University of California, San Diego
San Diego, California, 92122, United States
NCT Number: NCT06992791
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.
This study is active but is not currently recruiting participants.
18 year–51 year
Female
Interventional
Not applicable
San Diego, California, 92122, United States
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:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 6-12 weeks postpartum
Validated measurement for PTSD, scores 0-80 with higher being more symptomatic
Time frame: At enrollment and at 36-38 weeks of pregnancy
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
Time frame: 6-8 months postpartum
Validated measure of PTSD assessment, scores 0-80 with higher being more symptomatic over a longer time frame
Time frame: 0-2 weeks postpartum
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
Time frame: At delivery
Chart review recording the rate of labor interventions, including amniotomy, induction, epidural, doula use, and pitocin at delivery admission
Time frame: 0-6 weeks after delivery admission
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
Time frame: 6 weeks - 12 weeks postpartum
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
Time frame: 6 months to 8 months postpartum
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
Time frame: 6 weeks - 12 weeks postpartum
GAD-7 is a validated survey for anxiety, with scores ranging from 0-21 with higher score indicating increased symptom burden
Time frame: 6 months to 8 months postpartum
GAD-7 is a validated survey for anxiety, with scores ranging from 0-21 with higher score indicating increased symptom burden
University of California, San Diego
Other
Labor Education to Reduce Postpartum Traumatic Stress: A Randomized Controlled Trial
Acronym: LEPT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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