Pulsating electromagnetic fields for perineal lacerations and surgical wounds healing in the postpartum: a pilot study

Purpose The aim of our study was to assess the possible benefits of Therapeutic Magnetic Resonance (TMR) in the treatment of spontaneous perineal lacerations and episiotomies in the postpartum. Methods We performed a prospective, non-pharmacologic, non-profit, monocentric interventional study on women who had a spontaneous laceration and/or an episiotomy at delivery. The TMR device treatment was accepted by 52 women, while 120 women underwent standard care. Patients were visited 1 day postpartum, before starting the treatment; then a follow-up visit was performed at 3 weeks, 5 weeks, and 3 months after delivery. The main endpoint was the time required for complete healing of the laceration and/or the episiotomy. Secondary endpoints were the prevalence of dehiscence, infections, urinary discomfort, urinary leakage, and the quality of restoration of sexual function. Results In the treatment group the REEDA score was significantly better both at 3- and 5-weeks postpartum follow-up. At 3 weeks and 5 weeks postpartum, we observed a significantly better outcome in the treatment group for all subjective complaints and perineal complications associated with lacerations and episiotomies. The percentage of patients who scored above the cutoff for sexual dysfunction was significantly better in the treatment group (83.3%) than in the control group (31.8%) (p < 0.001). Conclusions With this pilot study, we introduced low dose Pulsating Electromagnetic Fields (PEMFs) as a novel conservative and not pharmacological approach to reduce complications of perineal lesions. Our results demonstrated to significantly improve perineal wound healing and to ameliorate the sexual function in the postpartum.


Background
In the last years, in the context of surgical healing techniques, there has been a growing interest in non-invasive biophysical treatments to support pharmacological therapies.Among these, the Pulsating Electromagnetic Fields (PEMFs), and in particular the Therapeutic Magnetic Resonance (TMR), which had originally been studied in orthopedics by Basset et al. [1], look promising.After the approval by the FDA in 1979, this technology has been investigated in other medical domains, including traumatology [2][3][4][5][6][7][8], neurology [9,10], oncology [11][12][13][14][15] and superficial wound healing.Possible applications in this latter field include the healing and microvascular circulation of chronic diabetic foot ulcers [16][17][18] and reducing postoperative pain after breast plastic surgery [19].
We hypothesized that the positive results of low intensity PEMFs could be applied after vaginal birth.The aim of our study was to assess the possible benefits of this technology in the treatment of spontaneous perineal lacerations and episiotomies in the postpartum.

