AzTrials
AzTrials

Postpartum ComplicationLEPTNCT06992791

Labor Education to Reduce Postpartum Traumatic Stress

A study testing Prenatal Education on Childbirth in people with Postpartum Complication and Posttraumatic Stress Symptoms, run by University of California, San Diego at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The goal of this randomized controlled trial is determine if education on common events in labor in nulliparous women can reduce the postpartum traumatic symptoms. The main question it aims to answer are: Does prenatal education on labor events reduce post-traumatic symptoms, as measured by thePost Traumatic Stress… Read more about this study

Who is it for?
Ages 18 to 51 years, women onlyHealthy volunteers can take part
What is being tested?
Prenatal Education on Childbirth
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
1 siteUnited States
Study dates
14 Oct 2025to 30 Jun 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 51 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Maternal age > 18 years
  • Nulliparous
  • Singleton pregnancy between 18-30 weeks
  • English Speaking

Who cannot join

  • Prenatal care outside of UCSD
  • Plan to deliver outside of UCSD
  • Contraindications to vaginal delivery at time of enrollment
  • Major fetal anomalies at time of Level II Ultrasound
  • No access to smart phone and/or internet

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of California, San Diego

    San Diego, California, 92122

Other trials in United States

About this study

Official title: Labor Education to Reduce Postpartum Traumatic Stress: A Randomized Controlled Trial

The goal of this randomized controlled trial is determine if education on common events in labor in nulliparous women can reduce the postpartum traumatic symptoms. The main question it aims to answer are:

  • Does prenatal education on labor events reduce post-traumatic symptoms, as measured by thePost Traumatic Stress Disorder Cecklist for Diagnostic and Statistical Manual for Mental Health Disorders (PCL-5) at 6 weeks postpartum?
  • Does prenatal education on labor affect labor outcomes?
Read more

Participants will be given surveys:

  • At enrollment on mental health and previous traumatic experiences
  • After education on expectations on childbirth
  • After delivery on experience of childbirth
  • At 6 weeks and 6 months postpartum on traumatic symptoms and mental health outcomes.

They will also have the option to participate in collection of discarded cerebrospinal fluid, blood and serum and physiologic sensitivity testing.

Read the detailed description

Hypothesis:

This randomized trial was designed to determine if prenatal education on intrapartum experiences reduces postpartum trauma symptoms compared to standard prenatal care.

Methods and Procedures:

