Application of OPC in Acupuncture clinical trial on perineal relaxation during fetal expulsion
In France, since 2009, the practice of acupuncture by midwives is legal provided that they hold the Diploma of Obstetric Acupuncture delivered by Universities in France.
- Patients and Method
In 2011, two midwives from Jeanne de Flandre Hospital in Lille (France) used the OPC methodology for evaluating the effects of SP6 (sanyinjiao) puncture on perineal relaxation during fetal expulsion.
Fifty-four primiparous (para 1) or biparous (para 2) pregnant women participated in the trial. The inclusion criteria were: a scarred uterus (those who underwent a cesarean section during their first pregnancy and had not given birththrough the vagina), vertex presentation, and with a gestational period ≥ 37 weeks (gestational age calculated from the first day of the mother’s last menstrual period). The exclusion criteria included: multiple pregnancies (twins or triples), breech presentation, gestational period < 37 weeks, multiparous women. The efficacy endpoint was the perineal tears caused by the vaginal delivery.
The needles were inserted bilaterally at SP6 (sanyinjiao), when the cervix was in complete dilation, or immediately or within a few minutes, even just before the expulsive efforts.
The results were compared with data from a reliable registry that served as a substitute to the traditional control group. It was the 2010 database (DB 10) of “Jeanne de Flandre Hospital” in Lille (France), collecting data about the same population than the study: para 1 and para 2 women with previous caesarean section (n = 2,216 patients).
For a high birth weight greater than 3,500 g (about 7.71 £), known to be a high risk factor for perineal tears during vaginal delivery, in DB 10, only 37.4% of patients have preserved an intact perineum after delivery (vs 48% in theAcupuncture Group of the study). No complex perineal tear in the Acupuncture Group was found (vs 4.20% in DB 10). In the Acupuncture Group, there were 16% of simple tear vs 35.2% in DB 10. On the other side, episiotomieswere higher in the acupuncture group than DB 10 (36% vs 23.2%). (Figure 1).
Figure 1. Assessment of the perineum according to fetal weight.
Another risk factor for perineal tears is an infant’s head circumference greater or equal to 35cm (about 13.78 inch). More than half (58.33%) women who gave birth to a baby with head circumference greater than 35 cm have preserved an intact perineum after childbirth in the acupuncture group (vs 44.55% in the DB10 group). (Figure 2). On the other side, episiotomies in the acupuncture group were higher than DB 10 (36% vs 23.2%). (Figure 1).
A bias may exist concerning a higher frequency of episiotomy in the acupuncture group. In the acupuncture group of 54 patients, there were 29 patients without instrumental delivery, 21 patients requiring instrument assisted delivery and 4 patients were excluded from the study due to caesarean section at the end of the labor. The use of forceps, vacuum extractor or a combination of both was respectively 38.1%, 44.28%, and 19%. These cases of instrumental birth generated a significant percentage of episiotomy, respectively 87%, 56% and 50%. But percentages and types of instrumental delivery in BD10 were unknown, less instrumental delivery could explain the higher number of episiotomy in our trial.
However, the difference was more significant if only childbirth from primiparous was considered: 47% of intact perineum in BD10 versus 72% in the acupuncture group.
These results showed that acupuncture has sufficiently relaxed the perineum to prevent severe perineal tears.
Figure 2. Assessment of the perineum according to infant’s head circumference.
3. Limitations of the study
The study was not randomized; therefore known and unknown bias could have influenced results.