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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if educating first-time mothers about childbirth expectations can reduce feelings of trauma post-birth. Participants will watch educational videos and complete surveys about their mental health and childbirth experiences. The trial will assess whether this prenatal education alters their feelings six weeks after delivery and impacts the birth itself. Women pregnant for the first time, between 18 and 30 weeks along, and receiving care at UCSD may be suitable for this study. As an unphased trial, this study offers the opportunity to contribute to valuable research that could enhance childbirth experiences for future mothers.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that prenatal education on childbirth is safe?

Research has shown that learning about childbirth before it occurs is generally safe and well-received. No reports indicate serious problems from providing information about labor and delivery. In fact, similar educational programs in other areas have proven safe. This study involves watching educational videos, a simple and low-risk method. Participants primarily provide feedback through surveys, which also carry minimal risk. Overall, this type of education is considered safe for expectant mothers. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the potential of prenatal education to prevent postpartum PTSD. Unlike traditional treatments for postpartum PTSD, which often involve therapy and medication after symptoms arise, this approach aims to provide education before childbirth. By using intrapartum education videos from Tinyhood, the trial hopes to empower expectant mothers with knowledge and coping strategies before delivery, potentially reducing the likelihood of developing PTSD symptoms. This proactive approach could represent a shift in how postpartum mental health is managed, focusing on prevention rather than treatment after the fact.

What evidence suggests that prenatal education on childbirth could be effective for reducing postpartum PTSD symptoms?

Research has shown that learning about childbirth before giving birth can help reduce symptoms of PTSD after delivery. In this trial, participants in the Prenatal Education Arm will access intrapartum education videos provided by Tinyhood between 30 weeks and delivery. One study found that women who learned what to expect during labor had fewer trauma symptoms afterward compared to those who did not receive this education. Another study confirmed that attending prenatal classes was linked to lower rates of PTSD. Additionally, learning about childbirth increased women's confidence in managing labor, which can help reduce stress. These findings suggest that understanding labor in advance may make the childbirth experience less traumatic. ^{2 4 5 6 7}

Are You a Good Fit for This Trial?

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

Nulliparous

English Speaking

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

Exclusion Criteria

Prenatal care outside of UCSD

Plan to deliver outside of UCSD

Contraindications to vaginal delivery at time of enrollment

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10252538/

Past Traumatic Life Events, Postpartum PTSD, and the ...

The aim of this study was to investigate the association of postpartum post-traumatic stress disorder (PP-PTSD) symptoms and subjective rates of traumatic ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06992791?aggFilters=status%3A

Labor Education to Reduce Postpartum Traumatic Stress

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

3.

bmcpregnancychildbirth.biomedcentral.com

bmcpregnancychildbirth.biomedcentral.com/articles/10.1186/s12884-024-06873-6

Childbirth self-efficacy and birth related PTSD symptoms

This study evaluated an online childbirth education course on childbirth self-efficacy and, subsequent birth related posttraumatic stress disorder (PTSD) ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S1871519225002495

The effect of a trauma-informed care video training ...

Trauma-informed care (TIC) by midwives has the potential to prevent re-traumatization among perinatal women and support midwives' mental ...

5.

nature.com

nature.com/articles/s41598-022-14508-z

Childbirth experience, risk of PTSD and obstetric ...

Antenatal class attendance may thus be associated with lower PTSD-FC rates. This cross-sectional study took place at a Swiss university hospital.

6.

withpower.com

withpower.com/trial/prenatal-education-for-postpartum-ptsd-3237d

Prenatal Education for Postpartum PTSD (LEPT 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 ...

7.

clinicaltrials.ucsd.edu

clinicaltrials.ucsd.edu/trial/NCT06992791

Labor Education to Reduce Postpartum Traumatic Stress

Details. Hypothesis: This randomized trial was designed to determine if prenatal education on intrapartum experiences reduces postpartum trauma ...