Pelvic floor dysfunction at 3 and 6 months postpartum. A sub-analysis of the Perineal Massage and Warm Compresses technique during second stage of labor randomized controlled trial (PeMWaC)

doi:10.21203/rs.3.rs-2479595/v1

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Pelvic floor dysfunction at 3 and 6 months postpartum. A sub-analysis of the Perineal Massage and Warm Compresses technique during second stage of labor randomized controlled trial (PeMWaC)

https://doi.org/10.21203/rs.3.rs-2479595/v1

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Purpose: The influence of perineal trauma in pelvic floor dysfunction (PFD) has been described. Although the perineal massage and warm compresses techniques during the second stage of labor reduce perineal trauma, but the impact of combined perineal massage and warm compresses technique in PFD has never been investigated. To evaluate the effects of combined perineal massage and warm compresses or hands-on technique on PFD symptoms at 3 and 6 months. Methods: Randomised controlled trial (PeMWaC - Perineal Massage and Warm Compresses) was carried out at Hospital of Braga from March 1st, 2019 to December 31st, 2020. The sample included 496 women (242 perineal massage and warm compresses and 254 hands-on) who had a singleton term spontaneous vaginal delivery. A sub-analysis of primary data was performed to assess postpartum PFD symptoms, Pelvic Floor Distress Inventory-20 (PFDI-20) survey was applied at 3 and 6 months postpartum.

Results: Of the 800 women recruited, 496 were included, 48.8% with combined perineal massage and warm compresses and 51.2% with standard-care. Frequency of intact perineum (p<0.001) and vaginal tears (p<0.001) were significantly higher in combined perineal massage and warm compresses. At 3 months postpartum, women undergoing standard care during the second stage of labor had higher Urinary Distress Inventory (UDI) score and global score with no differences at 6 months. After controlling for confounding variables, combined perineal massage and warm compresses technique were associated with lower UDI scores at 3 months postpartum.

Conclusion: Combined perineal massage and warm compresses technique, seems to be associated with a lower prevalence of early PFD symptoms, mainly regarding urinary distress.

Pelvic floor dysfunction (PFD) such as urinary incontinence (UI), fecal incontinence (FI), and pelvic organ prolapse (POP) have multifactorial etiology, but it is common to be associated with pregnancy and delivery [1]. Regarding POP, a meta-analysis with 13 observational studies concluded that the risk of POP significantly increased after any type of vaginal delivery (spontaneous and operative) compared to cesarean, even in women with spontaneous vaginal delivery only and also with both vaginal and cesarean delivery. Furthermore, no difference was found in the risk of POP between operative vaginal delivery (cup and forceps) vs spontaneous vaginal delivery [2]. In addition, Akervall et al. concluded that most likely, vaginal delivery is the only clinically dominant predictor of symptomatic POP [3]. Otherwise, in two studies the risk factors for POP were not identified in the long-term (6 months) postpartum period [4–5]. About UI, a systematic review of 29 studies (25452 women) showed that vaginal delivery (spontaneous and operative) and UI during pregnancy had the strongest association with postpartum UI [6]. In the same year, a meta-analysis of 45 studies (73010 women) identified 12 risk factors, including spontaneous vaginal delivery, forceps delivery, gestational UI, gestational Stress Urinary Incontinence (SUI), Prenatal UI, early postpartum UI, advanced age at gestation, advanced maternal Body Mass Index (BMI), recent weight gain during pregnancy, current BMI, diabetes and episiotomy to be associated with postpartum SUI [7]. According to studies conducted by Johannessen in 2014 and 2019, factors associated with fecal incontinence were fecal incontinence during pregnancy, maternal age > 35 years, prenatal BMI > 30 kg/m2, operative delivery, spontaneous delivery, acceleration with oxytocin and newborn weight > 4000g [8–9]. Operative vaginal birth was common risk factor to postpartum urinary incontinence and anal incontinence complications [5]. In addition, recent studies have recognised the influence of perineal trauma on POP and anal/urinary incontinence, as episiotomy was associated with postpartum SUI [7] or both episiotomy, perineal tear ≥ grade 2 were associated with UI [6]. Moreover, Obstetric anal sphincter injuries (OASIS) were an evident risk factor for PFD, but symptoms of pelvic floor disorder were common, even in women with mild to moderate perineal laceration [10]. Nonetheless, a Cochrane systematic review published in 2017, concluded that there is moderate-quality evidence suggesting that the use of warm compresses, and the use of massage during the second stage of labor, separately, may reduce the occurrence of OASIS (or third- and fourth-degree perineal tears) but evidence on the benefits of these techniques on intact perineum are unclear or inconsistent [11]. More recently, a meta-analysis that included three more trials than the Cochrane systematic review, concluded that warm compresses applied during the second stage of labor increase the incidence of intact perineum and lower the risk of episiotomy and OASIS [12]. Other systematic review and meta-analysis showed that perineal massage during the second stage of labor is associated with significantly lower risk of OASIS, and therefore a significantly higher incidence of intact perineum [13]. In fact, it is important to emphasise that there is no scientific evidence about the association of combined perineal massage and warm compresses technique during the second stage of labor and the prevalence and severity of PFD, which justifies the pertinence of this study. Furthermore, the following sub-analysis of the primary data obtained from PeMWaC aims to compare pelvic floor function at 3 and 6 months postpartum in women undergoing combined perineal massage and warm compresses and those undergoing hands-on technique during second stage of labor.

