Pregnancy RelatedNCT03654079
Patient Centered Simulation For Labor and Delivery
A study testing Simulation in people with Pregnancy Related, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- Simulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2027to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 44 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Nulliparous pregnant women
- In third trimester
Who cannot join
- Not planning on delivering with Wake Forest School of Medicine OB/GYN
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Wake Forest Baptist Health Downtown Health Plaza
Winston-Salem, North Carolina, 27103
Joshua F Nitsche, MD, 336-716-6489, jnitsche@wakehealth.edu
Mariam S Gomaa, BA, mgomaa@wakehealth.edu
About this study
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.
Read the 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.
- Conditions
- Pregnancy Related
- Being tested
- Simulation
- Keywords
- Simulation, Pregnancy, Labor and Delivery, Childbirth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimulationOther
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
| Study group | Role | What they receive |
|---|---|---|
| Simulation Arm | Active comparator | Subjects in this arm will participate in Interventions (In- Utero Simulation, Cesarean Section Simulation, and Pushing Simulation). Receives: Other: Simulation |
| Control Arm | No intervention | Subjects in this arm will not participate in any simulations. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Childbirth Experience Questionnaire (CEQ)
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
Measured: After delivery, up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study startJan 2027 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Women in Centering Pregnancy groups at Wake Forest School of Medicine's Obstetrics (OB) and Gynecology (GYN) department will be recruited and sequentially assigned to participate in simulations or serve as controls.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joshua F Nitsche, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03654079
- Sponsor's protocol ID
- IRB00052749
- Status last verified
- Dec 2025
- First submitted
- 28 Aug 2018
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 17645495Nilver 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.
PubMed 28662645Nilsson 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.
PubMed 21764400World 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 at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Centered Simulation For Labor and Delivery
- ClinicalTrials.gov ID
- NCT03654079
- Acronym / sponsor ID
- IRB00052749
- Conditions
- Pregnancy Related
- Keywords
- Simulation, Pregnancy, Labor and Delivery, Childbirth
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 31 Aug 2018 (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.
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.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Women in Centering Pregnancy groups at Wake Forest School of Medicine's Obstetrics (OB) and Gynecology (GYN) department will be recruited and sequentially assigned to participate in simulations or serve as controls.
| Arm | Type | Receives |
|---|---|---|
| Simulation Arm | Active comparator | Other: SimulationSubjects in this arm will participate in Interventions (In- Utero Simulation, Cesarean Section Simulation, and Pushing Simulation). |
| Control Arm | No intervention | –Subjects in this arm will not participate in any simulations. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Nulliparous pregnant women
- In third trimester
Key exclusion criteria (1 listed)
- Not planning on delivering with Wake Forest School of Medicine OB/GYN
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 |
|---|---|---|
| SimulationParticipants 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 | Other | Simulation Arm |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Background: PubMed 17645495Rudman 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.
- Background: PubMed 28662645Nilver 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.
- Background: PubMed 21764400Nilsson 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.
- BackgroundWorld Health Organization . WHO Statment: The prevention and elimiation of disrespect and abuse during facility-based childbirth. 2014.
- BackgroundFinnbogason, 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.
- 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.
Joshua F Nitsche, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simulation in people with Pregnancy Related, run by Wake Forest University Health Sciences 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 2 inclusion and 1 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: opening soon, as of the sponsor's last update on 31 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joshua F Nitsche, MD (336-716-4304, jnitsche@wakehealth.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Childbirth Experience Questionnaire (CEQ) (time frame: After delivery, up to 2 weeks). 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 NCT03654079, which also lists 5 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 31 Jul 2026.