Evaluation of the ease of use and acceptability of an innovative device - the 'Episiometer', in ensuring an accurate mediolateral episiotomy: a pilot study.

The present study was undertaken at the Port Moresby General Hospital, Papua New Guinea, to evaluate the ease of use and acceptability of a perineal measuring device (Episiometer) for giving a correct length and angle of a mediolateral episiotomy. An Episiometer was placed on the perineum to guide the angle and length immediately before giving an episiotomy. A feedback survey was collected and the angle and length of the episiotomy were measured at the time of delivery and at 6 weeks postpartum. The length and angle of episiotomy were found to be accurate in 86% of the cases. Forty-two of the fifty (86%) clinicians felt that the Episiometer was easy or very easy to use. They also found this device to be beneficial (92%). The Episiometer seems to be an easy-to-use and feasible device that is well accepted by clinicians and patients and may aid in standardising the length and angle of an episiotomy. Impact statement What is already known on this subject? Episiotomy is the commonest obstetric procedure performed worldwide. However, the angle and length of an episiotomy vary greatly amongst operators. It is also recognised that birth trauma and an inaccurate episiotomy result in debilitating anal sphincter injury. Therefore, a pilot study was conducted to evaluate the ease of use and acceptability of a new, inexpensive, low- tech device "Episiometer" to guide clinicians and midwives to perform an appropriate episiotomy. What do the results of this study add? This pilot study to evaluate the usability of the new innovation amongst clinician and patients revealed high acceptance of the device amongst clinicians and positive attitude of the patients towards the device. The clinicians also felt the device to be an effective teaching tool. Usage if the device results in a more accurate length and angle of an episiotomy. What are the implications of these findings for clinical practice and/or further research? Further research and multicentre randomised control trials are needed to establish the effectiveness of the device in reducing the complications of episiotomy and risk of OASIS. The present study has shown the Episiometer as an acceptable and easy to use device amongst clinicians and can benefit the young clinicians as a teaching tool in directing a correct angle and length of episiotomy.

Comparative study of episiotomy angles achieved by cutting with straight Mayo scissors and the EPISCISSORS-60 in a birth simulation model.

INTRODUCTION AND HYPOTHESIS: We compared the clinician's ability to cut episiotomies at the recommended 60° angle with traditional straight Mayo scissors compared with patented fixed-angle episiotomy scissors EPISCISSORS-60® in a simulated setting using mounted incision pads. The hypothesis was that fixed-angle episiotomies would achieve a more accurate cutting angle of 60°. METHODS: Angles were cut on episiotomy incision pads in a mounted birth model simulating crowning: 110 midwives and doctors cut an 60° episiotomy with Mayo scissors and then EPISCISSORS-60. Angles were measured with protractors. Average angles were calculated and the one-tailed paired t test was used to compare groups. RESULTS: Mean angle was 45° with Mayo scissors [SD = 9, 95% confidence interval (CI) = 43.3-46.7, interquartile range (IQR) 38-50] and 60° with the EPISCISSORS-60 (SD = 3, 95% CI = 59.3-60.7, IQR = 58-60). Two-thirds of cuts with Mayo scissors were below 50°. CONCLUSIONS: In a simulated setting the majority of operators are unable to cut an episiotomy at the recommended 60° angle with Mayo scissors. The EPISCISSORS-60 cut an episiotomy a statistically significant 15° wider than regular Mayo scissors and achieved the recommended 60° in the vast majority of cases. If these findings translate into real life situations, then cutting episiotomies at 60° is expected to make a valuable contribution in reducing third- and fourth-degree tears in both spontaneous and operative vaginal deliveries. Variability in mediolateral episiotomies should be reduced by use of fixed-angle scissors or through validated health professional training programmes to improve visual accuracy.

Duration of second stage of labor and instrumental delivery as risk factors for severe perineal lacerations: population-based study.

