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

NCT02221895 | Completed DMC

• 1 other identifier: 214030
• Study Type: interventional
• Target: 344
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy; Breastfeeding; Contraception; Cervical Cancer; Postpartum Depression

Keywords

postpartum appointment; breastfeeding; postpartum contraception; postpartum cervical cancer screening; postpartum depression screening

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• breastfeeding

  5-6 months postpartum

• Contraception

  up to 6 months after delivery

• Depression screen

  up to 8wk postpartum

• Appointment utilization

  8wk postpartum

• BAPT

  within 48hr of enrollment

Study Arms (2)

Early Follow-up

EXPERIMENTAL

Postpartum follow up appointment 2-3 weeks after delivery

Other: Postpartum follow up appointment 2-3 weeks after delivery

Traditional Follow-up

ACTIVE COMPARATOR

Postpartum follow up 6-8wk after delivery (current clinical standard)

Other: Postpartum follow up 6-8wk after delivery

Interventions

Postpartum follow up appointment 2-3 weeks after delivery OTHER

experimental arm

Early Follow-up

Postpartum follow up 6-8wk after delivery OTHER

control arm

Traditional Follow-up

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Madigan Army Medical Center: lead

Study Sites (1)

Madigan Army Medical Center

Tacoma, Washington, 98431, United States

Location

Related Publications (1)

• Abbott JL, Carty JR, Hemman E, Batig AL. Effect of Follow-Up Intervals on Breastfeeding Rates 5-6 Months Postpartum: A Randomized Controlled Trial. Breastfeed Med. 2019 Jan/Feb;14(1):22-32. doi: 10.1089/bfm.2018.0071. Epub 2018 Nov 9.

  PMID: 30412416 DERIVED

MeSH Terms

Conditions

Breast Feeding; Uterine Cervical Neoplasms; Depression, Postpartum

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Puerperal Disorders; Pregnancy Complications; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Jonathon Abbott, MD

  Madigan Army Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2014
• First Posted: August 21, 2014
• Study Start: March 1, 2014
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: September 21, 2020

Record last verified: 2020-09

Locations

US (1)