- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03654079
Patient Centered Simulation For Labor and Delivery
February 22, 2024 updated by: Wake Forest University Health Sciences
Patient satisfaction is an important outcome in the evaluation and development of healthcare services.
Studies have identified tools that successfully measure women's childbirth experiences, and have shown that multidimensional measures of women's satisfaction in labor and delivery provides a richer and diverse perspective on women's experiences of intrapartum care.
Childbirth experience can have significant effects, both positive and negative, on women's immediate and long term health outcomes.
Patients with negative experiences surrounding childbirth have been shown to have significant fear surrounding the labor and delivery experience that negatively impact subsequent deliveries.
Often fear is worsened by a lack of knowledge of what to expect during labor.
Women enrolled in this study will simulate some of the potentially stressful experiences that commonly occur during labor to determine if doing so decreases a woman's fear and anxiety about labor and delivery.
Study Overview
Detailed Description
Patient satisfaction is an important outcome in the evaluation and development of healthcare services.
Studies have identified tools that successfully measure women's childbirth experiences, and have shown that multidimensional measures of women's satisfaction in labor and delivery provides a richer and diverse perspective on women's experiences of intrapartum care.
Childbirth experience can have significant effects, both positive and negative, on women's immediate and long term health outcomes.
Patients with negative experiences surrounding childbirth have been shown to have significant fear surrounding the labor and delivery experience that negatively impact subsequent deliveries.
Often fear is worsened by a lack of knowledge of what to expect during labor.
Women enrolled in this study will simulate some of the potentially stressful experiences that commonly occur during labor to determine if doing so decreases a woman's fear and anxiety about labor and delivery.
Women in Centering Pregnancy groups will be approached and assigned to either the intervention or control arm by Centering Pregnancy group.
Those in the intervention arm will participate in simulations in the following areas: 1) In-Utero Resuscitation Simulation: the process that may occur if a baby has a significant drop in heart rate during labor, 2) Cesarean Section Simulation: the process of moving from the labor bed to the transport stretcher and on to the operating room in the event that a laboring woman needs a cesarean delivery, 3) Pushing Simulation: the pushing process after a laboring woman becomes completely dilated.
Those in the control arm will not receive this education.
All patient will complete a modified Childbirth Experience Questionnaire the day after delivery.
Responses will be compared between the woman that participated in the simulations to women who did not participate in simulations.
Study Type
Interventional
Enrollment (Estimated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Joshua F Nitsche, MD
- Phone Number: 336-716-4304
- Email: jnitsche@wakehealth.edu
Study Locations
-
-
North Carolina
-
Winston-Salem, North Carolina, United States, 27103
- Wake Forest Baptist Health Downtown Health Plaza
-
Contact:
- Joshua F Nitsche, MD
- Phone Number: 336-716-6489
- Email: jnitsche@wakehealth.edu
-
Contact:
- Mariam S Gomaa, BA
- Email: mgomaa@wakehealth.edu
-
Principal Investigator:
- Joshua F Nitsche, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 44 years (Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Nulliparous pregnant women
- In third trimester
Exclusion Criteria:
• Not planning on delivering with Wake Forest School of Medicine OB/GYN
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Simulation Arm
Subjects in this arm will participate in Interventions (In- Utero Simulation, Cesarean Section Simulation, and Pushing Simulation).
|
Participants assigned to the intervention group will participate in the following simulations: 1) the process that may occur if a baby has a significant drop in heart rate during labor, 2) the process of moving from the labor bed to the transport stretcher and on to the operating room in the event that a woman needs a cesarean delivery, 3) the pushing process after a woman becomes completely dilated
|
No Intervention: Control Arm
Subjects in this arm will not participate in any simulations.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Childbirth Experience Questionnaire (CEQ)
Time Frame: After delivery, up to 2 weeks
|
Childbirth Experience Satisfaction will be measured by the CEQ a 24 item questionnaire.
For 19 of the items the response format is a 4-point Likert Scale and three of the items are assessed using a visual analogue scale (VAS).
The VAS-scales scores were transformed to categorical values, 0-40 = 1, 41-60 = 2, 61-80 = 3 and 81-100 = 4.
Total score 24-92.
Higher scores indicate better childbirth experience
|
After delivery, up to 2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Joshua F Nitsche, MD, Wake Forest University Health Sciences
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Rudman A, El-Khouri B, Waldenstrom U. Women's satisfaction with intrapartum care - a pattern approach. J Adv Nurs. 2007 Sep;59(5):474-87. doi: 10.1111/j.1365-2648.2007.04323.x. Epub 2007 Jul 20.
- Nilver H, Begley C, Berg M. Measuring women's childbirth experiences: a systematic review for identification and analysis of validated instruments. BMC Pregnancy Childbirth. 2017 Jun 29;17(1):203. doi: 10.1186/s12884-017-1356-y.
- Nilsson C, Lundgren I, Karlstrom A, Hildingsson I. Self reported fear of childbirth and its association with women's birth experience and mode of delivery: a longitudinal population-based study. Women Birth. 2012 Sep;25(3):114-21. doi: 10.1016/j.wombi.2011.06.001. Epub 2011 Jul 20.
- World Health Organization . WHO Statment: The prevention and elimiation of disrespect and abuse during facility-based childbirth. 2014.
- Finnbogason, Christine. "Experiences and Satisfaction with Intrapartum Care: A Comparison of Normal Weight Women and Obese Women." University of Manitoba, University of Manitoba, 2016, pp. 149-154.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
July 1, 2024
Primary Completion (Estimated)
May 1, 2025
Study Completion (Estimated)
May 1, 2025
Study Registration Dates
First Submitted
August 28, 2018
First Submitted That Met QC Criteria
August 29, 2018
First Posted (Actual)
August 31, 2018
Study Record Updates
Last Update Posted (Estimated)
February 23, 2024
Last Update Submitted That Met QC Criteria
February 22, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IRB00052749
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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