NCT04766099

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
161

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 23, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

December 12, 2022

Status Verified

December 1, 2022

Enrollment Period

1.2 years

First QC Date

February 19, 2021

Last Update Submit

December 8, 2022

Conditions

Pregnancy RelatedEducational Problems

Outcome Measures

Primary Outcomes (1)

  • Length of the Second Stage of Labor

    Time from complete dilation to delivery of the fetus

    delivery

Secondary Outcomes (1)

  • Labor Satisfaction Scores

    1 day ( Assessed via survey prior to discharge from the hospital)

Study Arms (2)

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

Other: Childbirth Educational Video

Interventions

Childbirth Educational VideoOTHER

Educational video describing techniques for pushing

Educational Video

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Nulliparous women
  • Over 18 year of age
  • Single fetus
  • Term: has completed 36 weeks of pregnancy

You may not qualify if:

  • fetal anomalies
  • Prior cesarean delivery
  • contraindication to valsalva
  • blind patients
  • admission in the second stage of labor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barnes Jewish Hospital

St Louis, Missouri, 63108, United States

Location

Related Publications (10)

  • 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.

    PMID: 15056335BACKGROUND

  • 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.

    PMID: 28121831BACKGROUND

  • 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.

    PMID: 24453463BACKGROUND

  • 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.

    PMID: 12870624BACKGROUND

  • 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.

    PMID: 21629391BACKGROUND

  • 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.

    PMID: 30089070BACKGROUND

  • 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.

    PMID: 26518597BACKGROUND

  • 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.

    PMID: 32281410BACKGROUND

  • 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.

    PMID: 31682786BACKGROUND

  • Rimsza 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.

    PMID: 36940771DERIVED

Study Officials

  • Rebecca R Rimsza, MD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Fellow

Study Record Dates

First Submitted

February 19, 2021

First Posted

February 23, 2021

Study Start

May 1, 2021

Primary Completion

July 1, 2022

Study Completion

August 1, 2022

Last Updated

December 12, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)