Forceps and vacuum: one goal, two entities.

Damage to the pelvic floor during pregnancy and vaginal delivery is an inevitable consequence of the natural birthing process. As this damage is associated with functional and anatomical problems in later life, minimizing pelvic floor damage during pregnancy and vaginal delivery may serve as an important factor in the prevention of these unwanted sequelae. Operative vaginal delivery using forceps or vacuum extractor is common practice to achieve or expedite vaginal birth for maternal or fetal indications such as maternal exhaustion or fetal distress. However, operative vaginal delivery is associated with more extensive damage to the pelvic floor and perineal structures with forceps carrying a stronger risk compared to vacuum. The evidence on this subject is discussed with possible suggestions to minimize pelvic floor damage as much as possible.

Balloon catheter for induction of labor in women with one previous cesarean and an unfavorable cervix.

INTRODUCTION: When women with a previous cesarean section and an unfavorable cervix have an indication for delivery, the choice is to induce labor or to perform a cesarean section. This study aims to assess the effectiveness and safety of a balloon catheter as a method of induction of labor in women with one previous cesarean section and an unfavorable cervix compared with an elective repeat cesarean section. MATERIAL AND METHODS: We performed a prospective cohort study in 51 hospitals in the Netherlands on term women with one previous cesarean section, a live singleton fetus in cephalic position, an unfavorable cervix and an indication for delivery. We recorded obstetric, maternal and neonatal characteristics. We compared the outcome of women who were induced with a balloon catheter with the outcome of women who delivered by elective repeat cesarean section. Main outcomes were maternal and neonatal morbidity. Mode of delivery was a secondary outcome for women who were induced. Adjusted odds ratios (aOR) were calculated using logistic regression, adjusted for potential confounders. RESULTS: Analysis was performed on 993 women who were induced and 321 women who had a repeat cesarean section (August 2011 until September 2012). Among the women who were induced, 560 (56.4%) delivered vaginally and 11 (1.1%) sustained a uterine rupture. Composite adverse maternal outcome (uterine rupture, severe postpartum hemorrhage or postpartum infection) occurred in 73 (7.4%) in the balloon and 14 (4.5%) women in the repeat cesarean section group (aOR 1.58, 95% confidence interval [CI] 0.85-2.96). Composite adverse neonatal outcome (Apgar score <7 at 5 minutes or umbilical pH <7.10) occurred in 57 (5.7%) and 10 (3.2%) neonates, respectively (aOR 1.40, 95% CI 0.87-3.48). Women who were induced had a shorter postpartum admission time (2.0 vs 3.0 days (P < 0.0001)). CONCLUSIONS: In women with a previous cesarean section and a need for delivery, induction of labor with a balloon catheter does not result in a significant increase in adverse maternal and neonatal outcomes as compared with planned cesarean section.

The effectiveness of mediolateral episiotomy in preventing obstetric anal sphincter injuries during operative vaginal delivery: a ten-year analysis of a national registry.

INTRODUCTION AND HYPOTHESIS: Obstetric anal sphincter injuries (OASIS) are associated with an increased risk of faecal incontinence after vaginal delivery. The aim of this retrospective population-based cohort study was to assess whether mediolateral episiotomy is associated with a reduction in the rate of OASIS during operative vaginal delivery. METHODS: We used data from the Dutch Perinatal Registry (Perined) that includes records of almost all births between 2000 and 2010 in The Netherlands. In a cohort of 170,969 primiparous and multiparous women whose delivery was recorded, we estimated the association between mediolateral episiotomy and OASIS following both vacuum and forceps deliveries using univariate and multivariate logistic regression analysis. RESULTS: The incidences of OASIS following vacuum delivery in 130,157 primiparous women were 2.5% and 14% in those with and without a mediolateral episiotomy, respectively (adjusted OR 0.14, 95% CI 0.13-0.15), and in 29,183 multiparous women were 2.0% and 7.5%, respectively (adjusted OR 0.23, 95% CI 0.21-0.27). The incidences of OASIS following forceps delivery in 9,855 primiparous women were 3.4% and 26.7% in those with and without a mediolateral episiotomy, respectively (adjusted OR 0.09, 95% CI 0.07-0.11), and in 1,774 multiparous women were 2.6% and 14.2%, respectively (adjusted OR 0.13, 95% CI 0.08-0.22). CONCLUSIONS: The use of a mediolateral episiotomy during both vacuum delivery and forceps delivery is associated with a fivefold to tenfold reduction in the rate of OASIS in primiparous and multiparous women.