Study population

This was a single-centre, prospective, single-blinded, randomised controlled trial (RCT). It was conducted between March 1st, 2019, and December 31st, 2020, taking place in the Department of Obstetrics and Gynecology of Hospital de Braga, in northern Portugal. Eligible participants were women with 18 years or older, between 37 and 41 weeks pregnant, in whom a vaginal birth of a fetus in the cephalic presentation was planned and had to be able to provide informed oral and written consent. Exclusion criteria were multiple pregnancy, breech presentation, gestational age less than 37 weeks, meconial amniotic fluid, fetal distress, suspicion of fetal growth restriction and gestational hypertensive disorders. Women could withdraw from the study at any point without prejudice to their care or their relationship with their health practitioners. Women who met inclusion criteria were invited to participate in study, receiving a detailed explanation about its components and the informed consent. Eligibility and consent to participate were checked once the woman was in established labor. If accepted, correspondence (email or address), sociodemographic (age, level of education, marital status, current occupation) and clinical information were obtained directly from the patient and from electronic and paper records.

According to Wiegersma et al., 2016 [14] a Minimal Clinical Difference (MIC) for improvement in the PFDI-20 to be 13.5 points (95% CI, 6.2–20.9), which represents a 23% reduction in the PFDI- 20 score from baseline. In the present study, the necessary sample size to detect a MIC in PFDI-20 score between groups was 224 women, 112 women in each arm of the study. However, PFD was a secondary outcome of RCT about perineal trauma in spontaneous vaginal birth. According with primary outcome (intact perineum) the sample size was 782 women but taking in account the high participants withdraw 848 women were recruited. Block randomization was computer-generated, with blocks size of two, four and six, and used randomly mixed block sizes for the allocation to perineal massage and warm compresses combined technique or standard care. The randomization was made by a third party not otherwise involved in the trial. The allocation was concealed in 848 identical, opaque, sequentially numbered sealed envelope. Eligible participants were randomized at the second stage of labor. The randomization envelope was opened by the midwife when the participant entered the second stage of labor and was destroyed thereafter. The allocation was only shown to the midwife and if necessary, the obstetrician. The trial intervention took place during the second stage of the spontaneous vaginal birth. Participants were randomized to one of the two groups, perineal massage and warm compresses on second stage of labor or standard care. The participants could adopt the birth position they preferred.

Clear protocols for use of the perineal massage and warm compresses were available in the delivery ward. All midwives involved in the trial were trained in the technique and had regular updates sessions in the pilot study stage. The combination of perineal massage and warm compresses had not been used by most of the midwives participating in the trial previously, so education occurred in the pilot study stage (before the start of the trial). There were coordinators to supervise the procedure according to the protocol of the study. Regular checking of the procedure by the principal investigator ensured protocol compliance.

A combined soft perineal massage/warm compresses in second stage of labor programme: In the second stage of labor (from the completion of cervical dilation to delivery), the midwife performed a soft perineal massage between 3 o’clock and 9 o’clock positions (U-shaped reciprocating motion) wearing sterile gloves and lubricated their hand with sterile lubricant. The massage lasted 10 minutes and the degree of downward pressure by the thumb was determined according to mothers’ response. Perineal massage was established on the II Hodge Plan, between maternal contractions and regardless of maternal position.

After the perineal massage, the women could change and adopted the birth position that she preferred. The application of warm compresses was performed by the midwife between the III and IV Hodge plan, during pushes and regardless of maternal position. A metal jug filled with warm water (between 45° and 59°C) was used to soak the compresses, which were squeezed out before being gently placed on the perineum during contractions. The compresses were rewarmed between pushes. Water was changed each fifteen minutes and the compresses were changed as needed to maintain warmth and cleanliness at the end of the second stage of labor. Women assigned to the standard care group did not have the combination of perineal massage and warm compresses applied to their perineum on the second stage of labor.

