Same-day discharge after laparoscopic hysterectomy for benign/premalignant disease: A multicentre randomised controlled trial.

OBJECTIVE: To evaluate whether physical function and quality of life was influenced by discharge on the same-day after a total laparoscopic hysterectomy. DESIGN: Multicentre non-inferiority randomised controlled trial. SETTING: Five teaching hospitals and two university hospitals in the Netherlands. POPULATION: Patients undergoing laparoscopic hysterectomy for benign or premalignant disease. METHODS: Following informed consent, participants were allocated 1:1 either to same-day discharge (SDD) or next-day discharge (NDD). MAIN OUTCOME MEASURES: The primary outcome was physical function at 7 days after surgery measured by the Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function short Form 10A. Secondary outcomes were physical function and quality of life at 1 and 3 days and 6 weeks after surgery measured with PROMIS short Form 10A and the EuroQol questionnaire (EQ-5D-5L). RESULTS: Two hundred and five patients were included of whom 105 were allocated to SDD and 100 to NDD. Physical function 7 days after surgery was 35.95 in the SDD group and 35.63 in the control group (mean difference 0.32; 95% CI [0.07-0.57]). As the upper limit of the 95% CI does not exceed the non-inferiority margin of 4 points, non-inferiority of SDD could be demonstrated. No difference in physical function nor quality of life on Days 1 and 3 and 6 weeks could be found. CONCLUSION: This research demonstrates same-day discharge after laparoscopic hysterectomy is non-inferior to next day discharge in physical function 7 days after surgery.

Procedural sedation and analgesia versus general anesthesia for hysteroscopic myomectomy (PROSECCO trial): A multicenter randomized controlled trial.

BACKGROUND: Hysteroscopic resection is the first-choice treatment for symptomatic type 0 and 1 fibroids. Traditionally, this was performed under general anesthesia. Over the last decade, surgical procedures are increasingly being performed in an outpatient setting under procedural sedation and analgesia. However, studies evaluating safety and effectiveness of hysteroscopic myomectomy under procedural sedation are lacking. This study aims to investigate whether hysteroscopic myomectomy under procedural sedation and analgesia with propofol is noninferior to hysteroscopic myomectomy under general anesthesia. METHODS AND FINDINGS: This was a multicenter, randomized controlled noninferiority trial conducted in 14 university and teaching hospitals in the Netherlands between 2016 and 2021. Inclusion criteria were age ≥18 years, maximum number of 3 type 0 or 1 fibroids, maximum fibroid diameter 3.5 cm, American Society of Anesthesiologists class 1 or 2, and having sufficient knowledge of the Dutch or English language. Women with clotting disorders or with severe anemia (Hb < 5.0 mmol/L) were excluded. Women were randomized using block randomization with variable block sizes of 2, 4, and 6, between hysteroscopic myomectomy under procedural sedation and analgesia (PSA) with propofol or under general anesthesia (GA). Primary outcome was the percentage of complete resections, assessed on transvaginal ultrasonography 6 weeks postoperatively by a sonographer blinded for the treatment arm and surgical outcome. Secondary outcomes were the surgeon's judgment of completeness of procedure, menstrual blood loss, uterine fibroid related and general quality of life, pain, recovery, hospitalization, complications, and surgical reinterventions. Follow-up period was 1 year. The risk difference between both treatment arms was estimated, and a Farrington-Manning test was used to determine the p-value for noninferiority (noninferiority margin 7.5% of incomplete resections). Data were analyzed according to the intention-to-treat principle, including a per-protocol analysis for the primary outcome. A total of 209 women participated in the study and underwent hysteroscopic myomectomy with PSA (n = 106) or GA (n = 103). Mean age was 45.1 [SD 6.4] years in the PSA group versus 45.0 [7.7] years in the GA group. For 98/106 women in the PSA group and 89/103 women in the GA group, data were available for analysis of the primary outcome. Hysteroscopic resection was complete in 86/98 women (87.8%) in the PSA group and 79/89 women (88.8%) in the GA group (risk difference -1.01%; 95% confidence interval (CI) -10.36 to 8.34; noninferiority, P = 0.09). No serious anesthesiologic complications occurred, and conversion from PSA to GA was not required. During the follow-up period, 15 serious adverse events occurred (overnight admissions). All were unrelated to the intervention studied. Main limitations were the choice of primary outcome and the fact that our study proved to be underpowered. CONCLUSIONS: Noninferiority of PSA for completeness of resection was not shown, though there were no significant differences in clinical outcomes and quality of life. In this study, hysteroscopic myomectomy for type 0 and 1 fibroids with PSA compared to GA was safe and led to shorter hospitalization. These results can be used for counseling patients by gynecologists and anesthesiologists. Based on these findings, we suggest that hysteroscopic myomectomies can be performed under PSA in an outpatient setting. TRIAL REGISTRATION: The study was registered prospectively in the Dutch Trial Register (NTR 5357; registration date: 11 August 2015; Date of initial participant enrollment: 18 February 2016).

