Prenatal Education About Reducing Labor Stress (PEARLS)
United States33 participantsStarted 2011-10
Plain-language summary
The purpose of this small randomized controlled trial (RCT) is to compare the impact of a brief (16 hour) 3rd trimester mindfulness-based childbirth education program, "Mind in Labor (MIL): Working with Pain in Childbirth," with a standard care/"treatment as usual" (TAU) active control condition of standard hospital- and community-based childbirth education. The MIL group is expected to demonstrate a reduction in fear of labor (less pain catastrophizing and greater childbirth self-efficacy), less perceived pain in labor, less use of pain medication in labor, greater birth satisfaction, and better prenatal and postpartum psychological adjustment compared to the TAU group.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 18 or over
* No prior full-term pregnancy or live birth prior to the current pregnancy
* In 3rd trimester of healthy, singleton pregnancy
* Willingness to be randomized
* Able to read, write, and understand spoken English
* Planned hospital birth in the San Francisco Bay Area
Exclusion Criteria:
* Current or prior formal meditation experience
* Formal yoga practice prior to pregnancy (brief prenatal yoga practice will not lead to exclusion)
* Participation in other mind/body childbirth preparation course (e.g., with hypnosis focus)
* Planned elective Cesarean birth
* Planned homebirth or other non-hospital birth setting
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Fear of labor (childbirth self-efficacy and pain catastrophizing)
Timeframe: Baseline (pre-intervention, 3rd trimester); Post-intervention (prior to birth)
2
Perceived labor pain
Timeframe: Postpartum (average of 6 weeks post-birth)
3
Pain medication use during labor
Timeframe: Labor (during childbirth)
4
Childbirth satisfaction
Timeframe: Postpartum (average of 6 weeks post-birth)
5
Change in Depression
Timeframe: Baseline (pre-intervention, 3rd trimester); Post-intervention (prior to birth); Postpartum (average of 6 weeks postbirth); Follow-up (1-2 years post-birth)