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Osteopathic Manipulative Treatment in the Third Trimester of Pregnancy

N/A
Waitlist Available
Led By Eric Pearson
Research Sponsored by Spectrum Health - Lakeland
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up upon delivery
Awards & highlights
No Placebo-Only Group

Summary

Osteopathic Manipulative Therapy (OMT) is a hands-on approach to treating conditions that affect all areas of the body. Physicians trained in OMT (Doctors of Osteopathic Medicine or DO) use OMT to correct structural imbalances in the body, relieve pain, and improve circulation. Research shows that manual therapy is equally or more effective in treating pain and improving function versus oral analgesics (Bodine). OMT can decrease cost and improve function in patients with a minimal adverse effect profile. OMT applications include relieving asthma, irritable bowel syndrome, fibromyalgia, migraines, carpal tunnel syndrome, and sports-related injuries. In addition to the indications listed above, there is a growing body of research surrounding the use of OMT in pregnancy and its use in treatment and prevention of complications peripartum. Research Question: Does OMT during the third trimester of pregnancy improve delivery outcomes including: decreased labor times, less utilization of analgesics, fewer incidences of meconium fluid and perineal lacerations, and reduced risk of conversion to c-section or operative vaginal delivery? Though all research has shown that OMT is safe in pregnancy, there has been conflicting data on its benefits during the peripartum period. Additional research is needed to show its utility in decreasing labor times and need for analgesics during labor and reducing incidence of adverse outcomes including perineal lacerations and conversion to c-section and operative vaginal delivery. The current study will add to the growing body of knowledge about OMT during pregnancy and its potential benefits outside of musculoskeletal pain relief.

Eligible Conditions
  • Pregnancy
  • Chiropractic treatment

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~upon delivery
This trial's timeline: 3 weeks for screening, Varies for treatment, and upon delivery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Labor duration
Secondary study objectives
Degree of perineal laceration during labor
Number of patients who underwent operative vaginal delivery
Number of patients who were converted to c-section
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: OMT InterventionExperimental Treatment1 Intervention
The OMT intervention group will be patients who consent to participating in OMT through the Southwest Women's Clinic and Cass Community Clinic in Niles, MI. Case Inclusion: 1. Pregnant patients, ages 18-34 2. Primiparous and multiparous 3. Gestational age ≥34 weeks 4. Delivering at Corewell Health South Saint Joseph or Niles hospitals 5. Consent for treatment or as a control Case Exclusion: 1. Absolute contraindications to OMT 2. Acute abdomen 3. BP \>160/110 4. Unexplained visual disturbances 5. Heavy vaginal bleeding preceding delivery 6. \<34 weeks gestational age 7. Treatment refusal 8. Magnesium sulfate received for seizure prophylaxis in setting of preeclampsia w/ severe features or severe gestational HTN 9. Scheduled c-section due to prior OB conditions
Group II: Control GroupExperimental Treatment0 Interventions
The control group will be patients who consent to participating in the control group through the Southwest Women's Clinic and Cass Community Clinic in Niles, MI.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Osteopathic Manipulative Treatment
2008
Completed Phase 4
~2570

Find a Location

Who is running the clinical trial?

Spectrum Health - LakelandLead Sponsor
13 Previous Clinical Trials
1,234 Total Patients Enrolled
Eric PearsonPrincipal InvestigatorCorewell Health Lakeland
~25 spots leftby Aug 2025