A Randomized Controlled Trial on Evaluating

Effectiveness of Perineal Massage during

Pregnancy in Primiparous Women
Marie Shimada1) 2)
1) School of Nursing, The Jikei University 2) Department of Hygiene and
Preventive Medicine, Showa University School of Medicine

Key word: randomized controlled trial, perineal massage, pregnancy , primiparous women.

ABSTRACT: Self-massage on the perineum given by the pregnant woman in late

gestation has been a focus of constant attention as a measure of preventing the perineal
injury at delivery.
In view of the current circumstances, a randomized controlled trial was conducted to
evaluate the effectiveness of self-massage in primiparous women.
Among 90 women who met the conditions of this trial, 63 women participated in the study
and they were assigned to an intervention group (30 women) and a contrast group (33
women). The intervention group was given an instruction of how to give self-massage. The
massage was given at least four times a week until at the time of delivery (more than three
weeks).
There were two primary factors to be evaluated: reduction of episiotomy rates and
comparison of the degree of perineal injury. The episiotomy rates in the intervention group
were reduced by 21%, which cannot be said as a statistically significant decrease. As for
the comparison of the degree of perineal injury, those who continued the massage in the
intervention group had slighter injury than those in the contrast group.
It was suggested that perineal massage during late gestation could not reduce episiotomy
rates and make the perineal injury slighter.
The results were thought to have been affected by insufficient power of test. More
examination on the effectiveness of self-massage should be conducted, securing the
number of required subjects.

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 I.introduction.

Women who are postnatal often have various problems such as discomfort in the
perineum, pain and disorder of living activities due to episiotomy performed during vaginal
delivery.Therefore, the effect of perineal incision Regarding verification, many studies have
been done so far several systematic reviews (Woolley, 1995; Renfrew et al., 1998; Carrolin
et al., 2002)
According to these results, the perineal incision surgery is more effective for severe
lacerations such as III, IV degree and postpartum sexual life (by extending the incision)
than in the case of perineal laceration Increasing the incidence of disorders, reducing the
incidence of urinary incontinence in the early postpartum period and subsequent urinary
incontinence, which is considered to be an effect of the perineal incision, the newborn is in
good condition and effects such as being able to birth can not always be expected

Furthermore, irrespective of whether or not the perineal incision was performed.

Eason et al. (2000) clarified that injuries are aseptically or mildly comfortable as possible
after living. Eason et al. (2000) From the review of the randomized controlled trial
(hereinafter referred to as RCT), in order to make the perineal injury at the time of delivery
as mild as possible, eliminate the perineal incision, for the firstborn woman, the perineal
self massage was done at the end of pregnancy Avoiding forceps delivery, and making
sucking labor and natural births.
A perineal massage includes self massage performed by the pregnant woman himself, as
well as a self-massage performed by the care provider at the time of delivery.
There is a surge.In regard to massage at time of delivery, a large RCT such as Stamp et
al. (2001) resulted in an opinion that there is no effect of lightening perineal damage at
time of delivery On the other hand, perineum self-emphasized during pregnancy. As for the
massage, after the pregnancy 34 weeks, by oil massaging the part of the vaginal opening
(excluding the upper part of the vaginal opening), it is possible to improve the extensibility
of the skin and to acquire the relaxation of the pelvic floor muscle group, It is also in review
of Eason et al. (2000).

It is said that it reduces perineal injury during delivery. Even in Japan, guidance is given to
pregnant women at a small number of disease hospitals and maternity hospitals in
response to information from foreign countries, and from now on, with the guidance of
pregnant women themselves and guidance from midwives,
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It is speculated that the perineum self massage will be carried out more frequently, but it is
considered in the country that effect There are few studies to be done.As such a situation,
a midwife will be present at the second term of delivery
Under the circumstances in many hospitals in Japan where enforcement is carried out and
most of the births are delivered at the semi-Farah position on the delivery table
In the case of primary pregnant women performing perineal self massage at the end of
pregnancy, examining whether or not there is an effect is necessary to consider midwifery
practice based on the basis.

