Episiotomy and perineal tears presumed to be imminent: the influence on the urethral pressure profile, analmanometric and other pelvic floor findings--follow-up study of a randomized controlled trial

BACKGROUND: The influence of the restrictive use of episiotomy at perineal tears judged to be imminent on the urethral pressure profile, analmanometric, and other pelvic floor findings is unknown. METHODS: Follow-up study of a randomized controlled trial with two perineal management policies includes the use of episiotomy: (a) only for fetal indications and (b) in addition at a tear presumed to be imminent. Participants were 146 primiparous women with an uncomplicated singleton pregnancy >34 weeks of gestation. For the intention-to-treat analysis, 68 women after vaginal delivery were included who delivered a live full-term baby between January 1999 and September 2000. OUTCOME MEASURES: Maximum urethral closure pressure (MUCP, cmH2O), functional urethral length (mm), maximum anal pressure (MAP, mmHg), functional anal sphincter length (ASL, mmHg) at rest and during contraction, and pelvic floor muscle strength (5-grade Oxford score) are the outcome measures. The rate of dyspareunia, urinary incontinence, and anorectal incontinence was documented. RESULTS: At a mean follow up of 7.3 months, there were no statistically significant differences between the two groups (a versus b): mean MUCP at rest (98 versus 101 cmH2O), during contraction (95 versus 103 cmH2O), mean MAP at rest (113 versus 121 mmHg), during contraction (143 versus 166 mmHg), mean ASL at rest (50 versus 50 mmHg), during contraction (42 versus 45 mmHg), mean pelvic floor muscle strength (2.2 versus 2.6), no pain during sexual intercourse (79 versus 67%), prevalence of urinary incontinence (48 versus 27%), and anorectal incontinence (19 versus 24%). CONCLUSIONS: Episiotomy at a perineal tear presumed to be imminent does not have any advantage with regard to pelvic floor function and should be avoided.     

Diagnosis of anal sphincter tears to prevent fecal incontinence: a randomized controlled trial

OBJECTIVE: Maternal anal sphincter tears after vaginal delivery are frequently not diagnosed clinically and are associated with subsequent fecal incontinence. This study examined whether diagnosis of these tears by ultrasonography, followed by immediate surgical repair, reduces the occurrence of incontinence. METHODS: We conducted a randomized trial involving 752 primiparous women without a clinically evident anal sphincter tear to evaluate the benefit of adding endoanal ultrasonography immediately after vaginal delivery to the standard clinical examination of the perineum. When a sphincter tear was diagnosed, the perineum was surgically explored and the sphincter sutured. The main outcome evaluated was fecal incontinence 3 months postpartum graded by the Wexner incontinence scale, which measures incontinence to flatus and liquid or solid stools, need to wear a pad, and lifestyle alterations. RESULTS: Among women assessed by ultrasonography, 5.6% had a sphincter tear. Severe incontinence was reported 3 months after childbirth by 3.3% of women in the intervention group compared with 8.7% in the control group (risk difference -5.4%; 95% confidence interval -8.9 to -2.0; P = .002). The benefit of the intervention persisted 1 year after delivery, with 3.2% severe incontinence in the intervention group compared with 6.7% in the control group (risk difference -3.5%; 95% confidence interval -6.8% to -0.3%; P = .03). Ultrasonography needs to be performed in 29 women to prevent 1 case of severe fecal incontinence. CONCLUSION: Ultrasound examination of the perineum after childbirth improves the diagnosis of anal sphincter tears, and their immediate repair decreases the risk of severe fecal incontinence. LEVEL OF EVIDENCE: I.     

Episiotomy and third-degree tears

Summary. The relation of episiotomy to third-degree perineal tears was investigated in 21 273 singleton deliveries. The incidence of episiotomy was 28.4% ( n =6041). Third-degree tears occurred in 14% (85) of the deliveries with episiotomy and in 0.9% (132) of the deliveries without episiotomy ( P <0.01). To avoid the effect of confounding factors, we analysed a sub-sample that included only vertex presentations with spontaneous occipitoanterior vaginal deliveries. After stratification for birthweight and parity, no relation between episiotomy and third-degree tear was found.     

