[A rare cause of chronic pelvic pain]. / Een bijzondere oorzaak van chronische buikpijn.

BACKGROUND: Chronic pelvic pain, a continuous or intermittent, non-menstrual and non-cyclic pelvic pain, lasting for at least six months and of sufficient severity to interfere with daily activities, remains a medical challenge. Thorough evaluation is advised as unrecognized abnormalities can be present. CASE DESCRIPTION: A 22-years-old nulligravid with a inguinal herniorrhaphy during infancy was referred with chronic pelvic pain. The left ovary and tube were trapped in the inguinal canal. Laparoscopy confirmed the left ovary and tube adherent to the anterior abdominal wall. Dissection with adhesiolysis freed the dislocated left tube and ovary. A laparoscopic transabdominal pre-peritoneal (TAPP) procedure was performed to prevent hernia recurrence. The patient is since then pain free. CONCLUSION: Chronic pelvic pain can be a sing of an adnexal dislocation, which is a rare complication following inguinal hernia repair. Medical history is of great importance to reveal this unexpected condition.

Risk Factors for Adhesion-Related Readmission and Abdominal Reoperation after Gynecological Surgery: A Nationwide Cohort Study.

More than half of women in developed countries undergo surgery during their lifetime, putting them at risk of adhesion-related complications. Adhesion-related complications include small bowel obstruction, chronic (pelvic) pain, subfertility, and complications associated with adhesiolysis during reoperation. The aim of this study is to predict the risk for adhesion-related readmission and reoperation after gynecological surgery. A Scottish nationwide retrospective cohort study was conducted including all women undergoing a gynecological procedure as their initial abdominal or pelvic operation between 1 June 2009 and 30 June 2011, with a five-year follow-up. Prediction models for two- and five-year risk of adhesion-related readmission and reoperation were constructed and visualized using nomograms. To evaluate the reliability of the created prediction model, internal cross-validation was performed using bootstrap methods. During the study period, 18,452 women were operated on, and 2719 (14.7%) of them were readmitted for reasons possibly related to adhesions. A total of 2679 (14.5%) women underwent reoperation. Risk factors for adhesion-related readmission were younger age, malignancy as indication, intra-abdominal infection, previous radiotherapy, application of a mesh, and concomitant inflammatory bowel disease. Transvaginal surgery was associated with a lower risk of adhesion-related complications as compared to laparoscopic or open surgeries. The prediction model for both readmissions and reoperations had moderate predictive reliability (c-statistics 0.711 and 0.651). This study identified risk factors for adhesion-related morbidity. The constructed prediction models can guide the targeted use of adhesion prevention methods and preoperative patient information in decision-making.

[Seizures in pregnancy: not always eclamptic seizures]. / Een insult tijdens de zwangerschap.

BACKGROUND: The differential diagnosis of seizures during pregnancy is extensive and includes potentially fatal underlying diagnoses. Both pregnancy and non-pregnancy related aetiologies should be considered. CASE DESCRIPTION: A 38-years old pregnant woman presented to the emergency department at 31 weeks and 5 days with generalized tonic-clonic seizures. Initial an eclamptic seizure was suspected. Because the seizures lasted despite treatment with magnesium sulphate and anti-epileptic medication. Imaging of the head was performed and a brain tumour was suspected and a biopsy revealed the presence of a high-grade glioma. At 37 weeks of gestation, labour was induced and the patient delivered a healthy daughter. The patient was then palliatively treated with antiepileptic drugs and chemotherapy. CONCLUSION: Structural brain changes caused by a high-grade gliomas represent a rare cause of seizure during pregnancy, emphasizing the importance of considering non-obstetric causes of seizures in pregnant women.

The link between intrauterine adhesions and impaired reproductive performance: a systematic review of the literature.

