The Effectiveness of Prenatal Perineal Massage at Reducing the Risk of Perineal Trauma During Vaginal Delivery: a Meta-Analysis

ABSTRACT

THE EFFECTIVENESS OF PRENATAL PERINEAL MASSAGE AT REDUCING THE RISK OF PERINEAL TRAUMA DURING VAGINAL DELIVERY: A META-ANALYSIS

Background: Perineal injury occurs in 85% of all women who experience a vaginal delivery.1 Research has suggested that prenatal perineal massage can reduce the risk of perineal trauma. The purpose of this meta-analysis is to determine if perineal massage should be performed in pregnant women as preparation for their vaginal delivery. Methods: Electronic databases were searched and eligible articles involving prenatal perineal massage compared to standard routine care during pregnancy were gathered. The PEDro Scale was used to assess the quality of the studies included in this meta-analysis. Data including sample sizes were extracted to calculate the overall relative risk of an episiotomy or laceration occurring in the perineal massage group over the control group. Results: After screening, 7 controlled trials were included for analysis. Women were found to have a 30% risk reduction of experiencing a third- or fourth-degree tear after practicing perineal massage. Static massage decreased the risk of third- and fourth-degree tears by 73% and dynamic massage by 16%. Perineal massage 3-4 times per week decreased the risk of third- and fourth-degree tears by 73% compared to 22% for daily massage. Conclusion: Digital perineal massage reduced the severity of perineal injury. Future research should be conducted to determine the most effective parameters and techniques for perineal massage.

Kari Anne Turner May 2020

THE EFFECTIVENESS OF PRENATAL PERINEAL MASSAGE AT REDUCING THE RISK OF PERINEAL TRAUMA DURING VAGINAL DELIVERY: A META-ANALYSIS

by Kari Anne Turner

A project submitted in partial fulfillment of the requirements for the degree of Doctor of Physical Therapy in the Department of Physical Therapy College of Health and Human Services California State University, Fresno May 2020

APPROVED For the Department of Physical Therapy:

We, the undersigned, certify that the project of the following student meets the required standards of scholarship, format, and style of the university and the student's graduate degree program for the awarding of the doctoral degree.

Kari Anne Turner Project Author

Nupur Hajela (Chair) Physical Therapy

Jennifer Roos Physical Therapy

For the University Graduate Committee:

Dean, Division of Graduate Studies AUTHORIZATION FOR REPRODUCTION OF DOCTORAL PROJECT

X I grant permission for the reproduction of this project in part or in its entirety without further authorization from me, on the condition that the person or agency requesting reproduction absorbs the cost and provides proper acknowledgment of authorship.

Permission to reproduce this project in part or in its entirety must be obtained from me.

Signature of project author: ACKNOWLEDGMENTS

I would like to thank the following special people for the love, support, and laughter during this strenuous, yet rewarding process: Nupur Hajela, PT, DPT, PhD Jennifer Roos, PT, DPT, GCS Kenneth Paul Turner Glenn & Linda Silveira Alex & Katie Cabatic Kim & Paul Turner Sam Mendoza Aly Huber Alyssa Cabri Nicole Cope and Mason Rivera