This study is based on the principle of gynecology in the policy of not conducting perineal
incision as much as possible even for first pregnant women (incision is made only when
fetal asphyxia is expected and cases where extension of the perineum is bad) In the ward,
setting the first index (end point) that determines the effect of the massage as the
reduction of the perineal incision rate, and performing the perineal self massage during
pregnancy is effective for reducing the perineal incision rate Whether or not to decrease,
furthermore, as a second index, it is clear whether the degree of percussion injury
(evaluated from the situation of early postpartum pain and comparison of classified results)
can be made mild It aimed to make it appear.

II. Research method

1. Setting of the person to be studied
During the period from September 2003 to February 2004,
Of the women who are pregnant between 34 weeks and 36 weeks pregnant that are
managed at 1 general hospital obstetrics and gynecology located in the Tokyo
metropolitan area, they are (1) head position, (2) do not have pregnancy complications, (3)
you are expected to be vaginally delivered, and (4) you are taking a childbirth preparation
class at a hospital.
In calculating the number of research subjects, the same as this research: As we
could not find an existing study with a decrease in percutaneous incision rate as the end
point, we assumed that the effectiveness of the intervention will be reduced to the level of
the lady by the perineal incision of the first nursing woman. Also, it was confirmed that the
perineal incision rate of the primiparae before the study of the target facility was 36.8%,
the number of lactating women was almost half 18.0%, that the intervention group and the
control group were the same number. Calculations were made on the condition that a

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detection output of 70% or more was secured, it was thought that 104 subjects
(intervention group, 52 people in each group) were necessary.

2. Intervention and observation Implementation of researchers or research assistants to

the target facility
In the obstetrics and gynecologic outpatient clinics on the day when it was possible, from
the pregnant women who came to the health examination of pregnant women, we got
permission to extract pregnant women meeting the above requirements from the facility
side Firstly, We asked the target person to listen to the research cooperation from the
researcher, and the researcher or research supporter asked the target person the purpose,
contents and contents of this research We asked for cooperation using a written form
describing ethical consideration and obtained consent.

Next, those who gained consent were sorted out to either the intervention group or the
control group by the randomization assignment by the person 's lottery, and it is stated
which of the distributions belongs to We prepared the paper for the schedule, enclosed
them all in the same envelope, and put them in a state that it was not understood which of
both the target person and the researcher could be drawn.
For hospital medical staff, we ask them to accept that pregnant women are not involved in
the study and whether they belong to either group, and even pregnant women also study
I requested not to talk about cooperation. For the intervention group, the perineal self
massage method to be described later is continued until distribution until delivery at a
frequency of 4 times a week or more
We also instructed those who were able to continue for more than 3 weeks at least 4
lessons per week with a massager. In both groups, the course of pregnancy was followed
until delivery.

Data on pregnancy and parturition were collected from fertilized paddock books,
outpatient/inpatient records.The items collected in comparing the two groups were age,
parturition type, perineal injury during delivery Status of delivery, time of delivery, weight of
baby at birth, 1 minute later (Apgar score)

3. Perineal self-massage Interventions were carried out in this study were carried out in a
previous study

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This is a perineal self-massage method with a slight modification to the method of M. al.,
1999; Bodner-Adler et al., 2002), and if the researcher or research assistant instructs the
intervention group to fingers, using the original brochure, perineum etc. after bathing,
applying oil to the thumb or index finger (or the two fingers of the index finger and the
middle finger) that will perform the perineum and massage when the department is clean,
up to each first finger joint position (3 to 4 cm) Was inserted and the vaginal opening
(Around the bottom of the shadow), vaginal opening (necrotic) left-right portion, whole
except the upper portion of the vaginal opening and so on, and explain that massage is
performed for about 5 minutes, demonstration with the perineum model
And if it is difficult for pregnant women to implement themselves, they should be
implemented by husband or partner, and as long as the frequency of implementation is as
few as possible at least 4 times a week at least

Oil used for massage, in the preceding study described above

The researcher offered sweet almond oil being used to the pregnant women in the
intervention group.It is said that this oil does not cause an allergic reaction.However, a
reaction which is sensitive to the skin Since it is a pregnancy period that is likely to occur,
use a patch test before use and use it For the status of massage implementation, fill in the
dairy
At the same time, I confirmed the status of massage implementation at the outpatient visit
and by phone, and the intervention group pregnant women are not concerned, they are
positive I carried out follow-up so that I can carry out the masseuse in the same way.