BACKGROUND: Intrauterine adhesions (IUAs) are one of the main reproductive system diseases in women worldwide. Fusion between the injured opposing walls leads to partial-to-complete obliteration of the cavity and/or cervical canal. The main clinical manifestations in case of IUAs are menstrual disturbances, cyclic pain and reproductive disorders. The reproductive outcomes of women with IUAs remain limited and inefficient compared to women without IUAs, even after adhesiolysis. An exact understanding of the underlying mechanisms and processes to explain the compromised reproductive performance and outcomes in case of IUAs are lacking. METHODS: A systematic literature review of MEDLINE-PubMed (1966 to January 2022) and EMBASE (1974 to January 2022) was performed following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Studies were included if they reported underlying causes, related mechanisms and processes to explain the association between IUAs and impaired reproductive performance, pregnancy and obstetric complications. RESULTS: After an extensive review of the literature, 58 articles were identified reporting underlying mechanisms to explain the association between IUAs and impaired fertility. Intrauterine scarring influences the process of fertilization, reproductive performance and ultimately reproductive outcome. IUAs can disturb the cervico-utero-tubal sperm transport and result in an avascular and unresponsive endometrium with decreased receptivity and thickness. Abnormal decidualization and abnormal trophoblastic infiltration leads to placental attachment disorders. Moreover, the risk for premature delivery, intrauterine fetal growth restriction and fetal anomalies is increased in case of IUAs. CONCLUSION: The impact of IUAs on reproductive performance, even after adhesiolysis, is becoming more apparent. The postulated mechanisms to explain the association are related to sperm transport, embryo implantation and placentation. Prevention, by preserving the basal layer of the endometrium is essential. Effective and evidence-based strategies for the prevention of endometrial injury and formation of IUAs, are urgently needed.

Safety and Efficacy of a Novel Barrier Film to Prevent Intrauterine Adhesion Formation after Hysteroscopic Myomectomy: The PREG1 Clinical Trial.

STUDY OBJECTIVE: To evaluate the safety and potential efficacy of a novel degradable polymer film (DPF) designed to act as a 7-day barrier to prevent intrauterine adhesions (IUAs) after hysteroscopic myomectomy. DESIGN: A prospective single-arm, first-in-human clinical study. SETTING: Multicenter study involving 6 centers in France, Belgium, and the Netherlands. PATIENTS: Women aged 40 years or older with no plans to conceive who qualified for hysteroscopic myomectomy (at least 1 10-mm type 0, 1, or 2 myoma) and had a sounded length of the uterine cavity (fundus to exocervix) ranging between 6 cm and 9 cm were considered eligible for the study. INTERVENTIONS: The DPF was inserted after hysteroscopic transcervical myoma resection. The women were followed up by a telephone call at 30 days and second-look hysteroscopy 4 to 8 weeks after the procedure. MEASUREMENTS AND MAIN RESULTS: The chosen safety outcome measures were uterine perforation or cervical trauma at the time of the DPF insertion and unexpected fever, pain, or bleeding beyond 48 hours and up to 30 days after insertion, whereas the outcome measure for efficacy was the absence of IUAs on second-look hysteroscopy. A total of 23 women participated in the study. There were no incidents of uterine perforation or cervical trauma at the time of the DPF insertion. There were no reported adverse effects attributable to the DPF. On second-look hysteroscopy, 20 (87%) of the 23 women had no IUAs. CONCLUSION: The DPF is a novel, easy-to-apply, and acceptable device to prevent IUAs, with very promising initial safety and efficacy data.

Reproductive outcomes in women with mild intrauterine adhesions; a systematic review and meta-analysis.

BACKGROUND: Moderate to severe intrauterine adhesions (IUAs) may greatly impact fertility, predisposing to pregnancy and obstetric complications. The impact of mild IUAs on reproductive performance remains unclear. A systematic review and meta-analysis was performed to examine the long-term reproductive outcomes in women with hysteroscopic identified and treated mild IUAs mild intrauterine adhesions (IUAs). METHODS: An electronic literature search was conducted using MEDLINE and EMBASE from inception to June 2019. All prospective cohort, cross-sectional studies or randomized controlled trials Clinical trials in which reproductive outcomes of women with mild IUAs, were reported were included. RESULTS: Five studies, reporting on reproductive outcomes of 229 women with hysteroscopic identified and treated mild IUAs, were included. The pregnancy rate was 62.3% (142 of 228; 95% CI: 0.55-0.72, I2 25%, p = .21) and in 86.6% (123 of 142) a live birth was encountered (95% CI: 0.71-0.97) with 83.1% (108 out of 130) term deliveries (95% CI: 0.53-0.95). A miscarriage was reported in 10% (13 of 130; 95% CI: 0.02-0.26). Due to the lack of a control group, reproductive outcomes were compared to a general population. Pregnancy and live birth rates were significantly lower in women with identified and treated mild IUAs, 90% versus 62.3% and respectively 99.5% versus 86.6%. The miscarriage rate was similar. Data on obstetric and neonatal outcomes are lacking. CONCLUSIONS: Women with hysteroscopic identified and treated mild IUAs seem to have lower pregnancy and live birth rate compared to the general population. Future studies consisting of a large cohort of women with hysteroscopic identified and treated IUAs with structural follow-up and a control group are needed to confirm our findings.