  1. Identification. Participants will be identified by reviewing prenatal care providers (midwives, generalist obstetricians and perinatology) schedules for those that meet the inclusion criteria and approached in person at ultrasound or clinic appointments to be offered participation. Consent will be obtained at this time. Patient may also be called between appointments, and consent will be signed via HIPAA compliant REDCap.
  2. Randomization. Participants will be randomized 1:1 to one of the two study groups described below. Neither participants or medical providers will be blinded to the randomization group. The randomization will be done using the block randomization module in REDcap.
  3. Intervention: For those in Group 1, starting at 30 weeks they will be contacted by email and text to provide links to online education videos on intrapartum experiences. Patients will receive text reminders in the third trimester to encourage interaction with the videos, and interaction will be tracked online.
  4. Collection of health information. The medical record of the pregnant person and the neonate will be used to collect information related to the pregnancy, delivery, and immediate post-delivery care into REDCap database. Baseline characteristics will include demographic information, prenatal care details such as type of provider, gestational age which established care, visit types, maternal medical conditions and obstetric history. Delivery characteristics will include labor characteristics (length of labor, gestational age, fetal heart rate tracings, any interventions in labor, mode of delivery and newborn and maternal complications during delivery admission).
  5. Survey Administration. All participant will be give the same surveys on the same time scales. At enrollment, participants will be given a series of surveys on baseline mental health outcomes (Primary Care PTSD for DSM-5, Generalized Anxiety Disorder -7, Edinburgh Postnatal Depression Scale, Adverse Childhood Experiences), social experiences (Everyday Discrimination scale) and expectations for childbirth (Wijma Delivery Expectations Questionnaire (W-DEQ) on a iPad in clinic. Participants will be contacted via text and/or email for a repeat W-DEQ scale at term and after delivery. They will be contacted again via text and/or email at six weeks postpartum with 2 reminders if not replied (survey open 6 weeks-12 weeks) postpartum, and then again six months (with two reminders, survey open to 8 months) postpartum. All of these surveys will be administered by RedCap and collected securely.
  6. Collection of specimens. Cerebrospinal fluid will only be collected from patients who are already undergoing dural puncture as standard of care for their anesthesia plan. Usual standard of care for epidural anesthesia at our hospital is to perform a dural puncture at the time of epidural placement which results in 0.5-1 mL of cerebrospinal fluid release through the needle used to place the epidural. Instead of allowing this fluid to be discarded, we will collect it in sterile tubes. The anesthesia plan will in no way be impacted by our study. If the anesthesia team at the time of placement feels a dural puncture is not appropriate, then the dural space will not be entered and fluid will not be collected. The sample collected will not exceed the amount that would be discarded as waste in a routine procedure and will be collected in a sterile fashion, presenting no additional risk to patients. Additionally, up to 1 cc discarded urine from foley catheter drainage, and up to 1 cc of additional blood will be taken at the time of already scheduled blood draws. No additional blood draws or urine samples will be requested outside of routine care. Stool collection kits will also be given to participants on L\&D to collect if able, with instructions on how to collect stool off toilet paper and return samples. This will be used to create a biospecimen repository with no genetic or identifying information.
  7. Physiologic testing. A subgroup of participants will undergo cutaneous mechanical sensitivity assays, radiant heat assays and pressure sensitivity assays. The cutaneous mechanical sensitivity testing involves stimulation with von Frey filaments to determine the size of filament that the participant can detect. The heat sensitivity assay will be preformed a radiant heat devices that uses a focused light beam to slowly heat a participants skin through safety glass, with participants indicating first when temperature is detected and in a second trial, when it becomes painful. This was assembled according to the protocol attached, using the IITC Plantar Analgesia Meter assembled in the attached protocol using a Hargraves testing platform. The heat assay assessing constant temperature will apply a stimulus for 3 seconds and request rating of pain, set at the typical minimal stimulus required to feel pain. The pressure sensitivity assay involves a 2 cm probe pressed against participant skin until they identify the threshold where it becomes painful. The probe is a standard clinical threshold algometer, as shown in the picture. For all of these assays, they will be tested on the right and left forearm, and right and left calf. These will be done at admission to labor and delivery, and patients have can opt out without impacting survey collection. A convenience sample will be collected when researchers are available on labor and delivery (typically 10 am to 6 pm), expecting to be no more than 20% of the enrolled population to be captured at delivery admission. Patients will be approached if they are early in their admission, have not yet requested an epidural and have not opt-ed out to either biospecimen collection or physiologic testing.
Being tested
Prenatal Education on Childbirth
Keywords
Posttraumatic stress disorder, Childbirth related PTSD, prenatal education, traumatic childbirth, Posttraumatic stress syndrome
Medical subject headings
Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Prenatal Education on ChildbirthBehavioural

    Starting at 30 weeks, participants will be given access to Tinyhood, an online educational service aimed at perinatal education. Text reminders will be sent periodically throughout the third trimester to encourage interaction with educational videos and written materials, which will be tracked for number of interactions via the Tinyhyood interface. The videos include: "Pregnancy Milestones", "Physically and Mentally Preparing for Labor", "Finding Support During Labor", "Deciding Birth Preferences and Self-Advocacy", "Signs Labor Is Approaching", "Contractions", "Signs of Preterm Labor", "Going to the Hospital", "Baby's Positioning", "Stages of Labor", "Induction of Labor", "Managing Pain", "Pain Options in Labor", "Relaxation Techniques for Labor", " Breathing Techniques", "Labor Positions" and several handouts highlighting common obstetrical emergencies and possible interventions.

