Pregnancy RelatedNCT04766099
Video Education for Labor and Delivery
A study testing Childbirth Educational Video in people with Pregnancy Related and Educational Problems, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy Related, Educational Problems
- What is being tested?
- Childbirth Educational Video
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2021to 1 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Nulliparous women
- Over 18 year of age
- Single fetus
- Term: has completed 36 weeks of pregnancy
Who cannot join
- fetal anomalies
- Prior cesarean delivery
- contraindication to valsalva
- blind patients
- admission in the second stage of labor
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of a Video Education Tool for the Second Stage of Labor
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.
Read the 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
- Conditions
- Pregnancy Related, Educational Problems
- Being tested
- Childbirth Educational Video
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Childbirth Educational VideoOther
Educational video describing techniques for pushing
| Study group | Role | What they receive |
|---|---|---|
| Standard Treatment | No intervention | Standard bedside coaching by labor and delivery staff |
| Educational Video | Experimental | Patients will watch the provided coaching video in addition to standard bedside coaching by labor and delivery staff Receives: Other: Childbirth Educational Video |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of the Second Stage of Labor
Time from complete dilation to delivery of the fetus
Measured: delivery
Secondary outcomes (1)
Labor Satisfaction Scores
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.
Measured: 1 day ( Assessed via survey prior to discharge from the hospital)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start1 May 2021
- Primary completion1 Jul 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rebecca Rimsza, Washington University School of Medicine
- Investigators
- Rebecca R Rimsza, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04766099
- Sponsor's protocol ID
- 202101089
- Status last verified
- Dec 2022
- First submitted
- 19 Feb 2021
- Last updated
- 12 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 15056335Committee 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.
PubMed 28121831Declercq 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.
PubMed 24453463Lu 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.
PubMed 12870624Simpson 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.
PubMed 21629391Grobman 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.
PubMed 30089070Fenwick 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.
PubMed 26518597Cankaya 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.
PubMed 32281410Sperlich 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.
PubMed 31682786Rimsza RR, Perez M, Woolfolk C, Kelly JC, Carter EB, Frolova AI, Odibo AO, Raghuraman N. Video Instruction for Pushing in the Second Stage: a randomized controlled trial. Am J Obstet Gynecol. 2023 Jun;228(6):732.e1-732.e11. doi: 10.1016/j.ajog.2023.03.024. Epub 2023 Mar 20.
PubMed 36940771
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Video Education Tool for the Second Stage of Labor
- ClinicalTrials.gov ID
- NCT04766099
- Acronym / sponsor ID
- 202101089
- Conditions
- Pregnancy Related, Educational Problems
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 23 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Treatment | No intervention | –Standard bedside coaching by labor and delivery staff |
| Educational Video | Experimental | Other: Childbirth Educational VideoPatients will watch the provided coaching video in addition to standard bedside coaching by labor and delivery staff |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Nulliparous women
- Over 18 year of age
- Single fetus
- Term: has completed 36 weeks of pregnancy
Key exclusion criteria (5 listed)
- fetal anomalies
- Prior cesarean delivery
- contraindication to valsalva
- blind patients
- admission in the second stage of labor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Childbirth Educational VideoEducational video describing techniques for pushing | Other | Educational Video |
Primary outcome
Length of the Second Stage of Labor
Time frame: delivery
Time from complete dilation to delivery of the fetus
1 secondary outcome
Labor Satisfaction Scores
Time frame: 1 day ( Assessed via survey prior to discharge from the hospital)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2022.
- Background: PubMed 15056335Goodman 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.
- Background: PubMed 28121831Committee 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.
- Background: PubMed 24453463Declercq 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.
- Background: PubMed 12870624Lu 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.
- Background: PubMed 21629391Simpson 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.
- Background: PubMed 30089070Grobman 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.
- Background: PubMed 26518597Fenwick 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.
- Background: PubMed 32281410Cankaya 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.
- Background: PubMed 31682786Sperlich 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.
- Derived from this study: PubMed 36940771Rimsza RR, Perez M, Woolfolk C, Kelly JC, Carter EB, Frolova AI, Odibo AO, Raghuraman N. Video Instruction for Pushing in the Second Stage: a randomized controlled trial. Am J Obstet Gynecol. 2023 Jun;228(6):732.e1-732.e11. doi: 10.1016/j.ajog.2023.03.024. Epub 2023 Mar 20.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca R Rimsza, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Childbirth Educational Video in people with Pregnancy Related and Educational Problems, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of the Second Stage of Labor (time frame: delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04766099, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2022.