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Mindfulness for Moms-to-Be: could a special class ease pregnancy anxiety?

NCT ID NCT04327557

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused This study
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a mindfulness-based childbirth and parenting class can lower anxiety in pregnant women. Sixty women with elevated worry will be randomly assigned to either the mindfulness class or a standard childbirth education class. Researchers will track changes in anxiety, stress, and mood during pregnancy and up to a year after birth.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Mindfulness-Based Childbirth and Parenting (MBCP) course
What this could lead to
If it works, this could offer pregnant women a drug-free way to lower anxiety and improve their mood during pregnancy and early parenting.
What could go wrong
This is a small pilot study with only 60 participants, and it is currently suspended. The results may not apply to all pregnant women, and the benefits may be no better than standard childbirth classes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2019

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 40 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Maternal Inclusion Criteria: * A score on the Penn State Worry Questionnaire (PSWQ) of 50 or greater * Nulliparous and expecting a healthy (i.e., normal/low medical risk), singleton pregnancy * No more than 28 weeks gestation at time of enrollment (to allow time to complete the intervention before 37 weeks) * Comfortable reading, writing, and conversing in English. * Available and able to enroll in the MBCP class Infant Inclusion Criteria: * Born to a mother participating in the study Maternal Exclusion Criteria: * Severe medical conditions that would compromise the pregnancy (e.g., pre-eclampsia, severe hyperthyroidism); * Current or past bipolar disorder, schizophrenia, or post-traumatic stress disorder (PTSD); * Active psychopharmacological treatment (current or in the past 6 months). * Formal mindfulness meditation practice or long-term yoga practice * Significant injuries, illness or surgery that may impair parent-child interaction (e.g., traumatic brain injury) or that is unstably treated. * HIV or AIDS * Cancer in the past year * Major Autoimmune Disease * Infection while pregnant such as Toxoplasmosis, Rubella, Cytomegalovirus (CMV) infection, Herpes Simplex Virus (HSV), Syphilis * Prior childbirth Infant Exclusion Criteria: * Major neurosensory impairment: legally blind or coloboma * Isoimmunization * Severe jaundice * Facial cleft * Abnormal heart rate: ECG \>180 or \<80

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The places running it

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  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

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  3. A doctor treating you

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Contacts and locations

Locations

  • University of Wisconsin Madison

    Madison, Wisconsin, 53703-2637, United States

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