TABLE OF CONTENTS Page

LIST OF TABLES ...... vii

LIST OF FIGURES ...... viii

BACKGROUND ...... 1

Clinical Importance ...... 1

Anatomy & Physiology ...... 2

Degrees of Perineal Laceration ...... 4

Utilization of Episiotomy ...... 5

Current Research ...... 7

METHODS ...... 9

Search Strategy...... 9

Quality Appraisal ...... 10

Data Collection Process ...... 10

Operational Definitions ...... 11

Statistical Analysis ...... 12

RESULTS ...... 13

Study Selection...... 13

Study Characteristics ...... 13

Primary Analysis: Effects of Perineal Massage on Episiotomy and OASIS .. 14

Primary Sub-Analysis: Static vs. Dynamic Perineal Massage ...... 15

Secondary Sub-Analysis: Daily Vs. 3-4x Weekly ...... 15

DISCUSSION...... 17

Summary of Results ...... 18

Threats to Validity...... 19 vi vi Page

Limitations ...... 21

Clinical Implications ...... 22

Future Research ...... 23

Conclusion ...... 23

REFERENCES ...... 24

TABLES ...... 30

FIGURES...... 36

APPENDIX: PEDRO SCALE ...... 39

LIST OF TABLES

Page

Table 1. PEDro Scale of Eligible Studies...... 31

Table 2. Study Characteristics ...... 32

Table 3. Study Inclusion and Exclusion Criteria ...... 33

Table 4. Perineal Massage Characteristics ...... 34

Table 5. Results: Perineal Trauma after Massage ...... 34

Table 6. Results: Perineal Trauma with Static vs. Dynamic Massage ...... 35

Table 7. Results: Perineal Trauma with Daily vs. 3-4x Week Massage ...... 35

LIST OF FIGURES

Page

Figure 1. Grades of OASIS ...... 37

Figure 2. Stress-strain curve ...... 37

Figure 3. Perineal massage technique ...... 38

Figure 4. Consort map ...... 38

BACKGROUND

Perineal trauma commonly occurs to women during labor in a vaginal delivery. Trauma to the perineum results in injury, which can involve an episiotomy or a laceration. An episiotomy is an incision made by a medical doctor to enlarge the vaginal opening and a laceration is a spontaneous tear of soft tissue within the perineal region. Eighty-five percent of women sustain one or both of these types of perineal injuries during a vaginal delivery.1 Injury to the perineum leads to a variety of secondary morbidities during the postpartum period.2-4 The most common report from women following a perineal injury is pain.2 Perineal pain causes insomnia, anxiety, delay in or prevention of mother-neonate bonding, failure to find a tolerable position while breastfeeding, and dyspareunia.1,2 Another consequence of a perineal injury is urinary incontinence (UI). Urinary incontinence is the most frequently reported long-term morbidity following perineal trauma4,5 Up to 40% of women with postpartum UI, continue to experience UI for the duration of their lifetime.6 Urinary incontinence is highly associated with the development of subsequent psychological, physical, and social problems such as avoiding social interactions and physical activity due to fear of voiding in public.6 A longitudinal study conducted in 2006 determined that 42% of women continued to experience symptoms of UI 12 years following their vaginal delivery.7 Therefore, once a woman develops UI, she tends to experience symptoms for the duration of her lifetime.

Clinical Importance Perineal injuries are a concern for health care providers due to their tendency to contribute to long-term secondary morbidities such as UI.6,7 This is an 2 2 important matter for physical therapists because 43% of women with UI report limitations in their physical activity.8 Prolonged limitations occur because women with UI often avoid exercise due to psychological difficulties related to the fear of an involuntary release of urine.8 Lack of physical activity leads to sedentary lifestyle and research associates this with the development of an array of musculoskeletal morbidities involving neck, lower back, and shoulder pain.9 General physical therapists may not treat UI directly, but they will likely end up treating the musculoskeletal morbidities that are the result of long-term UI.10 Therefore, perineal trauma may lead to a sedentary lifestyle, which negatively impacts overall health and wellness.10,11

Anatomy & Physiology Damage to any of the soft tissue structures located within the space between the anus and vulva in women is considered a perineal injury. In terms of bony landmarks, the perineum is the region within the pubic symphysis and coccyx.12 The muscles and other soft tissue structures that make up the perineal region is best known as the pelvic floor. Functions of the pelvic floor muscles include maintaining continence of urine and feces, supporting the abdominal viscera, allowing sexual activity, and birthing a child.12,13 The pelvic floor is innervated by the pudendal nerve, which arises from S2-S4 nerve roots of the anterior division of the sacral plexus.12,14 The pudendal nerve branches into 3 divisions: the inferior rectal nerve, the dorsal nerve of penis or clitoris, and the perineal nerve.12 These nerves provide both sensory and motor control to the perineum.12 The pelvic floor muscles are separated into superficial and deep muscles and divided into 3 layers. Layer 1 is known as the urogenital triangle. This layer 3 3 includes the bulbocavernosus, ischiocavernosus, superficial transverse perineal, and the external anal sphincter.12 These structures are largely involved in constriction of the urethra, anus, and vagina such as when maintaining continence of urine or feces. The second layer of the pelvic floor is known as the urogenital diaphragm, and it is composed of the sphincter urethrae, compressor urethrae, sphincter urethral vaginalis, deep transverse perineal, and the perineal membrane.12 This layer plays a role in constricting the urethra and vagina as well as supporting the abdominal viscera. Support to the pelvic floor is predominantly provided by the deep transverse perineal muscle and the perineal membrane due to their fibrous structure. The third layer is known as the pelvic diaphragm. The pelvic diaphragm is made up of the levator ani, coccygeus, piriformis, and obturator internus muscles.12 The levator ani makes up the bulk of the pelvic floor musculature and it has an important role of elevating the pelvic floor. This function lends to support of the abdominal viscera as well as continence of the bladder and bowels.

Pelvic Floor Changes During Pregnancy Anatomical and physiological changes occur during gestation and vaginal delivery that may contribute to pelvic floor dysfunction. Pregnancy is associated with a decrease in pelvic floor muscle strength and endurance which can cause UI.15 Some women may experience damage to the pelvic floor fascia, ligaments, and nerves that control the bladder during pregnancy or delivery contributing to UI.15 As the fetus grows during pregnancy, the increasing weight and size forces the baby lower into the pelvic region.15,16 This places more stress on the pelvic floor structures and leads to damage.15,16 4 4

Hormonal changes during pregnancy involve the production of the hormone relaxin, which has direct effects on the musculoskeletal system.17 Relaxin increases collagen catabolism of the pubic symphysis and weakens pelvic ligaments to allow the pelvis to grow wider for fetal clearance in preparation for vaginal delivery.17 Increases in serum relaxin also leads to tendon laxity by producing enzymes that break down collagen.17 This decreases the total contractile force the pelvic floor muscles are able to exert.17 Vaginal delivery causes mechanical changes to the perineum including fascial, muscular, and neurogenic damage.16,18 Vaginal delivery requires laboring the baby through the vaginal opening, which places an extreme amount of pressure on the pelvic floor structures.16 Naturally relaxed structures also become weakened from the mechanical and hormonal changes during gestation.16 The pelvic floor changes that occur during pregnancy and vaginal delivery lead to dysfunction of the pelvic floor which predisposes women for injury.17 Perineal injury is often associated with a longer duration of childbirth which increases likelihood of injury.16 Women who receive treatment from a trained healthcare provider prior to their vaginal delivery will have a potential reduction of injury as well as an improved recovery following an injury.16