4.Precipitation method
Reduction of the first end point, perineal incision rate. In calculating the risk ratio (RR),
absolute risk reduction (ARR) was calculated.
Whether or not the degree of perineal damage as the second end point becomes mild is
determined by the degree of perineal pain in the early postpartum period

From the point of view, the situation of perineal injury was classified into 5 levels
and Mann - Whitney test was carried out.We reviewed the review of Wolley (1995) when
classifying the degree of percussion injury. In the review, since it showed multiple research
results that naturally occurred lacerations (including not only 1 degree but 2nd degree)
were less painful than episiotomy, it was either scar or mild (2 Vaginal wall laceration of
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first vaginal wall laceration, until the suturing of three needles), the first degree parochial
cleft wound, the second degree perineal laceration, the perineal notch retractor, the third
instar perineal laceration (including incision extension) Laceration (above the second
degree). For the analysis, the statistical software SPSS was used.

5. Ethical considerations
This research is directed to the nursing department and the department of obstetrics and
gynecology at the target facility. I submitted my research plan and got my consent to
research cooperation. Also, for the target audience, data is used for research purposes
only.
It is not guaranteed that it will not be subject to disadvantage due to refusal to show by
presentation method that individual can not be identified by anonymous name and that
cooperation cancellation in the middle of research is also free
did.

III. Results
The participation status of the target participants is shown in Figure 1. During the research
period in which the facility was consented at the facility, because the number of deliveries
was smaller than usual due to various circumstances of the facility side, 90 people were
able to request research cooperation, among which 63 (70%) obtained consent to
participate in research.
It was not possible to secure 104 people who were the first scheduled target number.As a
result of random assignment by lottery to these persons, 30 intervention groups, control
group. As a result, the detection power of this research was about 0.5.
Of the 30 intervention groups, 26 were vaginal births, the remaining 4 were Caesarian
section, but the first delivery It was a caesarean section due to fetal asphyxia and
termination of parturition during the period, and no facts suggesting the effect of massage
were observed.In addition, among 30 people, more than four weekly massages were
continued for 3 weeks or more, It was judged to be a massage prosecutor
There were 23 people (76.7%), mean duration week 4.4 weeks. I had an average of 5.3
masseurs per week.If 7 people who could not proceed with the massage, 6 were vaginal
Parturition, one was caesarean section, meaning that there were 30 vaginal babies among
the control group of 33. Of the three deviant cases, the emperor's incision There are 2
people.