Levonorgestrel-releasing intrauterine system versus endometrial ablation for heavy menstrual bleeding.

BACKGROUND: Heavy menstrual bleeding affects the physical functioning and social well-being of many women. The levonorgestrel-releasing intrauterine system and endometrial ablation are 2 frequently applied treatments in women with heavy menstrual bleeding. OBJECTIVE: This study aimed to compare the effectiveness of the levonorgestrel-releasing intrauterine system with endometrial ablation in women with heavy menstrual bleeding. STUDY DESIGN: This multicenter, randomized controlled, noninferiority trial was performed in 26 hospitals and in a network of general practices in the Netherlands. Women with heavy menstrual bleeding, aged 34 years and older, without a pregnancy wish or intracavitary pathology were randomly allocated to treatment with either the levonorgestrel-releasing intrauterine system (Mirena) or endometrial ablation, performed with a bipolar radiofrequency device (NovaSure). The primary outcome was blood loss at 24 months, measured with a Pictorial Blood Loss Assessment Chart score. Secondary outcomes included reintervention rates, patient satisfaction, quality of life, and sexual function. RESULTS: We registered 645 women as eligible, of whom 270 women provided informed consent. Of these, 132 women were allocated to the levonorgestrel-releasing intrauterine system (baseline Pictorial Blood Loss Assessment Chart score, 616) and 138 women to endometrial ablation (baseline Pictorial Blood Loss Assessment Chart score, 630). At 24 months, mean Pictorial Blood Loss Assessment Chart scores were 64.8 in the levonorgestrel-releasing intrauterine system group and 14.2 in the endometrial ablation group (difference, 50.5 points; 95% confidence interval, 4.3-96.7; noninferiority, P=.87 [25 Pictorial Blood Loss Assessment Chart point margin]). Compared with 14 women (10%) in the endometrial ablation group, 34 women (27%) underwent a surgical reintervention in the levonorgestrel-releasing intrauterine system group (relative risk, 2.64; 95% confidence interval, 1.49-4.68). There was no significant difference in patient satisfaction and quality of life between the groups. CONCLUSION: Both the levonorgestrel-releasing intrauterine system and endometrial ablation strategies lead to a large decrease in menstrual blood loss in women with heavy menstrual bleeding, with comparable quality of life scores after treatment. Nevertheless, there was a significant difference in menstrual blood loss in favor of endometrial ablation, and we could not demonstrate noninferiority of starting with the levonorgestrel-releasing intrauterine system. Women who start with the levonorgestrel-releasing intrauterine system, a reversible and less invasive treatment, are at an increased risk of needing additional treatment compared with women who start with endometrial ablation. The results of this study will enable physicians to provide women with heavy menstrual bleeding with the evidence to make a well-informed decision between the 2 treatments.

The (cost) effectiveness of procedural sedation and analgesia versus general anaesthesia for hysteroscopic myomectomy, a multicentre randomised controlled trial: PROSECCO trial, a study protocol.