Degrees of Perineal Laceration Perineal lacerations spontaneously occur during vaginal delivery from the excessive load placed on the pelvic floor structures that are already weakened by the anatomical changes taking place throughout pregnancy. A laceration is measured by a medical provider using a standardized grading scale to determine if an obstetrical anal sphincter injury (OASIS) is present.19 The grading scale is as follows: “first degree tear; injury to the perineal skin and/or the vaginal mucosa, 5 5 second degree tear; injury to the perineum involving the perineal muscles but not involving the anal sphincter, third degree tear; injury to the perineum involving the anal sphincter complex, fourth degree tear; injury to the perineum involving the anal sphincter complex and the anorectal mucosa” (Figure 1).20 Simply stated, first- and second-degree tears involve the perineum while third- and fourth-degree tears involve the anal complex in addition to the perineum. Current management of third and fourth-degree tears require surgery under anesthesia within the first 12 hours of vaginal delivery to suture the anal complex and perineum.21 Second- degree tears may also require suturing to assist in proper healing of the perineal muscles and soft tissues.21

Utilization of Episiotomy Episiotomy is a common procedure performed to increase clearance for the fetus during vaginal delivery.22 An incision is made by a physician through the vagina into the perineum. This procedure has been utilized since the mid-1700s and gained popularity during the 1900s.23 However, it was determined in the late 1900s that an episiotomy actually increases the likelihood of succumbing a third- or fourth-degree tear by creating a weak point in the soft tissue.23 This leads to a higher rate of tissue failure which makes a spontaneous tear more likely to occur in addition to the incision that was already made by the physician. This finding discounts the appeal of episiotomy for reducing the likelihood of perineal tears. Despite this finding, 25% of all vaginal deliveries resulted in an episiotomy in 2004.23 It is important to recognize that there are other known serious medical reasons to perform an episiotomy such as shoulder dystocia, prolonged second stage of delivery, abnormal fetal or maternal vitals, and avoidance of instrument assisted delivery, which may cause harm to the fetus.23 In 2006, the American 6 6

Congress of Obstetricians and Gynecologists recommended against the use of routine episiotomies due to its high association with other medical morbidities such as long term UI.23

Treatment Rationale Laceration of the perineum occurs during vaginal delivery due to soft tissue failure under the stress of labor. Soft tissues possess elastic properties that allow them to yield under mechanical stress and strain without damage. However, the elasticity of all tissue has a threshold, that when surpassed, can lead to tissue damage (Figure 2). This threshold of elasticity is not a set point, but it can adapt when exposed to an appropriate dose of stress consistently. When soft tissue mobilization (STM) is performed appropriately, soft tissue will adapt to the imposed demands. This allows the soft tissue to accommodate higher amounts of stress and strain without damage. This is in accordance of Davis’s Law, which states “soft tissue models itself along the demands imposed on itself.” 24 Benefits of STM at the physiological level consist of decreased scar tissue, increased vascular response, and increased fibroblast production.25 Fibroblasts are involved in the repair, regeneration and maintenance of soft tissue by manufacturing collagen and elastin.25 Collagen and elastin allow the soft tissue to stretch while maintaining its integrity. The production of collagen and elastin takes approximately 4-6 weeks to occur.26 It has been suggested in research that perineal massage helps protect the integrity of the perineum during vaginal delivery through this physiological process.22

Application of Perineal Massage Perineal massage can be performed by an obstetric gynecologist (OB- GYN), midwife, physical therapist, or by self. The purpose of perineal massage is 7 7 to stretch the vaginal opening and surrounding perineal muscles using external manual pressure.27 Self-perineal massage involves the use of inserting 1 or 2 fingers 3-5 cm into the vagina using a lubricant and applying a constant sweeping, downward motion or by holding a static, steady pressure along the inferior-lateral regions of the perineum (Figure 3).3,28,29 Parameters for perineal massage vary from 5-10 minutes daily and are frequently monitored by pain level.3,28,29 Women are educated to apply enough pressure to feel a mild burning sensation to ensure the perineum is being stressed enough to make physiological changes in the tissue in accordance to Davis’s Law.3,28,29

