Trial Outcomes & Findings for Prenatal Mindfulness & Hypertension Study (NCT NCT03679117)

NCT ID: NCT03679117

Last Updated: 2023-06-01

Results Overview

Number of participants that completed greater than 5 mindfulness sessions or completed the follow up interview.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 30 participants
• Primary outcome timeframe: Through study completion, an average of 20 weeks
• Results posted on: 2023-06-01

Participant Flow

One participant withdrew prior to randomization. This is why 30 participants were enrolled and 29 randomized.

Participant milestones

Measure	Mindfulness Training Phone-delivered mindfulness training Mindfulness Training: Phone-delivered mindfulness training. 8 weeks of 30 minute phone sessions with an instructor, plus 15 minutes of self-guided practice.	Treatment as Usual Usual prenatal care to prevent and treat hypertension
Overall Study STARTED	15	14
Overall Study COMPLETED	12	14
Overall Study NOT COMPLETED	3	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Prenatal Mindfulness & Hypertension Study

Baseline characteristics by cohort

Measure	Mindfulness Training n=15 Participants Phone-delivered mindfulness training Mindfulness Training: Phone-delivered mindfulness training. 8 weeks of 30 minute phone sessions with an instructor, plus 15 minutes of self-guided practice.	Treatment as Usual n=14 Participants Usual prenatal care to prevent and treat hypertension	Total n=29 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants	14 Participants n=7 Participants	29 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	33 years STANDARD_DEVIATION 4 • n=5 Participants	32 years STANDARD_DEVIATION 5 • n=7 Participants	32 years STANDARD_DEVIATION 4 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	14 Participants n=7 Participants	29 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=5 Participants	12 Participants n=7 Participants	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants	9 Participants n=7 Participants	20 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants	14 participants n=7 Participants	29 participants n=5 Participants
Systolic blood pressure	117 mmHg STANDARD_DEVIATION 11 • n=5 Participants	125 mmHg STANDARD_DEVIATION 14 • n=7 Participants	121 mmHg STANDARD_DEVIATION 13 • n=5 Participants

PRIMARY outcome

Timeframe: Through study completion, an average of 20 weeks

Number of participants that completed greater than 5 mindfulness sessions or completed the follow up interview.

Outcome measures

Measure	Mindfulness Training n=15 Participants Phone-delivered mindfulness training Mindfulness Training: Phone-delivered mindfulness training. 8 weeks of 30 minute phone sessions with an instructor, plus 15 minutes of self-guided practice.	Treatment as Usual n=14 Participants Usual prenatal care to prevent and treat hypertension
Retention and Adherence	12 Participants	11 Participants

SECONDARY outcome

Timeframe: Through study completion, an average of 20 weeks

Number of participants with a diagnosis of hypertensive disorders of pregnancy

Outcome measures

Measure	Mindfulness Training n=15 Participants Phone-delivered mindfulness training Mindfulness Training: Phone-delivered mindfulness training. 8 weeks of 30 minute phone sessions with an instructor, plus 15 minutes of self-guided practice.	Treatment as Usual n=14 Participants Usual prenatal care to prevent and treat hypertension
Hypertension Diagnosis	4 Participants	4 Participants

Adverse Events

Mindfulness Training

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Treatment as Usual

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Mindfulness Training n=15 participants at risk Phone-delivered mindfulness training Mindfulness Training: Phone-delivered mindfulness training. 8 weeks of 30 minute phone sessions with an instructor, plus 15 minutes of self-guided practice.	Treatment as Usual n=14 participants at risk Usual prenatal care to prevent and treat hypertension
Pregnancy, puerperium and perinatal conditions Suicidal ideation	0.00% 0/15 • Adverse events were recorded during participation in the RCT approximately 20 weeks.	7.1% 1/14 • Number of events 1 • Adverse events were recorded during participation in the RCT approximately 20 weeks.
Blood and lymphatic system disorders High blood pressure	53.3% 8/15 • Number of events 8 • Adverse events were recorded during participation in the RCT approximately 20 weeks.	50.0% 7/14 • Number of events 7 • Adverse events were recorded during participation in the RCT approximately 20 weeks.

Additional Information

Margaret Bublitz

Lifespan Hospital

Phone: 401-323-3356

Email: mbublitz@lifespan.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place