PROMOTE Study: Safety of Osteopathic Manipulative Treatment During the Third Trimester by Labor and Delivery Outcomes

Participants

• Number: 380 women (mean age 24.3 years)
• Criteria of inclusion: data taken from the PROMOTE study (Pregnancy Research on Osteopathic Manipulation Optimizing Treatment Effects), women aged from 18 to 35 years old, at the 30th week of pregnancy.
• Criteria of exclusion: women with high risk conditions (including preeclampsia, eclampsia, vaginal bleeding, oligohydramnios, gestational diabetes, hypertension) according to their obstetricians.
• Groups of study: 3 groups obtained by randomization
  • Group 1: standard of care with the addition of OMT, 129 women (mean age 24.1 years)
  • Group 2: standard of care with sham ultrasound treatment, 122 women (mean age 24.1 years)
  • Group 3: standard of care, 129 women (mean age 24.8 years)

The participants could be excluded from the study if they manifested high-risk conditions or underwent manual treatments outside of the study (OMT, physiotherapy, massages, chiropractic)

Interventions and evaluations

• Collection of the following data from hospital medical records after delivery: incidence of high-risk conditions, length of labor (divided into precipitous or prolonged labor), maternal fever during the labor, operative vaginal delivery, cesarean delivery, need for forceps or vacuum device, need of episiotomy, incidence of perineal laceration, meconium-stained amniotic fluid, infants’ Apgar scores
  • high-risk status is defined as any clinical factor that would have required a change in the control visits frequency, in the pharmacologic therapy or in activity levels, including preeclampsia, eclampsia, vaginal bleeding, oligohydramnios, gestational diabetes, hypertension, precipitous labor
  • precipitous labor, defined as labor lasting less than 3 hours
  • prolonged labor, defined as labor lasting more than 20 hours
• 7 20-minute OMT or sham treatment sessions at gestational weeks 30, 32, 34, 36, 37, 38 and 39
• OMT:
  • evaluation for somatic dysfunction in areas typically associated with pregnancy-related pain
  • treatment according to the following protocol: seated thoracic spine articulator techniques, supine cervical soft tissue myofascial release, occipitoatlantal decompression, thoracic inlet myofascial release, lumbosacral soft tissue techniques, abdominal diaphragm myofascial release, pelvic diaphragm myofascial release, sacroiliac articulation techniques, frog-leg sacral release, pubic symphysis decompression and compression of the fourth ventricle
• Ultrasound sham treatment: tactile stimulation using a switched off machine applied on the same body regions as those treated with OMT
• OMT and sham treatment performed by the same doctors certified by the American Osteopathic Board of Neuromusculoskeletal Medicine
  • the doctors were trained in order to apply the OMT protocol

Results

Primary outcomes: the only outcomes difference between the three groups were the incidence of high-risk conditions and prolonged labor. In particular, OMT reported a lower incidence of high-risk conditions compared to the other groups in a statistically significant way. Compared to the group with standard of care alone, OMT reported a reduction by 2.6 times in the likelihood of occurrence of high-risk conditions, while obtaining a reduction by 2.3 times in the same value compared to the group with sham treatment (however, this second result was not statistically significant, although very close).

With regard to the incidence of prolonged labor on the other hand, the OMT group reported a likelihood to induce prolonged labor 2.3 times greater than the group with standard of care alone and 4 times greater than the sham treatment group. A slight trend, that did not reach statistical significance, showed a greater Apgar score at 1 minute in the OMT group in comparison to the standard of care alone.

Discussion

OMT proved to be safe as it seems to have promoted a lesser incidence of high-risk conditions. This result, added to the reduction of lower back pain and associated disability as emerged in the PROMOTE study, leads to taking OMT into consideration in the management of the third trimester of pregnancy. However, the increased incidence of prolonged labor requires further investigation as labor with longer duration is linked to greater maternal fatigue and fetal distress, which can lead to the need for a cesarean section or to the risk of chorioamnionitis or postpartum hemorrhage. It should be noted, however, how none of these negative outcomes (or similar to them) occurred in the OMT group and how, instead, other studies have found an association between OMT (performed before and/or during labor) and shorter duration of labor.

Some possible explanations may lie in the difficulty encountered in obtaining data on the actual length of the work as well as in the inconsistent coordination observed between the different hospital personnel who recorded the data. This fact pushes us to simply look at labor in three generic macro-categories, ie, precipitous, normal or prolonged.