Reproductive performance of women with and without intrauterine adhesions following recurrent dilatation and curettage for miscarriage: long-term follow-up of a randomized controlled trial.

STUDY QUESTION: Are the long-term reproductive outcomes following recurrent dilatation and curettage (D&C) for miscarriage in women with identified and treated intrauterine adhesions (IUAs) comparable to women without IUAs. SUMMARY ANSWER: Reproductive outcomes in women with identified and treated IUAs following recurrent D&C for miscarriage are impaired compared to women without IUAs; fewer ongoing pregnancies and live births are achieved with a prolonged time to a live birth. WHAT IS KNOWN ALREADY: The Prevention of Adhesions Post Abortion (PAPA) study showed that application of auto-crosslinked hyaluronic acid (ACP) gel, an absorbable barrier in women undergoing recurrent D&C for miscarriage resulted in a lower rate of IUAs, 13% versus 31% (relative risk 0.43, 95% CI 0.22 to 0.83), lower mean adhesion score and significant less moderate to severe IUAs. It is unclear what the impact is of IUAs on long-term reproductive performance. STUDY DESIGN, SIZE, DURATION: This was a follow-up of the PAPA study, a multicenter randomized controlled trial evaluating the application of ACP gel in women undergoing recurrent D&C for miscarriage. All included women received a diagnostic hysteroscopy 8-12 weeks after randomization to evaluate the uterine cavity and for adhesiolysis if IUAs were present. Here, we present the reproductive outcomes in women with identified and treated IUAs versus women without IUAs, 46 months after randomization. PARTICIPANTS/MATERIALS, SETTING, METHODS: Between December 2011 and July 2015, 152 women with a first-trimester miscarriage with at least one previous D&C, were randomized for D&C alone or D&C with immediate intrauterine application of ACP gel. Participants were approached at least 30 months after randomization to evaluate reproductive performance, obstetric and neonatal outcomes and cycle characteristics. Additionally, the medical files of all participants were reviewed. Main outcome was ongoing pregnancy. Outcomes of subsequent pregnancies, time to conception and time to live birth were also recorded. MAIN RESULTS AND THE ROLE OF CHANCE: In women pursuing a pregnancy, 14/24 (58%) ongoing pregnancies were recorded in women with identified and treated IUAs versus 80/89 (90%) ongoing pregnancies in women without IUAs odds ratio (OR) 0.18 (95% CI 0.06 to 0.50, P-value <0.001). Documented live birth was also lower in women with IUAs; 13/24 (54%) with versus 75/89 (84%) without IUAs, OR 0.22 (95% CI: 0.08 to-0.59, P-value 0.004). The median time to conception was 7 months in women with identified and treated IUAs versus 5 months in women without IUAs (hazard ratio (HR) 0.84 (95% CI 0.54 to 1.33)) and time to conception leading to a live birth 15 months versus 5.0 months (HR 0.54 (95% CI: 0.30 to 0.97)). In women with identified and treated IUAs, premature deliveries were recorded in 3/16 (19%) versus 4/88 (5%) in women without IUAs, P-value 0.01. Complications were recorded in respectively 12/16 (75%) versus 26/88 (30%), P-value 0.001. No differences were recorded in mean birth weight between the groups. LIMITATIONS, REASONS FOR CAUTION: In the original PAPA study, randomization was applied for ACP gel application. Comparing women with and without IUAs is not in line with the randomization and therefore confounding of the results cannot be excluded. IUAs, if visible during routine hysteroscopy after randomization were removed as part of the study protocol; the influence of IUAs on reproductive outcome may therefore be underestimated. Women undergoing a recurrent D&C for miscarriage were included, a specific group likely to generate clinically significant adhesions. The findings should therefore not be generalized to all women undergoing D&C for miscarriage. WIDER IMPLICATIONS OF THE FINDINGS: As IUAs have an impact on reproductive performance, even after hysteroscopic adhesiolysis, primary prevention is essential. Expectative and medical management should therefore be considered as serious alternatives for D&C in women with a miscarriage. In case D&C is necessary, application of ACP gel should be considered. STUDY FUNDING/COMPETING INTEREST(S): The original PAPA study (NTR 3120) was an investigator initiated study that was funded by the Foundation for scientific investigation in Obstetrics and Gynaecology of the Saint Lucas Andreas Hospital (currently renamed OLVG Oost), SWOGA. The syringes containing ACP gel were received from Anika Therapeutics, the manufacturer of Hyalobarrier® Gel Endo. The current follow-up study was also an investigator-initiated study without funding. The funder and sponsor had no role in the design of this follow-up study, data collection, data analysis, data interpretation, trial design, patient recruitment, writing of the report or any aspect pertinent to the study. ABH, RAL, JAFH and JWRT have no conflict to declare. HAMB reports being a member of safety board research Womed. TRIAL REGISTRATION NUMBER: Netherlands Trial Register NTR 3120.