BACKGROUND: In women with abnormal uterine bleeding, fibroids are a frequent finding. In case of heavy menstrual bleeding and presence of submucosal type 0-1 fibroids, hysteroscopic resection is the treatment of first choice, as removal of these fibroids is highly effective. Hysteroscopic myomectomy is currently usually performed in the operating theatre. A considerable reduction in costs and a higher patient satisfaction are expected when procedural sedation and analgesia with propofol (PSA) in an outpatient setting is applied. However, both safety and effectiveness - including the necessity for re-intervention due to incomplete resection - have not yet been evaluated. METHODS: This study is a multicentre randomised controlled trial with a non-inferiority design and will be performed in the Netherlands. Women > 18 years with a maximum of 3 symptomatic type 0 or 1 submucosal fibroids with a maximum diameter of 3.5 cm are eligible to participate in the trial. After informed consent, 205 women will be randomised to either hysteroscopic myomectomy using procedural sedation and analgesia with propofol in an outpatient setting or hysteroscopic myomectomy using general anaesthesia in a clinical setting in the operating theatre. Primary outcome will be the percentage of complete resections, based on transvaginal ultrasonography 6 weeks postoperatively. Secondary outcomes are cost effectiveness, menstrual blood loss (Pictorial blood assessment chart), quality of life, pain, return to daily activities/work, hospitalization, (post) operative complications and re-interventions. Women will be followed up to one year after hysteroscopic myomectomy. DISCUSSION: This study may demonstrate comparable effectiveness of hysteroscopic myomectomy under procedural sedation and analgesia versus general anaesthesia in a safe and patient friendly environment, whilst achieving a significant cost reduction. TRIAL REGISTRATION: Dutch trial register, number NTR5357 . Registered 11th of August 2015.

Electronic Health Program to Empower Patients in Returning to Normal Activities After General Surgical and Gynecological Procedures: Intervention Mapping as a Useful Method for Further Development.

BACKGROUND: Support for guiding and monitoring postoperative recovery and resumption of activities is usually not provided to patients after discharge from the hospital. Therefore, a perioperative electronic health (eHealth) intervention ("ikherstel" intervention or "I recover" intervention) was developed to empower gynecological patients during the perioperative period. This eHealth intervention requires a need for further development for patients who will undergo various types of general surgical and gynecological procedures. OBJECTIVE: This study aimed to further develop the "ikherstel" eHealth intervention using Intervention Mapping (IM) to fit a broader patient population. METHODS: The IM protocol was used to guide further development of the "ikherstel" intervention. First, patients' needs were identified using (1) the information of a process evaluation of the earlier performed "ikherstel" study, (2) a review of the literature, (3) a survey study, and (4) focus group discussions (FGDs) among stakeholders. Next, program outcomes and change objectives were defined. Third, behavior change theories and practical tools were selected for the intervention program. Finally, an implementation and evaluation plan was developed. RESULTS: The outcome for an eHealth intervention tool for patients recovering from abdominal general surgical and gynecological procedures was redefined as "achieving earlier recovery including return to normal activities and work." The Attitude-Social Influence-Self-Efficacy model was used as a theoretical framework to transform personal and external determinants into change objectives of personal behavior. The knowledge gathered by needs assessment and using the theoretical framework in the preparatory steps of the IM protocol resulted in additional tools. A mobile app, an activity tracker, and an electronic consultation (eConsult) will be incorporated in the further developed eHealth intervention. This intervention will be evaluated in a multicenter, single-blinded randomized controlled trial with 18 departments in 11 participating hospitals in the Netherlands. CONCLUSIONS: The intervention is extended to patients undergoing general surgical procedures and for malignant indications. New intervention tools such as a mobile app, an activity tracker, and an eConsult were developed. TRIAL REGISTRATION: Netherlands Trial Registry NTR5686; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5686.

A revised prediction model for natural conception.

One of the aims in reproductive medicine is to differentiate between couples that have favourable chances of conceiving naturally and those that do not. Since the development of the prediction model of Hunault, characteristics of the subfertile population have changed. The objective of this analysis was to assess whether additional predictors can refine the Hunault model and extend its applicability. Consecutive subfertile couples with unexplained and mild male subfertility presenting in fertility clinics were asked to participate in a prospective cohort study. We constructed a multivariable prediction model with the predictors from the Hunault model and new potential predictors. The primary outcome, natural conception leading to an ongoing pregnancy, was observed in 1053 women of the 5184 included couples (20%). All predictors of the Hunault model were selected into the revised model plus an additional seven (woman's body mass index, cycle length, basal FSH levels, tubal status,history of previous pregnancies in the current relationship (ongoing pregnancies after natural conception, fertility treatment or miscarriages), semen volume, and semen morphology. Predictions from the revised model seem to concur better with observed pregnancy rates compared with the Hunault model; c-statistic of 0.71 (95% CI 0.69 to 0.73) compared with 0.59 (95% CI 0.57 to 0.61).

Semen analysis and prediction of natural conception.

