Original Contribution  |   November 2016
PROMOTE Study: Safety of Osteopathic Manipulative Treatment During the Third Trimester by Labor and Delivery Outcomes
Author Notes
  • From the Departments of Osteopathic Manipulative Medicine (Dr Hensel), Internal Medicine (Dr Roane), and Obstetrics and Gynecology (Dr Smith-Barbaro) at the University of North Texas Health Science Center Texas College of Osteopathic Medicine (Student Doctor Chaphekar) in Forth Worth. 
  • Support: This study was supported by grants K23AT003304 and K23AT3304-4S1 from the National Center for Complementary and Alternative Medicine at the National Institutes of Health and grant 06-11-549 from the American Osteopathic Association. Additional financial support was provided by the Medical Education Foundation of the American College of Osteopathic Obstetricians and Gynecologists, the American Academy of Osteopathy, the Osteopathic Heritage Foundations, and The Osteopathic Research Center at the University of North Texas Health Science Center. 
  • Disclaimer: Dr Hensel, a JAOA associate editor, was not involved in the editorial review or decision to publish this article. 
  •  *Address correspondence to Kendi L. Hensel, DO, PhD, 3500 Camp Bowie Blvd, Fort Worth, TX 76107-2644. E-mail: kendi.hensel@unthsc.edu
     
Article Information
Obstetrics and Gynecology / Osteopathic Manipulative Treatment
Original Contribution   |   November 2016
PROMOTE Study: Safety of Osteopathic Manipulative Treatment During the Third Trimester by Labor and Delivery Outcomes
The Journal of the American Osteopathic Association, November 2016, Vol. 116, 698-703. doi:10.7556/jaoa.2016.140
The Journal of the American Osteopathic Association, November 2016, Vol. 116, 698-703. doi:10.7556/jaoa.2016.140
Abstract

Background: Few quality data exist on the safety of osteopathic manipulative treatment (OMT) during pregnancy. The Pregnancy Research on Osteopathic Manipulation Optimizing Treatment Effects (PROMOTE) study was a randomized controlled clinical trial that studied the application of an OMT protocol to manage pain and dysfunction in pregnant patients during their third trimester.

Objective: To evaluate the safety of an OMT protocol applied during the third trimester of pregnancy by analyzing incidence of high-risk status and labor and delivery outcomes.

Methods: In the PROMOTE study, 400 pregnant patients were randomly assigned to 1 of 3 study groups: usual care plus OMT (OMT), usual care plus placebo ultrasound treatment (PUT), or usual care only (UCO). The incidence of high-risk status of participants and outcomes of labor and delivery, including length of labor, fever in mother during labor, operative vaginal delivery, conversion to cesarean delivery, need for forceps or vacuum device, need for episiotomy, incidence of perineal laceration, meconium-stained amniotic fluid, and infants’ Apgar scores, were analyzed.

Results: Data from 380 participants were studied. High-risk status was less likely to develop in participants who received OMT (95% CI, 0.16-0.91; P=.03). The OMT protocol also did not increase risk of precipitous labor, operative vaginal delivery, conversion to cesarean delivery, need for forceps or vacuum device, need for episiotomy, incidence of perineal laceration, or meconium-stained amniotic fluid when compared with participants in the other 2 groups (P>.05). Of all other maternal outcomes examined, no difference was reported among the 3 treatment groups with the exception of incidence of prolonged labor in the OMT group. Participants receiving OMT had longer durations of labor than participants in the other groups (P=.002).

Conclusion: These results suggest that the OMT protocol given during the third trimester of pregnancy as applied in the PROMOTE study is safe with regard to labor and delivery outcomes. The increased duration in labor in the OMT group needs further study. (ClinicalTrials.gov number NCT00426244)

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