The long-term costs and effects of tubal flushing with oil-based versus water-based contrast during hysterosalpingography.

RESEARCH QUESTION: What are the long-term costs and effects of oil- versus water-based contrast in infertile women undergoing hysterosalpingography (HSG)? DESIGN: This economic evaluation of a long-term follow-up of a multicentre randomized controlled trial involved 1119 infertile women randomized to HSG with oil- (n = 557) or water-based contrast (n = 562) in the Netherlands. RESULTS: In the oil-based contrast group, 39.8% of women needed no other treatment, 34.6% underwent intrauterine insemination (IUI) and 25.6% had IVF/intracytoplasmic sperm injection (ICSI) in the 5 years following HSG. In the water-based contrast group, 35.0% of women had no other treatment, 34.2% had IUI and 30.8% had IVF/ICSI in the 5 years following HSG (P = 0.113). After 5 years of follow-up, HSG using oil-based contrast resulted in equivalent costs (mean cost difference -€144; 95% confidence interval [CI] -€579 to +€290; P = 0.515) for a 5% increase in the cumulative ongoing pregnancy rate compared with HSG using water-based contrast (80% compared with 75%, Relative Risk (RR) 1.07; 95% CI 1.00-1.14). Similarly, HSG with oil-based contrast resulted in equivalent costs (mean cost difference -€50; 95% CI -€576 to +€475; P = 0.850) for a 7.5% increase in the cumulative live birth rate compared with HSG with water-based contrast (74.8% compared with 67.3%, RR 1.11; 95% CI 1.03-1.20), making it the dominant strategy. Scenario analyses suggest that the oil-based contrast medium is the dominant strategy up to a price difference of €300. CONCLUSION: Over a 5-year follow-up, HSG with an oil-based contrast was associated with a 5% increase in ongoing pregnancy rate, a 7.5% increase in live birth rate and similar costs to HSG with water-based contrast.

[A woman with a tumour in her lesser pelvis]. / Een vrouw met een tumor in het kleine bekken.

A 63-year-old postmenopausal woman was referred for a mass on MRI: a well-defined 13 cm hyperechoic mass with high fat content. Exploratory laparotomy revealed normal ovaries and an enlarged uterus; hysterectomy was performed. Histological examination found uterine lipoleiomyoma, a rare benign type of uterine myoma.

Pregnancy and neonatal outcomes 42 months after application of hyaluronic acid gel following dilation and curettage for miscarriage in women who have experienced at least one previous curettage: follow-up of a randomized controlled trial.

OBJECTIVE: To study whether intrauterine application of auto-crosslinked polymers of hyaluronic acid (ACP) gel after dilation and curettage (D&C) improves reproductive outcomes. DESIGN: Follow-up of a prospective randomized trial. SETTING: University and university-affiliated teaching hospitals. PATIENT(S): Women with a miscarriage at <14 weeks' gestation with at least one previous D&C were randomized to D&C plus ACP gel (intervention) or D&C alone (control). A hysteroscopy was performed after 8-12 weeks, and if intrauterine adhesion (IUAs) were encountered, adhesiolysis was executed. INTERVENTION(S): Participants received a questionnaire 30 months after treatment. MAIN OUTCOME MEASURE(S): Ongoing pregnancy and outcome of subsequent pregnancies. RESULT(S): Ongoing pregnancies were recorded in 74.6% (50/67) of the intervention group versus 67.2% (43/64) of the control group, and in, respectively, 94.3% (50/53) versus 71.7% (43/60) in the women wishing to conceive. The median times to conception leading to a live birth were, respectively, 21.9 versus 36.1 months. Reduced menstrual blood loss was reported in 7.5% (5/67) versus 20.3% (13/64) and dysmenorrhea in 14.9% (10/67) versus 34.4% (22/64), respectively. CONCLUSION(S): Application of ACP gel following D&C performed after miscarriage seems to have a favorable effect on subsequent reproductive outcomes in women with at least one previous D&C. Given the fact that the study was not powered for reproductive outcomes, the data should be interpreted with caution. The effect may be underestimated due to routine removal of IUAs. DUTCH CLINICAL TRIAL REGISTRY NUMBER: NTR 3120.

