Pregnancy Clinical Trial
Official title:
Osteopathic Manipulative Medicine in Pregnancy: Physiologic and Clinical Effects
Verified date | August 2018 |
Source | University of North Texas Health Science Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine to what extent and by what physiological mechanisms Osteopathic Manipulative Medicine (OMM) affects selected conditions related to pregnancy, labor and delivery.
Status | Completed |
Enrollment | 400 |
Est. completion date | September 2011 |
Est. primary completion date | July 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 35 Years |
Eligibility |
Inclusion Criteria: - The woman must have medical clearance from her obstetrician at each study visit - Must be less than or at 30 weeks gestation at the start of the study Exclusion Criteria: - Deemed high risk by the obstetrician (including but not limited to: abruptio placenta, placenta previa, severe pre-eclampsia/eclampsia, vaginal bleeding, gestational diabetes) - Age 17 years or younger. Females 17 years of age and younger are considered pediatric high risk pregnancies and therefore ineligible for inclusion - If a patient receives any other manual therapies such as massage, physical therapy, or chiropractic therapy, during the trial, she will be dropped from the study - Subjects with a history of syncope either before or during this pregnancy will be excluded from participation in the substudy |
Country | Name | City | State |
---|---|---|---|
United States | University of North Texas Health Science Center | Fort Worth | Texas |
Lead Sponsor | Collaborator |
---|---|
University of North Texas Health Science Center | American Academy of Osteopathy, American Osteopathic Association, Med Ed Foundation of the Am Coll of Osteopathic Obstetricians & Gynecologists, National Center for Complementary and Integrative Health (NCCIH), Osteopathic Heritage Foundations |
United States,
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* Note: There are 69 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Roland-Morris Low Back Pain and Disability Questionnaire at each visit. | 5 years | ||
Primary | Quadruple Visual Analog Scale at each visit. | 5 years | ||
Primary | Ware's Short Form-12 (SF-12)at each visit. | 5 years | ||
Primary | PHYSIOLOGICAL STUDY -All measures at visit 1 (30 weeks) and visit 4 (36 weeks) | 5 years | ||
Primary | Heart rate and blood pressure variability as measured by ECG and power spectral analysis. | 5 years | ||
Primary | BIOMECHANICAL STUDY - All measures taken at visit 1 (30 weeks) and visit 4 (36 weeks) | 5 years | ||
Primary | Step length as measured by the GAITRite walkway. | 5 years | ||
Primary | Foot angle of progression as measured by the GAITRite walkway. | 5 years | ||
Primary | Gait Symmetry as measured by the GAITRite walkway. | 5 years | ||
Secondary | CLINICAL STUDY | 5 years | ||
Secondary | Subject Confidence in Treatment Assessment at visits 1,7,and 9. | 5 yers | ||
Secondary | Meconium staining of the amniotic fluid as recorded on the delivery record. | 5 years | ||
Secondary | Other outcomes of pregnancy, labor and delivery including incidence of high-risk status, incidence of pre-term labor, length of labor, use of forceps or suction device, and pain medication use as recorded in the prenatal and delivery record. | 5 years | ||
Secondary | PHYSIOLOGICAL STUDY-All measures at visit 1 (30 weeks) and visit 4 (36 weeks) | 5 years | ||
Secondary | Heart rate as measured by ECG. | 5 years | ||
Secondary | Arterial pressure as measured by finger photoplethysmographic monitor. | 5 years | ||
Secondary | Respiration as measured by a strain gauge belt. | 5 years | ||
Secondary | Saphenous vein diameter and flow as measured by surface ultrasound. | 5 years | ||
Secondary | Calf muscle EMG as measured by surface electromyographic activity of the gastrocnemius | 5 years | ||
Secondary | Total leg volume as estimated by strain gauge plethysmography. | 5 years | ||
Secondary | Tissue water content as measured by surface dielectric probe. | 5 years | ||
Secondary | Venous flow rate as measured by calf plethysmography. | 5 years | ||
Secondary | BIOMECHANICAL STUDY -All measures taken at visit 1 (30 weeks) and visit 4 (36 weeks) | 5 years | ||
Secondary | Gait cadence as measured by the GAITRite walkway. | 5 years |
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