breastfeeding Contraception Cervical Cancer Postpartum Depression Other: Postpartum follow up appointment 2-3 weeks after delivery Other: Postpartum follow up 6-8wk after delivery Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 346 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Effect of Early (2-3 Week Postpartum) Versus Traditional (6-8 Week Postpartum) Follow-Up on Breastfeeding Rates at 6 Months
Study Start Date : March 2014
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Early Follow-up
Postpartum follow up appointment 2-3 weeks after delivery
Other: Postpartum follow up appointment 2-3 weeks after delivery
experimental arm

Active Comparator: Traditional Follow-up
Postpartum follow up 6-8wk after delivery (current clinical standard)
Other: Postpartum follow up 6-8wk after delivery
control arm




Primary Outcome Measures :
  1. breastfeeding [ Time Frame: 5-6 months postpartum ]
    Breastfeeding is defined, for purposes of this study, as any breast milk produced by the mother and fed to the infant (by placing the infant to the breast or by pumping or manually expressing and feeding to the infant by other means). Nominal/categorical assessment (breastfeeding to any degree: yes or no) of breastfeeding will be used to determine the primary outcome.


Secondary Outcome Measures :
  1. breastfeeding [ Time Frame: 5-6 months postpartum ]
    Subset analysis of primary outcome using additional nominal characterization (breastfeeding only with no other foods/water, breastfeeding with some table foods, breastfeeding and formula feeding with or without some table foods, formula feeding with or without some table foods, formula only).

  2. Contraception [ Time Frame: up to 6 months after delivery ]
    Choice, use, prescription for contraception in the 6 months postpartum period.

  3. Depression screen [ Time Frame: up to 8wk postpartum ]
    Score of Edinburgh depression screen at time of postpartum encounter

  4. Cervical cytology [ Time Frame: up to 8 weeks postpartum ]
    Adequacy of cytology collected at the postpartum visit

  5. Appointment utilization [ Time Frame: 8wk postpartum ]
    Total number of appointments in the 8 weeks after delivery

  6. BAPT [ Time Frame: within 48hr of enrollment ]
    use of the BAPT screening tool to predict breastfeeding attrition

  7. pelvic exam [ Time Frame: up to 8wk postpartum ]
    number of patients who had a pelvic examination at the time of their postpartum appointment



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02221895


Contacts
Contact: Jonathon Abbott, MD 253-968-5161 jonathon.l.abbott6.mil@mail.mil

Locations
United States, Washington
Madigan Army Medical Center Recruiting
Tacoma, Washington, United States, 98431
Contact: Alison Batig, MD    253-968-5161    alison.l.batig.mil@mail.mil   
Contact: Jon Abbott, MD    253-968-5161    jonathon.l.abbott6.mil@mail.mil   
Sub-Investigator: Alison Batig, MC         
Principal Investigator: Jonathon Abbott, MD         
Sub-Investigator: Timothy Clem, DO         
Sub-Investigator: Logan Peterson, MD         
Sponsors and Collaborators
Madigan Army Medical Center
Investigators
Principal Investigator: Jonathon Abbott, MD Madigan Army Medical Center

Responsible Party: Madigan Army Medical Center
ClinicalTrials.gov Identifier: NCT02221895     History of Changes
Other Study ID Numbers: 214030
First Posted: August 21, 2014    Key Record Dates
Last Update Posted: November 3, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Madigan Army Medical Center:
postpartum appointment
breastfeeding
postpartum contraception
postpartum cervical cancer screening
postpartum depression screening

Additional relevant MeSH terms:
Depression
Uterine Cervical Neoplasms
Depression, Postpartum
Behavioral Symptoms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Puerperal Disorders
Pregnancy Complications
Depressive Disorder
Mood Disorders
Mental Disorders