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
Patients will be enrolled at 28w0d-36w0d. Randomized to one of two arms:
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
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.
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 →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.
Exclusion Criteria:
Complication in pregnancy including:
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
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
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
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
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
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
| Milestone | Labor Podcast Group | Usual Care |
|---|---|---|
| Started | 101 | 100 |
| Completed | 78 | 75 |
| Not completed | 23 | 25 |
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.
| score on a scale | Labor Podcast Group | Usual Care |
|---|---|---|
| Labor Agentry Scale | 57 (50 to 63) | 54 (47 to 62) |
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.
| score on a scale | Labor Podcast Group | Usual Care |
|---|---|---|
| Birth Satisfaction | 20 (18 to 21) | 18 (16 to 21) |
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
| score on a scale | Labor Podcast Group | Usual Care |
|---|---|---|
| Edinburgh Postpartum Depression Scale | 4 (1 to 5) | 3 (1 to 7) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Labor Podcast Group | — | — | — |
| Usual Care | — | — | — |
| Age, Categorical(Participants) | Labor Podcast Group | Usual Care | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 78 | 75 | 153 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Labor Podcast Group | Usual Care | Total |
|---|---|---|---|
| Mean | 30.4 ± 5.26 | 29.3 ± 6.08 | 30 ± 6 |
| Sex: Female, Male(Participants) | Labor Podcast Group | Usual Care | Total |
|---|---|---|---|
| Female | 78 | 75 | 153 |
| Male | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Labor Podcast Group | Usual Care | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 12 | 6 | 18 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 23 | 24 | 47 |
| White | 38 | 35 | 73 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 5 | 10 | 15 |
| Region of Enrollment(participants) | Labor Podcast Group | Usual Care | Total |
|---|---|---|---|
| United States | 78 | 75 | 153 |
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