Considering the technique hands-on, the nurse-midwife placed the index, middle ring and little fingers of the left hand close together on the infant's occiput, with the palm turned toward the anterior region of the perineum, when the infant's head was crowning. In this manner, expulsion was controlled, by maintaining the flexion of the head, protecting the anterior region of the perineum and bilaterally supporting the ischio-cavernous and bulbo-cavernous muscles, the urethral introitus, and the labia majora and minora. Simultaneously, the right hand was flattened out and placed on the posterior perineum, with the index finger and the thumb, forming a "U" shape, exerting pressure on the posterior region of the perineum during the crowning process. The nurse-midwife left no area without protection, particularly the region of the fourchette. During the birth of the shoulders and the remainder of the body, the right hand was kept in place, protecting the posterior region of the perineum, while the left hand supported the infant's head, allowing external rotation and the birth of the shoulders spontaneously. If this did not occur, the professional continued with posterior perineal pressure, and with the left hand, pulled gently downward to deliver the anterior shoulder. Once the anterior shoulder was delivered, gentle traction was applied upward to ease birth of the posterior shoulder. After both shoulders had been delivered, the practitioner removed the right hand from the posterior perineum and supported the infant's neck with one hand, while supporting the remainder of the body with the other hand.

Following the time of recruitment, at 3 and 6 months after delivery, women were directly contacted via email.

During the recruitment period, a total of 848 women initially agreed to participate and were recruited to the study. Of the 848 women, only 800 fulfilled the inclusion criteria. Regarding these 800 women, no woman had a history of OASI, 70.6% (565) answered the 3 months questionnaire and 62.2% (498) answered the 6 months questionnaire. From the 70.6% (565) women who answered the 3 months questionnaire, 3.1% (18) women were excluded because they had UI during pregnancy and 9% (51) women were excluded since they didn't answer the 6 months questionnaire. Finally, women who answered at 3 and 6 months postpartum the Pelvic Floor Distress Inventory-20 (PFDI-20) were included. A total of 496 (62%) women were included in the study (242 perineal massage and warm compresses and 254 standard care). To evaluate postpartum PFD symptoms, a Portuguese version of a validated questionnaire, PFDI-20 [15] was sent to all participants by e-mail at 3 and 6 months after delivery. The PFDI questionnaire is a condition-specific questionnaire developed to measure quality-of-life and the extent of injury to the pelvic floor in patients with all forms of PFD. The PFDI-20 is a shorter version of the PFDI composed of 20 questions along with three subscales: Urinary Distress Inventory (UDI, 6 questions), Colorectal-Anal Distress Inventory (CRADI, 8 questions), and Pelvic Organ Prolapse Distress Inventory (POPDI, 6 questions). Participants could answer either “yes” or “no” to the questionnaire items. “No” is given a value of “0” whereas “yes” is followed by a ranking of the level of bother on a scale between 1 and 4 (1 = “not at all,” 2 = “somewhat,” 3 = “moderately,” and 4 = “quite a bit”). For each patient, there is an option to calculate a scale score and a summary score. The scale score is the mean value of all questions answered per scale multiplied by 25. The answers were converted to a numerical scale and a partial (0–100 in each subscale) and global score (0–300, sum of the 3 subscale scores) were calculated. The higher the score, the worse the PFD symptoms are.

Outcome measures

Primary outcomes were intact perineum (absence of tissue separation at any site), anterior compartment tears (without episiotomy or any other degree of perineal trauma), first-degree perineal tear (posterior compartment), second-degree perineal tear (posterior compartment), OASIS (third- and fourth-degree tears without episiotomy), vaginal tears (without any other degree of perineal trauma), and the incidence of episiotomy (without spontaneous perineal trauma or vaginal tears). Secondary outcomes were PFD symptoms at 3 and 6 months and to assess PFD symptoms, PFDI-20 survey was applied at 3 and 6 months postpartum.

This study is a sub analysis of Perineal Massage and Warm Compresses technique trial (PeMWaC) and was approved by Hospital de Braga Ethics Committee (Reference nº 1; approved February 2019). A code was attributed to each participant to ensure data confidentiality and this code was used to compile the different survey replies at each time point.

Statistical analysis

Statistical analysis was performed using the Statistical Package for the Social Science (SPSS)® program, version 26.0. Descriptive statistics was used to report demographic and clinical characteristics. Categorical variables were described with frequencies and percentages, whereas continuous variables were described with arithmetic means and standard deviations. In cases where the distribution of the continuous variables did not meet the assumptions of normality (verified with Shapiro-Wilk test), median and interquartile range were used for the description of the variables.