Episiotomy and third-degree tears

The relation of episiotomy to third-degree perineal tears was investigated in 21 278 singleton deliveries. The incidence of episiotomy was 28.4% (n = 6041). Third-degree tears occurred in 1.4% (85) of the deliveries with episiotomy and in 0.9% (132) of the deliveries without episiotomy (P less than 0.01). To avoid the effect of confounding factors, we analysed a sub-sample that included only vertex presentations with spontaneous occipitoanterior vaginal deliveries. After stratification for birthweight and parity, no relation between episiotomy and third-degree tear was found.     

Antibiotic prophylaxis for prevention of postpartum perineal wound complications: a randomized controlled trial

OBJECTIVE: To estimate whether prophylactic antibiotics at the time of repair of third- or fourth-degree perineal tears after vaginal delivery prevent wound infection and breakdown. METHODS: This was a prospective, randomized, placebo-controlled study. Patients who sustained third- or fourth-degree perineal tears after a vaginal delivery were recruited for the study. Each patient was given a single intravenous dose of a second-generation cephalosporin (cefotetan or cefoxitin) or placebo before repair of third- or fourth-degree perineal tears. Obstetricians and patients were blinded to study drug. The perineum was inspected for evidence of infection or breakdown at discharge from the hospital and at 2 weeks postpartum. Primary end points were gross disruption or purulent discharge at site of perineal repair by 2 weeks postpartum. RESULTS: One hundred forty-seven patients were recruited for the study. Of these, 83 patients received placebo and 64 patients received antibiotics. Forty patients (27.2%) did not return for their 2-week appointment. Of the patients seen at 2 weeks postpartum, 4 of 49 (8.2%) patients who received antibiotics and 14 of 58 (24.1%) patients who received placebo developed a perineal wound complication (P=.037). There were no differences between groups in parity, incidence of diabetes, operative delivery, or third-degree compared with fourth-degree lacerations. CONCLUSION: By 2 weeks postpartum, patients who received prophylactic antibiotics at the time of third- or fourth-degree laceration repair had a lower rate of perineal wound complications than patients who received placebo. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clincaltrials.gov, NCT00186082. LEVEL OF EVIDENCE: I.     

Antenatal perineal massage and subsequent perineal outcomes: a randomised controlled trial

Objective To study the effects of antenatal perineal massage on subsequent perineal outcomes at delivery.
Design A randomised, single-blind prospective study.
Setting Department of Obstetrics and Gynaecology, Watford General Hospital.
Participants Eight hundred and sixty-one nulliparous women with singleton pregnancy and fulfilling criteria for entry to the trial between June 1994 and October 1995.
Results Comparison of the group assigned to massage with the group assigned to no massage showed a reduction of 6.1% in second or third degree tears or episiotomies. This corresponded to tear rates of 75.1% in the no-massage group and 69.0% in the massage group (   P = 0.073  ). There was a corresponding reduction in instrumental deliveries from 40.9% to 34.6% (   P = 0.094  ). After adjustment for mother's age and infant's birthweight these reductions achieved statistical significance ( P = 0.024 and   P = 0.034  , respectively). Analysis by mother's age showed a much larger benefit due to massage in those aged 30 and over and a smaller benefit in those under 30.
Conclusion Antenatal perineal massage appears to have some benefit in reducing second or third degree tears or episiotomies and instrumental deliveries. This effect was stronger in the age group 30 years and above.     

Continuous versus interrupted sutures for repair of episiotomy or second-degree perineal tears: a randomised controlled trial