Study design, setting and population
We performed a prospective, non-pharmacologic, non-profit, monocentric interventional study.This pilot study was conducted on women who delivered and were admitted to the postpartum ward of Mangiagalli Center High risk Obstetric Unit-Ospedale Maggiore Policlinico of Milan between 8th January to 8th August 2023.
Each consecutive Wednesday, we recruited patients who suffered either a spontaneous laceration and/or an episiotomy at delivery.Exclusion criteria were presence of clinical signs and /or symptoms of infection of the suture, pregestational or gestational diabetes under pharmacologic therapy, autoimmune diseases, other diseases that could interfere with the process of wound healing.
Fort this study 172 women were eligible, but only 52 women accepted to participate to this pilot study with TMR device (registered trademark Diapason by There-son®) (treatment group).The treatment was declined by 120 women, but they accepted standard care (control group) and follow-up according to the same schedule as those treated by TMR.
Treatment with TMR device required two sessions per day for 15 days.During the treatment, patients were lying down on the body emitter mat, while the local, smaller therapy emitter mat was positioned on the lower abdomen to cover the pubic bones and pelvis.Each treatment consisted of two phases, for a total of 32 min.During the first phase ("Local phase"), which lasted 16 min, the intensity ranged between 150 and 250 µT, and the electromagnetic fields were focused on the pelvic area.During the second phase ("Total phase"), which also lasted 16 min, the intensity ranged between 130-250 µT and the electromagnetic fields were focused at different locations (chest, abdomen, and lower limbs).Upon discharge form the Hospital, patients were provided with a TMR device to perform the treatment at home.Standard care was based on perineal hygiene with the addition of a topic spray until complete healing of the suture.
Patients were visited one day postpartum, before starting the treatment; then a follow-up visit was performed at 3 weeks (time 1), 5 weeks (time 2), and 3 months (time 3) after delivery.
To determine the status of the wound before the treatment, one day postpartum, and to assess the progression of healing at the 3-and 5-weeks follow-ups, we assigned to each patient a score, based on the REEDA (Redness, Edema, Ecchymosis, Discharge, Approximation) scale [47] (Table 1), which can be used to assess all types of postpartum perineal trauma.For each assessed item, a score ranging from 0 to 3 can be assigned by the healthcare provider.A higher score indicates a greater level of tissue trauma.
At the 3-and 5-weeks follow-up visits, in addition to the healing progression, we also evaluated other possible complications and complaints, such as urinary discomfort and urinary leakage, infections, suture dehiscence, and fistulas.
At 3 months after delivery, patients were contacted via e-mail to answer the FSFI (Female Sexual Function Index) questionnaire [48,49] (Table 2).This questionnaire collects self-reported answers on six sexual domains (desire, arousal, lubrication, orgasm, satisfaction, and pain) and can provide a key to interpreting Female Sexual Dysfunctions.The total score is a sum of each domain score, ranging from 2 to 36 (Table 3), where a score below 26.5 is a good indicator of sexual dysfunction [50].
The main endpoint of the study was the time required for complete healing of the laceration and/or the episiotomy.Secondary endpoints were the prevalence of dehiscence, infections, urinary discomfort, urinary leakage, and the quality of restoration of sexual function.

Statistical analysis
Descriptive statistics were used to summarize selected baseline characteristics of intervention and control group.
Categorical data were presented as absolute frequencies and percentages, while quantitative data were expressed as mean and standard deviation.Differences in categorical variables between the two groups were tested by using Fisher test.Continuous variables were compared by using the t-test for independent samples.
The REEDA scores obtained from women in the treatment and control groups 1 day, 3 weeks, and 5 weeks postpartum were expressed as median and interquartile range (IQR), and differences were tested by Wilcoxon rank-sum test.The frequencies of selected adverse outcomes were reported separately according to treatment, and Fisher test was used to assess differences between the two groups.
Finally, results from the FSFI questionnaire were reported as both categorical (i.e.≤ 26.5 and > 26.5) and continuous scores (expressed as median and IQR).Differences were tested with Fisher test and Wilcoxon rank-sum test.

Results
The study included 172 patients with a mean maternal age of 33.5 years (range 18-46), the majority of whom were nulliparous (82.0%).They gave birth at an average gestational age of 39.5 weeks and the mean birth weight was 3320.0 g.Episiotomy was performed in 62.2% of cases and first, second and third degree lacerations occurred in 40.7%, 54.7% and 4.7% of cases respectively.52 women underwent treatment by PEMFs with TMR device, while 120 women underwent standard care.
Table 4 shows demographic and clinical characteristics of the two groups.The women who underwent TMR were older, more likely to have had a vacuum-assisted birth using Kiwi-cup ®, and had more severe perineal lacerations.In the treatment group, 49 patients (94.2%) came to at least one of the 3-or 5-weeks follow-up, and 24 patients (46.2%) answered the FSFI questionnaire at 3 months postpartum.In the control group, 67 patients (55.8%) came to at least one visit at 3-or 5-weeks, while only 22 patients (18.3%) answered the FSFI questionnaire.
Table 5 shows the differences in wound healing, according to the REEDA score, between the treatment group and the control group.At baseline (1 day after delivery), no differences emerged (p = 0.874).The REEDA scores obtained at 3 (p = 0.005) and 5 (p < 0.001) weeks postpartum were lower in women who underwent TMR.
The complications of wound healing and other subjective complaints related to perineal dysfunctions at the 3and 5-week follow-ups, are reported in Tables 6 and 7.
At 3 weeks postpartum, we observed a significantly better outcome in the treatment group in terms of healing, dehiscence, urinary discomfort, and urinary leakage.The only aspect that was not statistically significant was the occurrence of surgical site infections.Not any fistula occurred in this study.As for healing and urinary disorders, similar significantly better outcomes were observed at 5 weeks postpartum.At this time, no cases of dehiscence or infection were reported.
Figure 1 shows box and whiskers plot of FSFI scores for the treatment group (light grey box) and the control group (dark grey box).The median FSFI score was 31.4 (28.4-33.0) in the treatment group and 21.8 (14.8-27.2) in the control group (p < 0.001).With the limitation of the cases lost to follow-up, the number of patients who scored above the cutoff for sexual dysfunction (i.e., 26.5) was significantly higher in the treatment group (20/24, 83.3%) than in the control group (7/22, 31.8%)(p < 0.001).