In terms of inferential statistics, the comparison between control and experimental groups was performed by Mann-Whitney, Chi-square and/or Fisher’s exact test regarding variables that did not meet the requirements for parametric statistical analysis (e.g., the PFDI-20 scores). In those situations where the result variables were normally distributed, and the variance was constant, independent sample t-test was used to compare the control and experimental groups.

The analysis of association between the pre-pregnancy BMI and the different variables associated with PFD symptoms was performed by the Pearson correlation coefficient (r_p). The analysis of association between the obstetric characteristics (intact perineum, vaginal tears, episiotomy) and the different variables associated with PFD symptoms was performed by the Point-biserial correlation coefficient (r_pb).

The analysis of association between the perineal protection technique (standard versus combined perineal massage and warm compresses, respectively, coded by 0 and 1) and the different variables associated with PFD symptoms was performed by partial correlations, in order to control for possible confounding variables. In this last set of correlations tests, the correlation coefficients were evaluated as direct measures of the effect sizes, and the following cutoff points were considered to classify the magnitude of the effect size of the study variable: low (|r| = 0.1), moderate (|r| = 0.3), and high (|r| = 0.8). A p-value < 0.05 was considered statistically significant. The manuscript was prepared in accordance with CONSORT recommendations for reporting randomised, controlled, clinical trials involving nonpharmacologic treatment [16].

Demographic and clinical characteristics of the participants are presented in Table 1, according to the type of perineal protection technique on the second stage of labor. Women included in the present study had a mean age of 31.5 ± 5.1 years, were mostly married (97.7%), caucasian (98.6%), and had completed high school (37.3%) or higher education (21.2%). No differences were found between the type of perineal protection techniques with regard to demographic characteristics. Regarding clinical characteristics, more women did prenatal childbirth preparation course, 48% (122/254), (p=0.024), received fundal pressure 20.5% (52/254), (p=0.015), had episiotomy (only episiotomy without spontaneous perineal trauma or vaginal tears) 24% (61/254), (p < 0.001), and second grade tear (without episiotomy) 10.2% (26/254), (p=0.031), in standard care group. Otherwise, more women had vaginal tears (without any other degree of perineal trauma) 12.4% (30/242), (p=0.031), and intact perineum (without vaginal tears or any other degree of perineal trauma) 46.7% (113/242) (p<0.001), in combined perineal massage and warm compresses group. No differences were found regarding newborn admission to Neonatal Intensive Care Unit (NICU) and obstetrics complications such as endometritis, perineal wound dehiscence, or infection.

Table 2 compares PFDI-20 by type of perineal technique protection at 3 and 6 months after birth. At 3 months, CRADI-8 median (P25-50), (6.2 (0-25.0) versus 6.2 (0-25.0) p=0.823) and POPDI-6 median (P25-50), (0 (0-0) versus 0 (0-0) p=0.124) were not significantly different in combined perineal massage and warm compresses when compared to standard care. Otherwise, UDI-6 median (P25-50), (0 (0-4.1) versus 0 (0-16.6) p<0.001) and PFDI-20 (total) median (P25-50), (13.5 (0-25.0) versus 25.0 (4.1-31.2) p<0.001) were significantly different between groups. At this time point (3 months), 3.6% (18/254) of women in standard care group were considered to have worse results in pelvic floor function (PFDI≥100 total score), with a statistically significant difference (p<0.001) compared to 0% of women in combined perineal massage and warm compresses. At 6 months, no differences were identified between the comparison groups.

We also explored the possible associations between maternal (age, pre-pregnancy BMI), obstetric (parity, prenatal childbirth preparation course, duration of second stage of labor, fetal position, fundal pressure, Valsalva maneuver, type of pushing, birth position, intact perineum, vaginal tears, second degree tears, severe perineal tear, episiotomy and perineum height) and newborn variables (birth weight and head circumference) with PFD at 3 months postpartum, correlations between those and the scores obtained in the PDFI-20 were analysed. As shown in Table 3, it was found that pre-pregnancy BMI and performance of episiotomy correlated positively with UDI and PFDI scores. Additionally, occurrence of intact perineum (without vaginal tears) and vaginal tears (minor tears) correlated negatively with UDI and PDFI scores. As presented in table 4, partial correlations were carried out controlling the variables associated with higher PFD symptoms scores (pre-pregnancy BMI, performance of episiotomy, occurrence of intact perineum and vaginal tears) to verify if the association found between PeMWaC and PFD symptoms at 3 months was independent of those factors. When controlling for pre-pregnancy BMI, performance of episiotomy, occurrence of intact perineum and vaginal tears, only UDI symptoms at 3 months postpartum seemed to be negatively correlated with PeMWaC (r < 0).

