Childbirth Education Pilot Study

University of Wisconsin (UW)

Status: Suspended

Conditions: Anxiety; Pregnancy

Treatments: Behavioral: Non-MBCP Childbirth Education Course; Behavioral: MBCP Childbirth Education Course

Study type: Interventional

Funder types: Other

Identifiers

NCT04327557

2018-1575

Protocol Version 2/3/2020 (Other Identifier)

SOHE/GENERAL ADMINISTRATION (Other Identifier)

A271000 (Other Identifier)

Details and patient eligibility

About

This study aims to investigate the effects of mindfulness training on prenatal maternal anxiety using a randomized controlled trial (RCT). An RCT of mindfulness training for prenatal anxiety has distinct clinical and scientific advantages.

The investigators will use the Mindfulness-Based Childbirth and Parenting (MBCP) intervention in this study to build on previous findings by focusing on anxiety in pregnancy while also teaching mindfulness skills shown to promote positive childbirth appraisals and sensitive parenting through mindful parenting skills that have been shown to be linked to maternal-infant stress physiology in other work.

This study will enroll pregnant women with elevated anxiety (N = 60) who will be randomly assigned to the MBCP condition (n = 30) or an active control condition (a treatment as usual (TAU) condition; n = 30) which is a standard childbirth education class. Mothers will be assessed pre- and post-intervention and postpartum. Infant multi-modal neuroimaging will occur at age 1 month, at home questionnaire follow-up will occur at age 3 months, and a behavioral observation of parenting and child social-emotional functioning will occur at age 12 months. The hypothesis is that there will be greater benefits from MBCP relative to TAU controls, and enhanced connectivity between the amygdala and relevant cortico-limbic areas in from MBCP relative to TAU controls.

Full description

Baseline (Pre-Class) Visit : Once study eligibility has been confirmed, the participant will come to the lab for an in-person visit. If they choose to continue in the study after reading and signing the consent form, they will complete a series of questionnaires and collect saliva samples at home.

Childbirth Education Intervention: The participant will be randomly assigned to one of two childbirth and parenting education groups (either the MBCP course offered at UW Health or a TAU course). Participants in the TAU group will be provided options of courses to select. Courses may last up to 9 weeks long. The course is provided as part of the study. Participants are asked to complete the course before the 37th week of pregnancy.

Post-Intervention (Post-Class) Visit: After completing the childbirth and parenting education course, the participant will complete a series of questionnaires and collect another set of saliva samples. This can happen in person or remotely.

1-Month Follow-Up Visit: One month after birth, the participant and their child will come to the lab for an MRI scan of the child's brain while he or she sleeps as well as complete another series of questionnaires.

3-Month Follow-Up Visit: Three months after birth, the participant will complete a series of questionnaires.

12-Month Follow-Up Visit: Twelve months after birth, the participant and their child will come to the lab for one final visit to do a behavioral assessment as well as complete a final series of questionnaires.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

MBCP Childbirth Education Course

Experimental group

Description:

This arm will undergo the 9-week MBCP course.

Treatment:

Behavioral: MBCP Childbirth Education Course

Non-MBCP Childbirth Education Course

Active Comparator group

Description:

This arm will undergo the TAU (treatment as usual) childbirth education course (one that does not have a huge mindfulness component).

Treatment:

Behavioral: Non-MBCP Childbirth Education Course