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CompletedNCT04933708LaPPSUpdated Apr 24, 2025Results posted

LaPPS: Labor Podcast for Patient Satisfaction

An interventional study of Labor Podcast in Labor Onset and Length Abnormalities and Pregnancy Related, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-24.

Sponsored by University of Pennsylvania · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
201
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Female
01

Study summary

Patients will be enrolled at 28w0d-36w0d. Randomized to one of two arms:

  1. Labor podcasts - Seven labor podcasts that can be downloaded for any podcast app
  2. Usual care
Read the detailed description

Objectives Overall objectives To assess the effect of listening to physician-created podcasts of common labor topics on patient satisfaction and perception of their birth experience Primary outcome variable(s) Patient satisfaction as measured by LAS + 2 satisfaction questions Secondary outcome variable(s) Edinburgh Postpartum Depression Scale (EPDS) scores Logistic regression for multivariate analysis with regards to demographics and other birth outcomes

Background Recently, podcasts have been used for both undergraduate and graduate medical education, with studies showing that they are feasible, acceptable, and effective. Learners appear to enjoy podcast learning because they increased efficiency by allowing listeners to multitask, made listeners keep up to date with medical literature, and increased overall knowledge. However, podcast learning has not been as widespread for patient education. There have been some studies that showed that podcast patient education is feasible, and one small study showed increased knowledge scores after listening to podcasts.

To our knowledge, podcast learning has never been studied in the obstetric population. Labor and delivery is usually a time that is fraught with questions from first time mothers, and more education may increase these women's perception of control and satisfaction overall with birth and the postpartum period. The Labor Agentry Scale (LAS)-10 is a validated instrument measuring expectancies and experiences of personal control during childbirth. The Edinburgh Postnatal Depression Scale (EPDS) is also a validated scale that measures levels of postpartum depression that is commonly used at our institution both immediately postpartum and at the postpartum visit 4-6 weeks after delivery.

Study Design Design Pregnant patients between 28w0d - 36w0d will be randomized to one of the following study arms upon enrollment. Patients will be approached after 20 weeks for consent and randomized after they reach 28 weeks. The study will be done in an intent-to-treat fashion. Due to the nature of the study, blinding will not be possible.

Study Arms 1) Labor Podcast Group - Women randomized to this arm will receive access to a link to download seven HUP physician created labor podcasts in addition to usual care during labor, delivery, and postpartum

o Podcast topics: Labor Anesthesia, Induction of Labor, Second Stage of Labor, Reasons for Cesarean Section, Postpartum Recovery, Complications of Labor and Birth, Normal Labor

  • LAS-10 and Birth Satisfaction survey - Women will be sent these surveys on postpartum day 2 via method they indicated they desire (either email or text message)
  • EPDS - Women will receive this survey on postpartum day 7 via method they desire

    1. Usual care Women randomized to this arm will receive usual care during labor, delivery, and postpartum with the following exceptions:
  • LAS-10 and Birth Satisfaction survey Women will be sent these surveys on postpartum day 2 via method they indicated they desire (either email or text message)
  • EPDS Women will receive this survey on postpartum day 7 via method they desire

Study duration Estimated length of time to enroll all subjects and complete the study Length of a subject's participation time in study Project date of the proposed study

Estimated length of time to enroll all subjects and complete study:

Based on previous studies using the LAS-10, average score ranged between 45-53/70, with standard deviations ranging from 6-12. Therefore, we would estimate that the LAS score in the usual care group to be approximately 50. To be able to detect an effect size of 4, with a standard deviation of 9, and to achieve a power of 0.8 and alpha of 0.05, we would need a sample size of approximately 79 subjects per group. Calculating for a 20% loss to follow-up rate, we would anticipate recruiting 95 subjects per group.

Our city has an average of 16% preterm birth rate. Our hospital averages 1400 nulliparous deliveries/year. We would conservatively estimate approaching 50% of these women in the prenatal period for enrollment. If we assume a 75% consent rate for the RCT, which is standard for our center, we anticipate enrolling 30-36 women per month in our study. We would therefore anticipate it taking 6 months before we reach our target sample size.

We would then require an additional 6 months to compile and analyze the data.