Principal findings

To date, no study evaluated the influence of perineal protection techniques on PFD symptoms postpartum. The present study is the first in this field. The results here shown seem to indicate that the combined perineal massage and warm compresses technique has a protective effect on pregnant women’s health, reducing the risk of PFD symptoms at 3 months postpartum (UDI and PFDI scores, Table 4, r < 0 and p < 0.001), although this same effect disappears at 6 months postpartum, when comparing the experimental with the control group. The moderate effect size (UDI and PFDI scores, |r| ≈ 0.3, Table 4) associated with the study variable also shows the good clinical significance of the combined perineal massage and warm compresses technique. Frequency of intact perineum (p < 0.001) and vaginal tears (p < 0.001) were significantly higher in combined perineal massage and warm compresses. At 3 months postpartum, women undergoing standard care during the second stage of labor had higher Urinary Distress Inventory (UDI) score and global score with no differences at 6 months postpartum. After controlling for confounding variables, combined perineal massage and warm compresses technique were associated with lower UDI scores at 3 months postpartum. Gao et al., found that diabetes, abortion history, vaginal delivery, newborn’s weight ≥ 3kg, epidural anesthesia, and duration of second stage of labor ≥ 90 minutes were risk factors for SUI [17]. In the PeMWaC study, were explored those risk factors but no correlation was identified with early PFD symptoms on postpartum.

Several studies confirmed that UI during pregnancy was the strongest risk factor to postpartum urinary incontinence [1, 6]. Other studies included the UI during pregnancy as one of the risk factors to postpartum UI [18, 19]. According to Jansson et al. vaginal delivery was the major risk factor for SUI, followed by reporting SUI during pregnancy [20]. Hence, the present study explored UI during pregnancy and at follow-up time points (twenty-four hours, 3 and 6 months postpartum). However, in this study, women with UI during pregnancy were excluded to avoid the bias of this risk factor.

Regarding vaginal delivery being strongly related with PFD symptoms [21 − 20], since this sample was composed for exclusively spontaneous vaginal birth, and according with several publications, it was relevant to explore the influence of perineal trauma after childbirth on PFD symptoms. Many studies demonstrated the association between the occurrence of OASIS and urinary and fecal incontinence postpartum [18, 22, 23, 24]. The results published by Schei et al. added that women with OASIS were at increased risk of anal incontinence compared women with cesarean sections only or with vaginal birth but without OASIS [22]. In the present study, there was no association between OASIS and PFD symptoms postpartum.

In this study, was investigated the association between fundal pressure in the second stage of labor and PFD symptoms. According with Youssef et al. fundal pressure was associated with more than 2-fold risk of levator ani avulsion, after adjusted to possible confounders factors such as maternal age, BMI, length of first and second stage of labor, episiotomy, epidural analgesia and newborn weight [25]. Consequently, levator ani muscle injury is associated with a significantly increased risk of developing pelvic floor dysfunction, especially pelvic organ prolapse [26]. Mainly, the prolapse of anterior and central compartments of pelvic floor, which increases the risk of UI postpartum and recurrence of symptoms even after surgery [25]. Another recent study showed that women with OASIS had significantly higher risks of symptoms of prolapse and urge urinary incontinence [10]. The PeMWaC study found that PFD symptoms were not significantly associated with occurrence of OASIS or with presence of fundal pressure. In the study conducted by Huber et al., 2021, they included vacuum extraction, and the OASIS sample size was larger (n = 19) than in the present study (n = 5).

A study conducted by Van Delft et al. used the ultrasound imaging to demonstrate that there was no levator avulsion following cesarean section, which suggests that injury is relative to management of vaginal delivery [27]. However, to date, it was not possible to establish a link between presence of fundal pressure, occurrence of severe laceration, occurrence of levator ani muscle injury and PFD symptoms. More studies are needed in this field. Otherwise, according to data from this study, vaginal tears or intact perineum were relevant to better results on PFD symptoms at 3 months postpartum since were negatively associated with early PFD symptoms on postpartum.