Objective  To evaluate the repair techniques of continuous and interrupted methods for episiotomy or perineal tears.
Design  A randomised controlled trial.
Setting  The Hospital Universitario Principe de Asturias, a state hospital belonging to the community of Madrid.
Sample  Four hundred forty-five women who had undergone vaginal deliveries with episiotomies or second-grade tearing of the perineum between September 2005 and July 2007.
Methods  One group was repaired with continuous, nonlocking sutures involving the vagina, perineum, and subcutaneous tissues. The other group had continuous, locking sutures of the vagina, interrupted sutures in the perineal muscles, and interrupted transcutaneous sutures. The threads used for stitching were identical in both groups.
Main outcome measures  The participants were questioned regarding the sensation of pain and the use of painkillers on the second and the tenth days, and 3 months postpartum.
Results  When comparing the group with continuous suture to the group with interrupted sutures, the differences included less repair time (1 minute; P = 0.017) and less suture material used (relative risk [RR], 3.2, 95% CI: 2.6–4.0). The comparison of pain on the second and tenth days, and 3 months postpartum were not statistically different between the two techniques (RR, 1.08, 95% CI: 0.74–1.57; RR, 0.96, 95% CI: 0.59–1.55; and RR, 0.68, 95% CI: 0.19–2.46, respectively).
Conclusions  Although we did not demonstrate that one technique was better than the other in the incidence of pain in the short or long term, we showed that episiotomy and perineal tear repairs with continuous suturing were quicker and used less suture material without an increase in complication than interrupted suturing.     

Topical lidocaine-prilocaine cream versus lidocaine infiltration for pain relief during repair of perineal tears after vaginal delivery: randomized clinical trial

Objective: The current study aims to compare the analgesic effect of lidocaine-prilocaine (LP) cream with lidocaine infiltration during repair of perineal tears after vaginal delivery.

Materials and methods: A single center open-labeled randomized clinical trial was carried out in a tertiary University Hospital between October 2016 and May 2017 (Clinical Trials.Gov: NCT02883179). We included parous women, who delivered at gestational age >37 weeks with first- or second-degree perineal tears. The participants were randomized in a 1:1 ratio to either lidocaine infiltration (Group I); or application of LP cream (Group II) for pain relief during perineal repair. The primary outcome was the difference in mean pain score during perineal repair. Secondary outcomes included the participants’ satisfaction, the need for additional anesthesia, the duration of perineal repair, and the rate of adverse effects of both medications.

Results: The study included 144 participants randomized to both groups. The mean pain score during perineal repair was significantly lower in the LP cream group (3.86?±?1.59) than the lidocaine infiltration group (5.99?±?1.47) [p?=?.001]. The duration of repair was significantly shorter in the LP group than the lidocaine infiltration group (6.37?±?3.68 versus 8.17?±?2.75?min, respectively, p?=?.001). The need for additional anesthesia was quite similar in both groups (p?=?.371). More women in the LP cream group were satisfied than the other group with statistical significant difference (76.4 versus 30.6%, p?=?.000). No difference between side effects in both groups (p?=?.171)

Conclusions: Topical application of lidocaine-prilocaine cream is an effective analgesic during repair of perineal tears with no harmful side effects.     

The impact of obstetric gel on the second stage of labor and perineal integrity: a randomized controlled trial

Objective: Dianatal® is a bioadhesive gliding film which reduces the opposing force to vaginal childbirth. We aimed to investigate the safety, applicability, and impact of Dianatal® obstetric gel on second stage of labor and perineal integrity.

Methods: Low-risk singleton pregnancies at term were prospectively enrolled. Eligible women were randomly assigned to either labor management without using obstetric gel, or labor management using intermittent application of obstetric gel into the birth canal during vaginal examinations, starting at active phase of labor (≥4?cm dilation). The primary measured outcome was the length of second stage of labor.

Results: Overall, 200 cases were analyzed. Demographic, obstetrical, and labor characteristics were similar between the groups. Neither adverse events nor maternal or neonatal side effects were observed. The mean lengths of the active and second stages of labor were comparable between the obstetric gel-treated and the control groups (157 versus 219 min and 48 versus 56 min, respectively). None of the women had grade III/IV perineal tears. Maternal and neonatal outcomes were not negatively influenced by using obstetric gel. No difference was found after sub-group analysis for spontaneous vaginal delivery.

Conclusion: Dianatal® obstetric gel is safe in terms of maternal or neonatal use. Albeit a trend toward shorter labor stages using Dianatal® obstetric gel, no significant differences were noted among the groups. In order to further investigate the influence of the obstetric gel on labor stage interval, perineal integrity and maternal and neonatal outcomes, larger randomized clinical trials are needed to be carried out.     

