Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2026-03-03 @ 8:10 AM
Study NCT ID:
NCT02203734
Status:
COMPLETED
Last Update Posted:
2015-10-09
First Post:
2013-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Massage To Improve Uterine Artery Blood Flow
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-08', 'studyFirstSubmitDate': '2013-11-28', 'studyFirstSubmitQcDate': '2014-07-28', 'lastUpdatePostDateStruct': {'date': '2015-10-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change Doppler Ultrasound', 'timeFrame': 'First Day of Study and 10 Weeks After', 'description': 'Change in Doppler Ultrasound to assess Uterine Artery Resistance Index values'}], 'secondaryOutcomes': [{'measure': 'Change in CES-D', 'timeFrame': 'First Day of Study and 10 Weeks After', 'description': 'Change in Depression Questionaire Scores'}, {'measure': 'Change Saliva Samples', 'timeFrame': 'First Day of Study and 10 Weeks After', 'description': 'Saliva samples to assess changes in cortisol and alpha amylase'}, {'measure': 'Birth Outcome Data', 'timeFrame': 'Birth', 'description': 'Obtain birth outcome data (Birthweight and Gestational age) from medical records after birth of baby'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pregnancy', 'Depression', 'Massage'], 'conditions': ['Pregnancy', 'Depression']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www6.miami.edu/touch-research/', 'label': 'Touch Research Institute'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Uncomplicated singleton pregnancy\n* Depression\n* \\< 20 weeks GA at recruitment\n\nExclusion Criteria:\n\n* Pregnancy complications\n* HIV\n* Smoking, drug use'}, 'identificationModule': {'nctId': 'NCT02203734', 'briefTitle': 'Massage To Improve Uterine Artery Blood Flow', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'Massage to Reduce Intrauterine Artery Resistance, Prematurity and Low Birthweight', 'orgStudyIdInfo': {'id': '20080617'}, 'secondaryIdInfos': [{'id': 'R21HD069872-01A1', 'link': 'https://reporter.nih.gov/quickSearch/R21HD069872-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Moderate Pressure Massage', 'description': 'Moderate Pressure Massage Therapy', 'interventionNames': ['Procedure: Moderate Pressure Massage']}, {'type': 'SHAM_COMPARATOR', 'label': 'Light Pressure Massage', 'description': 'Light Pressure Massage Therapy', 'interventionNames': ['Procedure: Light Pressure Massage']}], 'interventions': [{'name': 'Moderate Pressure Massage', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['Moderate Pressure Massage']}, {'name': 'Light Pressure Massage', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['Light Pressure Massage']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Miguel Diego', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Research Associate Professor', 'investigatorFullName': 'Miguel Diego', 'investigatorAffiliation': 'University of Miami'}}}}