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Perineal Tear clinical trials

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NCT ID: NCT04616170 Enrolling by invitation - Perineal Tear Clinical Trials

The Patient Positioning for Perineal Protection Study

4P
Start date: April 5, 2021
Phase: N/A
Study type: Interventional

It is common practice for practitioners to instruct patients to forcibly flex the hips at the time of delivery of the fetal vertex. Though this is commonplace, it is reasonable to assume that this forced stretching of the perineum at the time of fetal vertex emergence could potentially lead to higher rates of severe lacerations and their sequelae. This study will examine whether extending the hips, as compared to usual care, at the time of crowning of the fetal vertex during vaginal delivery decreases maternal perineal trauma among nulliparous women.

NCT ID: NCT04544488 Recruiting - Perineal Tear Clinical Trials

Descriptive Evaluation of Expulsive Efforts During Pregnancy in Term Nulliparous Women by Measurement of Intra Bladder Pressure: Pilot Observational Study.

ACCOUPIV
Start date: December 28, 2021
Phase: N/A
Study type: Interventional

Severe complications of childbirth are common. Many factors have been studied to assess their imputability in the occurrence of perineal tears. While women subjectively have different push profiles in terms of intensity, frequency and duration of each push effort, no study has evaluated this variability in a relevant, simple and reproducible way. Through this work, it is expected to establish a qualitative evaluation of the expulsive efforts during childbirth in term nulliparous women by measuring the intra bladder pressure which testifies of the pressure exerted on the perineal tissues due to maternal pushing efforts

NCT ID: NCT04370340 Completed - Perineal Tear Clinical Trials

Application of a Perineal Protection Device in Vacuum-assisted Births

Start date: August 1, 2020
Phase: Phase 3
Study type: Interventional

Visible birth tears are common in vaginal births, especially in vacuum-assisted births. One aim of obstetrical work is to minimize such injuries by an adequate birth management , for example with a proper perineal support. The medical device "BabySlide®" was developed as an auxilliary device for perineal support and already evaluated in a multicenter randomized controlled trial in Schweden in pregnant women during vaginal birth. It could be seen, that the application of the device significantly reduced the rate of vagibal tears and low-grade perineal tearsin the intervention group (with application of the BabySlide®) in contrast to the controlo group (without application of the BabySlide®) by about 10%. In this study, solely 10% of births were ended by vacuum assistance. However, birth tears appear much more often in vacuum-assisted births than in normal spontaneous births. Therefore, the aim of this study is to evaluate the application of the device explicitly in vacuum-assisted births and to investigate if the application should be recommende in vacuum extractions in general in the future.

NCT ID: NCT03983343 Recruiting - Perineal Tear Clinical Trials

Skin Glues Compared to Running Sutures for Perineal Skin Repair After Vaginal Delivery. A Randomized Controlled Trial

Start date: October 1, 2019
Phase: N/A
Study type: Interventional

The incidence of a perineal tears during labor is 70 to 90%, while in 96% of the cases it's a minor perineal tear (grade 1). In about 3% to 4% the perineal tear is major and involve the external (grade 3) and the internal anal sphincter (grade 4). Episiotomy, which is considered an iatrogenic grade 2 tear, is performed in about 12% of vaginal deliveries. Complications related to perineal tears include bleeding, the most common, that may lead to the development of vaginal or perineal hematoma. Additionally, local infection can develop and complicate the recovery from the injury. In rare cases, abscesses may occur and in rarer cases necrotizing fasciitis or recto-vaginal fistula may also evolve. The "gold standard" method for repairing perineal tears is to use absorbable (preferably fast-absorbing) sutures. Grade 1 tears that do not bleed and do not disrupt the anatomical structure of the perineum usually do not require repair. Grade 2 tears are usually sewn in a continuous absorbent suture and less in the form of single stitches. The use of adhesive glue to repair skin injuries began 20 years ago and the main adhesive used is dermabond® (Ethicon Inc. octyl-2-cyanoacrylate). The use of glue is faster and lead to less pain than the use of stitches or staples. It can be used for a variety of large or small, traumatic or iatrogenic wounds, with a cosmetic result, infection rate, and dehiscence rate similar to those achieved by stitches or staples. In light of this, the investigators intend to conduct a randomized trial that will examine the advantages and disadvantages of the use of glue compared to the traditional sutures for closure of the skin in perineal tears grade 1 and 2 and episiotomies after vaginal delivery. The investigators hypothesis is that the use of adhesive glue to close the skin in perineal tears grade 1 and 2 (including episiotomy), will be faster and associated with less pain compared to the traditional suturing method, without a significant difference in the rate of complications.