Indeed, few studies evaluated the effect of minor tears (vaginal, first degree tears and from anterior compartment tears) on UI and AI postpartum. In this study, anterior compartment tears (labial and paraclitoral) were not significantly associated with PFD symptoms. This result is consistent with other studies [28–29]. In addition, urinary incontinence was not associated with anterior compartment tears or vaginal tears but more often with perineal trauma in the posterior compartment [29]. Otherwise, in the present study, performance of episiotomy was positively correlated with UDI and early (3 months) PFD symptoms. About episiotomy, a systematic review published by Wang et al., from 8 studies (7390 women), demonstrated that episiotomy was associated with postpartum SUI [7]. However, another study showed that lateral episiotomy was not significantly associated with UI at 5 and 8 months after delivery [30]. Also, episiotomy (midline and mediolateral) was not significantly associated with any PFD at 5–10 years after first delivery [31]. Although, another study reported that the risk of urinary incontinence at six months postpartum increased with the combination of newborn weight, head circumference and episiotomy [18]. The PeMWaC study results about episiotomy are consistent with the policy to promote the restrictive episiotomy on management of spontaneous vaginal delivery.

The PeMWaC study found that pre-pregnancy BMI was significantly associated with PFD symptoms at 3 months postpartum, mainly in UI. These results are consistent with other publications that found BMI before pregnancy ≥ 24kg/m2, was a risk factor for postpartum SUI [17, 19]. However, these results change when adjusted to one possible confounding factor, perineal protection techniques during the second stage of labor.

Strengths and limitations

The strengths of the PeMWaC study include its prospective, randomised design and the use of standardised questionnaires allowing it to support the current literature. Indeed, no studies have previously compared the influence of combined perineal massage and warm compresses among hands-on techniques during the second stage of labor on postpartum dysfunction of the pelvic floor. It also adds new perspectives about an intervention during the second stage of labor, perineal massage and warm compresses, showing that it could be a useful alternative to hands-on technique. Additionally, this study had a bigger sample than other studies and a lower drop-out rate than other studies about the PFD. Finally, potentially important confounders were taken into consideration, as prenatal UI, pregnancy UI, parity, type of previous birth, perineal protection techniques during the second stage of labor, fundal pressure and perineum height. On the other hand, limitations of the PeMWaC study include the absence of objective measures, such as in-person examinations, during follow-up. Also, marital status and racial demographics were considered as limitations due to potential source of bias. Another limitation is represented by the proportion of women who underwent episiotomy, since our teaching hospital has lower rates than those reported in the literature. Also, the mean pre-pregnancy BMI is normal, which means that the findings may not be generalizable to a population of different habitus. Future studies should include objective measures, such as in-person examinations during follow-up.

Combined perineal massage and warm compresses technique seems to be statistically associated with a lower prevalence of early PFD symptoms, mainly regarding urinary distress. This evidence has important implications for clinical practice in terms of recommending to women and health professionals that an adequate management of the second stage of labor, including perineal massage and warm compresses, reduces the risk of PFD symptoms postpartum. In addition, preventive strategies for PFD should focus on how to avoid the adverse events related to a vaginal delivery. Preventing morbidity from pelvic floor injury will also lower health care costs.

Ethical statement

Approval was granted by the Ethics Committee of Hospital of Braga (Reference nº 1; approved February 2019).

Informed consent

Informed consent was obtained from all individual participants included in the study.

Acknowledgements

We gratefully acknowledge all staff in the labor ward of Hospital of Braga for their support and cooperation.

Funding

The authors declare that no funds, grants, or other support were received during the preparation of this manuscript.

Competing interests

The authors have no relevant financial or non-financial interests to disclose.

Authors’ contributions

SR: Protocol/project development; Data collection or management; Data analysis; Manuscript writing/editing, PS: Manuscript writing/editing, ACB: Data analysis, NQS: Data analysis; Manuscript writing/editing, JNS: Data analysis; Manuscript writing/editing, RE: Protocol/project development; Data collection or management; Data analysis; Manuscript writing/editing. And all authors have approved the submitted version.

Consent to publish

Not Applicable.

Conflict of interests statement The authors declare that they have no conflict of interests.

