Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05282160 |
| Other study ID # |
ULondrina1 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 15, 2018 |
| Est. completion date |
December 15, 2020 |
Study information
| Verified date |
November 2020 |
| Source |
Universidade Estadual de Londrina |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Perineal injury is the most common maternal obstetric complication associated with vaginal
delivery (1). It is estimated that perineal lacerations of first and second degree occur in
38% of spontaneous vaginal deliveries in primiparous and in 36% in multiparous women (2). The
perineal traumas are associated with significant maternal morbidity, including pain, urinary
and fecal incontinence, genital prolapses, dyspareunia, physical and psychological damage
(3,4). Episiotomy is a surgical procedure used in obstetrics to increase vaginal opening with
an incision in the perineum at end of the second stage of vaginal delivery. However, this
procedure is commonly used improperly as routine in the delivery attendance in many health
services. For a successful vaginal delivery, the vaginal opening should slowly dilate in
order to allow stretching because when the baby descends rapidly, the tissues can tear (11).
The degree of muscle stretching or distension in the vaginal delivery may lead to pelvic
floor muscle trauma (12). Urinary incontinence is the involuntary loss of urine, with impacts
on women in terms of their quality of life, and is considered a social and hygiene problem
(16). The muscle strength of the pelvic floor is important for the prevention, diagnosis and
treatment of pelvic floor dysfunction. EPI-NO is a device that was invented by a German
obstetrician in order to prepare and train the pelvic floor for normal delivery. The purpose
of this study is to verify the effect of 10 sessions of pelvic floor elongation with Epi-No
in the prevention of urinary incontinence and dyspareunia 6 months after delivery.
Description:
The control group (G1) will be composed of women over 18 years of age attended by Lucila
Balalai Municipal Maternity in Londrina. Recruitment will be done through a chart review,
which will include single-fetus primiparous that delivered on full term without intercurrence
(between 37 and 42 weeks). After birth they will receive project information while still
hospitalized and are scheduled for evaluation 5 months after delivery if they consent to
participate in the project. The study group (G2) will be composed of women over 18 years of
age, primigravidae, between 30 and 32 weeks of gestation attended by the Basic Health Units
of the central region of Londrina. Only those who agree to participate in the study and sign
the free and informed consent form (Appendix 1) will be included.
Group one will be evaluated before the intervention (between 30th and 32nd week) and 6 months
after delivery. The control group will be evaluated only once in the sixth month after
delivery. The evaluators will be blind and the evaluation will be composed by:
- Anamnesis containing data on pregnancy and delivery (hours of expulsive period, use of
instruments and / or maneuvers, degree of laceration, episiotomy, and characterization
of possible urinary or sexual complaints);
- Physical examination: inspection and vaginal palpation in order to verify the capacity
of external and internal perineal contraction and tenderness with touch;
- Visual Analogue Scale for dyspareunia included;
- Validated sexual dysfunction assessment questionnaire for Portuguese: Female Sexual
Function Index (FSFI) .
- Quality of life questionnaire SF-36.
The pregnant women will perform 10 sessions (twice a week for 5 weeks) of perineal
preparation with the Epi-No device (pressure gauge connected to an inflatable soda that
simulates the baby's head the vaginal canal). The evaluations and sessions of Epi-No will be
individual and will take place in the research laboratory of the physiotherapy outpatient
clinic of the University Hospital of Londrina.
The protocol was developed by a group of researchers based on the suggestions of already
developed studies and clinical practice. After the introduction of the deflated probe (only
the first half of the device), it is minimally inflated until the perception in the vaginal
canal. The first 5 minutes will be for perception of the pelvic floor with contraction and
relaxation with the purpose of toning and maintaining muscular strength, followed by 15
minutes of perineal elongation respecting the tolerance of the pregnant woman. After 20
minutes in total, the pregnant woman relaxes so that the inflated device leaves gently of her
vaginal cavity and the physiotherapist helps at that moment. After the device is removed,
note the circumference reached on the day.
After the procedure the pregnant woman sits on the ball and performs some contractions of
perineum to relieve the eventual sensation of burning.