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Since the name was transferred to the hospital after participation in the research, it was
possible to track the delivery results
There was no one who was performing the perineal self massage during pregnancy in the
control group.
The background of the subjects is shown in Table 1. The average age of pregnant women
at the time of assignment was 29.1 years (SD 4.1) for the intervention group, 28.4 years
for the control group (SD 4.4) .The delivery time required for transvaginal delivery was
12.7 hours for the intervention group and 12.1 hours for the control group, and the average
weight of the offspring was 2,389 (SD 387) and 2,964 (SD 385), respectively, 1 minute
after the newborn, the apogar score was 8 points or more in all cases, 1 intervention group
(3.3%), , The control group (3 persons (9.0%) became aspiration labor.
In addition, concerning the agreement that the target person does not tell the medical
doctor that it is participating in the present study, all the members said that they observed
compliance, also confirmed to the midwife who carried out the birth control assistance
However, it seems that pregnant women did not hear about such things, but 2 women who
had intervention group hope that they do not want to open the perineum, lying position on
the table.
In Table 2-1, the comparison of the opening cut-off rate is shown in Table 2. In the
case of Intention to Treat Analysis (hereinafter referred to as ITT analysis), those who
received perineal incision at the time of delivery The intervention's risk ratio (RR) was 0.42
(95% confidence interval; 0.15 to 1.16), with 4 (15.4%) and 11 (36.7%)
The risk reduction ratio (ARR) was calculated to be 0.21 (95% confidence interval; - 0.01
to 0.43) and the result that the perineal self-massage reduces the rate of the incisive
incision by 21% However, it was not recognized that there was a statistically effective
effect.In addition, when the person who became the emperor's incision technique and the
person who transferred to the control group became vaginal delivery The worst scenario
that can be considered (RR) and the absolute risk reduction rate (ARR), as shown in Table
2.
The worst case scenario shown in Table 2-2 was a caesarean section with an
intervention group It is a pattern that all those who underwent percutaneous incision and
who caesarean section of the control group and the inpatient do not all have access to the
perineal incision procedure In this case, It is the same result as the above ITT analysis,
and it is not recognized that there is an effect of decreasing the perineal incision rate in the
massage.In the best scenario shown in Table 2-3, however, A person who entered and
caesarean section did not receive an opening procedure for all parties and those who
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caesarean section of the control group and those who transferred to the hospital received
all of the patients perineal incision The risk ratio (RR) is 0.31 (95% confidence interval;
0.11 to 0.85), the absolute risk reduction rate (ARR) is 0.29 (95% confidence interval; 0.08
to 0.50), and the perineum self Massager supposedly opened the club opening rate by
29%.

It is recognized that it is effective to decrease the perineal incision rate. Also, among the
intervention group, one who could continue massaging. From the point that there is no big
difference between the perinatal incision rate of the control group and the perineal incision
rate of the whole premature baby before the start of the study, the results of this study are
believed to be reliable. At the two end points, in the ITT analysis, there is no statistically
significant difference, and the perineal self-massage decreases the rate of perineal
incision in the delivery of the first-eclampanized woman, can not be said to have the effect
of mildly affecting the perineal injury However, with the first endpoint, in the best scenario
assuming that a person who became an empiric incision has become vaginal baby, the
rate of perineal incision is higher Considering that the result was significantly decreased,
and that the absolute risk reduction rate (ARR) showed a significant result in On Treatment
Analysis, the perineal self-massage reduces the perineal incision rate It is inferred that it
can not be concluded that there is no effect.

In addition, the second end point, early pregnancy party. Even in the comparison of the
degree of perineal damage classified from genital pain, it is only in the case of the
treatment analysis. However, the degree of damage was significantly higher in the
intervention group than in the control group It was mild.This result is one viewpoint of
perineal pain. For the sake of convenience, rank the state of the perineum after parturition
to the 5th level And it was obtained, and exactly states of each perineal damage. Although
it does not reflect, it can not be concluded that this also has no effect on perineal self-
massage
It is a suggestive result. Both of the two end points are not effective. One of the reasons
for being a fruit is that the number of subjects to be studied has not reached the
preliminary number and the statistical detection power is insufficient.The number of
required subjects is secured in the future It is necessary to further investigate and to
investigate the effect.

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Confounding factors of this research include document search (Renfrew et Al., 1998;
Davidson et al., 2000), as a result of the respiratory respiration method (whether a
caregiver instructs the second term of parturient delivery. In the comparison with the
control group (hereinafter referred to as On Treatment Analysis; Table 2-4), the risk ratio
(RR) was 0.27 (95% confidence; 0.06 to 1.10), the absolute risk reduction Rate (ARR) is
0.27 (95% confidence interval; 0.05 to 0.48). Although not statistically significant, ARR
shows statistically significant results did.

Next, the degree of perineal damage as the second end point. The comparison results are
shown in Table 3-1 and Table 3-2 In the ITT analysis, there was no significant difference
between the intervention group and the control group (Z = 1.69, p = 0.091) In On
Treatment Analysis, a significant difference was observed, with the result that the degree
of injury was lower in the intervention group than in the control group (Z = 2.19, p = 0.028).

