Labor Education to Reduce Postpartum Traumatic Stress

NCT06992791 | Enrolling By Invitation DMC

• 1 other identifier: 812358
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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 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? 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.

Conditions

Postpartum Complication; Posttraumatic Stress Symptoms

Keywords

Posttraumatic stress disorder; Childbirth related PTSD; prenatal education; traumatic childbirth; Posttraumatic stress syndrome

Outcome Measures

Primary Outcomes (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

  6-12 weeks postpartum

Secondary Outcomes (9)

• Change in Fear of Childbirth as measured by Wijma Delivery Experience Form A

  At enrollment and at 36-38 weeks of pregnancy

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

  6-8 months postpartum

• Delivery Experience as measured by Wijma Delivery Experience Form B

  0-2 weeks postpartum

• Rate of Labor Interventions

  At delivery

• Rate of Obstetric Complications

  0-6 weeks after delivery admission

Study Arms (2)

Prenatal Education Arm

EXPERIMENTAL

Those in Group 1 (intervention group) will be given access to intrapartum education videos provided by Tinyhood between 30weeks and delivery.

Behavioral: Prenatal Education on Childbirth

Control Arm

NO INTERVENTION

Those 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.

Interventions

Prenatal Education on Childbirth BEHAVIORAL

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.

Prenatal Education Arm

Eligibility Criteria

• Age: 18 Years - 51 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California, San Diego

San Diego, California, 92122, United States

Location

Related Publications (2)

• 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.

  PMID: 28060280 BACKGROUND

• 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.

  PMID: 38233316 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: May 28, 2025
• Study Start: October 14, 2025
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): January 30, 2028
• Last Updated: November 14, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
• Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact rwiley@health.ucsd.edu

Locations

US (1)