Current Research Perineal massage has been studied in the past, particularly by midwives, who performed perineal massage on women during active labor. Pre-existing research has demonstrated that perineal massage during labor is effective at reducing perineal trauma.22,30 A randomized controlled trial conducted in 2017 with a sample of 195 nulliparous women determined that perineal massage during active labor significantly reduced the frequency of episiotomy and severity of perineal laceration.1 If perineal massage during active labor can prevent perineal trauma, then preparatory perineal massage during the pre-partum period may have even greater effects. This is based on the notion that soft tissue changes take 4-6 weeks to occur.26 Beginning perineal massage 4-6 weeks prior to the expected due date should allow time for true soft tissue changes.26 This may lead to an even greater reduction in perineal trauma when compared to perineal massage performed solely during active labor. 8 8 Limitations of Research Perineal massage during the third trimester of pregnancy has been researched, although results have been inconclusive, and no meta-analysis has been performed to date. The purpose of this meta-analysis is to determine if perineal massage should be performed in pregnant women as preparation for their vaginal delivery. This information will be valuable as patient education for pregnant women. Proper education may increase the likelihood of delivering babies with an intact perineum.29 Without injury to the perineum the recovery following a vaginal delivery will be smoother and quicker. This will allow women to return to their prior level of function at an increased rate. It will also help reduce potential comorbidities associated with perineal trauma such as insomnia, anxiety, delay in or prevention of mother-neonate bonding, failure to find a tolerable position while breastfeeding, dyspareunia, and UI.2 The alternative hypothesis for this meta-analysis is that pregnant women who begin prenatal perineal massage at least 4 weeks prior to their due date will reduce their risk of perineal trauma during vaginal delivery. The null hypothesis is that pregnant women who begin prenatal perineal massage at least 4 weeks prior to their due date will have no change in their risk of perineal trauma during vaginal delivery.

METHODS

Search Strategy This meta-analysis was structured in accordance with the “Preferred Reporting Items for Systematic Reviews and Meta-Analyses”, better known as the PRISMA guidelines.31 Databases searched included PubMed, Physiotherapy Evidence Database Scale (PEDro; see Appendix), OneSearch via Henry Madden Library, and the International Journal of Gynecology & Obstetrics. The literature search commenced in July 2019 and concluded in October 2019. One reviewer performed a preliminary screen of articles based on titles and abstracts from peer- reviewed journals only. Controlled clinical trials, meta-analyses, randomized- controlled trials, and systematic reviews were filters applied to all searches. The search used various combinations of the following words and phrases: perineal massage, antenatal, pregnancy, antepartum, and perinatal. Secondary searches occurred after reviewing references of all included articles to determine if they met search criteria.

Eligibility Criteria To be included in this meta-analysis, all studies needed to be controlled clinical trials. Studies were comprised with 1 experimental group that involved perineal massage compared to a control group that received routine care during pregnancy. Nulliparous and multiparous women were separated in the included studies. Women of all ages who performed perineal massage for at least 4 weeks during the third trimester of their pregnancy were eligible. All participants were expecting a vaginal delivery over a cesarean section. Women were excluded who received perineal massage during active labor or for less than 4 weeks prior to their due date. Premature deliveries defined as 10 10 prior to 37 weeks of gestation were excluded due to smaller fetus size. Babies that are premature place less stress on the pelvic floor during vaginal delivery and bias results for perineal massage. Women with medically complicated pregnancies that placed them at risk for prolonged labor such as from multiple gestation, preeclampsia, and neurological disorders associated with fatigue were excluded since it would bias results against perineal massage. Participants were also excluded if they were at risk for a cesarean delivery.

Quality Appraisal The quality of the studies used in this meta-analysis were reviewed using the PEDro Scale.32 The PEDro Scale was created to rate the quality of clinical trials using an 11-point scoring system32. Criteria in the PEDro Scale assess threats to internal and external validity by analyzing potential biases and errors in experimental design. This scale has been an integral factor in the evolution of evidence-based practice in the physical therapy field, allowing physical therapists to choose the highest quality research to incorporate into their clinical practice. A score between 6-10 is considered high-quality literature, 4-5 fair quality, and 3 and less poor quality.33

Data Collection Process Data including sample sizes, relative risk (RR), and confidence intervals (CI) were extracted from each eligible study by searching available text, tables, and figures. Statistical analysis was performed by determining the sample of individuals who received perineal massage, and of these individuals, how many received an episiotomy or tore during vaginal delivery. The same was completed for those who did not receive massage. The RR is the fraction of the outcome occurring in the perineal massage group over the control group.34 11 11 Operational Definitions Nulliparous, pregnant women of all ages with normal, uncomplicated pregnancies were included in this study. Perineal massage was defined as any hands-on manual technique using external pressure without assistance from instruments. This could be performed as a static hold along the inferior and lateral borders of the vaginal opening or as a dynamic motion across the perineum. Perineal massage was compared to standard routine care during pregnancy. Standard routine care is defined as patient education, simple pelvic floor muscle training exercises involving kegels, and regular OB-GYN visits approximately once a month during the first 2 trimesters of pregnancy and every 2 weeks during the last trimester.35-37

Outcome Measures Outcome measures included the rate of occurrence of an episiotomy as well as the presence of OASIS. There are many factors that affect the decision to perform an episiotomy such as the physician’s experience and clinical decision making skills, the weight of the infant, and the circumference of the baby’s head.23 Although the occurrence of episiotomies is trending down since 2006, episiotomies are still commonly performed today and are therefore relevant to use as an outcome measure.23 The grading scale to determine the presence of OASIS is used universally across obstetrical care providers.19 Inspection for perineal injury following vaginal delivery is performed with adequate lighting by a trained health care provider. The examiner places 1 index finger into the anus and the ipsilateral thumb into the vagina and uses a “pin-rolling” technique to assess the thickness of the perineum.19 They then grade the severity of OASIS using a scale broken down into first-, second-, third-, and fourth-degree tears. 12 12 Statistical Analysis Analyses of sample sizes of all groups to calculate the overall RR of episiotomy, first-degree, second-degree, and third- and fourth-degree tears occurred using Excel. A sub-analysis was performed on the 2 different types of perineal massage used across studies, static and dynamic. A secondary sub- analysis was performed to determine the effectiveness of the different frequencies of perineal massage used across studies, daily massage versus 3-4 times per week. The control event rate (CER) and the experimental event rate (EER) was calculated. The CER and EER is the percentage of participants who experienced the outcome in each group.34 These statistics were required to calculate the relative risk reduction (RRR). The RRR is the percentage of risk reduced in an intervention group compared to the control group.34