STUDY QUESTION: Do two semen analyses predict natural conception better than a single semen analysis and will adding the results of repeated semen analyses to a prediction model for natural pregnancy improve predictions? SUMMARY ANSWER: A second semen analysis does not add helpful information for predicting natural conception compared with using the results of a single semen analysis and addition of the second analysis to a prediction model for natural conception did not improve predictions. WHAT IS KNOWN ALREADY: A major problem with semen analyses is the large variability of results within an individual. High-quality evidence is lacking on how many semen analyses need to be performed during the fertility workup to achieve an accurate prediction of conception. STUDY DESIGN, SIZE, DURATION: We conducted a prospective cohort study of 897 consecutive couples presenting with subfertility in two university hospitals in the period 2002-2004 in the Netherlands. PARTICIPANTS/MATERIALS, SETTING, AND METHODS: The laboratories scored sperm parameters according to the 1999 WHO criteria. Sperm concentration was counted and motility was assessed in a Makler counting chamber at a magnification of ×200. All assessments were performed by trained laboratory technicians. Follow-up started at the completion of the infertility workup and ended after 12 months. Primary end-point was natural conception resulting in an ongoing pregnancy. We constructed models for three strategies for the prediction of natural conception, using univariable and multivariable Cox hazard regression analyses. We evaluated the performance of the three strategies by comparing goodness-of-fit, discrimination and calibration. First, we analysed the semen parameters only. Secondly, we analysed the semen parameters in addition to the multivariable Hunault prediction model. MAIN RESULTS AND THE ROLE OF CHANCE: Of the 897 couples, 132 (15%) achieved a pregnancy by natural conception. Using the results of a single semen analysis only, the calculated probabilities of natural conception within 12 months across the study population ranged from 0.12 to 0.38, with a median of 0.16 (IQR: 0.16-0.17). Using the results of two semen analyses did not lead to a better goodness-of-fit. Discriminative capacity was rather poor, with an area under the ROC curve (AUC) ranging from 0.51 to 0.56. Using the Hosmer-Lemeshow test statistic we found no signs of poor calibration. Using the results of two semen analyses in combination with the Hunault model did not significantly increase goodness-of-fit compared with using a single semen analysis. The Hunault model with the addition of the semen parameters fitted the data significantly better than the Hunault model itself (difference in -2 Log likelihood: 13; 3 df; P = 0.002). Using the Hosmer-Lemeshow test statistic we found no signs of poor calibration. LIMITATIONS, REASONS FOR CAUTION: The academic setting possibly explains the relatively low natural conception rates, with only 15% achieving a natural conception within 1 year. Men with azoospermia were excluded. WIDER IMPLICATIONS OF THE FINDINGS: Performing more than one semen analysis will not increase the prognostic power of the test in clinical practice. Adding the first semen analysis to the Hunault model for the prediction of natural conception improved performance significantly compared with using the Hunault model alone. External validation, in other populations, should follow to confirm our conclusions, and to evaluate the generalizability or transportability of the extended Hunault model. STUDY FUNDING/COMPETING INTEREST(S): No external funding was involved in this study. None of the authors has any conflict of interest to declare.

Levonorgestrel releasing intrauterine system (Mirena) versus endometrial ablation (Novasure) in women with heavy menstrual bleeding: a multicentre randomised controlled trial.

BACKGROUND: Heavy menstrual bleeding is an important health problem. Two frequently used therapies are the levonorgestrel intra-uterine system (LNG-IUS) and endometrial ablation. The LNG-IUS can be applied easily by the general practitioner, which saves costs, but has considerable failure rates. As an alternative, endometrial ablation is also very effective, but this treatment has to be performed by a gynaecologist. Due to lack of direct comparison of LNG-IUS with endometrial ablation, there is no evidence based preferred advice for the use of one of these treatment possibilities. METHOD/DESIGN: A multicenter randomised controlled trial, organised in a network infrastructure in the Netherlands in which general practitioners and gynaecologists collaborate. DISCUSSON: This study, considering both effectiveness and cost effectiveness of LNG-IUS versus endometrial ablation may well improve care for women with heavy menstrual bleeding. TRIAL REGISTRATION: Dutch trial register, number NTR2984.

Long-term outcome in couples with unexplained subfertility and an intermediate prognosis initially randomized between expectant management and immediate treatment.

