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
NCT number | NCT02221895 |
Other study ID # | 214030 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 2014 |
Est. completion date | May 2017 |
Verified date | September 2020 |
Source | Madigan Army Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 344 |
Est. completion date | May 2017 |
Est. primary completion date | May 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
United States | Madigan Army Medical Center | Tacoma | Washington |
Lead Sponsor | Collaborator |
---|---|
Madigan Army Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | breastfeeding | 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. | 5-6 months postpartum | |
Secondary | breastfeeding | 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). | 5-6 months postpartum | |
Secondary | Contraception | Choice, use, prescription for contraception in the 6 months postpartum period. | up to 6 months after delivery | |
Secondary | Depression screen | Score of Edinburgh depression screen at time of postpartum encounter | up to 8wk postpartum | |
Secondary | Appointment utilization | Total number of appointments in the 8 weeks after delivery | 8wk postpartum | |
Secondary | BAPT | use of the BAPT screening tool to predict breastfeeding attrition | within 48hr of enrollment | |
Secondary | Cervical cancer screening | number of patients who had a pelvic examination at the time of their postpartum appointment | up to 8wk postpartum |
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