NCT ID: NCT03926559 Recruiting - Perineal Tear Clinical Trials

The Effect of Neuraxial Morphine (Duramorph) on Pain Control

Start date: April 1, 2019
Phase: Early Phase 1
Study type: Interventional

With the rise of the opioid epidemic, it is important for physicians to be more mindful of the amount of narcotic prescriptions that are being written every day. In the early postpartum period, pain and fatigue are the most common problems reported by women. Untreated pain has negative consequences on the amount of opioid narcotics used, postpartum depression, and the potential development of persistent chronic pain. While pain can interfere with a woman's ability to adequately take care of her newborn, narcotic abuse can lead to excessive maternal drowsiness and increased infant mortality in the new breastfeeding mother. The most common sources of pain after a vaginal delivery include breast engorgement, uterine contractions and perineal lacerations. Perineal lacerations are immediate postpartum complications of the vaginal birth process, defined as injury that involves the bulbocavernosum muscle complex (second degree), and may involve the anal sphincter complex (third degree) or the anal epithelium (fourth degree). Prevention of chronic and severe postpartum pain, especially after a cesarean delivery has been extensively studied, however, much paucity in research exists for the management of postpartum pain from perineal tears. Compared to patients with first degree tears or intact perineum, women with severe perineal lacerations (second degree or greater) have increased analgesic requirement up to the fifth postpartum day. . Epidural morphine has been accepted by anesthesiologists as treatment for acute pain. In obstetrics, 2-3 mg of epidural morphine was found to be sufficient to provide post-episiotomy analgesia. Neuraxial morphine has been used for analgesic management after a cesarean section, especially to reduce the amount of oral pain medications used in the first 24 hours, but limited data exists on the use of neuraxial morphine after a severe perineal laceration repair in the setting of a vaginal delivery. Niv et al (1994) studied the effect of epidural morphine and monitored its timing of administration in post-epiostomy pain onset. They noted that if epidural morphine is administered before the onset of pain in an episiotomy repair it is much more effective than if given after the onset. This study hopes to take the prior 1994 study a step further and incorporates it's data to investigate whether neuraxial morphine given after a severe perineal laceration repair mitigates postpartum pain.

NCT ID: NCT03825211 Completed - Perineal Tear Clinical Trials

Continuous Versus Discontinuous Suture in the Perineals Lesions

Start date: November 1, 2016
Phase: N/A
Study type: Interventional

The hypothesis: Women who have a continuous suture have better health outcomes Two types of sutures were placed in the perineal lesion, using different techniques. Group A received continuous sutures and Group B had interrupted sutures placed. The women were followed-up as follows: Day of childbirth and in the postpartum period.

NCT ID: NCT03770962 Completed - Clinical trials for Pelvic Floor Disorders

One Plus One Equals Two, Will That do?

Oneplus
Start date: December 10, 2018
Phase: N/A
Study type: Interventional

A new clinical practice to reduce perineal trauma has been adopted by many maternity wards in Sweden. This practice involves collegial midwifery assistance during the second stage of labor and the birth of the baby. The midwife responsible for the birth is the primary carer of the woman and the second midwife observes the birth or assists the primary midwife if asked to. The hypothesis is that the presence and support of an extra midwife will reduce severe perineal trauma (trauma to the anal sphincter (OASI)). The objective of this trial is to evaluate whether collegial midwifery assistance during the second stage reduces perineal trauma grade III-IV.

NCT ID: NCT03670420 Completed - Pain Clinical Trials

The Application of Honey on Perineal Sutures

Start date: September 10, 2018
Phase: N/A
Study type: Interventional

Evaluate the effect of honey on perineal tears or episiotomies pain associated or not with anterior vulvar tears after vaginal delivery.

NCT ID: NCT03605615 Completed - Perineal Tear Clinical Trials

Vocalization for the Second Stage of Labor (VOCAL)

VOCAL
Start date: August 1, 2018
Phase: N/A
Study type: Interventional

A randomized open-label trial will be conducted to evaluate the effect of vocalization as a perineal protection maneuver during the second period of labor. The study will be carried out in the "Espaço Aconchego" sector of the IMIP, which has a team of obstetrical nurses, medical coordination and physiotherapeutic support. The study population will consist of low-risk parturients, with no prior cesarean indication, admitted to the sector. Those parturients who meet the inclusion criteria, after signing the Informed Consent Term, will be allocated to two groups: Group A (experimental) and Group B (control). Group A will be stimulated to keep the glottis minimally open during spontaneous pushing and to emit sounds when exhaling (vocalization), and Group B will undergo usual routine. Study outcomes will be evaluated by assistents immediately after delivery. After 24 hours of delivery, the conditions of the perineum will be assessed by inspection and palpation of the region,evaluating the presence of edema or other abnormality.

NCT ID: NCT03559816 Completed - Perineal Tear Clinical Trials

Selective Use of Episiotomy: the Impact on Perineal Trauma.

SEPT-1
Start date: February 1, 2021
Phase:
Study type: Observational

Vaginal delivery is commonly accompanied by trauma of the genital tract. Perineal trauma is classified into four degrees based on anatomic structures involved and severity of lacerations according to the American College of Obstetricians and Gynaecologists (ACOG) and the Royal College of Obstetricians and Gynaecologists (RCOG). Episiotomy is an intentional perineal incision performed by midwifes or obstetricians to enlarge vaginal opening during the second stage of childbirth and has become the most common surgical procedure worldwide. A routine use of episiotomy was proposed to prevent severe spontaneous lacerations, although it failed to to demonstrate a clear protective role with no benefits both for mother and baby. Therefore the guidelines changed in a selective use of episiotomy, and we have introduced it in our routine obstetrics care. Nevertheless, second-degree lacerations comprise a wide range of lesions, from a minimal involvement to a massive damage of the perineal muscles. Therefore, it was never confirmed that selective use of episiotomy reduce the perianal trauma in the range of second degree lesions. We designed a prospective observational study with the introduction of a new classification of perineal trauma recorded with the usual data retrieved in delivery ward register. The aim is to definitively investigate if selective use of episiotomy reduce the overall perineal trauma.