BACKGROUND: We recently reported that treatment with intrauterine insemination and controlled ovarian stimulation (IUI-COS) did not increase ongoing pregnancy rates compared with expectant management (EM) in couples with unexplained subfertility and intermediate prognosis of natural conception. Long-term cost-effectiveness of a policy of initial EM is unknown. We investigated whether the recommendation not to treat during the first 6 months is valid, regarding the long-term effectiveness and cumulative costs. METHODS: Couples with unexplained subfertility and intermediate prognosis of natural conception (n=253, at 26 public clinics, the Netherlands) were randomly allocated to 6 months EM or immediate start with IUI-COS. The couples were then treated according to local protocol, usually IUI-COS followed by IVF. We followed couples until 3 years after randomization and registered pregnancies and resources used. Primary outcome was time to ongoing pregnancy. Secondary outcome was treatment costs. Analysis was by intention-to-treat. Economic evaluation was performed from the perspective of the health care institution. RESULTS: Time to ongoing pregnancy did not differ between groups (log-rank test P=0.98). Cumulative ongoing pregnancy rates were 72-73% for EM and IUI-COS groups, respectively [relative risk 0.99 (95% confidence interval (CI) 0.85-1.1)]. Estimated mean costs per couple were € 3424 (95% CI € 880-€ 5968) in the EM group and € 6040 (95% CI € 4055-€ 8125) in the IUI-COS group resulting in an estimated saving of € 2616 per couple (95% CI € 385-€ 4847) in favour of EM. CONCLUSIONS: In couples with unexplained subfertility and an intermediate prognosis of natural conception, initial EM for 6 months results in a considerable cost-saving with no delay in achieving pregnancy or jeopardizing the chance of pregnancy. Further comparisons between aggressive and milder forms of ovarian stimulation should be performed.

Pain scores during oocyte retrieval for IVF/ICSI: A retrospective cohort study comparing three different analgesia protocols.

OBJECTIVE: Oocyte retrieval is a painful, but essential element of IVF/ICSI. Evidence for the best method of analgesia is lacking. In the Netherlands, the three most common analgesia protocols entail administration of oral analgesics, intravenous opioids, and intramuscular opioids. The aim of this study was to compare these methods. METHODS: A retrospective cohort study was conducted at three clinics. Clinic one provided oral analgesics (1000 mg paracetamol and 500 mg naproxen). The main component of analgesia at clinic two was opioids intravenously (50-100 µg fentanyl), and at clinic three, this was opioids intramuscularly (0.01 mg/kg alfentanil). Intraprocedural pain was registered on an 11-point scale. Univariate analyses were performed to identify factors significantly associated with pain scores. A mixed linear model was used to uncover mean pain scores per clinic. RESULTS: In total, 2,127 oocyte retrievals were included. Pain scores were lower in older women; scores decreased 0.06 points per year (95%-confidence interval (CI): 0.04-0.08). Per extra follicle, scores were 0.05 points higher (95%-CI: 0.03-0.06). Endometriosis resulted in 0.45-point higher scores (95%-CI: 0.01-0.88). Primary subfertility resulted in a 0.36-point increase in scores (95%-CI: 0.15-0.56). Nulliparous women had a 0.41-point higher score than multiparous women (95%-CI: 0.19-0.63). These effects were mostly similar in all clinics. Mean pain scores were 5.6 at clinic number 1 (95%-CI: 5.3-5.8), 5.1 at clinic number 2 (95%-CI: 4.9-5.3), and 3.9 at clinic number 3 (95%-CI: 3.8-4.1). CONCLUSION: The lowest pain scores were achieved in the clinic that used intramuscular administration of alfentanil, followed by intravenous fentanyl and, finally, non-sedative oral analgesics. Significant correlations between patient characteristics and pain scores were identified.

Predicting the development of stress urinary incontinence 3 years after hysterectomy.

INTRODUCTION AND HYPOTHESIS: We aimed to develop a prediction rule to predict the individual risk to develop stress urinary incontinence (SUI) after hysterectomy. METHODS: Prospective observational study with 3-year follow-up among women who underwent abdominal or vaginal hysterectomy for benign conditions, excluding vaginal prolapse, and who did not report SUI before surgery (n = 183). The presence of SUI was assessed using a validated questionnaire. RESULTS: Significant prognostic factors for de novo SUI were BMI (OR 1.1 per kg/m(2), 95% CI 1.0-1.2), younger age at time of hysterectomy (OR 0.9 per year, 95% CI 0.8-1.0) and vaginal hysterectomy (OR 2.3, 95% CI 1.0-5.2). Using these variables, we developed the following rule to predict the risk of developing SUI: 32 + BMI-age + (7.5 × route of surgery). CONCLUSIONS: We defined a prediction rule that can be used to counsel patients about their individual risk on developing SUI following hysterectomy.

