Prenatal Education for Postpartum PTSD

(LEPT Trial)

Overseen By Nicole Teal, MD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of California, San Diego

Disqualifiers: Prenatal care outside UCSD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

400 Participants Needed

Trial Summary

What is the purpose of this 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? 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.

Eligibility Criteria

This trial is for first-time pregnant women with no prior childbirth experience. It aims to see if teaching them about what happens during labor can help prevent stress after the baby is born. Women who want to join should be willing to fill out several surveys and may choose to give samples like blood or cerebrospinal fluid.

Inclusion Criteria

I am pregnant with one baby and between 18-30 weeks along.

Nulliparous

English Speaking

Exclusion Criteria

Prenatal care outside of UCSD

Plan to deliver outside of UCSD

Contraindications to vaginal delivery at time of enrollment

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Prenatal Education

Participants receive online education videos on intrapartum experiences starting at 30 weeks of pregnancy

10 weeks

Virtual interactions

Delivery and Immediate Post-Delivery

Collection of health information and biospecimens during delivery and immediate post-delivery care

0-2 weeks postpartum

In-person during delivery

Follow-up

Participants are monitored for postpartum traumatic symptoms and mental health outcomes

6-8 months postpartum

Surveys at 6 weeks, 6 months, and 8 months postpartum

Treatment Details

Interventions

• Prenatal Education on Childbirth

Trial Overview The study tests whether prenatal education on childbirth can reduce postpartum traumatic stress. Participants will receive this education and then complete surveys assessing their mental health, experiences of childbirth, and any traumatic symptoms at various stages before and after delivery.

Participant Groups

Group I: Prenatal Education Arm Experimental Treatment 1 Intervention

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

Group II: Control Arm Active Control 1 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.

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+