The MOVE-trial: Monocryl® vs. Vicryl Rapide™ for skin repair in mediolateral episiotomies: a randomized controlled trial.

BACKGROUND: Previous studies have shown that complaints after episiotomy repair depend on the method and material used for repair. The objective of our study was to determine which of two frequently used suture materials, Monocryl® (poliglecaprone 25) and Vicryl Rapide™ (polyglactin 910), is superior for intracutaneous closure of the skin in mediolateral episiotomies. METHODS: In a randomized controlled trial performed in a teaching hospital in the Netherlands between 2010 and 2013 250 primiparous women with uncomplicated mediolateral episiotomies were randomly allocated to intracutaneous skin closure with either Monocryl® or Vicryl Rapide™. All other layers were sutured with Vicryl 2-0 and Vicryl 0 in both groups. Pain scores and complications were documented using questionnaires during the first three months post partum. The primary outcome was pain 10 days after delivery in sitting position established by Visual Analogous Scale (VAS). Secondary outcomes were pain scores at different time points and reported complications such as infections, dehiscence and dyspareunia one day, 10 days, six weeks and three months after delivery. RESULTS: Of 250 allocated women 54% returned questionnaires. No statistical difference was found between both groups for the primary outcome (VAS 2,8 (95% CI 2,18-3,44) vs. VAS 2,5 (95% CI 2,00-2,98), p = 0,43). With regard to secondary outcomes only self-reported dehiscence was significantly different, favouring Monocryl® (10% vs. 25%, p = 0.016). CONCLUSIONS: Use of Monocryl® 3-0 and Vicryl Rapide™ 3-0 for intracutaneous closure of the skin after mediolateral episiotomy leads to equal pain scores ten days after delivery and therefore both materials may be considered for this use. Monocryl® 3-0 might be favourable over Vicryl Rapide™ 3-0 due to less self-reported dehiscence after intracutaneous closure of the skin in mediolateral episiotomies. TRIAL REGISTRATION: The trial was retrospectively registered under trial nr. ISRCTN29869308 on 20-04-2016.

Cervical ripening with Foley catheter for induction of labor after cesarean section: a cohort study.

OBJECTIVE: To evaluate spontaneous vaginal delivery and complication rates after induction of labor with a transcervical Foley catheter in women with a previous cesarean delivery. DESIGN: Retrospective cohort study. SETTING: Secondary teaching hospital in the second largest city of the Netherlands. POPULATION: Women with a history of cesarean delivery (n = 208), undergoing induction of labor with a Foley catheter in a subsequent pregnancy. MATERIAL AND METHODS: The women who had induction of labor with a transcervical Foley catheter in the Ikazia Hospital, Rotterdam, between January 2003 and January 2012, were identified in a computerized database. Patient's records were checked for accuracy. MAIN OUTCOME MEASURES: Vaginal delivery rate, cesarean section rate, uterine rupture and maternal and neonatal (infectious) morbidity. RESULTS: Of the women 60% had a spontaneous vaginal delivery and 11% were delivered by vacuum extraction. Uterine rupture occurred in one woman. Postpartum hemorrhage was the most common maternal complication (12%). Maternal intrapartum and postpartum infections occurred in 5% and 1%. Proven neonatal infection was found in 3% of the cases. Two perinatal deaths occurred (1%), of which one was related to uterine rupture. CONCLUSION: Induction of labor with a transcervical Foley catheter is an effective method to achieve vaginal delivery in women with a previous cesarean delivery. There is a low risk of uterine rupture and maternal and neonatal (infectious) morbidity in this cohort.

Foley catheter versus vaginal misoprostol: randomized controlled trial (PROBAAT-M study) and systematic review and meta-analysis of literature.

