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NCT04300894 · ClinicalTrials.gov registry record · NA

"Mamma Mia" for Perinatal Health and Wellness

A NA study, sponsored by Virginia Commonwealth University.

Completed
Registry status
NA
Development phase
1,757
Enrollment target

NCT04300894: Completed NA study, sponsored by Virginia Commonwealth University.

NCT04300894 is a NA study that has completed, run by Virginia Commonwealth University. The registered enrollment target is 1,757 participants, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (25% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04300894, a NA study, has completed, sponsored by Virginia Commonwealth University.

COMPLETED
Registry status
NA
Development phase
1,757 participants
Enrollment target

Study Summary

The purpose of this research study is to find out about ways to enhance well-being during pregnancy and the postpartum period (after the baby is born). The "Mamma Mia" program and/or guided support from study staff ("Mamma Mia Plus") may be helpful because the app provides skills and information related to many important topics during and after pregnancy. This study will allow us to learn more about whether and how the program is helpful to women.

Primary Outcome

Measured by the Edinburgh Postpartum Depression Scale (EPDS), it uses a 10-item self-report questionnaire that screens for symptoms of depression and anxiety during pregnancy and the first year postpartum. Mothers are asked to select the answer that comes closest to how they have felt over the past 7 days. Each of the 10 questions is scored from 0 to 3, yielding a maximum total score of 30. Some questions (items 3, 5, 6, 7, 8, 9, 10) are reverse-scored (e.g., 3, 2, 1, 0 instead of 0, 1, 2, 3). 0

Interventions

  • DEVICE Mamma Mia
  • OTHER Mamma Mia Plus

Trial Details

FieldValue
Enrollment Target 1,757 participants
Start Date 2020-10-15
Est. Completion 2025-06-01
Phase NA
Virginia Commonwealth University

558 total trials

What the finished NCT04300894 record still lists

NCT04300894 is an interventional study that assigns participants to a tested intervention. Its 1,757 participants enrollment target places it among the larger protocols in the corpus, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (25% higher).

The record links to 0 conditions, and to 2 interventions - of which Mamma Mia is the first listed.

NCT04300894 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04300894 about?

NCT04300894 is a clinical study titled ""Mamma Mia" for Perinatal Health and Wellness". The purpose of this research study is to find out about ways to enhance well-being during pregnancy and the postpartum period (after the baby is born). The "Mamma Mia" program and/or guided support from study staff ("Mamma Mia Plus") may be helpful because the app provides skills and information rel...

What is the current status of trial NCT04300894?

This trial is currently completed. It is a NA study. The enrollment target is 1,757 participants. The study started on 2020-10-15. Estimated completion is 2025-06-01.

What interventions are being tested in trial NCT04300894?

The interventions under investigation include: Mamma Mia (DEVICE), Mamma Mia Plus (OTHER).

Who is sponsoring clinical trial NCT04300894?

This trial is sponsored by Virginia Commonwealth University, which has 558 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04300894's enrollment target sits among peer trials

1,757 61st of 2000 higher than 1,940 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04300894, the US trial registry maintained by the National Library of Medicine. NCT04300894 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.