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Table 1. Maternal, obstetric and neonatal characteristics.
		Total n=496	PeMWaC (Perineal Massage and Warm Compresses) n=242	Standard care (Hands-on) n= 254	p-value
Maternal Characteristics
Maternal age (years), mean ± SD		31.5 ± 5.1	31.8 ± 5.3	31.3 ± 4.8	0.769
Familiar status, n (%)	Single/ divorced	11 (2.2)	4 (1.7)	7 (2.8)	0.300
Familiar status, n (%)	Married/ together	485 (97.8)	238 (98.3)	247 (97.2)
Currently employed, n (%)		473 (95.4)	234 (96.7)	239 (97.2)	0.223
Pre-Pregnancy BMI, mean ± SD		23.9 ± 4.2	23.9 ± 4.2	24.0 ± 4.2	0.563
Obstetric characteristics
Primiparous, n (%)		230 (46.4)	109 (44.6)	121 (47.6)	0.771
Gestational age, mean ± SD		39.2 ± 1.0	39.2 ± 1.0	39.2 ± 1.0	0.908
Diabetes, n (%)		85 (17.1)	45 (18.5)	40 (15.7)	0.375
Abortion history, n (%)		23 (4.6)	11 (4.5)	12 (4.7)	0.563
Prenatal childbirth preparation course, n (%)	Yes	216 (43.5)	94 (38.8)	122 (48)	0.024*
Prenatal childbirth preparation course, n (%)	No	280 (56.5)	148 (61.2)	132 (52)
Type Previous Birth, n (%)	Vaginal birth	225 (45.4)	110 (45.5)	115 (45)	0.706
	Cesarean section	30 (6)	16 (6.6)	14 (5.5)
	Vaginal birth + Cesarean section	11 (2.2)	7 (2.9)	4 (1.6)
Onset of labor, n (%)	Spontaneous	322 (64.8)	156 (64.5)	166 (65.4)	0.441
Onset of labor, n (%)	Induction	174 (35.2)	86 (35.5)	88 (34.6)
Rupture of membranes, n (%)	Before labor	129 (26)	65 (26.9)	64 (25.4)	0.375
Rupture of membranes, n (%)	During labor	367 (74)	177 (73.1)	190 (74.8)
Analgesia, n (%)	Epidural	473 (95.4)	235 (97.1)	238 (93.7)	0.183
	Raquianestesy	8 (1.6)	2 (0.8)	6 (2.3)
	No analgesy	15 (3)	5 (2)	10 (3.9)
Maternal birth position, n (%)	Lithotomy	261 (52.6)	126 (52.1)	135 (53.2)	0.440
Maternal birth position, n (%)	Alternative birth position	235 (47.4)	116 (47.9)	119 (46.8)
Duration of the first stage of labor (h), mean ± SD		4.8 ± 3.2	4.6 ± 2.8	5.0 ± 3.5	0.069
Duration of the active second stage of labor (min), mean ± SD		39.7 ± 31.7	40.9 ± 31.5	38.5 ± 31.9	0.609
Duration of oxytocin augmentation in second stage of labor (min), mean ± SD		15.6 ± 24.8	15.9 ± 26.3	15.3 ± 23.4	0.845
Type of cephalic presentation, n (%)	Occiput anterior	485 (97.8)	235 (97.1)	250 (98.4)	0.245
Type of cephalic presentation, n (%)	Occiput posterior	11 (2.2)	7 (2.8)	4 (1.6)
Nuchal cord, n (%)	Yes	169 (34.1)	91 (37.6)	78 (30.7)	0.068
Nuchal cord, n (%)	No	326 (65.7)	151 (62.4)	175 (68.9)
Height Perineum (cm), mean ± SD		3.3 ± 0.5	3.2 ± 0.5	3.3 ± 0.5	0.297
Fundal Pressure (Kristeller maneuver), n (%)	Yes	83 (16.7)	31 (12.8)	52 (20.5)	0.015*
Fundal Pressure (Kristeller maneuver), n (%)	No	413 (83.3)	211 (87.2)	202 (79.5)
Valsalva Maneuver, n (%)	Yes	73 (14.7)	34 (14)	39 (15.4)	0.396
Valsalva Maneuver, n (%)	No	423 (85.3)	208 (86)	215 (84.6)
Method of pushing, n (%)	Directed pushing technique	31 (6.3)	13 (5.3)	18 (7.1)	0.995
	Spontaneous pushing	301 (60.7)	148 (61.3)	153 (60.2)
	Both	164 (33)	81 (33.4)	83 (32.7)
Episiotomy (without spontaneous perineal trauma or vaginal tears), n (%)		84 (16.9)	23 (9.5)	61 (24)	<0.001*
Episiotomy + second degree tears n (%)		3 (0.6)	1 (0.4)	2 (0.8)	0.323
Intact perineum (absence of tissue separation at any site, without vaginal tears or any other degree of perineal trauma), n (%)		185 (37.3)	113 (46.7)	72 (28.3)	<0.001*
Anterior Compartment tears (without episiotomy or any other degree of perineal trauma), n (%)		16 (3.2)	7 (2.9)	9 (3.5)	0.806
First degree tears (posterior compartment), n (%)		113 (22.8)	53 (21.9)	60 (23.6)	0.180
Second degree tears (posterior compartment), n (%)		39 (7.9)	13 (5.4)	26 (10.2)	0.031*
Vaginal tears (without any other degree of perineal trauma), n (%)		51 (10.3)	30 (12.4)	21 (8.2)	0.031*
OASIS (3º or 4º degree tears without episiotomy), n (%)		5 (1)	2 (0.8)	3 (1.2)	0.523
Endometritis, n (%)		2 (0.4)	0 (0)	2 (0.8)	0.238
Wound Infection, n (%)		2 (0.4)	2 (0.8)	0 (0)	0.262
Wound Dehiscence, n (%)		2 (0.4)	1 (0.4)	1 (0.4)	0.738
Neonatal Characteristics
Newborn birth weight (g), mean ± SD		3327 ± 382.2	3331 ± 376.9	3322 ± 388.4	0.813
Head circumference (cm) mean ± SD		34.7 ± 1.7	34.7 ± 1.3	34.9 ± 1.2	0.260
NICU admission, n (%)		1 (0.2)	1 (0.4)	0 (0)	0.487