OBJECTIVES: To assess effectiveness and safety of Foley catheter versus vaginal misoprostol for term induction of labor. STUDY DESIGN: This trial randomly allocated women with singleton term pregnancy to 30-mL Foley catheter or 25-µg vaginal misoprostol tablets. Primary outcome was cesarean delivery rate. Secondary outcomes were maternal and neonatal morbidity and time to birth. Additionally, a systematic review was conducted. RESULTS: Fifty-six women were allocated to Foley catheter, 64 to vaginal misoprostol tablets. Cesarean delivery rates did not differ significantly (25% Foley versus 17% misoprostol; relative risk [RR] 1.46, 95% confidence interval [CI] 0.72 to 2.94), with more cesarean deliveries due to failure to progress in the Foley group (14% versus 3%; RR 4.57, 95% CI 1.01 to 20.64). Maternal and neonatal outcomes were comparable. Time from induction to birth was longer in the Foley catheter group (36 hours versus 25 hours; p < 0.001). Meta-analysis showed no difference in cesarean delivery rate and reduced vaginal instrumental deliveries and hyperstimulation in the Foley catheter group. Other outcomes were not different. CONCLUSION: Our trial and meta-analysis showed no difference in cesarean delivery rates and less hyperstimulation with fetal heart rate changes and vaginal instrumental deliveries when using Foley catheter, thereby supporting potential advantages of the Foley catheter over misoprostol as ripening agent.

Induction of labour with a Foley catheter or oral misoprostol at term: the PROBAAT-II study, a multicentre randomised controlled trial.

BACKGROUND: Induction of labour is a common obstetric procedure. At present, different methods are used for induction of labour in women with an unfavourable cervix. Recently, we showed that in term women with an unfavorable cervix the use of a Foley catheter in comparison with vaginal Prostaglandin E2 gel, results in a comparable vaginal delivery rate. A meta-analysis on the subject indicated lower rates of hyperstimulation, and probably as a sequel fewer cases of postpartum haemorrhage. Misoprostol (PgE1) is another type of prostaglandin frequently used for labour induction, recommended by the international federation of gynaecology and obstetrics (FIGO). Misoprostol can be administered by vaginal, rectal and oral route. There is evidence that oral administration results in less asphyxia and hyperstimulation than vaginal administration. At present, valid comparisons between oral misoprostol and Foley catheter are lacking. Therefore, we propose a randomised controlled trial comparing Foley catheter to oral misoprostol in order to assess safety and cost-effectiveness. METHODS/DESIGN: We plan a multicentre, randomised, controlled, open-label clinical trial among term pregnant women with a vital singleton in cephalic presentation, unfavorable cervix, intact membranes and an indication for induction of labour. After informed consent, women will be randomly allocated by a webbased randomisation system to transcervical Foley catheter or oral misoprostol (50 mcg every 4 hours). The primary outcome will be a composite of complications of uterine hyperstimulation, i.e. post partum haemorrhage and asphyxia. Secondary outcomes are mode of delivery, maternal and neonatal morbidity, costs and women's preference. Serious adverse events such as severe maternal or neonatal morbitity or mortality will be monitored and reported to an independent data safety monitory board. With a sample size of 1860 women we will be able to demonstrate a 5% non-inferiority of the Foley catheter as compared to misoprostol for the composite outcome. DISCUSSION: Worldwide, various methods are being used for labour induction. Results of the proposed trial will contribute to the answer which method of induction of labour is most safe, cost-effective, and patient friendly and will help to construct evidence based guidelines. TRIAL REGISTRATION: The Netherlands Trial Register NTR3466.

Foley catheter versus vaginal prostaglandin E2 gel for induction of labour at term (PROBAAT trial): an open-label, randomised controlled trial.