BACKGROUND: We sought to investigate the impact of the duration of second stage of labor on risk of severe perineal lacerations (third and fourth degree). METHODS: This population based cohort study was conducted in the Stockholm/Gotland region, Sweden, 2008-2014. Study population included 52 211 primiparous women undergoing vaginal delivery with cephalic presentation at term. Unconditional logistic regression analysis was used to calculate crude and adjusted odds ratios (OR), using 95% confidence intervals (CI). Main exposure was duration of second stage of labor, and main outcome was risks of severe perineal lacerations (third and fourth degree). RESULTS: Risk of severe perineal lacerations increased with duration of second stage of labor. Compared with a second stage of labor of 1 h or less, women with a second stage of more than 2 h had an increased risk (aOR 1.42; 95% CI 1.28-1.58). Compared with non-instrumental vaginal deliveries, the risk was elevated among instrumental vaginal deliveries (aOR 2.24; 95% CI 2.07-2.42). The risk of perineal laceration increased with duration of second stage of labor until less than 3 h in both instrumental and non-instrumental vaginal deliveries, but after 3 h, the ORs did not further increase. After adjustments for potential confounders, macrosomia (birth weight > 4 500 g) and occiput posterior fetal position were risk factors of severe perineal lacerations. CONCLUSIONS: The risk of severe perineal laceration increases with duration until the third hour of second stage of labor. Instrumental delivery is the most significant risk factor for severe lacerations, followed by duration of second stage of labor, fetal size and occiput posterior fetal position.

The Development of a New Medical Device for Standardized Episiotomy: A Pre-Clinical Validation Study.

BACKGROUND: The aim of this study was to present the validation and optimization process for a new innovative medical device to create a standardized episiotomy. DESIGN: We performed a preclinical validation study. SETTING: This study was performed at the University hospital. SAMPLE: Animal, cadaver. METHODS: Together with technical engineers, we designed a new medical device that involves a knife and cuts back from buttock toward introitus, in contrast to the conventional episiotomy. We optimized the design and its performance in consecutive animal and cadaver studies. MAIN OUTCOME MEASURES: Ability to perform a standardized incision, ease of use. RESULTS: After multiple adjustments, based on the results of multiple animal and cadaver studies, a medical device was developed to perform a standardized clean-cut episiotomy of 4-6 cm length. CONCLUSION: We have shown that optimizing the technical performance and safety of an innovative device in animals, prior to opposing patients to its potential hazards, is feasible. Our design optimizing study can be used as a model for the pre-clinical validation of future innovative medical devices.

Role of blunt suture needle in episiotomy repair at uncomplicated vaginal deliveries in reducing glove perforation rate: a randomized controlled trial.

AIM: The aim of this study was to evaluate the role of blunt suture needles for episiotomy repair at uncomplicated vaginal deliveries in reducing glove perforation rate. METHODS: This was a prospective randomized controlled trial wherein 300 nulliparous women with uncomplicated vaginal deliveries were randomized to episiotomy repair with either blunt or sharp suture needles. Patient demographics and clinical variables were collected. Postoperatively, the surgeons were surveyed regarding ease of using the needle, and glove perforation was determined by three tests: air insufflation, water filling and water load. RESULTS: A total of 41 perforations occurred in the 39 episiotomy repairs with glove perforations (13%). There was a significantly higher number of glove perforations using the sharp suture needles (28/150; 18.7%) than with the blunt suture needles (11/150; 7.3%) (P = 0.005). Glove perforation of the non-dominant hand occurred in 90% of the cases. Using a blunt suture needle took significantly more time (P < 0.001) to complete the repair than using a sharp needle. Surgeons reported that blunt needles were more difficult to use than sharp needles (P < 0.001). CONCLUSION: Blunt suture needles for episiotomy repair were shown to have a significantly lower instance of glove perforation but required more time and are perceived to be more difficult to complete the repair as compared to sharp needles.

A double blind randomized controlled trial using copper impregnated maternity sanitary towels to reduce perineal wound infection.

OBJECTIVE: To investigate the effect of copper impregnated sanitary towels on the infection rate following vaginal delivery (VD). DESIGN: Single center double blind randomized controlled trial. PARTICIPANTS: Women aged 18 or over who had a sutured second-degree tear or episiotomy following VD. INTERVENTIONS: All women were randomized to receive either a copper-oxide impregnated sanitary towel (study group) or a non-copper sanitary towel (control group). MAIN OUTCOME MEASURES: The primary study outcome was the incidence of wound infection within a 30-day period from VD, assessed via telephone questionnaire. Secondary outcomes were length of hospital stay and risk factors of infection. RESULTS: 450 women were enrolled in the study of whom 225 were randomized to the copper impregnated sanitary towel (study group) and 225 to the non-copper sanitary towel (control group) group. Follow-up rate was 98.2%. A total of 102 women (23.1%) developed an infection within 30 days following VD, 19 in the study group (8.6%) and 83 (37.4%) in the control group (P = <0.001, absolute risk reduction (ARR) of 28.8%). The incidence of superficial/deep and organ/space infections was significantly lower in the study group (7.7% vs. 30.2%, P = <0.001 and 4.6% vs. 31.5%, P = <0.001 respectively) with an ARR of 22.5% and 27.0% respectively. Multivariable analysis reported Asian ethnicity and prolonged rupture of membranes as significant risk factors; for the development of infection (OR 1.91, P = 0.03 and OR = 1.97, P = 0.04 respectively). CONCLUSIONS: This is the first study to demonstrate a significant reduction in infection rate following VD with the use of copper impregnated sanitary towels.

