Slow and Deep Breathing to Lower Blood Pressure in Women With Pregnancy-induced Hypertension

NCT04059822 | Terminated DMC

• 1 other identifier: 251062
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 2

Brief Summary

This study evaluates the effect of slow and deep breathing on lowering blood pressure in women with pregnancy-induced hypertension. Slow and deep breathing will be practised daily for 10 minutes from enrolment until the woman gives birth. This feasibility study aims to investigate the practicality of conducting a proposed future randomised controlled trial.

Conditions

Pregnancy-Induced Hypertension

Keywords

Slow and deep breathing; Feasibility study

Outcome Measures

Primary Outcomes (1)

• Adherence to the breathing exercise intervention

  Proportion of days breathing exercise completed per participant and average proportion of days breathing exercise completed

  Up to 22 weeks (From enrolment to giving birth)

Secondary Outcomes (1)

• Proportion of women referred to obstetric-led care

  Up to 22 weeks (From enrolment to giving birth)

Other Outcomes (11)

• Proportion of women eligible to participate in study

  5 months (From start to end of recruitment period)

• Recruitment rates of participation using a hospital antenatal unit

  5 months (From start to end of recruitment period)

• Proportion of women who would be willing to be randomised in future trials

  Between gestational age 36 weeks and birth. If participant gives birth prior to 36 weeks they will be invited to participate in the questionnaire when appropriate, but before 36 weeks

Study Arms (1)

Slow and deep breathing

EXPERIMENTAL

Daily practice of slow and deep breathing for 10 minutes per day. Breathing frequency will be 6 breaths per minute, with participants accessing a video aid to help guide their breathing. Breathing exercises will be conducted from enrolment until birth (maximum \~20 weeks if enrolment at 20 weeks gestation until \~40 weeks gestation birth)

Other: Slow and deep breathing

Interventions

Slow and deep breathing OTHER

Please see arm description

Slow and deep breathing

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with pregnancy-induced hypertension (PIH). Defined as "new hypertension presenting after 20 weeks of pregnancy without significant proteinuria (urinary protein:creatinine ratio greater than 30mg/mmol" by NICE guidelines (2010) OR diagnosed as having one-off high blood pressure but at risk of developing PIH;
• Single pregnancy;
• Capable of giving informed consent;
• Age over 18.

You may not qualify if:

• Under 18 years old;
• Referred immediately to obstetric-care after PIH diagnosis for an immediate intervention, with systolic blood pressure over 160 mmHg or diastolic blood pressure over 100 mmHg;
• Multiple pregnancy (twins, triplets, etc.);
• Current smoker;
• Current diagnosis of respiratory diseases; asthma, COPD (Chronic Obstructive Pulmonary disease), bronchitis. (A previous occurrence or diagnosis that has not been present for longer than 1 year ago does not exclude participants, i.e. childhood asthma);
• Allergy/reaction to gel used on ECG tabs;
• Vulnerable participants who are unable to give informed consent.

Sponsors & Collaborators

• Bournemouth University: lead

Study Sites (2)

Bournemouth University

Bournemouth, BH8 8GP, United Kingdom

Location

University Hospitals Dorset NHS Foundation Trust

Poole, United Kingdom

Location

Related Publications (1)

• Felton M, Hundley VA, Grigsby S, McConnell AK. Effects of slow and deep breathing on reducing obstetric intervention in women with pregnancy-induced hypertension: a feasibility study protocol. Hypertens Pregnancy. 2021 Feb;40(1):81-87. doi: 10.1080/10641955.2020.1869250. Epub 2021 Jan 19.

  PMID: 33463384 DERIVED

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Malika Felton

  Postgraduate Researcher

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants will take part in the slow and deep breathing daily exercises.

Study Record Dates

• First Submitted: August 13, 2019
• First Posted: August 16, 2019
• Study Start: January 14, 2020
• Primary Completion: April 28, 2023
• Study Completion: April 28, 2023
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)