eDoula App for Pregnancy

Overseen By Women's Health Research Unit Department of Ob/Gyn

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Oregon Health and Science University

Disqualifiers: Planned cesarean, Pregnancy complications, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

60 Participants Needed

Trial Summary

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the eDoula App treatment for pregnancy?

Research on similar mobile apps, like the Baby Buddy app, shows limited evidence for improving pregnancy outcomes, but technology-supported lifestyle interventions have shown potential in optimizing gestational weight gain and postpartum weight retention, suggesting that apps like eDoula could be beneficial. ^{1 2 3 4 5}

How is the eDoula App treatment for pregnancy different from other treatments?

The eDoula App is unique because it is a digital tool designed to support pregnant individuals, unlike traditional medical treatments that involve medications or physical interventions. It offers guidance and resources through an app, making it a novel approach to pregnancy support. ^{6 7 8 9 10}

What is the purpose of this trial?

eDoula is an app that will give patients reading material and videos to watch based on their due date. It also provides helpful postpartum guidance. First, patients without access to the app will be recruited and surveyed on their labor and satisfaction outcomes. Then, recruitment will begin for the intervention arm of the study. Participants will be recruited to use the app and complete a survey during the postpartum period.

Research Team

Fei Cai, MD

Principal Investigator

Oregon Health and Science University

Eligibility Criteria

This trial is for first-time pregnant individuals with a single baby, who speak English and own a smartphone or device that can download the eDoula app. They must have delivered at 36 weeks of gestation or later.

Inclusion Criteria

I have never given birth.

I speak English.

I am pregnant with one baby.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Recruitment and Baseline

Participants are recruited and surveyed on their labor and satisfaction outcomes

19-28 weeks gestation

Intervention

Participants in the intervention arm use the eDoula app during pregnancy

From recruitment to delivery

Postpartum Follow-up

Participants complete surveys on labor satisfaction and postpartum guidance

7 days following delivery

Treatment Details

Interventions

• eDoula App

Trial Overview The eDoula Feasibility and Acceptability study tests an app providing educational content and postpartum guidance based on due dates. Participants will use the app then complete surveys to assess its impact on their labor experience and satisfaction.

Participant Groups

Group I: eDoula Intervention Experimental Treatment 1 Intervention

These participants will have access to the eDoula app during pregnancy.

Group II: Control Active Control 1 Intervention

These participants will receive routine pregnancy and delivery care.

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials

1,024

Recruited

7,420,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Evaluation of Mobile Applications Intended to Aid in Conception Using a Systematic Review Framework. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Study protocol: differential effects of diet and physical activity based interventions in pregnancy on maternal and fetal outcomes--individual patient data (IPD) meta-analysis and health economic evaluation. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Use of Mobile-Based Application for Collection of Patient-Reported Outcomes in Cardiac Surgery. [2021]

4. China pubmed.ncbi.nlm.nih.gov

The Bumps and BaBies Longitudinal Study (BaBBLeS): a multi-site cohort study of first-time mothers to evaluate the effectiveness of the Baby Buddy app. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Effect of Lifestyle Coaching Including Telemonitoring and Telecoaching on Gestational Weight Gain and Postnatal Weight Loss: A Systematic Review. [2020]

6. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

Use of everolimus following kidney transplantation during pregnancy: A case report and systematic review. [2023]

7. Croatia pubmed.ncbi.nlm.nih.gov

[Anti-TNF therapy in inflammatory bowel diseases during pregnancy and breast-feeding]. [2019]

8. Canada pubmed.ncbi.nlm.nih.gov

Effects and treatment of inflammatory bowel disease during pregnancy. [2021]

9. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Inflammatory bowel disease and pregnancy]. [2012]

10. Korea (South) pubmed.ncbi.nlm.nih.gov

Maternal and fetal outcomes in pregnant Japanese women with inflammatory bowel disease: our experience with a series of 23 cases. [2020]