Obstetric anal sphincter injuries before and after the introduction of the Episcissors-60: A multi-centre time series analysis.

OBJECTIVE: To investigate the impact of the Episcissors-60 on obstetric anal sphincter injury (OASI) rates. STUDY DESIGN: Observational multi-centre time series analysis at four maternity units in the North-East of England. The main outcome measures were obstetric anal sphincter injury rates and delivery blood loss. RESULTS: Data were analysed for women who had a vaginal birth of a singleton pregnancy before (11,192) and after (8064) the introduction of the Episcissors-60. There were 2115 episiotomies before and 1498 after the introduction of the Episcissors-60, of which 1311 (87.5%) were undertaken with the Episcissors-60, 114 (7.6%) with other scissors and the scissors used were not stated in 73 (4.8%) women. There was no significant association between the introduction of Episcissors-60 and the performance of an episiotomy (χ2 = 0.006, p  = 0.94). Episiotomy was associated with a significant reduction in OASI rates (1.9% Vs 2.8%, odds ratio = 0.67 [0.51 - 0.86]; p =  0.001). There was no significant association between the introduction of the Episcissors-60 and the occurrence of OASIs in all women (χ2 = 0.6, p =  0.46) or in women who had an episiotomy (χ2 = 0.20, p = 0.71). In women who had an episiotomy, the mean estimated delivery blood loss was 550.3 ±â€¯8.2 ml before and 598.8 ±â€¯10.9 ml after the introduction of the Episcissors-60 (p <  0.001). CONCLUSION: Introduction of the Episcissors-60 was not associated with a change in OASI or episiotomy rates but may be associated with a small increase in delivery blood loss.

The use of Episcissors-60 to reduce the rate of Obstetric Anal Sphincter Injuries: A systematic review.

OBJECTIVES: The aim of this systematic review is to evaluate the effect of Episcissors-60, which were designed to improve the accuracy of episiotomies, on the rate of Obstetric Anal Sphincter Injuries. STUDY DESIGN: This review is registered with the International Prospective Register of Systematic Reviews (PROSPERO) database (CRD42018094935). A literature search of the PubMed, Embase and Cochrane databases was performed from inception to May 2018. All peer-reviewed studies evaluating the use of Episcissors-60 in clinical practice and the resulting Obstetric Anal Sphincter Injury incidence were included. Data on study population demographics, incidence of Obstetric Anal Sphincter Injuries, rate of episiotomies and angle of episiotomy achieved while using the Episcissors-60 were recorded. RESULTS: A total of seven studies were identified, five of which were included in the review. A total of 3509 women of whom 1050 had episiotomies performed. Included studies demonstrated that introduction of Episcissors-60, when combined with other preventative measures including manual perineal support at delivery, can reduce Obstetric Anal Sphincter Injuries by up to 50%. In all studies, operators were able to consistently achieve post-suturing episiotomy angles of more than 40°. An increase in episiotomy rates, especially during spontaneous vaginal deliveries, was also reported. CONCLUSION: The results of this systematic review support the use of Episcissors-60, combined with other preventative measures, to reduce the incidence of Obstetric Anal Sphincter Injuries.

[Perineal infiltration anaesthesia for episiotomy: a needle which is bent manually may break off and migrate through the body]. / Perineale infiltratieanesthesie voor een episiotomie: een met de hand voorgebogen naald kan afbreken en gaan zwerven.

A 28-year-old pregnant woman was given local anaesthesia in the perineum with a Monoject disposable needle in preparation for an episiotomy. The needle was bent manually in order to facilitate infiltration. During infiltration the needle broke off and disappeared. The delivery was uneventful. Radio diagnostic examination located the needle deep in the patient's left buttock. It was removed a week later via a small incision. Breakage of the needle was probably caused by the bending in combination with a sudden movement by the patient at the moment of infiltration. In obstetrics episiotomy is a common surgical procedure. For infiltration anaesthesia of the perineum a long, flexible, reusable Unimed needle is recommended instead of a short, inflexible, disposable Monoject needle.