Prediction of success of external cephalic version after 36 weeks.

We aimed to develop a predictive model for the chance of a successful external cephalic version (ECV). We performed a prospective cohort study of women with a singleton fetus in breech presentation with a gestational age of 36 weeks or more. Data on parity, maternal age, body mass index, ethnicity, gestational age, placental location, fetal position, estimated fetal weight, and amniotic fluid were recorded in all participants. Multivariable logistic regression analysis with a stepwise backward selection procedure was used to construct a prediction model for the occurrence of successful ECV. We included a total of 310 women. Multivariable logistic regression analysis demonstrated that multiparity, increasing estimated fetal weight, and normal amniotic fluid were favorable predictors of successful ECV. Anterior placenta location was an unfavorable predictor for ECV outcome. Discrimination of the model was fair (area under the curve 0.71), and the calibration of the model was acceptable. Our prediction model appears to discriminate between women with a poor chance of successful ECV (less than 20%) and women with a good chance of success (more than 60%). When this model is validated externally, it could be used for patient counseling and clinical decision making.

Effect of needle diameter on pain during oocyte retrieval-a randomized controlled trial.

OBJECTIVE: To study pain in women undergoing oocyte retrieval with a reduced needle (20/17 gauge) compared to a standard needle (16 gauge). DESIGN: Single-center randomized controlled trial. SETTING: Fertility clinic. PATIENTS: Women undergoing their first oocyte retrieval for in vitro fertilization or intracytoplasmic sperm injection. INTERVENTIONS: Oocyte retrieval with a reduced needle (20/17 gauge) or with a standard needle (16 gauge). MAIN OUTCOME MEASURES: The primary outcome measure was intraoperative pain on an 11-point visual analogue scale (VAS). Secondary outcome measures included the following: dosage of fentanyl requested; pain at 5, 15 and 30 minutes after retrieval; and pain and analgesia until 4 days after retrieval. RESULTS: A total of 47 women were randomized for the reduced needle (RN) and 48 for the standard needle (SN). Pain scores were significantly lower during and after retrieval with the RN. During retrieval, mean VAS scores in the RN group were 4.3 versus 6.3 in the SN group. Pain remained significantly lower in the RN group after retrieval, with VAS-scores of 1.2 vs. 2.1 directly after retrieval, 0.0 versus 2.0 5 minutes after retrieval, and 0.0 versus 1.0 30 minutes after retrieval. In the RN group, three patients (6.4%) requested more fentanyl during the procedure, versus 16 (33.3%) in the SN group. A total of 79 patients submitted their follow-up questionnaire (response rate 83%). Pain on the first 2 days following retrieval was significantly less in the RN group, with VAS scores of 1.6 versus 2.4 in the SN group, and 1.2 versus 2.5. In line with this finding, fewer patients in the RN group took analgesia on the days after the procedure. This difference was statistically significant only on day 3. CONCLUSION: Use of a thinner needle results in significantly and clinically relevant lower pain scores during oocyte retrieval, and patients in the reduced needle group requested significantly less analgesia during oocyte retrieval than patients in the standard needle group. Pain scores remained significantly lower up until 2 days after the procedure. DUTCH TRIAL REGISTRATION NUMBER: NTR6064 (www.trialregister.nl).

Validation of existing prognostic models in patients with early-stage cervical cancer.

OBJECTIVE: Models that predict survival and recurrence in patients with early-stage cervical cancer are important tools in patient management. We validated 12 existing prognostic models in an independent population of patients with early-stage cervical cancer. MATERIALS AND METHODS: We searched the literature for prognostic models in patients with surgically treated early-stage cervical cancer. The prognostic performance of these models was assessed in a consecutive group of surgically treated patients with early-stage cervical cancer treated in our hospital between 1982 and 2004. The performance of the models was visually assessed with calibration plots, which display the relation between the predicted and observed survival. RESULTS: Twelve published prognostic models met the inclusion criteria. The models categorized the patients into two to four risk groups. Prognostic factors most frequently used in these models were depth of invasion, lymph node metastasis, vascu/vascular space involvement, and tumor size. The models were validated in 563 consecutive patients with early-stage cervical cancer. All of the models underestimated the recurrence-free survival or disease-specific survival in our patients. Only two models performed reasonably well in our population. The use of more than three prognostic categories in the models was not meaningful. CONCLUSION: In general, the models underestimated the survival. Only 2 of the 12 prognostic models for patients with early-stage cervical cancer were valid for the prediction of the recurrence-free or disease-specific survival in our patient population.