Tubal flushing with oil-based or water-based contrast at hysterosalpingography for infertility: long-term reproductive outcomes of a randomized trial.

OBJECTIVE: To determine the impact of oil-based versus water-based contrast on pregnancy and live birth rates ≤5 years after hysterosalpingography (HSG) in infertile women. DESIGN: A 5-year follow-up study of a multicenter randomized trial. SETTING: Hospitals. PATIENT(S): Infertile women with an ovulatory cycle, 18-39 years of age, and having a low risk of tubal pathology. INTERVENTION(S): Use of oil-based versus water-based contrast during HSG. MAIN OUTCOME MEASURE(S): Ongoing pregnancy, live births, time to ongoing pregnancy, second ongoing pregnancy. RESULT(S): A total of 1,119 women were randomly assigned to HSG with oil-based contrast (n = 557) or water-based contrast (n = 562). After 5 years, 444 of 555 women in the oil group (80.0%) and 419 of 559 women in the water group (75.0%) had an ongoing pregnancy (relative risk [RR] 1.07; 95% confidence interval [CI] 1.00-1.14), and 415 of 555 women in the oil group (74.8%) and 376 of 559 women in the water group (67.3%) had live births (RR 1.11; 95% CI 1.03-1.20). In the oil group, 228 pregnancies (41.1%) were conceived naturally versus 194 (34.7%) pregnancies in the water group (RR 1.18; 95% CI 1.02-1.38). The time to ongoing pregnancy was significantly shorter in the oil group versus the water group (10.0 vs. 13.7 months; hazard ratio, 1.25; 95% CI 1.09-1.43). No difference was found in the occurrence of a second ongoing pregnancy. CONCLUSION(S): During a 5-year time frame, ongoing pregnancy and live birth rates are higher after tubal flushing with oil-based contrast during HSG compared with water-based contrast. More pregnancies are naturally conceived and time to ongoing pregnancy is shorter after HSG with oil-based contrast. CLINICAL TRIAL REGISTRATION NUMBER: Netherlands Trial Register (NTR) 3270 and NTR6577(www.trialregister.nl).

Perinatal outcomes of frequent attendance in midwifery care in the Netherlands: a retrospective cohort study.

BACKGROUND: Over the last decade, a trend towards high utilisation of primary maternity care was observed in high-income countries. There is limited research with contradictory results regarding frequent attendance (FA) and perinatal outcomes in midwifery care. Therefore, this study examined possible associations between FA in midwifery care and obstetric interventions and perinatal outcomes. METHODS: A retrospective cohort study was performed in a medium-sized midwifery-led care practice in an urban region in the Netherlands. Frequent attenders (FAs) were categorised using the Kotelchuck-Index Revised. Regression analyses were executed to examine the relationship between FAs and perinatal outcomes, stratified by antenatal referral to an obstetrician. Main outcomes of interest were Apgar score ≤ 7 and perinatal death, birth weight, mode of delivery, haemorrhage, place of birth, transfer during labour, and a requirement for pain relief. RESULTS: The study included 1015 women, 239 (24%) FAs and 776 (76%) non-FAs, 538 (53%) were not referred and 447 (47%) were referred to an obstetrician. In the non-referred group, FA was significantly associated with a requirement for pain relief (OR 1.98, 95% CI 1.24-3.17) and duration of dilatation (OR 1.20, 95% CI 1.04-1.38). In the referred group, FA was significantly associated with induction of labour (OR 1.86, 95% CI 1.17-2.95), ruptured perineum (OR 0.50, 95% CI 0.27-0.95) and episiotomy (OR 0.48, 95% CI 0.24-0.95). In the non-referred and the referred group, FA was not associated with the other obstetric and neonatal outcomes. Due to small numbers, we could not measure possible associations of FA with an Apgar score ≤ 7 and perinatal death. CONCLUSION: In our study, perinatal outcomes differed by FA and antenatal referral to an obstetrician. In the non-referred group, FA was significantly associated with medical pain relief and duration of dilatation. In the referred group, FA was significantly associated with induction of labour, ruptured perineum, and episiotomy. Further research with a larger study population is needed to look for a possible association between FA and primary adverse birth outcomes such as perinatal mortality.