RESULTS

Study Selection A total of 7 studies were included to be a part of this meta-analysis. The database search produced a total of 125 results. Eighteen results were immediately discarded due to duplicates across databases. The titles and abstracts of the 107 results were examined and 75 articles were excluded as they did not match the appropriate search criteria. The remaining 32 articles were analyzed further and eventually rejected due to lack of meeting the appropriate inclusion/exclusion measures of the PICO. The residual 7 studies were chosen for data comparison. The PEDro scale further analyzed the remaining articles to distinguish the level of quality. A consort map was created to explain the study selection process in greater detail (Figure 4).

Study Characteristics The studies included in this meta-analysis were conducted by the following authors Labrecque et al. 199438, Labrecque et al. 199939, Shimada et al.40, Shipman et al.41, Ugwu et al.3, Bodner et al.42, and Mei-dan et al.43 Each article appropriately met the PICO requirements to be included in this meta-analysis. The risk of bias within each study was assessed using the PEDro Scale scores. The PEDro scores of the 7 studies ranged from 5-9/10 with an average Pedro score of 7/10. All trials included a comparison group that did not receive the intervention being studied as well as point measures for at least 3 outcomes. The PEDro scale results for each study is listed in Table 1. All studies were conducted between the years 1994-2018. They were organized by a medical doctor (MD), nurse, midwife, or OB-GYN. Sample sizes ranged from 46-1034 participants with an average sample size of 413 participants 14 14 and a total sample size of 2,891 women included in this meta-analysis. Table 2 displays the study characteristics in greater detail. Participant groups from each of the studies used in this meta-analysis included the following characteristics: nulliparous, practiced perineal massage for at least 4 weeks prior to their planned due date. The specific inclusion and exclusion criteria of each study is listed in Table 3. It is important to note that the parameters and techniques of perineal massage varied amongst the 7 included studies. Four of the articles including Labrecque et al.199438, Labrecque et al. 199939, Shipman et al.41, and Ugwu et al.3 performed perineal massage using a dynamic, continuous sweeping motion along the perineum. Two of the articles including Bodner et al. and Mei-dan et al. performed perineal massage using a static, constant pressure to stretch the perineum and enlarge the vaginal opening.42,43 Shimada et al. did not specify the technique used while performing perineal massage.40 Labrecque et al. 199438, Labrecque et al. 199939, Ugwu et al.3, and Mei-dan et al.43 required perineal massage to be performed daily while Shimada et al.40, Shipman et al.41, and Bodner et al.42 required it to be performed 3-4 times per week. The time perineal massage was performed varied from 4-10 minutes across all studies. A summary of the perineal massage characteristics used in each study can be seen in Table 4.

Primary Analysis: Effects of Perineal Massage on Episiotomy and OASIS All 7 studies analyzed the risk of acquiring an episiotomy after performing perineal massage for at least 4 weeks. The relative risk reduction was the primary piece of data used to determine the effectiveness of reducing the risk of an OASIS after using perineal massage. Women who practiced perineal massage were 13% (0.87 RR) less likely to receive an episiotomy during vaginal delivery. 15 15

Women were found to have a reduced likelihood of experiencing a first- degree tear by 7% (0.93 RR) when compared to the control group. There was no difference in the incidence of second-degree perineal tears compared to the intervention and control groups. Six of the 7 studies analyzed the risk of experiencing a third- and fourth- degree laceration after performing perineal massage for at least 4 weeks. Women were found to have a 30% (0.70 RR) reduction in the likelihood of experiencing a third- or fourth-degree tear after practicing perineal massage. These results are displayed in Table 5.

Primary Sub-Analysis: Static vs. Dynamic Perineal Massage A sub-analysis was conducted to further determine which type of perineal massage was preferable. Two studies, Bodner et al.42 and Mei-dan et al.43, performed perineal massage using a static hold rather than a dynamic, continuous motion. The results determined that static hold decreased the risk of episiotomy by 5% (0.95 RR) while the dynamic, continuous motion decreased episiotomy by 18% (0.82 RR). For first-degree tears, static massage decreased risk by 10% (0.90 RR) while dynamic massaged reduced it by 5% (0.95 RR). Static massage decreased the risk of second-degree tears by 5% (0.95 RR) while dynamic massage decreased it by 1% (0.99 RR). For third- and fourth-degree tears, static massage decreased the risk by 73% (0.27 RR) and dynamic massage decreased it by 16% (0.84 RR). The results are displayed in Table 6.