Introduction of a dedicated team increases the success rate of external cephalic version: A prospective cohort study.

OBJECTIVE: To investigate the influence of a dedicated team on the success rate of external cephalic version and mode of delivery. STUDY DESIGN: This prospective cohort study included 673 women with a singleton fetus in breech presentation who underwent external cephalic version between January 2013 and December 2017 at Jeroen Bosch Hospital, 's-Hertogenbosch, The Netherlands. In January 2014, a dedicated team consisting of six gynaecologists and six midwives was introduced at the study clinic. The success rate of external cephalic version and mode of delivery were analysed. In addition, predictors for success were examined by logistic regression analysis. Successful external cephalic version was defined as fetal cephalic presentation immediately following the procedure. RESULTS: Following the introduction of a dedicated team in 2014, the success rate of external cephalic version increased from 39.8% in 2013 to 69.5% in 2017 (p < 0.001), with the greatest increase in nulliparous women (from 23.5% to 58.5%, p = 0.002). Over the 5-year study period, the vaginal delivery rate after external cephalic version increased from 43% in 2013 to 71% in 2017 (p < 0.05). The rate of caesarean section after external cephalic version decreased from 55% to 27% (p < 0.05). Anterior placenta [odds ratio (OR) 0.7, 95% confidence interval (CI) 0.48‒0.97] and complete breech (OR 0.2, 95% CI 0.07‒0.90) were significantly associated with a lower success rate. CONCLUSIONS: This study showed that introduction of a dedicated team led to a significant increase in the success rate of external cephalic version, and a significant decrease in the rate of caesarean section for women presenting with breech in pregnancy.

Different methods of pain relief for IVF and ICSI oocyte retrieval - A Dutch survey.

OBJECTIVE: Which analgesia methods are used during oocyte retrieval in the Netherlands? STUDYDESIGN: In April 2017, an online survey containing questions on the analgesia protocol used for IVF/ICSI oocyte retrieval was sent to all clinics in the Netherlands that perform oocyte retrievals. RESULTS: The response rate was 97%. We uncovered the large variety of medication protocols used for pain relief during oocyte retrieval in the Netherlands. Based on the main component of the given analgesia, we distinguished the three most frequently used analgesia protocols: intravenously (i.v.) administered opioids, intramuscularly (i.m) administered opioids, and non-sedative oral analgesics. Aside from analgesia, 61% provided anxiolysis with a benzodiazepine. Nearly half of the clinics registered pain scores. The vital functions were monitored at all clinics administering opioids i.v., but at none of the clinics administering opioids i.m. CONCLUSIONS: A wide variety of analgesia protocols are used. The three most frequently used are i.v. administered opioids, i.m. administered opioids, and non-sedative oral analgesics. The variety of analgesia protocols is not desirable in the context of good clinical practice, and considering the risks of combining opioids and benzodiazepines. Monitoring of vital functions was only performed after administration of i.v. medication. A comparison of the pain scores could be a first step in finding the optimal method of analgesia, thereby forming the basis of guidelines for analgesia during oocyte retrieval.

Obesity affects spontaneous pregnancy chances in subfertile, ovulatory women.

BACKGROUND: Obesity is increasing rapidly among women all over the world. Obesity is a known risk factor for subfertility due to anovulation, but it is unknown whether obesity also affects spontaneous pregnancy chances in subfertile, ovulatory women. METHODS: We evaluated whether obesity affected the chance of a spontaneous pregnancy in a prospectively assembled cohort of 3029 consecutive subfertile couples. Women had to be ovulatory and had to have at least one patent tube, whereas men had to have a normal semen analysis. Time to spontaneous ongoing pregnancy within 12 months was the primary endpoint. RESULTS: The probability of a spontaneous pregnancy declined linearly with a body mass index (BMI) over 29 kg/m(2). Corrected for possible related factors, women with a high BMI had a 4% lower pregnancy rate per kg/m(2) increase [hazard ratio: 0.96 (95% CI 0.91-0.99)]. CONCLUSIONS: These results indicate that obesity is associated with lower pregnancy rates in subfertile ovulatory women.