OASIS- Obstetric anal sphincter injuries

NICU- Newborn Intensive Care Unit.

*Statistical significance p <0.05.

Table 2. Comparison between Perineal Massage and Warm Compresses (PeMWaC) and Standard-care (Hands-on) groups, at 3 and 6 months postpartum, regarding Pelvic Floor Dysfunction Inventory (PFDI-20). Mann-Whitney (U) test.
	PeMWaC (Perineal Massage and Warm Compresses) med (P25-75)	Standard care (Hands-on) med (P25-75)	Mann-Whitney (p-value)
3 months(n=496)	n=242	n=254
UDI-6	0 (0-4.1)	0 (0-16.6)	<0.001*
CRADI-8	6.2 (0-25.0)	6.2 (0-25.0)	0.823
POPDI-6	0 (0-0)	0 (0-0)	0.124
PFDI-20 (total)	13.5 (0-25.0)	25.0 (4.1-31.2)	<0.001*
6 months(n=496)	n=242	n=254
UDI-6	0 (0-4.1)	0 (0-3.1)	0.332
CRADI-8	3.1 (0-12.5)	3.1 (0-12.5)	0.571
POPDI-6	0 (0-0)	0 (0-0)	0.124
PFDI-20 (total)	6.77 (0-15.6)	6.25 (0-16.6)	0.834

*Statistical significance p <0.05.

Table 3. Correlations between maternal and obstetric characteristics and Pelvic Floor Dysfunction (PFD) symptoms at 3 months postpartum. Pearson Correlaction Coefficient (r_p) and Point-Bisserial Correlation Coefficient (r_pb).
	UDI score		POPDI score		CRADI score		PFDI score
		p-value		p-value		p-value		p-value
3 months
Pre-pregnancy BMI	r_p = 0.108	0.016*	r_p =0.071	0.115	r_p =-0.024	0.594	r_p =0.070	0.120
Intact perineum	r_pb = 0.107	0.017*	r_pb = -0.031	0.485	r_pb = -0.038	0.400	r_pb = -0.125	0.006*
Vaginal tears	r_pb = -0.091	0.015*	r_pb = -0.045	0.318	r_pb = -0.021	0.637	r_pb = -0.091	0.044*
Episiotomy	r_pb = 0.108	0.016*	r_pb = 0.040	0.377	r_pb = 0.086	0.056	r_pb = 0.156	<0.001*

UDI Urinary Distress Inventory, POPDI Pelvic Organ Prolapse Distress Inventory Index, CRADI Colorectal-Anal Distress Inventory, PFDI-20 Pelvic Floor Dysfunction Inventory.

*Statistical significance p<0.05.

Table 4. Partial correlations between type of perineal protection techniques (perineal massage and warm compresses versus standard care) and Pelvic Floor Dysfunction (PFD) symptoms at 3 months postpartum. Point-Bisserial Correlation Coefficient (r_pb).
	UDI score		POPDI score		CRADI score		PFDI score
	r_pb	p-value	r_pb	p-value	r_pb	p-value	r_pb	p-value
3 months
Type of Perineal Protection Technique (PeMWaC versus Standard care)	-0.287	<0.001*	-0.032	0.487	-0.017	0.711	-0.223	<0.001*

UDI Urinary Distress Inventory, POPDI Pelvic Organ Prolapse Distress Inventory Index, CRADI Colorectal-Anal Distress Inventory, PFDI-20 Pelvic Floor Dysfunction Inventory.

*Statistical significance p<0.05a Controlled for pre-pregnancy BMI, performance of episiotomy, occurrence of vaginal tears and intact perineum.

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Pelvic floor dysfunction at 3 and 6 months postpartum. A sub-analysis of the Perineal Massage and Warm Compresses technique during second stage of labor randomized controlled trial (PeMWaC)

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