IV. Discussion
Currently, in Japan, perineal incision is routinely performed at delivery. Although it is
often done, it is not necessarily shown in the systemic review of Europe and the United
States, its benefit is not necessarily shown, and the percussion injury is an important factor
to lower the QOL of the puerperage, and considering measures to prevent percussion
injury as much as possible is important not only for maternal care but also for maternal and
child health. It is very important to bear in mind.
This research is a meeting that has been proposed as one method. For the effect of the
genital self massage method on primary pregnant women, an intervention study with
randomization assignment was conducted and evaluated. As a research design, we
adopted a method which is hard to enter bias, and as for evaluation of end of the
episiotomy, we decided the extensibility of the perineum at the time of delivery, Doctors
and midwives who decide whether or not to perform the perineal incision are not informed
of the participation or participation of research and their blinds.

On the other hand, according to the analysis of fleece tail labor in 2,891 cases and
450 cases in Shorten et al. (2002) and Ohno (2002) In the case of the lateral decubitus
position, the rate of delivering the most tearlessly was high, and according to the review of
Renfrew et al. (1998) 77 literature, the upright position and parturition in laboratory chair
were It has been clarified that posture at the time of parturition is a factor related to
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perineal injury at birth, such as increasing the incidence of negative incision while
increasing the incidence of natural lacerations. In the present study, under circumstances
where a midwife is protecting the perineal cortex, the situation of the delivering body
position (semi-farer position except for two cases of intervention group) and the condition
of breathing method Are almost unified, and it is inferred that the influence of intertwined
factors was small. In this study, 80% or less of those who could continue massaging with
interventional group are less than 80%, and implementation of massage
The surveillance situation was not satisfactory. A large RCT related to the effectiveness
verification of the perineal self-massage of Labrecque et al. (1999), even if it is more than
four times a week A pregnant woman who was able to continue the surge for 3 weeks or
more (primary pregnant woman) was 65.1% of the subjects, and in a study of Avery et al.
(1987) who selected the intervention group and the control group by the pregnant woman
himself Also, the rate of those who could not continue can reach 15%

Continuing the massage at least every other day (4 or more times a week) for 4 to 5 weeks
is considered to require a high degree of compliance.Thus, from this result, clinical In case
of instructing massage to applicant at the place of doctor, it is necessary to give sufficient
explanation in advance, and if there is any doubt or anxiety during massage, system that
can respond to consult at any time It is necessary to maintain.

V. Conclusion
We investigated the effects of perineal self-massaging during pregnancy on random
pregnancy intervention studies.The results showed that the primary endpoint of this study,
the perineal incision rate. Regarding the decrease, 21% reduction was obtained by the
intervention, but it was not recognized as a statistically significant decrease. In the early
postpartum perineal region used as the second end point even in the comparison of the
degree of perineal damage classified from pain, in the ITT analysis, the intervention group.

There was no difference between the control group and the control group and the
intervention group was the result that the degree of percussion injury was mild only in then
Treatment Analysis.Therefore, in labor, the perineal self-massage decreased the perineal
incision rate and it was not recognized that there was the effect of mildly affecting the
perineal injury.The results show that the low detection output There is also the possibility
that it is necessary to have a compulsory trial securing.

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Acknowledgments: Acknowledgment: We would like to thank the target audience, the
principal of the target facility and the staff of the target facility, and also to Professor Toshio
Nakagami of the Showa University School of Medicine under guidance.
In this research, Ministry of Education, Culture, Sports, Science and Technology, Ministry
of Education, Culture, Sports, Science and Technology. Also, in this research, the
researcher was an outsider facility Therefore, the place involved in the intervention group
is restricted to one corner of the outside. it was impossible to provide specific guidance
such as instructing pregnant women in the intervention group to carry out a massage, or
confirming whether the massage was correctly implemententation. Even if it exerts an
influence, the influence of not being able to properly carry out massage, that is, influence
of intervention group and control group It is thought that it affected the direction to weaken
the difference.

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