[Fracture of a surgical needle in suture management of episiotomy]. / Bruch der chirurgischen Nadel bei Nahtversorgung der Episiotomie.

The complication of a break of the surgical needle during the suture of an episiotomy and the disappearance of the fragment in the perineal tissue has not been dealt with in the available literature. From our own material, a frequency of 0.17/1000 (n = 22,374) can be calculated. For the authors, the best method of coping with this complication is the removal of the needle fragment under a portable digital imaging system with two needleholders according to Bozemann.

Curved versus straight scissors to avoid 3rd and 4th degree perineal tears: a randomised feasibility study.

BACKGROUND: Severe perineal tears sustained during childbirth cause significant distress and morbidity amongst women. The objective of this study was to compare the use of straight scissors for cutting an episiotomy with the use of curved scissors, which are designed to curve away from the anal sphincter. METHODS: We used a single-centre, randomised feasibility trial. The intervention was the use of curved scissors. Women were recruited during a prenatal visit and randomised in the delivery suite, when it became clear that an episiotomy was required. The feasibility outcomes were the proportion of women able to be recruited, randomised and followed up. We also calculated the incidence of obstetric anal sphincter injury when either straight or curved scissors were used to cut an episiotomy. Other outcomes assessed were pain, length of hospital stay, perineal infection and perineal dehiscence. RESULTS: Of the 155 patients recruited in the prenatal period, only 20 (12.9%) were eventually randomised at birth. The main reasons for the high loss were that women either did not have a vaginal delivery (38, 24.5%), or they did not need an episiotomy (72, 46.5%). Rates of obstetric anal sphincter injury and other outcomes were similar between groups. DISCUSSION: Anal sphincter injury during childbirth remains an important problem. Although the use of curved scissors provides a theoretical solution, we found that the high attrition rate made feasibility of conducting a suitably powered, randomised trial using the current design untenable. Alternative strategies have been suggested to make any future study more viable.

Suturing after childbirth--a randomised controlled study testing a new monofilament material.

The aim of this study was to assess if a monofilament suture material (Biosyn) compared with a commonly used multifilament suture (Dexon II) would cause fewer problems and lower levels of discomfort and pain after suturing lacerations and episiotomies following vaginal delivery. Women (1139) who required suturing by a midwife were allocated for repair with either the multifilament polyglycolic acid suture (Dexon II) or with a new monofilament of glycomer 631 (Biosyn). The outcome assessment involved inspection of the sutured area and measuring levels of discomfort and pain with a Visual Analogue Scale (VAS). At follow up after 8-12 weeks, more women in the monofilament group reported problems with the sutured area.

Importancia del ángulo de la episiotomía / Significance of the angle of episiotomy

La metodología de los estudios que evalúan el papel de la episiotomía mediolateral carece de la calidad necesaria y no puede extraerse actualmente de ellos conclusión alguna acerca del traumatismo perineal grave y la incontinencia anal. Se identificaron cuatro problemas: la definición y la ejecución práctica de la episiotomía mediolateral, y el diagnóstico y clasificación del traumatismo perineal. La definición y ejecución de la episiotomía mediolateral difieren ampliamente entre las distintas instituciones y los distintos individuos. El problema principal es la precisión de la dirección elegida. Se introdujeron tres términos: ángulo de incisión, de sutura y de cicatrización de episiotomía. Anteriormente, la episiotomía mediolateral se definía por un ángulo de incisión mínimo de 40°. Sin embargo,cuando se incide a 40°, el ángulo mediano luego de la reparación era de 20°, mientras que el ángulo de cicatrización era de 30° en los casos de desgarros de tercer grado frente a 38° en los controles. Al usar un ángulo de incisión de 60°, el ángulo mediano de sutura fue de 45° y el de cicatrización de 48°. Actualmente se propone que la episiotomía mediolateral se defina como “una incisión en el perineo durante la última parte de la segunda etapa del trabajo de parto, que comienza en el perineo medial pero se dirige lateralmente en un ángulo de al menos 60° en dirección de la tuberosidad isquial”. Se requieren más investigaciones para evaluar la seguridad de este ángulo de incisión.