Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00426244
Status:
COMPLETED
Last Update Posted:
2018-08-21
First Post:
2007-01-22
Brief Title:
Osteopathic Manipulative Medicine in Pregnancy Physiologic and Clinical Effects
Sponsor:
University of North Texas Health Science Center
Organization:
University of North Texas Health Science Center
Study Overview
Official Title:
Osteopathic Manipulative Medicine in Pregnancy Physiologic and Clinical Effects
Status:
COMPLETED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
The osteopathic philosophy of health is built on a model in which basic body functions are coordinated and integrated by the musculoskeletal system Osteopathic medical students are taught to consider these aspects in assessing diagnosing and treating the individual patient As a treatment method that reflects the osteopathic philosophy osteopathic manipulative medicine OMM is a body-based modality in which the patient is evaluated and treated as a whole to improve physiologic functioning and remove impediments to optimal health and functioning
During pregnancy a womans body is challenged by significant and extensive physiological and biomechanical changes Some physiological changes such as increased fluid volume and sympathetic tone may lead to consequences such as edema preterm labor and meconium-staining of the amniotic fluid The biomechanical state of the womans body is also drastically affected as the fetus grows and the uterus expands the center of gravity shifts forward rotating the pelvis anteriorly and increasing the lordosis of the low back and may also affect the motion of the hips and legs These postural changes also have consequences such as low back pain decreased functional status and altered gait Both these physiologic and biomechanical consequences can have a significant long-term impact on the health of the mother and child
OMM is theorized to facilitate the bodys adjustment to the physiological and biomechanical demands of pregnancy and improve the outcomes of pregnancy labor and delivery Clinical case studies report reduced back pain shorter labor and fewer incidences of peripartum complications in patients who receive prenatal OMM However to date we have found no published systematic investigations of the efficacy of OMM in managing the adverse effects that pregnancy has on a womans musculoskeletal system nor have we found any published systematic studies to prove the mechanisms of action of OMM in managing pain edema or gait in pregnant patients
Thus the overall question that guides this proposal is to what extent and by what physiological mechanisms does Osteopathic Manipulative Medicine OMM affect selected conditions related to pregnancy labor and delivery Based on the principles and theories of OMM and the limited previous studies the hypothesis of this study is that OMM improves clinical outcomes including low back pain functional status incidence of meconium-stained amniotic fluid and complications of labor and delivery and that the physiological changes related to improved autonomic regulation peripheral hemodynamic regulation and biomechanical changes related to gait are in part responsible for these clinical benefits
During pregnancy a womans body is challenged by significant and extensive physiological and biomechanical changes Some physiological changes such as increased fluid volume and sympathetic tone may lead to consequences such as edema preterm labor and meconium-staining of the amniotic fluid The biomechanical state of the womans body is also drastically affected as the fetus grows and the uterus expands the center of gravity shifts forward rotating the pelvis anteriorly and increasing the lordosis of the low back and may also affect the motion of the hips and legs These postural changes also have consequences such as low back pain decreased functional status and altered gait Both these physiologic and biomechanical consequences can have a significant long-term impact on the health of the mother and child
OMM is theorized to facilitate the bodys adjustment to the physiological and biomechanical demands of pregnancy and improve the outcomes of pregnancy labor and delivery Clinical case studies report reduced back pain shorter labor and fewer incidences of peripartum complications in patients who receive prenatal OMM However to date we have found no published systematic investigations of the efficacy of OMM in managing the adverse effects that pregnancy has on a womans musculoskeletal system nor have we found any published systematic studies to prove the mechanisms of action of OMM in managing pain edema or gait in pregnant patients
Thus the overall question that guides this proposal is to what extent and by what physiological mechanisms does Osteopathic Manipulative Medicine OMM affect selected conditions related to pregnancy labor and delivery Based on the principles and theories of OMM and the limited previous studies the hypothesis of this study is that OMM improves clinical outcomes including low back pain functional status incidence of meconium-stained amniotic fluid and complications of labor and delivery and that the physiological changes related to improved autonomic regulation peripheral hemodynamic regulation and biomechanical changes related to gait are in part responsible for these clinical benefits
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5K23AT003304-05 | NIH | None | httpsreporternihgovquickSearch5K23AT003304-05 |