Secondary Sub-Analysis: Daily Vs. 3-4x Weekly A secondary sub-analysis was conducted to determine if daily massage is necessary to induce positive outcomes. Four studies, Labrecque et al. 199438, 16 16

Labrecque et. al 199939, Ugwu et al.3, and Mei-dan et al.43 required perineal massage to be performed daily. The remaining 3 studies included in this meta- analysis, Shimada et al.40, Shipman et al.41, and Bodner et al.42, recommended perineal massage frequency 3-4 times per week. The results of this analysis determined that daily massage reduced the risk of episiotomy by 17% (0.83 RR), first-degree tears by 16% (0.84 RR), second-degree tears by 0% (1.00 RR), and third- and fourth-degree tears by 22% (0.78 RR). Perineal massage 3-4 times per week decreased the risk of episiotomy by 6% (0.94 RR), first-degree tears by 1% (0.99 RR), and third- and fourth-degree tears by 73% (0.27 RR). Risk of a second- degree tear increased by 5% (1.05 RR) for participants who performed perineal massage 3-4 times per week compared to daily. This sub-analysis had similar sample sizes: daily massage (n = 1,417) versus 3-4 times per week (n= 1,444).The results are displayed in Table 7.

DISCUSSION

The purpose of this meta-analysis was to determine the effectiveness of perineal massage on reducing the likelihood of perineal trauma during vaginal delivery in pregnant women. Although a meta-analysis exists on the use of perineal massage during active labor, a meta-analysis examining the use of regular perineal massage during the third trimester of pregnancy does not exist.4 A systematic review on digital perineal massage during the third trimester was conducted by Beckmann et al. in 2013, which found a statistically significant reduction in the incident of episiotomies in women who practice perineal massage.2 However, Beckmann et al. did not distinguish parameters of perineal massage to ensure proper technique.2 In 2018, Ugwu et al. published a randomized control trial on perineal massage during the third trimester that found a reduction of episiotomies to be statistically significant.3 The objective of this meta-analysis was to strengthen the existing literature on perineal massage by providing more evidence on appropriate parameters to encourage regular use of this technique in clinic. The findings from this study determined that perineal massage is effective at reducing the risk of trauma during vaginal delivery. Perineal massage is most effective at reducing the severity of perineal lacerations. For these reasons, the null hypothesis was rejected which stated there would be no change in risk of perineal trauma when performing prenatal perineal massage. This discussion reviews the results of this meta-analysis in further detail as well as the flaws and limitations that may affect the validity of these findings. Further discussion points will reveal clinical applications and recommendations for future research about this topic. 18 18 Summary of Results Digital perineal massage reduced the severity of perineal injury during vaginal delivery. Perineal massage demonstrated the greatest reduction in the likelihood of third- and fourth-degree perineal lacerations. This is an important finding because medical management of third- and fourth-degree lacerations involves emergency surgery under anesthesia to repair the perineum.21 This meta- analysis revealed that there is less reduction in risk of first- and second-degree perineal tears compared to third- and fourth-degree tears following massage. This is a positive finding because first- and second-degree tears are more ideal outcomes when compared to third- and fourth-degree tears. Also, if less women are experiencing third- and fourth-degree tears, then naturally more women are likely experiencing first- and second-degree tears. The results from the sub-analysis comparing static versus dynamic perineal massage indicated that static perineal massage is more effective at reducing the likelihood of third- and fourth-degree tears. Static perineal massage reduced the risk of third- and fourth-degree tears by 57% compared to dynamic perineal massage. Static perineal massage is similar to a low-load prolonged stretch, which research has indicated to be more effective than a dynamic stretch at treating joint contractures.44 Therefore, static stretching was likely more successful at increasing the muscle length of the pelvic floor, which allowed the vaginal canal to open wider during vaginal delivery, preventing third- and fourth-degree tears. A sub-analysis on frequency of perineal massage helped distinguish effective parameters. Perineal massage practiced 3-4 times per week had a greater reduction in third- and fourth-degree tears by 51% compared to daily perineal massage. Less frequent perineal massage was more beneficial according to this meta-analysis. It is suspected from clinical practice that this may be due to 19 19 compliance issues amongst the participants. Research has found that a common reason for lack of compliance in home exercise programs during physical therapy practice are frequently due to time consumptions.45 Therefore, women asked to perform daily massage were likely less compliant than the women asked to perform massage 3-4 times per week.

Threats to Validity

Internal Validity Random allocation of selected participants into groups was present in all studies with the exception of Bodner et al.42 and Mei-dan et al.43 Mei-dan et al.43 allowed participants to choose if they would like to be in the massage group, while Bodner et al.42 did not mention randomization of groups or concealment of allocation, so it must be assumed it was not present. This is a threat to internal validity since selection bias may have been present when sorting participants into the massage or control group. Blinding of assessors who determined perineal outcomes was present in 4 out of 7 studies. Assessors were not blinded in Labrecque et al.199438, Shimada et al.40, or Bodner et al.42 Therefore, the assessors may have been biased for perineal massage and minimized the severity of perineal injury while grading participants. However, all assessors used the OASIS standardized grading scale to determine the degree of laceration, which likely helped reduce the amount of bias during assessment.19 Recipients of perineal massage were blinded in 1 study, Shimada et al.40 Since the participants did not know what the researchers were measuring, the recipients of massage were considered blinded in this 1 study. All other participants across studies were not considered blinded to the treatment since they knew the purpose for perineal massage. Women in all the studies performed 20 20 perineal massage at home unsupervised. Although most researchers called participants weekly to assess compliance throughout the course of treatment this is a threat to validity. Researchers were relying on the participant’s honesty to determine compliance and correctness of massage technique within the assigned parameters.

