Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04258709 · ClinicalTrials.gov registry record · NA
PRenatal Video-Based Education and PostPARtum Effects
A NA study, sponsored by University of Pittsburgh.
- Completed
- Registry status
- NA
- Development phase
- 280
- Enrollment target
NCT04258709 is a NA study that has completed, run by University of Pittsburgh. The registered enrollment target is 280 participants.
The verdict
NCT04258709, a NA study, has completed, sponsored by University of Pittsburgh.
- COMPLETED
- Registry status
- NA
- Development phase
- 280 participants
- Enrollment target
Study Summary
The purpose of this randomized controlled trial is to examine the impact of a remotely-delivered antenatal milk expression (AME) intervention versus an attention control condition on breastfeeding outcomes among a sample of 280 nulliparous, non-diabetic women with pre-pregnancy body mass indices ≥ 25. AME involves milk expression and collection in the third pregnancy trimester and is theorized to address multiple barriers to breastfeeding among women with higher BMI, including impaired breastfeeding self-efficacy, insufficient milk supply (critical period endocrine modulation of milk volume), and early formula supplementation in the context of a medically complex birth (availability of banked antenatal milk). Participants will be enrolled in their third trimester of pregnancy and allocated into one of two study arms: 1) AME instruction delivered by remote, live International Board Certified Lactation Consultants via an innovative app-based telelactation platform; or 2) an attention control condition (video-based infant care education unrelated to infant feeding). Video-based education for both groups will occur in weekly study visits from 37 to 40 weeks gestation, with women in the intervention group continuing AME 1-2 times per day at home. Measured outcomes of interest will include short and long-term breastfeeding practices (e.g., breastfeeding duration, exclusivity) and participants' experiences with and perceptions of AME.
Interventions
- BEHAVIORAL AME
- BEHAVIORAL Video-based infant care education
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 280 participants |
| Start Date | 2020-09-23 |
| Est. Completion | 2024-11-29 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04258709
The ClinicalTrials.gov registry entry for NCT04258709 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 280 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pittsburgh, which has 1,238 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which AME is the first listed.
NCT04258709 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04258709 about?
NCT04258709 is a clinical study titled "PRenatal Video-Based Education and PostPARtum Effects". The purpose of this randomized controlled trial is to examine the impact of a remotely-delivered antenatal milk expression (AME) intervention versus an attention control condition on breastfeeding outcomes among a sample of 280 nulliparous, non-diabetic women with pre-pregnancy body mass indices ≥ 2...
What is the current status of trial NCT04258709?
This trial is currently completed. It is a NA study. The enrollment target is 280 participants. The study started on 2020-09-23. Estimated completion is 2024-11-29.
What interventions are being tested in trial NCT04258709?
The interventions under investigation include: AME (BEHAVIORAL), Video-based infant care education (BEHAVIORAL).
Who is sponsoring clinical trial NCT04258709?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.