Length of subject's participation:

Women will be followed from time of consent until 7 days postpartum Women will be followed from time of consent until 7 days postpartum.

Project date of the proposed study:

Proposed to start April 2021 for recruitment and enrollment. We anticipate enrolling all patients by end of September 2021. We would likely be able to conclude the study by April 2022.

Resources necessary for human research protection Subjects will be recruited from looking at antepartum clinic charts and messaged via MPM once they are deemed eligible. This can be one by Dr. Cai and Dr. Srinivas. Both will be trained in the study protocol prior to enrolling subjects.

The research staff will also distribute information regarding the study to the aforementioned prenatal clinics so that written information can be handed out by providers to patients. This will allow for patients to be aware of the study. However, only study personnel will be able to consent and enroll patients.

02

Conditions studied

  • Labor Onset and Length Abnormalities
  • Pregnancy Related

Keywords

  • Nulliparity
  • Podcast
  • Labor
03

In context

Congenital Abnormalities

980 studies on the registry are indexed under Congenital Abnormalities; 177 are open to participants now.

This study's enrollment of 201 is above the median of 49 across 491 interventional studies indexed under Congenital Abnormalities.

Browse Congenital Abnormalities studies →

Lead sponsor

University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.

Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Nulliparous
  • Singleton pregnancy
  • English-speaking
  • Age 18-50
  • Own a smart phone or device capable of downloading podcasts
  • Reached at least 36w0d of gestation
  • Willing and able to sign consent form

Exclusion criteria

Exclusion Criteria:

  • Planned cesarean delivery
  • Complication in pregnancy including:

    • Placenta accrete spectrum
    • Vasa previa
    • Intrauterine fetal demise
    • Known major fetal anomaly
  • Delivery planned at location other than the Hospital of the University of Pennsylvania
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Care provider)
Enrollment
201 participants (actual)

Study arms

  • Experimental
    Labor Podcast Group

    1) Labor Podcast Group - Women randomized to this arm will receive access to a link to download six HUP physician created labor podcasts in addition to usual care during labor, delivery, and postpartum o Podcast topics: Labor Anesthesia, Induction of Labor, Second Stage of Labor, Reasons for Cesarean Section, Postpartum Recovery, Complications of Labor and Birth * LAS-10 and Birth Satisfaction survey - Women will be sent these surveys on postpartum day 2 via method they indicated they desire (either email or text message) * EPDS - Women will receive this survey on postpartum day 7 via method they desire

    Behavioral: Labor Podcast

  • No intervention
    Usual Care

    2. Usual care Women randomized to this arm will receive usual care during labor, delivery, and postpartum with the following exceptions: * LAS-10 and Birth Satisfaction survey Women will be sent these surveys on postpartum day 2 via method they indicated they desire (either email or text message) * EPDS Women will receive this survey on postpartum day 7 via method they desire

Interventions

  • BehavioralLabor Podcast

    Listening to podcasts. Topics include: Labor Anesthesia, Induction of Labor, Second Stage of Labor, Reasons for Cesarean Section, Postpartum Recovery, Complications of Labor and Birth

06

What researchers measure

Primary outcomes

  1. Labor Agentry Scale

    Subjects will complete the labor agentry scale after delivery. Score on labor agentry scale will be compared between groups. Score range: 10-70. Higher scores indicate more agentry, which we consider to be better for this study.

    Time frame: 2 days after delivery

Secondary outcomes

  1. Birth Satisfaction

    Subjects will also complete a birth satisfaction survey after delivery. Score on birth satisfaction will be compared between two groups. Score range: 3 - 21. Higher scores indicate higher satisfaction.

    Time frame: 2 days after delivery

  2. Edinburgh Postpartum Depression Scale

    Subjects will complete the EPDS 7 days postpartum. Scores will be compared between the two groups. Score range: 0-30. Higher scores indicate more risk of depression

    Time frame: 7 days postpartum

07

Results

Posted Oct 16, 2024

Participant flow

Participant flow — Overall Study
MilestoneLabor Podcast GroupUsual Care
Started101100
Completed7875
Not completed2325

Outcome measures

PrimaryLabor Agentry Scale

Subjects will complete the labor agentry scale after delivery. Score on labor agentry scale will be compared between groups. Score range: 10-70. Higher scores indicate more agentry, which we consider to be better for this study.