BACKGROUND: Induction of labour is a common obstetric procedure. Both mechanical (eg, Foley catheters) and pharmacological methods (eg, prostaglandins) are used for induction of labour in women with an unfavourable cervix. We aimed to compare the effectiveness and safety of induction of labour with a Foley catheter with induction with vaginal prostaglandin E2 gel. METHODS: We did an open-label, randomised controlled trial in 12 hospitals in the Netherlands between Feb 10, 2009, and May 17, 2010. We enrolled women with a term singleton pregnancy in cephalic presentation, intact membranes, an unfavourable cervix, an indication for induction of labour, and no prior caesarean section. Participants were randomly allocated by an online randomisation system to induction of labour with a 30 mL Foley catheter or vaginal prostaglandin E2 gel (1:1 ratio). Because of the nature of the intervention this study was not blinded. The primary outcome was caesarean section rate. Secondary outcomes were maternal and neonatal morbidity and time from intervention to birth. All analyses were done on an intention-to-treat basis. We also did a meta-analysis that included our trial. The trial was registered with the Dutch trial registry, number NTR 1646. FINDINGS: 824 women were allocated to induction of labour with a Foley catheter (n=412) or vaginal prostaglandin E2 gel (n=412). Caesarean section rates were much the same between the two groups (23%vs 20%, risk ratio [RR] 1·13, 95% CI 0·87-1·47). A meta-analysis including our trial data confirmed that a Foley catheter did not reduce caesarean section rates. We recorded two serious maternal adverse events, both in the prostaglandin group: one uterine perforation and one uterine rupture. INTERPRETATION: In women with an unfavourable cervix at term, induction of labour with a Foley catheter is similar to induction of labour with prostaglandin E2 gel, with fewer maternal and neonatal side-effects. FUNDING: None.

The effect of a mediolateral episiotomy during operative vaginal delivery on the risk of developing obstetrical anal sphincter injuries.

OBJECTIVE: The objective of the study was to evaluate the frequency of obstetrical anal sphincter injuries (OASIS) in women undergoing operative vaginal deliveries (OVD) and to assess whether a mediolateral episiotomy is protective for developing OASIS in these deliveries. STUDY DESIGN: We performed a retrospective cohort study. Maternal and obstetrical characteristics of the 2861 women who delivered liveborn infants by an OVD at term in the years 2001-2009 were extracted from a clinical obstetrics database and were analyzed in a logistic regression model. RESULTS: The frequency of OASIS was 5.7%. Women with a mediolateral episiotomy were at significantly lower risk for OASIS compared with the women without a mediolateral episiotomy in case of an OVD (adjusted odds ratio, 0.17; 95% confidence interval, 0.12-0.24). CONCLUSION: We found a 6-fold decreased odds for developing OASIS when a mediolateral episiotomy was performed in OVD. Therefore, we advocate the use of a mediolateral episiotomy in all operative vaginal deliveries to reduce the incidence of OASIS.

Protocol for the value of urodynamics prior to stress incontinence surgery (VUSIS) study: a multicenter randomized controlled trial to assess the cost effectiveness of urodynamics in women with symptoms of stress urinary incontinence in whom surgical treatment is considered.

BACKGROUND: Stress urinary incontinence (SUI) is a common problem. In the Netherlands, yearly 64.000 new patients, of whom 96% are women, consult their general practitioner because of urinary incontinence. Approximately 7500 urodynamic evaluations and approximately 5000 operations for SUI are performed every year. In all major national and international guidelines from both gynaecological and urological scientific societies, it is advised to perform urodynamics prior to invasive treatment for SUI, but neither its effectiveness nor its cost-effectiveness has been assessed in a randomized setting. The Value of Urodynamics prior to Stress Incontinence Surgery (VUSIS) study evaluates the positive and negative effects with regard to outcome, as well as the costs of urodynamics, in women with symptoms of SUI in whom surgical treatment is considered. METHODS/DESIGN: A multicentre diagnostic cohort study will be performed with an embedded randomized controlled trial among women presenting with symptoms of (predominant) SUI. Urinary incontinence has to be demonstrated on clinical examination and/or voiding diary. Physiotherapy must have failed and surgical treatment needs to be under consideration. Patients will be excluded in case of previous incontinence surgery, in case of pelvic organ prolapse more than 1 centimeter beyond the hymen and/or in case of residual bladder volume of more than 150 milliliter on ultrasound or catheterisation. Patients with discordant findings between the diagnosis based on urodynamic investigation and the diagnosis based on their history, clinical examination and/or micturition diary will be randomized to operative therapy or individually tailored therapy based on all available information. Patients will be followed for two years after treatment by their attending urologist or gynaecologist, in combination with the completion of questionnaires. Six hundred female patients will be recruited for registration from approximately twenty-seven hospitals in the Netherlands. We aspect that one hundred and two women with discordant findings will be randomized. The primary outcome of this study is clinical improvement of incontinence as measured with the validated Dutch version of the Urinary Distress Inventory (UDI). Secondary outcomes of this study include costs, cure of incontinence as measured by voiding diary parameters, complications related to the intervention, re-interventions, and generic quality of life changes. TRIAL REGISTRATION: Clinical Trials NCT00814749.

