- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04766099
Video Education for Labor and Delivery
Impact of a Video Education Tool for the Second Stage of Labor
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Childbirth education is critical to maternal outcomes. Receiving formal education on the birthing process sets the stage for optimal mother/baby bonding, postpartum mood, and future interactions with healthcare professionals. The American Congress of Obstetrics and Gynecology recommends patients attend birthing classes prior to labor and delivery, however previous studies found that attendance is dropping with only 56% of first-time mothers attending childbirth education classes in 2005 compared to 70% in 2001.
Multiple barriers to accessing prenatal childbirth education have been identified. Traditionally, childbirth education classes are structured as in person lectures with multiple sessions over a period of weeks and are taken prior to the onset of labor. Most childbirth education classes have accompanying costs ranging from $20-$50 for hospital classes and hundreds of dollars for private classes. Significant barriers impact patients ability to attend these classes including difficulty obtaining childcare, financial constraints, getting time off from work, and obtaining transportation. The Coronavirus pandemic has further worsened barriers to accessing childbirth education as most in-person group classes have been cancelled due to lack of funding or need for social distancing.
Most childbirth education focuses on preparation for labor and pain management in the first stage of labor neglecting the second stage. This is the stage of labor that requires the most maternal involvement and effort. Among women with epidural anesthesia pushing may not be instinctive and hence, coaching and preparation are integral to success.
The current standard of care for teaching a patient how to push is nurse-led coaching performed at the bedside immediately before the patient starts pushing. At this point, most patients are tired, anxious, and have not had enough time to process the new knowledge learned about how to push. A long or abnormal second stage is associated with adverse outcomes such as cesarean delivery, infection, and hemorrhage. Nulliparous patients are especially vulnerable to these adverse outcomes in the second stage so long as they do not feel empowered, knowledgeable, or involved in their own birth experiences.
Previous literature shows that coached pushing can decrease second stage duration up to 13 minutes. This is important as a prolonged second stage of labor is associated with maternal and neonatal morbidity including higher rates of cesarean delivery, chorioamnionitis, perineal trauma, NICU admission, neonatal sepsis, and APGAR score < 4 at 5 minutes. In most clinical scenarios, the standard of care is coaching or guidance from the nurse or provider once the patient reaches complete dilation. There are limitations to this approach as waiting to coach after a potentially long and arduous labor course is suboptimal. While physicians and nurses are qualified to coach, they may not be universally available to all patients and the quality of coaching may be impacted by volume and acuity on Labor & Delivery.
In theory, the advent of video-based education can easily be transferred to the hospital to address this issue and allows for education during labor once an epidural is placed, the patient is comfortable, and well before pushing starts. The average duration of labor and delivery in a first-time mother ranges from 14 to 20 hours. This presents an opportune window of time for video-based childbirth education to narrow gaps in childbirth education disparities and increase maternal involvement without the barriers present in the outpatient setting. The efficacy of this novel way of providing childbirth education has not been tested.
To address this quality gap, we propose a randomized trial comparing an intrapartum video education tool to standard provider-based coaching
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Missouri
-
Saint Louis, Missouri, United States, 63108
- Barnes Jewish Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Nulliparous women
- Over 18 year of age
- Single fetus
- Term: has completed 36 weeks of pregnancy
Exclusion Criteria:
- fetal anomalies
- Prior cesarean delivery
- contraindication to valsalva
- blind patients
- admission in the second stage of labor
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Standard Treatment
Standard bedside coaching by labor and delivery staff
|
|
|
Experimental: Educational Video
Patients will watch the provided coaching video in addition to standard bedside coaching by labor and delivery staff
|
Educational video describing techniques for pushing
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Length of the Second Stage of Labor
Time Frame: delivery
|
Time from complete dilation to delivery of the fetus
|
delivery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Labor Satisfaction Scores
Time Frame: 1 day ( Assessed via survey prior to discharge from the hospital)
|
Labor satisfaction as measured by the Mackey Childbirth Satisfaction Rating Scale.
Scores are given by patients on a scale from 1-5 with 5 being the highest and 1 being the lowest.
|
1 day ( Assessed via survey prior to discharge from the hospital)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Rebecca R Rimsza, MD, Washington University School of Medicine
Publications and helpful links
General Publications
- Grobman WA, Rice MM, Reddy UM, Tita ATN, Silver RM, Mallett G, Hill K, Thom EA, El-Sayed YY, Perez-Delboy A, Rouse DJ, Saade GR, Boggess KA, Chauhan SP, Iams JD, Chien EK, Casey BM, Gibbs RS, Srinivas SK, Swamy GK, Simhan HN, Macones GA; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Labor Induction versus Expectant Management in Low-Risk Nulliparous Women. N Engl J Med. 2018 Aug 9;379(6):513-523. doi: 10.1056/NEJMoa1800566.
- Goodman P, Mackey MC, Tavakoli AS. Factors related to childbirth satisfaction. J Adv Nurs. 2004 Apr;46(2):212-9.
- Committee on Obstetric Practice. Committee Opinion No. 687: Approaches to Limit Intervention During Labor and Birth. Obstet Gynecol. 2017 Feb;129(2):e20-e28. doi: 10.1097/AOG.0000000000001905.
- Declercq ER, Sakala C, Corry MP, Applebaum S, Herrlich A. Major Survey Findings of Listening to Mothers(SM) III: Pregnancy and Birth: Report of the Third National U.S. Survey of Women's Childbearing Experiences. J Perinat Educ. 2014 Winter;23(1):9-16. doi: 10.1891/1058-1243.23.1.9.
- Lu MC, Prentice J, Yu SM, Inkelas M, Lange LO, Halfon N. Childbirth education classes: sociodemographic disparities in attendance and the association of attendance with breastfeeding initiation. Matern Child Health J. 2003 Jun;7(2):87-93. doi: 10.1023/a:1023812826136.
- Simpson KR, Newman G, Chirino OR. Patients' perspectives on the role of prepared childbirth education in decision making regarding elective labor induction. J Perinat Educ. 2010 Summer;19(3):21-32. doi: 10.1624/105812410X514396.
- Fenwick J, Toohill J, Gamble J, Creedy DK, Buist A, Turkstra E, Sneddon A, Scuffham PA, Ryding EL. Effects of a midwife psycho-education intervention to reduce childbirth fear on women's birth outcomes and postpartum psychological wellbeing. BMC Pregnancy Childbirth. 2015 Oct 30;15:284. doi: 10.1186/s12884-015-0721-y.
- Cankaya S, Simsek B. Effects of Antenatal Education on Fear of Birth, Depression, Anxiety, Childbirth Self-Efficacy, and Mode of Delivery in Primiparous Pregnant Women: A Prospective Randomized Controlled Study. Clin Nurs Res. 2021 Jul;30(6):818-829. doi: 10.1177/1054773820916984. Epub 2020 Apr 13.
- Sperlich M, Gabriel C, St Vil NM. Preference, knowledge and utilization of midwives, childbirth education classes and doulas among U.S. black and white women: implications for pregnancy and childbirth outcomes. Soc Work Health Care. 2019 Nov-Dec;58(10):988-1001. doi: 10.1080/00981389.2019.1686679. Epub 2019 Nov 4.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 202101089
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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