External & Construct Validity Although multiparous women were considered in this meta-analysis, existing literature predominantly studied nulliparous women. The eligible studies which matched the PICO included women who were experiencing their first expected vaginal delivery. This is a threat to external validity since the results of the study are not representative of all women. Women experiencing their second, third, fourth, etc. vaginal delivery were not represented in this meta-analysis. Previous research has determined that nulliparous women are at a higher risk for perineal injury, particularly third- and fourth-degree tears.11 For this reason, nulliparous women have predominantly been studied over the years. If perineal massage works for nulliparous women, the population most at risk, it will likely work for multiparous women, as well.11 Furthermore, it is important to note that all women involved in this meta- analysis were recruited at medical facilities. This may have affected participant compliance with perineal massage and is a threat to external validity because the results do not represent all women, such as women who did not attend these medical facilities. Also, none of the studies included in this meta-analysis were conducted in the United States and is predominantly representative of Canadian and European women (Table 2). 21 21

Shipman et al. (n=861) provided 4 vaguely described pelvic floor muscle training exercises including kegels to both the intervention and control groups within his study.41 The study was included in this meta-analysis due to both groups performing the same exercises meaning they were identical at baseline. Also, it has been reported that 69% of women perform some type of pelvic floor muscle training exercises including kegels throughout their pregnancy.46 However, this still may be a threat to construct validity and should be considered when analyzing the results of this meta-analysis. The 7 studies’ (n =2,016) control groups included standard routine care that involved regular OB-GYN visits throughout the duration of pregnancy with no educational instruction on perineal massage.

Limitations Lack of utilization of a standardized grading scale to measure the amount of pressure applied during perineal massage is a limitation to this study. Across studies, women were given subjective forms of measuring manual pressure during massage. Two of the studies, Mei-dan et al.43 and Ugwu et al. 3 instructed women to apply pressure until the area felt “numb,” then move to new location and repeat the same process. Shipman et al. instructed women to apply enough pressure to feel “tingling” but no pain.41 The 4 remaining studies made no mention of using a standardized way to measure pressure. Another potential limitation to this study was lack of supervision during perineal massage application. Women performed perineal massage at home by self or by partner. Although each study either called the women weekly or recommended they fill out a diary to encourage compliance, the researchers were relying on the participant’s subjective to determine if massage was being performed correctly. This is a limitation because women could have been 22 22 dishonest about frequency of perineal massage. This could skew results by making perineal massage appear less effective than it truly is if women weren’t following instructions, yet reporting that they were.

Clinical Implications This meta-analysis reinforces the literature on the effectiveness of prenatal perineal massage at reducing the severity of perineal injury following vaginal delivery. Women who have normal, uncomplicated pregnancies should be informed on the benefits of beginning perineal massage during their third trimester of pregnancy. The American Academy of Family Physicians has deemed perineal massage to be a safe and well-accepted form of conservative treatment to reduce perineal trauma associated with vaginal deliveries.47 Specialized pelvic health physical therapists are trained in performing perineal massage and interventions that treat incontinence as well as other pelvic health dysfunctions. Although general physical therapists may not perform perineal massage, they are qualified to provide patient education regarding what the literature on perineal massage demonstrates as well as a referral to a pelvic health physical therapist if appropriate. Physical therapists are in an ideal position to provide education on perineal massage since pregnant females often seek physical therapy treatment for other musculoskeletal dysfunctions during pregnancy. The physical therapy business model allows physical therapists to develop relationships with their patients since they are frequently seen over a course of weeks. Other health care practitioners in the medical model may not have the time to educate their patients on perineal massage, or the opportunity to build a patient relationship that makes this sensitive topic more easily accepted. Perineal massage involves the musculoskeletal system, which is the specialty of physical therapists, making them 23 23 the most suitable health care provider to perform and/or instruct prenatal perineal massage.

Future Research Although research demonstrates that perineal massage is effective at reducing the risk of perineal injury, more information is needed on how perineal massage should be performed. Specific guidelines should determine the appropriate amount of pressure to be applied to the perineum to induce soft tissue changes. This could be measured in a standardized way by using the Numeric Pain Rating Scale (NPRS).48 Future research should utilize 2 intervention groups with 1 group performing dynamic massage and the second group performing static massage. The NPRS should be used to monitor pain level in both groups to standardize the amount of pressure being applied during massage. This will provide better information on the most appropriate parameters for perineal massage.

Conclusion The literature presented in this meta-analysis demonstrated that prenatal perineal massage during the third trimester of pregnancy is an effective conservative treatment to reduce the severity of perineal lacerations during vaginal delivery. These results were found to be statistically significant. Healthy, nulliparous women should be made aware of the likely benefits of prenatal perineal massage by their health care providers and referred to a pelvic health physical therapist for proper instruction. Research should continue to be conducted on this topic to better understand and standardize the way perineal massage should be performed to produce the most positive outcomes in post-partum women.