[Better training in perineal injury is desirable]. / Betere training over perineumletsel gewenst.

Better training in perineal injury is desirable One of the most common complaints from women following childbirth is perineal pain, caused by perineal trauma. The episiotomy technique, the suture material chosen, the suture technique, and the knowledge and skills of the care-provider all influence healing and subsequent symptoms. Evidence-based techniques are associated with fewer symptoms and complications; however, the literature reveals that care-providers are often inexperienced, not well trained or not conscientious enough in: performing an accurate episiotomy; assessing perineal trauma; diagnosing anal-sphincter injuries; and evidence-based repair techniques. The angle at which an episiotomy is performed and the suture techniques used vary considerably, while the evidence shows emphatically which techniques are optimal. We believe that the responsibility for the improvement of knowledge and skills lies with the care-providers. Despite the absence of obligation, they should attend repeated training sessions, to guarantee the optimal quality of perineal care following childbirth.

Implementation of a perineal support programme for reduction of the incidence of obstetric anal sphincter injuries and the effect of non-compliance.

OBJECTIVE: Obstetric anal sphincter injury (OASI) is a serious complication of a vaginal delivery. In 2005, a Norwegian nation-wide training programme to reduce the OASI rate was successfully implemented. The aim of the present study was to assess the impact of a perineal support programme, inspired by the Norwegian programme, on the incidence of OASIs in a Dutch hospital with a low a priori rate. STUDY DESIGN: Prospective cohort study with historical comparison group. Three midwives and one obstetrician were trained on site by an expert midwife from Norway. These four trained the rest of the obstetrical staff. Data were prospectively recorded using the Dutch National Perinatal Registry, with additional recording whether the manual perineal support was actually applied in individual deliveries. OASI rates in three time periods were studied: the year preceding the training programme, the training period of 7 months and the year after the training period (respectively "control period", "training period" and "result period"). After exclusion of caesarean sections, preterm deliveries, breech and twin deliveries, a total of 4391 deliveries were recorded during the study period. RESULTS: During the training period, the OASI rate decreased significantly from 2.0 to 0.7% (aOR 0.34; 95%CI 0.15-0.76). In the result period, manual perineal support was performed in 72.7% of the deliveries and the overall OASI rate raised to 1.7% again, mainly because of non-compliance to the programme during vacuum deliveries. Nevertheless, multivariate logistic regression analysis with correction for known OASI risk factors showed that the OASI rate was 83% lower with application of perineal support (aOR 0.17; 95%CI 0.07-0.39). CONCLUSION: A perineal support programme decreases OASI rate. Continuous verification of application and repetitive training is necessary, especially during vacuum deliveries.

Cervical ripening in the Netherlands: a survey.

Objective. We aim to investigate methods and use of cervical ripening in women without and with a prior cesarean delivery in The Netherlands. Methods. In 2010, we conducted a postal survey in all Dutch hospitals with a labor ward. One gynecologist per hospital was addressed and was asked to respond on behalf of the staff. The questionnaire contained 31 questions concerning cervical ripening and induction of labor. We compared this survey to a similar Dutch survey conducted in 2006. Results. Response rate was 78% (70/92 hospitals). In women without a prior cesarean and in need of cervical ripening, all hospitals (100%) applied prostaglandins (either E1 or E2). In women with a prior cesarean, 21.4% of the hospitals performed an elective cesarean section if delivery was indicated (26.0% in 2006). In case of cervical ripening, 72.7% used mechanical methods (49.1% in 2006), 20.0% used prostaglandins (40.4% in 2006), 3.6% used a combination of prostaglandins and mechanical methods, and 3.6% used membrane-sweeping or oxytocin. Conclusions. In 2010, in The Netherlands, prostaglandins and Foley catheters were the preferred methods for cervical ripening in women without and with a prior cesarean, respectively. Use of mechanical methods in women with a prior cesarean has increased rapidly between 2006 and 2010, corresponding with decreasing use of prostaglandins and elective repeat cesarean sections.

