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Massage To Improve Uterine Artery Blood Flow

Massage to Reduce Intrauterine Artery Resistance, Prematurity and Low Birthweight

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02203734
Enrollment
24
Registered
2014-07-30
Start date
2012-02-29
Completion date
2015-09-30
Last updated
2015-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Pregnancy

Keywords

Pregnancy, Depression, Massage

Brief summary

This project will investigate the effects of massage therapy on depressed pregnant women. The investigators expect that massage therapy will improve blood flow from the mother to the fetus and reduce prematurity and depression.

Detailed description

Prenatal depression has been associated with adverse neonatal outcomes including preterm birth and low birthweight. Potential underlying mechanisms for prenatal depression effects on prematurity and low birthweight involve the elevated sympathetic nervous system SNS and Hypothalamic Pituitary Adrenal HPA Axis function noted in depressed pregnant women. These may lead to increased uterine artery resistance and the resulting limited blood flow, oxygen and nutrients to the fetus. Moderate pressure massage therapy may reduce this problem in depressed pregnant women by decreasing SNS and HPA axis function, resulting in decreased uterine artery resistance, increased oxygen and nutrients to the fetus and lower prematurity and low birthweight. An alternative model being explored here is that moderate pressure massage may increase progesterone/estriol ratios, which counteract the negative cortisol effects on gestational age. Eighty pregnant women with depression symptoms will be recruited at approximately 20 weeks gestation and randomly assigned to a moderate pressure massage therapy or to a SHAM light pressure massage touch/attention control group. The women will receive 20-minute weekly massage therapy sessions from 20 to 30 weeks gestation. At 20 and 30 weeks gestation, depressed symptoms will be assessed using the CES-D, and saliva samples will be collected to assay alpha amylase as an SNS marker, cortisol as an HPA axis marker and progesterone and estriol levels. Maternal Doppler ultrasound will be conducted to assess the uterine artery resistance index as an estimate of uterine artery blood flow. Upon delivery, the mothers' medical charts will be reviewed to record gestational age and birthweight. The investigators are hypothesizing that the moderate pressure massage group will elicit an increase in progesterone/estriol ratios and decreases in alpha amylase and cortisol levels, which in turn will lead to reduced uterine artery resistance and a lower incidence of prematurity and low birthweight.

Interventions

PROCEDUREModerate Pressure Massage

The massage therapy will begin with the mother in a side-lying position, with pillows positioned behind her back and between her legs for support. The massage is given in the following sequence and repeated twice (10 minutes on each side for 20 minutes total) on the following areas: 1) Head and neck: 2) Back: 3) Arms: and 4) Legs. The effective moderate pressure (measured by a pressure meter) is 8 db or a slight indentation in the skin.

PROCEDURELight Pressure Massage

The light pressure massage group will receive light pressure massage in contrast to the treatment group who will receive moderate pressure massage. As with moderate pressure massage, each session will begin with the mother in a side-lying position, with pillows positioned behind her back and between her legs for support. The massage is given in the following sequence and repeated twice (10 minutes on each side for 20 minutes total) on the following areas: 1) Head and neck: 2) Back: 3) Arms: and 4) Legs.

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
Miguel Diego
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

* Uncomplicated singleton pregnancy * Depression * \< 20 weeks GA at recruitment

Exclusion criteria

* Pregnancy complications * HIV * Smoking, drug use

Design outcomes

Primary

MeasureTime frameDescription
Change Doppler UltrasoundFirst Day of Study and 10 Weeks AfterChange in Doppler Ultrasound to assess Uterine Artery Resistance Index values

Secondary

MeasureTime frameDescription
Change in CES-DFirst Day of Study and 10 Weeks AfterChange in Depression Questionaire Scores
Change Saliva SamplesFirst Day of Study and 10 Weeks AfterSaliva samples to assess changes in cortisol and alpha amylase
Birth Outcome DataBirthObtain birth outcome data (Birthweight and Gestational age) from medical records after birth of baby

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026