Pregnancy RelatedPEAICENCT06787521
Patient Empowerment and Agency Through Intrapartum Counseling and Education
A study testing evidence-based labor guide in people with Pregnancy Related, run by Oregon Health and Science University at 1 site in United States.
Trial summary
A single-blind randomized controlled trial to study the effects of a labor guide on perceived control in labor. The experimental arm will receive an evidence-based labor guide at the time of admission for scheduled induction of labor. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- evidence-based labor guide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2025to 28 Feb 2026
- 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 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Nulliparous
- Singleton pregnancy
- English-speaking
- Undergoing induction of labor for a medical or elective indication
- Reached at least 36 weeks 0 days gestation
- Willing and able to sign a consent form
- Delivering at OHSU
Who cannot join
- Undergoing induction termination
- Fetal complications such as multiple gestation, major fetal anomalies, fetal demise
- Decisionally-impaired adults
- Minors
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health and Science University
Portland, Oregon, 97239
About this study
Official title: PEAICE: Patient Empowerment and Agency Through Intrapartum Counseling and Education: a Randomized Controlled Study
A single-blind randomized controlled trial to study the effects of a labor guide on perceived control in labor. The experimental arm will receive an evidence-based labor guide at the time of admission for scheduled induction of labor. The control arm will receive the standard of care in-person counseling regarding options for labor interventions
Read the detailed description
Participants will be randomized to receive an evidence-based labor guide at the time of admission for scheduled induction of labor, or the standard of care. Following delivery, patients will be surveyed about their labor experience. Chart review will be done to collect data on obstetric interventions and outcomes and neonatal outcomes.
- Conditions
- Pregnancy Related
- Being tested
- evidence-based labor guide
- Keywords
- Intrapartum, Labor Agency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
evidence-based labor guideOther
Participants will be provided with written education about potential complications and interventions. Information will be provided at the time of admission for labor induction.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Participants will receive an evidence-based labor guide at the time of admission for scheduled induction of labor Receives: Other: evidence-based labor guide |
| Control Group | No intervention | Participants will receive the standard of care in-person counseling regarding options for labor interventions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Labor Agentry Scale-10 (LAS-10)
A validated questionnaire that measures patient-perceived control during labor
Measured: 1-7 days following delivery
Secondary outcomes (5)
Labor Interventions
Whether patients received labor interventions including Pitocin, misoprostol, cook balloon, intra-uterine pressure catheter, manual rotation
Measured: During labor
Maternal hyper/hypotension
Whether the patient experience hypertension or hypotension
Measured: During induction of labor
Intrapartum blood loss
The amount of blood loss a patient experienced during delivery
Measured: Labor and delivery
Cesarean section
Whether a patient requires a cesarean delivery
Measured: Delivery
Time to delivery
The duration from admission for induction to delivery
Measured: Admission for induction to delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start1 Apr 2025
- Primary completion28 Feb 2026
- Study completion28 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 Oregon Health and Science UniversityThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 randomization will be done using REDCap.
- Masking
- None (open label)
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fei Cai, Oregon Health and Science University
- Investigators
- Fei Cai, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06787521
- Sponsor's protocol ID
- OHSU IRB 28141
- Acronym
- PEAICE
- Status last verified
- Jul 2026
- First submitted
- 16 Jan 2025
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Melville SJF, Codding L, Lee BM, Rincon M, Garg B, Lyons K, Cai F. Patient Empowerment and Agency through Intrapartum Counseling and Education (PEAICE): A randomized controlled trial. Pregnancy (Hoboken). 2026 Sep 24;2(5):e70458. doi: 10.1002/pmf2.70458. eCollection 2026 Sep.
PubMed 42787682
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PEAICE: Patient Empowerment and Agency Through Intrapartum Counseling and Education: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06787521
- Acronym / sponsor ID
- PEAICE / OHSU IRB 28141
- Conditions
- Pregnancy Related
- Keywords
- Intrapartum, Labor Agency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 28 Feb 2026 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 22 Jan 2025 (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.
A single-blind randomized controlled trial to study the effects of a labor guide on perceived control in labor. The experimental arm will receive an evidence-based labor guide at the time of admission for scheduled induction of labor. The control arm will receive the standard of care in-person counseling regarding options for labor interventions
Detailed description
Participants will be randomized to receive an evidence-based labor guide at the time of admission for scheduled induction of labor, or the standard of care. Following delivery, patients will be surveyed about their labor experience. Chart review will be done to collect data on obstetric interventions and outcomes and neonatal outcomes.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1:1 randomization will be done using REDCap.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: evidence-based labor guideParticipants will receive an evidence-based labor guide at the time of admission for scheduled induction of labor |
| Control Group | No intervention | –Participants will receive the standard of care in-person counseling regarding options for labor interventions. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Nulliparous
- Singleton pregnancy
- English-speaking
- Undergoing induction of labor for a medical or elective indication
- Reached at least 36 weeks 0 days gestation
Key exclusion criteria (4 listed)
- Undergoing induction termination
- Fetal complications such as multiple gestation, major fetal anomalies, fetal demise
- Decisionally-impaired adults
- Minors
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 |
|---|---|---|
| evidence-based labor guideParticipants will be provided with written education about potential complications and interventions. Information will be provided at the time of admission for labor induction. | Other | Experimental Group |
Primary outcome
Labor Agentry Scale-10 (LAS-10)
Time frame: 1-7 days following delivery
A validated questionnaire that measures patient-perceived control during labor
5 secondary outcomes
Labor Interventions
Time frame: During labor
Maternal hyper/hypotension
Time frame: During induction of labor
Intrapartum blood loss
Time frame: Labor and delivery
Cesarean section
Time frame: Delivery
Time to delivery
Time frame: Admission for induction to delivery
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 20 Jul 2026.
- Derived from this study: PubMed 42787682Melville SJF, Codding L, Lee BM, Rincon M, Garg B, Lyons K, Cai F. Patient Empowerment and Agency through Intrapartum Counseling and Education (PEAICE): A randomized controlled trial. Pregnancy (Hoboken). 2026 Sep 24;2(5):e70458. doi: 10.1002/pmf2.70458. eCollection 2026 Sep.
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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.
Fei Cai, MD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing evidence-based labor guide in people with Pregnancy Related, run by Oregon Health and Science University 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 7 inclusion and 4 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 20 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?
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?
Labor Agentry Scale-10 (LAS-10) (time frame: 1-7 days following 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 NCT06787521, which also lists 1 linked publication.
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 20 Jul 2026.