Discussion
The main outcome of data we collected and compared in the intervention and in the control group confirmed that PEMFs achieved a significantly better progression of wound healing at 3-and 5-weeks postpartum according to the REEDA score.Similarly, complications of wound healing and other subjective complaints related to perineal dysfunctions at 5 weeks were significantly more reported in the control group despite the relative prevalence of first-degree perineal lacerations.The Female Sexual Dysfunctions proved a significantly better outcome in the treatment group.
With this study, we introduced for the first time in the clinical practice, PEMFs as a novel conservative and not pharmacological approach to reduce complications and costs of the treatment of perineal lesions [16][17][18].
PEMFs technology has been reported to accelerate the healing of cutaneous wounds and ulcers by modulating the course of processes such as inflammation, tissue repair, and establishment of homeostasis [18,[35][36][37][38].Our study confirmed that PEMS technology could speed up the complete healing of postpartum perineal lacerations and episiotomies.
Postpartum perineal tear or episiotomy can be complicated by wound dehiscence in around 0,1%-0,2% of cases.This complication is among the main reasons driving women towards an elective cesarean section for maternal request [51,52].The possible therapeutic options are currently medical conservative approach or an early wound re-suturing [53][54][55][56].This pilot study provides evidence that this technology could be tested in these severe complications frequently associated with permanent dysfunctions of the pelvic floor.
This study had several strengths: the study population presented a variety of obstetric perineal traumas, spanning from mediolateral episiotomies to different degrees of spontaneous lacerations, either occurring alone or associated with episiotomies, thus providing a wide range of lesions to be observed during healing process.Although the intervention and the control group were not the result of randomization, the number of complicated lacerations, grade 2 and grade 3 lacerations and complicated episiotomies was not significantly different between the two groups.
In order to evaluate the process of healing and, later, the sexual function, we used validated and established scales, like the REEDA scale and the FSFI questionnaire.
The main limitation of our study was the relatively small sample size which does not represent a wide population.In addition, the data derived by the FSFI questionnaire should be considered with caution given the number of dropouts and the close follow-up.

Conclusion
The main finding of this study is that a biophysical therapeutic approach based on PEMFs technology has allowed a faster and complete healing of postpartum perineal lacerations and episiotomies.Our results highlight that this new technology may be effective also to ameliorate the sexual discomfort following postpartum perineal lesions, and we advocate to validate this innovative therapeutic approach in a multicenter prospective trial.Overall, these data claim individualized clinical care on postpartum sexual recovery and long-term studies are needed to explore this crucial, and too often undermined, aspect of postpartum perineal well-being.Standardized follow-up protocols must be set in place to allow a better comparison with alternative therapeutic strategies and to allow the best choice both from a clinical and cost related point of view.

Table 2
The Female Sexual Function Index (FSFI) questionnaire

Table 3
Interpretation of the FSFI score

Table 5
Comparison between REEDA score in the treatment group and in the control group 1 day, 3 weeks, and 5 weeks postpartum REEDA score is expressed as median (interquartile range, IQR)

Table 6
Outcomes at 3 weeks postpartum Data are reported as absolute number and percentage in brackets

Table 7
Outcomes at 5 weeks postpartum Data are reported as absolute number and percentage in brackets *Wilcoxon rank-sum test