Time frame:
2 days after delivery
Reported as:
Median · score on a scale
Labor Agentry Scale
score on a scaleLabor Podcast GroupUsual Care
Labor Agentry Scale57 (50 to 63)54 (47 to 62)
SecondaryBirth Satisfaction

Subjects will also complete a birth satisfaction survey after delivery. Score on birth satisfaction will be compared between two groups. Score range: 3 - 21. Higher scores indicate higher satisfaction.

Time frame:
2 days after delivery
Reported as:
Median · score on a scale
Birth Satisfaction
score on a scaleLabor Podcast GroupUsual Care
Birth Satisfaction20 (18 to 21)18 (16 to 21)
SecondaryEdinburgh Postpartum Depression Scale

Subjects will complete the EPDS 7 days postpartum. Scores will be compared between the two groups. Score range: 0-30. Higher scores indicate more risk of depression

Time frame:
7 days postpartum
Reported as:
Median · score on a scale
Edinburgh Postpartum Depression Scale
score on a scaleLabor Podcast GroupUsual Care
Edinburgh Postpartum Depression Scale4 (1 to 5)3 (1 to 7)

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Labor Podcast Group———
Usual Care———

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Labor Podcast GroupUsual CareTotal
<=18 years000
Between 18 and 65 years7875153
>=65 years000
Age, Continuous
Age, Continuous(years)Labor Podcast GroupUsual CareTotal
Mean30.4 ± 5.2629.3 ± 6.0830 ± 6
Sex: Female, Male
Sex: Female, Male(Participants)Labor Podcast GroupUsual CareTotal
Female7875153
Male000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Labor Podcast GroupUsual CareTotal
American Indian or Alaska Native000
Asian12618
Native Hawaiian or Other Pacific Islander000
Black or African American232447
White383573
More than one race000
Unknown or Not Reported51015
Region of Enrollment
Region of Enrollment(participants)Labor Podcast GroupUsual CareTotal
United States7875153
08

Study locations

1 site
  • Hospital of the University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
09

References and documents

Publications

  • Lee SC, Huang H, Minard CG, Schackman J, Rajagopalan S. The use of podcast videos for airway skills. Clin Teach. 2019 Dec;16(6):585-588. doi: 10.1111/tct.12984. Epub 2018 Dec 27. PubMed 30592144 ↗
  • Cai F, Burns RN, Kelly B, Hampton BS. CREOGs Over Coffee: Feasibility of an Ob-Gyn Medical Education Podcast by Residents. J Grad Med Educ. 2020 Jun;12(3):340-343. doi: 10.4300/JGME-D-19-00644.1. PubMed 32595856 ↗
  • Young B, Pouw A, Redfern A, Cai F, Chow J. Eyes for Ears-A Medical Education Podcast Feasibility Study. J Surg Educ. 2021 Jan-Feb;78(1):342-345. doi: 10.1016/j.jsurg.2020.06.041. Epub 2020 Jul 21. PubMed 32709568 ↗
  • Malecki SL, Quinn KL, Zilbert N, Razak F, Ginsburg S, Verma AA, Melvin L. Understanding the Use and Perceived Impact of a Medical Podcast: Qualitative Study. JMIR Med Educ. 2019 Sep 19;5(2):e12901. doi: 10.2196/12901. PubMed 31538949 ↗
  • Chin A, Helman A, Chan TM. Podcast Use in Undergraduate Medical Education. Cureus. 2017 Dec 9;9(12):e1930. doi: 10.7759/cureus.1930. PubMed 29464137 ↗

Study documents

  • Protocol and statistical analysis plan · Jul 16, 2021
  • Informed consent form · Jul 16, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04933708
Lead sponsor
University of Pennsylvania
Responsible party
Fei Cai, MD (Professor of Obstetrics and Gynecology, University of Pennsylvania) — Principal investigator
First posted
Jun 22, 2021
Start date
Jul 1, 2021
Primary completion
Jul 1, 2022
Completion
Jul 1, 2022
Results posted
Oct 16, 2024
Last update
Apr 24, 2025

Study contacts

Sindhu Srinivas, MD
principal investigator · University of Pennsylvania

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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