Study groups in NCT06992791
Study groupRoleWhat they receive
Prenatal Education ArmExperimentalThose in Group 1 (intervention group) will be given access to intrapartum education videos provided by Tinyhood between 30weeks and delivery.
Receives: Behavioral: Prenatal Education on Childbirth
Control ArmNo interventionThose in the control arm will be given a series of surveys administered by RedCap, and will continue with standard prenatal care. These participants will also have access to community prenatal education classes.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Post-traumatic stress disorder checklist for Diagnostic and Statistical Manual of Mental Health Disorders-5 (PCL-5)

    Validated measurement for PTSD, scores 0-80 with higher being more symptomatic

    Measured: 6-12 weeks postpartum

Secondary outcomes (9)
  1. Change in Fear of Childbirth as measured by Wijma Delivery Experience Form A

    A change in scores over the third trimester using wijma Delivery Expectations Form A, a validated scale on expectations and delivery experiences with scores from 0-165, with higher scores indicating more fear of childbirth

    Measured: At enrollment and at 36-38 weeks of pregnancy

  2. Post-traumatic stress disorder checklist for Diagnostic Statistics and Mental Health Manual-5 (PCL 5)

    Validated measure of PTSD assessment, scores 0-80 with higher being more symptomatic over a longer time frame

    Measured: 6-8 months postpartum

  3. Delivery Experience as measured by Wijma Delivery Experience Form B

    Wijma Delivery Expectations Form B, a validated scale on expectations and delivery experiences with scores from 0-165, with higher scores indicating more fear of childbirth

    Measured: 0-2 weeks postpartum

  4. Rate of Labor Interventions

    Chart review recording the rate of labor interventions, including amniotomy, induction, epidural, doula use, and pitocin at delivery admission

    Measured: At delivery

  5. Rate of Obstetric Complications

    Chart review recording the rate of composite of adverse obstetric outcomes including postpartum hemorrhage, shoulder dystocia, cesarean delivery or operative delivery and indication, development of venous thromboembolism, obstetric anal sphincter injuries, hysterectomy, intensive care unit admission or death

    Measured: 0-6 weeks after delivery admission

  6. Postpartum Depression as assessed by Edinburgh Postnatal Depression Screen

    EPDS (Edinburg Postnatal Depression Screen) is a validated survey for pre and postnatal depression, with scores ranging from 0-30 with higher score indicating increased symptom burden

    Measured: 6 weeks - 12 weeks postpartum

  7. Postpartum Depression as assessed by Edinburgh Postnatal Depression Screen

    EPDS (Edinburg Postnatal Depression Screen) is a validated survey for pre and postnatal depression, with scores ranging from 0-30 with higher score indicating increased symptom burden with a second outcome at a longer time scale

    Measured: 6 months to 8 months postpartum

  8. Postpartum Anxiety as assessed by Generalized Anxiety Disorder - 7 item (GAD-7)

    GAD-7 is a validated survey for anxiety, with scores ranging from 0-21 with higher score indicating increased symptom burden

    Measured: 6 weeks - 12 weeks postpartum

  9. Postpartum Anxiety as assessed by Generalized Anxiety Disorder - 7 item (GAD-7)

    GAD-7 is a validated survey for anxiety, with scores ranging from 0-21 with higher score indicating increased symptom burden

    Measured: 6 months to 8 months postpartum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 May 2025
  2. Study start14 Oct 2025
  3. Primary completion15 Oct 2026 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06992791
Sponsor's protocol ID
812358
Acronym
LEPT
Status last verified
Jun 2026
First submitted
30 Apr 2025
Last updated
23 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All of the individual participant data collected during the trial, after deidentification

Publications

  • Kostek M, Polaski A, Kolber B, Ramsey A, Kranjec A, Szucs K. A Protocol of Manual Tests to Measure Sensation and Pain in Humans. J Vis Exp. 2016 Dec 19;(118):54130. doi: 10.3791/54130.

    PubMed 28060280
  • Horsch A, Garthus-Niegel S, Ayers S, Chandra P, Hartmann K, Vaisbuch E, Lalor J. Childbirth-related posttraumatic stress disorder: definition, risk factors, pathophysiology, diagnosis, prevention, and treatment. Am J Obstet Gynecol. 2024 Mar;230(3S):S1116-S1127. doi: 10.1016/j.ajog.2023.09.089. Epub 2024 Jan 9.

    PubMed 38233316

Questions about this trial

What is this clinical trial studying?

A study testing Prenatal Education on Childbirth in people with Postpartum Complication and Posttraumatic Stress Symptoms, run by University of California, San Diego 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: under way, not looking for participants, as of the sponsor's last update on 23 Jun 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?

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?

Post-traumatic stress disorder checklist for Diagnostic and Statistical Manual of Mental Health Disorders-5 (PCL-5) (time frame: 6-12 weeks postpartum). 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 NCT06992791, which also lists 2 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 23 Jun 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in