Clinical trial NCT04766099: Video Education for Labor and Delivery
Official title: Impact of a Video Education Tool for the Second Stage of Labor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Related
Educational Problems
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2021-02-23
Enrollment: 161
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The second stage of labor or the pushing stage can be challenging and intimidating for patients delivering for the fist time. Among women with neuraxial anesthesia pushing may not be instinctive and therefore various coaching methods are used to maximize maternal expulsive efforts and minimize pushing time. Time intensive strategies including transperineally ultrasound and bio-feedback have been employed to assist with pushing but they are difficult to implement widely. While some women may attend birthing classes or have previously been coached on pushing prior to the onset of labor, many women are unable to access classes prior to labor or do not retain what they learned in a class weeks prior to labor. Previous studies have evaluated the effect of coached pushing on the length of second stage and have indicated that coaching can decrease the second stage up to 13 minutes. In most clinical scenarios, coaching or guidance from the nurse or provider happens once the patient attains complete dilation. There are limitations to this approach as waiting to coach after a potentially long and arduous labor is suboptimal. Therefore, we propose a randomized controlled trial investigating the use of an educational video during the first stage of labor on length of the second stage.

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

Eligibility criteria: 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

Primary outcomes:
measure: Length of the Second Stage of Labor
timeFrame: delivery
Secondary outcomes:
measure: Labor Satisfaction Scores
timeFrame: 1 day ( Assessed via survey prior to discharge from the hospital)
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Barnes Jewish Hospital
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Rebecca R Rimsza, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Goodman P, Mackey MC, Tavakoli AS. Factors related to childbirth satisfaction. J Adv Nurs. 2004 Apr;46(2):212-9. doi: 10.1111/j.1365-2648.2003.02981.x.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.