Antioxidant therapy to prevent preeclampsia: a randomized controlled trial

OBJECTIVE: To study whether antioxidant supplementation will reduce the incidence of preeclampsia among patients at increased risk. METHODS: A randomized, placebo-controlled, double-blind clinical trial was conducted at four Brazilian sites. Women between 12 0/7 weeks and 19 6/7 weeks of gestation and diagnosed to have chronic hypertension or a prior history of preeclampsia were randomly assigned to daily treatment with both vitamin C (1,000 mg) and vitamin E (400 International Units) or placebo. Analyses were adjusted for clinical site and risk group (prior preeclampsia, chronic hypertension, or both). A sample size of 734 would provide 80% power to detect a 40% reduction in the risk of preeclampsia, assuming a placebo group rate of 21% and alpha=.05. The alpha level for the final analysis, adjusted for interim looks, was 0.0458. RESULTS: Outcome data for 707 of 739 randomly assigned patients revealed no significant reduction in the rate of preeclampsia (study drug, 13.8% [49 of 355] compared with placebo, 15.6% [55 of 352], adjusted risk ratio 0.87 [95.42% confidence interval 0.61-1.25]). There were no differences in mean gestational age at delivery or rates of perinatal mortality, abruptio placentae, preterm delivery, and small for gestational age or low birth weight infants. Among patients without chronic hypertension, there was a slightly higher rate of severe preeclampsia in the study group (study drug, 6.5% [11 of 170] compared with placebo, 2.4% [4 of 168], exact P=.11, odds ratio 2.78, 95% confidence interval 0.79-12.62). CONCLUSION: This trial failed to demonstrate a benefit of antioxidant supplementation in reducing the rate of preeclampsia among patients with chronic hypertension and/or prior preeclampsia. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.ClinicalTrials.gov, NCT00097110 LEVEL OF EVIDENCE: I.     

Episiotomy and perineal lesions in spontaneous vaginal deliveries.

OBJECTIVE: To evaluate the influence of mediolateral episiotomy on the perineal state after spontaneous, singleton vaginal deliveries with fetus in the occiput anterior position. DESIGN: The study was a population based, observational study. Two approaches were used in the analyses. Initially, we considered the parturients as quasi-randomised to one of three equally sized groups of midwives with different attitudes towards episiotomy. Secondly, we studied the effect of episiotomy on the state of the anal sphincter, controlling for birthweight, parity, and duration of second stage of labour. SUBJECTS: 2188 pregnant women delivering consecutively. MAIN OUTCOME MEASURES: Perineal lacerations and tear of the anal sphincter. RESULTS: Women allocated to the group of midwives with the lowest rate of episiotomy were more likely to have intact perineum after delivery (OR = 1.8 (1.4-2.2)), had a slight tendency towards more perineal lacerations (OR = 1.3 (1.0-1.5)), but no increase risk of having tear of the anal sphincter, compared with the women allocated to the two groups of midwives with higher frequencies of episiotomy. The second approach showed that episiotomy was related to an increased risk of tear of the anal sphincter (OR = 2.3 (1.2-4.6)). However, this relation was not found among the group of parturients delivered by the midwives with the lowest rate of episiotomy (22%). CONCLUSIONS: Our results encourage a conservative approach to the use of mediolateral episiotomy, and in the light of previous findings, it seems reasonable to suggest that episiotomy should ideally be used in about one in five spontaneous vaginal deliveries.     

Episiotomy and perineal repair practices among obstetricians in Greece

Objective

To assess current preferences regarding episiotomy and management of obstetric perineal injuries used by obstetricians in Greece, and to assess the impact of evidence-based information on everyday practices.

Methods

A questionnaire survey of obstetricians regarding episiotomy use and the management of obstetric perineal injuries.

Results

Fifty-one percent of obstetricians reported routinely performing an episiotomy during a normal vaginal delivery in primiparous women and 89% reported performing an episiotomy during vacuum-assisted deliveries. Forty-two percent of the respondents performed lateral, 44% mediolateral, and 14% midline episiotomies. Following an obstetric anal sphincter tear, half of the respondents recommended a vaginal delivery, regardless of bowel symptoms. There was significant heterogeneity of practices regarding the repair techniques of all obstetric perineal injuries.

Conclusion

The majority of obstetricians prefer to perform routine mediolateral and lateral episiotomies, for both normal and operative vaginal deliveries. The adoption of evidence-based information should be implemented while considering working and cultural backgrounds.