Status:
COMPLETED
The Effect of Early Versus Traditional Follow-Up on Breastfeeding Rates at 6 Months
Lead Sponsor:
Madigan Army Medical Center
Conditions:
Pregnancy
Breastfeeding
Eligibility:
FEMALE
18-50 years
Phase:
NA
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...
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 postpart...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2017
Estimated Enrollment :
344 Patients enrolled
Trial Details
Trial ID
NCT02221895
Start Date
March 1 2014
End Date
May 1 2017
Last Update
September 21 2020
Active Locations (1)
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1
Madigan Army Medical Center
Tacoma, Washington, United States, 98431