Safety of Osteopathic Manipulative Treatment on Labor and Delivery Outcomes
Roane, Brandy Ph.D., CBSM
Smith-Barbaro, Peggy Ph.D.
Hensel, Kendi DO, Ph.D.
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1. Objective: Osteopathic Manipulative Treatment (OMT) has been used in pregnant women since its beginning, but little quality data exists on its safety. The Pregnancy Research in Osteopathic Manipulation Optimizing Treatment Effects (PROMOTE) study was a NIH-funded, randomized controlled clinical trial with the objective of evaluating the safety and efficacy of OMT during third-trimester pregnancy. 2. Materials and Methods: In PROMOTE, 400 study subjects were randomly assigned to one of three study groups: Usual Care Only (UCO), Usual Care plus Placebo Ultrasound Treatment (PUT) or Usual Care plus OMT (OMT). The primary objective of the current analysis was to evaluate safety of OMT on labor and delivery by comparing the incidence of high-risk status of pregnant women; labor and delivery outcomes such as length of labor, perineal lacerations, operative vaginal delivery, meconium-stained amniotic fluid; and APGARs of infants born to mothers in each of the three study groups. 3. Results: Data from this study showed that the application of the OMT protocol does not result in increased risk of high-risk status, in fact, women who received OMT were less likely to develop high risk status. The OMT protocol also did not increase risk of precipitous labor, conversion to caesarian section, perineal laceration, meconium-stained amniotic fluid, or requiring the use of forceps or a vacuum device. In all the maternal outcomes examined, no difference was reported among the three study groups with the exception of incidence of prolonged labor. Women receiving OMT were able to successfully labor longer and vaginally deliver with no increased incidence of complications, including perineal laceration, episiotomy, and use of forceps or vacuum device. 4. Conclusion: These results suggest that the OMT protocol as applied in PROMOTE is a safe intervention during the third trimester.