Accepted for/Published in: Journal of Medical Internet Research
Date Submitted: Feb 19, 2025
Date Accepted: Aug 30, 2025
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Testing the Birth APP: a Randomized Controlled Trial
ABSTRACT
Background:
Early labor is often managed at home without professional support. The Birth APP is a mHealth application designed to support women during early labor. A pilot-study revealed that women found the app's exercises simple, understandable, and useful. The app was perceived as useful and appreciated by women, although areas for improvement were identified, primarily related to technical issues. During the development and test period the updated app was tested in a randomized controlled trial (RCT).
Objective:
To investigate whether women using the Birth APP during pregnancy and childbirth experience less distress during early labor compared to those receiving standard antenatal care.
Methods:
This RCT used online recruiting in a non-blinded three-part blended care model with 1:1:1 randomization. Group 1: Birth APP intervention. Group 2: Birth APP Plus, combining the app with in-person additional midwifery contacts. Group 3: Control group receiving standard antenatal care. Pregnant nulliparous women were invited via social media. Eligibility criteria were: nulliparity, planning a vaginal birth, from gestational week 25+0 to 35+6 weeks, proficiency to understand Swedish, and having access to a smartphone or tablet.
Results:
A total of 391 women completed the baseline questionnaire, and 334 women responded to the questionnaire 1 month postpartum, yielding a response rate of 85.4%. Most participants experienced a spontaneous onset of labor across all groups, with no significant statistical differences. Women in the intervention groups remained at home longer during early labor, with a mean of 16.76 hours (SD 20.45) for group 1, and 14.47 hours (SD 16.82) for group 2 compared to 12.90 hours (SD 15.99) for group 3 (control), although this difference was not statistically significant. For the primary outcome, emotional distress in early labor, only women with spontaneous onset of labor were included in the analysis. The primary outcome showed similar mean values across groups. No statistically significant differences were identified for any of the secondary outcomes (childbirth experience, pain-relief and support from partner). However, when assessing fear of future birth, the intervention groups had lower mean values than the control group and pairwise testing revealed a statistically significant difference for both intervention groups (p-value .002 and < .001) with a medium effect size from baseline to follow-up.
Conclusions:
Our results indicate that the Birth APP, in conjunction with additional midwifery support, can serve as a valuable tool for pregnant women and their partners, during pregnancy and childbirth. The observed reduction in fear of forthcoming childbirth associated with the Birth APP warrants further investigation. Clinical Trial: ClinicalTrials.gov (ref. no. NCT05122390).
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