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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:
Participants will be given surveys:
They will also have the option to participate in collection of discarded cerebrospinal fluid, blood and serum and physiologic sensitivity testing.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | At enrollment and at 36-38 weeks of pregnancy |
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Inclusion criteria:
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Diego | San Diego | California | 92122 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28060280 | Background | 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. | |
| 38233316 | 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. |
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All of the individual participant data collected during the trial, after deidentification
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 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
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| 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 | 6-8 months postpartum |
| 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 | 0-2 weeks postpartum |
| Rate of Labor Interventions | Chart review recording the rate of labor interventions, including amniotomy, induction, epidural, doula use, and pitocin at delivery admission | At delivery |
| 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 | 0-6 weeks after delivery admission |
| 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 | 6 weeks - 12 weeks postpartum |
| 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 | 6 months to 8 months postpartum |
| 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 | 6 weeks - 12 weeks postpartum |
| 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 | 6 months to 8 months postpartum |