Perineal Tear Resulting From Childbirth
Conditions
Keywords
Perineum
Brief summary
The aim of this study is to evaluate the effect of a combined perineal massage and warm compresses intervention on the perineum integrity during second stage of labor.
Detailed description
A single-centre, prospective, randomized controlled trial was conducted. Eligibility and informed consent to participate were checked once the woman was in established labor. Eligible participants were randomized at the second stage of labor. 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 control group (hands-on).
Interventions
PROCEDUREPerineal Massage and Warm Compresses (PeMWaC)
Perineal Massage was performed in the II Hodge Plan, between maternal contractions and regardless of maternal position. Warm Compresses were applied by the midwife between Hodge plans III and IV, during pushing and regardless of maternal position.
PROCEDUREControl Group (Hands-on)
The midwife placed the index, middle, and little fingers of the non-dominant hand together on the child's occiput, with the palm facing the anterior region of the perineum, when the child's head was crowning. In this way, the expulsion was controlled, maintaining the flexion of the head. Simultaneously, the dominant hand was flattened and placed on the posterior region of the perineum, with the index finger and thumb, forming a U, exerting pressure on the posterior region of the perineum during the crowning process. During the birth of the shoulders and the rest of the body, the dominant hand was kept in place, protecting the posterior region of the perineum.
Sponsors
Universidade do Porto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
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 control group (hands-on). The participants were blinded to their allocation. After the placenta delivery, a blinded midwife not otherwise involved in the birth but trained, assessed the perineum (graded the perineal tears). The data about the variables included in the study were registered by the midwife responsible for the birth. Midwives who assess the primary outcomes and the principal investigator were blinded to the randomization.
Intervention model description
The present study was a single-centre, prospective, randomized controlled trial. Eligibility and informed consent to participate were checked once the woman was in established labor. All participants signed an informed consent form and received a copy wherein the study was described in detail.Eligible participants were randomized at the second stage of labor.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 control group (hands-on). The participants could adopt the birth position they preferred.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Women with 18 years or older * Between 37 and 41 weeks of pregnancy * Expected spontaneous vaginal birth * Fetus in the cephalic presentation * Able to provide informed written consent
Exclusion criteria
* Multiple pregnancy * Meconial amniotic fluid * Fetal distress * Suspicion of fetal growth restriction * Gestational hypertensive disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anterior Compartment tears | up to 10 minutes after childbirth | Without episiotomy or any other degree of perineal trauma |
| Second-degree perineal tear | up to 10 minutes after childbirth | Skin and muscle tear (posterior compartment) |
| OASIS | up to 10 minutes after childbirth | Obstetric anal sphincter injuries (Third-degree tears (injury of anal sphincter) and Fourth-degree tears (Injury of anal sphincter and the anal canal or rectum) without episiotomy |
| OASIS + episiotomy | up to 10 minutes after childbirth | Third and fourth degree tear with episiotomy |
| Episiotomy | up to 10 minutes after childbirth | without spontaneous perineal trauma or vaginal tears |
| Episiotomy and first degree tear | up to 10 minutes after childbirth | Episiotomy with spontaneous skin tear |
| Episiotomy and second degree tear | up to 10 minutes after childbirth | Episiotomy and spontaneous skin and muscle tear |
| OASIS with/without episiotomy | up to 10 minutes after childbirth | with and without episiotomy |
| Vaginal tears | up to 10 minutes after childbirth | only vaginal tear |
| Intact Perineum | up to 10 minutes after childbirth | Absence of tissue separation at any site, without vaginal tears or any other degree of perineal trauma) |
| First-degree perineal tear | up to 10 minutes after childbirth | Skin and vaginal tear |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Admission to Neonatal Intensive Unit Care | up to 2 hours after childbirth | Admission to Neonatal Intensive Unit Care |
| Maternal satisfaction with intervention | 24 hours after childbirth | Question about maternal satisfaction with intervention |
| Recommend an intervention allocated to a friend | 24 hours after childbirth | Question about whether women would recommend the intervention they received to a friend |
| Female Sexual Function Index score | 24 hours, 3 months and 6 months after childbirth | Female Sexual Function Index score (2-36) higher scores mean better outcome |
| Pelvic Floor Dysfunction symptoms | 24 hours, 3 months and 6 months after childbirth | Pelvic Floor Distress Inventory (0-300) higher scores mean worse outcome |
| Maternal Pain | 24 hours, 3 months and 6 months after childbirth | Numerical Pain score (0-10) higher scores mean worse outcome |
| Breastfeeding | 24 hours, 3 months and 6 months after childbirth | Exclusive breastfeeding |
| Apgar 5 minutes | 5 minutes after childbirth | Apgar Score at 5 minutes (0-10) higher scores mean better outcome |
Countries
Portugal
Outcome results
None listed