Foley catheter or prostaglandin E2 inserts for induction of labour at term: an open-label randomized controlled trial (PROBAAT-P trial) and systematic review of literature.

OBJECTIVE: To assess the safety and effectiveness of a transcervical Foley catheter compared to vaginal prostaglandin E2 inserts for term induction of labour. STUDY DESIGN: We conducted an open-label randomized controlled trial in five hospitals in the Netherlands. Women with a singleton term pregnancy in cephalic presentation, intact membranes, unfavourable cervix, and no prior caesarean section were enrolled. Participants were randomly allocated by a web-based randomization system to induction of labour with a 30 ml Foley catheter or 10mg slow-release vaginal prostaglandin E2 inserts in a 1:1 ratio. Due to the nature of the intervention this study was not blinded. The primary outcome was the caesarean section rate. Secondary outcomes were maternal and neonatal morbidity and time from intervention to birth. Additionally, we carried out a systematic review and meta-analysis of similar studies. RESULTS: We analyzed 226 women: 107 received a Foley catheter and 119 inserts. Caesarean section rates were comparable (20% versus 22%, RR 0.90, 95% CI 0.54-1.50). Secondary outcomes showed no differences. We observed no serious maternal or neonatal morbidity. Meta-analysis showed comparable caesarean section rates, but significantly fewer cases of hyperstimulation during the ripening phase when a Foley catheter was used. CONCLUSIONS: We found, in this relatively small study, no differences in effectiveness and safety of induction of labour with a Foley catheter and 10mg slow release vaginal prostaglandin E2 inserts. Meta-analysis confirmed a comparable caesarean section rate, and showed fewer cases of hyperstimulation when a Foley catheter was used.

Anal sphincter damage after vaginal delivery: relationship of anal endosonography and manometry to anorectal complaints.

PURPOSE: This study was designed to assess the relationship of anal endosonography and manometry to anorectal complaints in the evaluation of females a long time after vaginal delivery complicated by anal sphincter damage. METHODS: Thirty-four patients with anal sphincter damage after delivery, 22 with and 12 without anorectal complaints, and 12 controls without anorectal complaints underwent anal endosonography, manometry, and rectal sensitivity testing. Complaints were assessed by questionnaire, with a median follow-up of 19 years. RESULTS: Median maximum anal resting pressures were significantly lower in patients with anal sphincter damage with complaints (31 mmHg) than in controls (52 mmHg; P < 0.001). Median maximum anal squeeze pressures were significantly lower in patients with (55 mmHg) and without (69 mmHg) complaints than in controls (112 mmHg; P < 0.001 for both). Maximum anal resting pressures were significantly lower in patients with anorectal complaints after anal sphincter damage than in patients without complaints (P = 0.02). Results of anal manometry showed a large overlap between all groups. Rectal sensitivity showed no significant differences between the three groups. Persisting sphincter defects, shown by anal endosonography, were significantly more present in patients with anal sphincter damage after delivery with (86 percent) and without (67 percent) complaints than in controls (8 percent; P < 0.001 and P < 0.01, respectively). No differences in the number of echocardiographically proven sphincter defects were found between patients with or without anorectal complaints after anal sphincter damage CONCLUSIONS: Echographically proven sphincter defects are strongly associated with a history of anal sphincter damage during delivery. Sphincter defects are present in the majority of patients with anorectal complaints. Anal manometry provides little additional therapeutic information when performed after anal endosonography in patients with anorectal complaints after anal sphincter damage during delivery.