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TABLES 31 31 Table 1. PEDro Scale of Eligible Studies

PEDro Labrecque Labrecque Shimada Shipman Ugwu Bodner Mei-dan

Criteria 1994 1999 2005 1997 2018 2002 2008 Random Allocation X X X X X -

Allocation Concealed X X X X X - X

Baseline Comparability - X X - X X X

Blind Subjects - - X - - - -

Blind Therapists - - X - - - -

Blind Assessors - X - X X - X

Adequate follow-up X X X - X X -

Intention to treat analysis - X X X - X X

Between group comparisons X X X X X X X

Point Estimates and X X X X X X X variability

32 32

Table 2. Study Characteristics Source Origin Researcher Participants Average PEDro Type (n) Age Score Labrecque Canada MD 46 N/A 5/10 1994 Labrecque Canada MD 1034 28.0 8/10 1999 Shimada 2005 Japan Nurse 63 N/A 9/10 Shipman 1997 England Midwife 861 28.0 6/10 Ugwu 2018 Nigeria OB-GYN 108 28.4 7/10 Bodner 2002 Australia OB-GYN 531 28.6 5/10 Mei-dan 2008 Israel OB-GYN 234 26.5 6/10

33 33 Table 3. Study Inclusion and Exclusion Criteria Study Inclusion Exclusion 32- to 34-week-pregnant Likely to require a cesarean section (placenta Labrecque 1994 nulliparas previa, severe intrauterine growth retardation, multiple gestation) and those with a history of genital herpes lesions during the pregnancy Women without a High risk of cesarean delivery, including Labrecque 1999 previous vaginal birth previous cesarean delivery for cephalope during the third trimester lvic disproportion; multiple gestation; placenta previa; severe fetal growth restriction; breech presentation; preeclampsia; nonparticipating physicians; outbreak of genital herpes during the current pregnancy; and inability to speak French or English, inability to understand the instructions, and already doing the massage Women without previous High likelihood of birth by caesarean section Shimada 2005 vaginal birth between 34 to 36 weeks Nulliparous women Multiple pregnancy, planned caesarean Shipman 1997 section, already performing perineal massage, premature delivery, medical conditions necessitating hospital admission, an allergy to nuts or nut products, or inability to speak and read English All primigravidae with Unsure of date, evidence of any Ugwu 2018 uncomplicated singleton contraindications to vaginal delivery, pregnancies in cephalic medical diseases in pregnancy, vaginal presentations, at 34–36 herpes or thrush and premature rupture of weeks gestation, without membranes uterine contractions Primiparous women who High risk of cesarean delivery Bodner 2002 were expecting a normal vaginal birth of a singleton baby with cephalic presentation Nulliparous women at 30– History of any vaginal surgical procedure, Mei-dan 2008 34 weeks gestation multiple gestation, use of a different perineal planning a vaginal massage oil during the current pregnancy, delivery and communication difficulties

34 34 Table 4. Perineal Massage Characteristics Source Type Oil Duration Frequency Application (min) Labrecque dynamic almond 5-10 daily for 6 self or 1994 weeks partner Labrecque dynamic almond 10 daily for 5-6 self or 1999 weeks partner Shimada N/A almond 5 4x week for self or 2005 4 weeks partner Shipman dynamic almond 4 3-4x week self or 1997 for 6 weeks partner Ugwu 2018 dynamic KY jelly 10 Daily for 4-6 self or weeks partner Bodner 2002 static almond 5-10 3-4x week N/A for 6 weeks Mei-dan 2008 static Calendula 10 Daily for 6 self oil with weeks added Vitamin E

Table 5. Results: Perineal Trauma after Massage Outcome Measure RR with 95% CI RRR

Episiotomy 0.87 (0.77, 0.98) 13%

first Degree Tear 0.93 (0.78, 1.11) 7%

second Degree Tear 1.00 (0.85, 1.17) 0%

third & fourth Degree Tear 0.70 (0.49, 1.00) 30%

35 35 Table 6. Results: Perineal Trauma with Static vs. Dynamic Massage Outcome Measure RR of Static RRR RR of Dynamic RRR Massage with Massage with 95% CI 95% CI Episiotomy 0.95 (0.83, 1.08) 5% 0.82 (0.72, 0.93) 18%

first Degree Tear 0.90 (0.55, 1.48) 10% 0.95 (0.75, 1.20) 5%

second Degree Tear 0.95 (0.66, 1.36) 5% 0.99 (0.83, 1.18) 1%

third & fourth 0.27 (0.08, 0.89) 73% 0.84 (0.57, 1.24) 16% Degree Tear

Table 7. Results: Perineal Trauma with Daily vs. 3-4x Week Massage Outcome Measure RR of Daily RRR RR of 3-4x per RRR Massage with Week Massage 95% CI with 95% CI Episiotomy 0.83 (0.70, 0.99) 17% 0.94 (0.81, 1.09) 6%

first Degree Tear 0.84 (0.67, 1.06) 16% 0.99 (0.75, 1.31) 1%

second Degree Tear 1.00 (0.79, 1.27) 0% 1.05 (0.85, 1.30) +5%

third & fourth 0.78 (0.53, 1.15) 22% 0.27 (0.09, 0.78) 73% Degree Tear

FIGURES 37 37

Figure 1. Grades of OASIS

Figure 2. Stress-strain curve 38 38

Figure 3. Perineal massage technique

Figure 4. Consort map

APPENDIX: PEDRO SCALE 40 40

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