Which factors play a role in clinical decision-making in external cephalic version?

OBJECTIVE: To assess the clinical factors that influence the estimates of clinicians of the success of an external cephalic version(ECV), and the subsequent management decisions made by clinicians. DESIGN: We constructed 16 fictional vignettes of women with a term fetus in breech position eligible for ECV. Setting. Secondary and tertiary clinics in The Netherlands. POPULATION: Thirty-seven gynaecologists, residents and midwifes. METHODS: Sixteen case summaries concerning a hypothetical patient eligible for ECV. Potential prognostic factors that varied between the cases were parity, maternal body mass index, engagement of the fetus, amniotic fluid, fetal growth, fetal presentation and placental localisation. For each case presentation, the clinicians were asked for their inclination to perform an ECV, and whether or not they would use tocolysis. RESULTS: The estimated probabilities of success varied between 20 and 60%. The number of clinicians that would attempt an ECV varied per case between 32 and 97%. Amniotic fluid and engagement contributed 80% of the variation in the decision to perform ECV. In the case of oligohydramnios or an engaged breech, the clinicians tended not to perform an ECV. CONCLUSION: Amniotic fluid and engagement seem to be the main factors in the clinical decision-making of clinicians in ECV.This decision-making is probably experience based. Systematic knowledge of clinical prognosticators and subsequent assessment of their prognostic capacity is needed.

A prediction model for ongoing pregnancy after in vitro fertilization in couples with male subfertility.

OBJECTIVE: To assess the predictive capacity of male and female characteristics on in vitro fertilization (IVF) outcome in couples with male subfertility and to construct an IVF prediction model. STUDY DESIGN: We performed a cohort study including all couples with male subfertility undergoing IVF. The main outcome measure was an ongoing pregnancy after IVF. The baseline characteristics from a couple including parameters of the semen-analysis were included in a univariable and multivariable analysis to construct a prediction model (model I). The addition of antisperm antibodies (ASA) and post-wash total motile count (TMC) to models I, II and III, respectively, were analyzed. RESULTS: We included 275 couples with male subfertility who underwent 473 IVF cycles with an ongoing pregnancy rate of 19% per cycle. A prediction model containing female age, secondary subfertility, percentage progressively motile sperm, percentage sperm with normal morphology, prewash total motile sperm count, bilateral tubal pathology, history of intrauterine insemination and cycle number was constructed (model I). Prediction with model I resulted in the selection of 95 couples, of whom 55 conceived (pregnancy rate of 28% per cycle). Use of the model with n ASA (Model II) resulted in the selection of 79 couples, of whom still 55 conceived (30% per cycle). CONCLUSION: In couples with male subfertility, the use of a prediction model including ASA improves the efficiency of IVF.

Treatment strategies and cumulative live birth rates in WHO-II ovulation disorders.

OBJECTIVE: To assess the live birth rate in women with WHO II anovulation and the proportion of women that need second or third line treatments if the initial therapy fails. STUDY DESIGN: In this multicenter cohort study we included couples with unfulfilled child wish who were referred to three fertility clinics in the Netherlands and selected women with a WHO II ovulation disorder as the only final infertility diagnosis (n = 468). RESULTS: The cumulative live birth rate of the total group was 82% (383/468). The majority started with clomiphene-citrate as first-line treatment (n = 378) resulting in 180 (48%) live births. There were 153 couples (40%) who underwent a second-line treatment (recombinant-FSH or laparoscopic electrocoagulation of the ovaries, LEO) and 52 couples (14%) a third-line treatment (IVF/ICSI), resulting in 44% and 63% treatment dependent live births rates, respectively. Of all couples, 92 (20%) conceived naturally, 186 (40%) after clomiphene-citrate, 60 (13%) after recombinant-FSH, nine (2%) after LEO and 36 (8%) after IVF. CONCLUSION: Subfertile women with a WHO II ovulation disorder have a good prognosis on live birth, and most did so after ovulation induction with clomiphene-citrate. If first-line ovulation induction has failed ovulation induction with gonadotrophins or IVF still result in a live birth in about half of the cases.