Determinants and underlying causes of frequent attendance in midwife-led care: an exploratory cross-sectional study.

BACKGROUND: An adequate number of prenatal consultations is beneficial to the health of the mother and fetus. Guidelines recommend an average of 5-14 consultations. Daily practice, however, shows that some women attend the midwifery practice more frequently. This study examined factors associated with frequent attendance in midwifery-led care. METHODS: We conducted a cross-sectional study in a large midwifery practice in the Netherlands among low-risk women who started prenatal care in 2015 and 2016. Based on Andersen's behavioral model, we collected data on potential determinants from the digital midwifery's practice database. Prenatal healthcare utilization was measured by a revised version of the Kotelchuck Index, which measures a combination of care entry and numbers of visits. Logistic regression models were fitted to estimate the likelihood of frequent attendance compared to the recommended number of visits, adjusted for all relevant factors. Separate models were fitted on the non-referred and the referred group of obstetric-led care, as referral was found to be an effect modifier. RESULTS: The prevalence of frequent attendance was 23% (243/1053), mainly caused by worries and/or vague complaints (44%; 106/243). Among non-referred women, 53% (560/1053), frequent attendance was associated with consultation with an obstetrician (OR = 3.99 (2.35-6.77)) and exposure to sexual violence (OR = 2.17 (1.11-4.24)). Among the referred participants, 47% (493/1053), frequent attendance was associated with a consultation with an obstetrician (OR = 2.75 (1.66-4.57)), psychosocial problems in the past or present (OR = 1.85 (1.02-3.35) or OR = 2.99 (1.43-6.25)), overweight (OR = 1.88 (1.09-3.24)), and deprived area (OR = 0.50 (0.27-0.92)). CONCLUSION: Our exploratory study indicates that the determinants of frequent attendance in midwifery-led care differs between non-referred and referred women. Underlying causes for frequent attendance was mainly because of non-medical reasons. IMPLICATION FOR PRACTICE: A trustful midwife-client relationship is known to be needed for clients such as frequent attenders to share more detailed, personal stories in case of vague complaints or worries, which is necessary to identify their implicit needs.

Aggregate analysis of sentinel events as a strategic tool in safety management can contribute to the improvement of healthcare safety.

OBJECTIVE: To examine if clustering of root causes of sentinel events (SEs) can contribute to organisational improvement of healthcare and patient safety by providing insight into organisational risk factors, patterns and trends. DESIGN: Retrospective, cross-sectional review of SEs from a hospital database reported to the Board of directors in 2016. SETTING: A regional teaching hospital in the Netherlands. INTERVENTION(S): Clustering of characteristics and variables of SEs to establish vulnerabilities and patterns of failure factors of the organisation. MAIN OUTCOME MEASURE(S): Characteristics and contributory causes of failure of SEs identified via root cause analysis (RCA). Outcomes reported using descriptive statistics. RESULTS: A total of 21 events were included involving 21 patients. Mean age was 56.7 years (SD 24.4), 71.4% were above 50 years of age. In 81.8%, the care was multi-disciplinary and in 76.2% the event resulted in permanent harm or injury. Of the 132 identified contributory root causes, most were related to human factors (53.8%) and organisational factors (40.2%). Technical and patient-related factors were identified in 3.0%. Organisational improvement strategies focused on the care of elderly patients, patients subjected to multi-disciplinary care and on improving knowledge, protocols and coordination of care. CONCLUSION: Clustering variables of SEs and contributory factors of failure through RCA helps to delineate a hospital-specific profile by providing a detailed insight into risk factors, patterns and trends in an organisation and to determine the best strategies for improvement by drawing lessons across events.

Reproductive performance after the application of hyaluronic acid gel after dilation and curettage in women who have experienced at least one previous curettage: long-term results of a multicenter prospective randomized trial.

OBJECTIVE: To examine whether intrauterine application of auto-cross-linked hyaluronic acid (ACP) gel after dilation and curettage (D&C) improves reproductive performance. DESIGN: Multicenter prospective randomized trial. SETTING: One university and seven university-affiliated teaching hospitals. PATIENT(S): A total of 149 women who have experienced a miscarriage at <14 weeks of gestation, with at least one previous D&C for miscarriage or termination of pregnancy, were randomly assigned to either D&C plus ACP gel (intervention group) or D&C alone (control group). A hysteroscopy was performed 8-12 weeks after the procedure. Where intrauterine adhesions (IUAs) were found, adhesiolysis was executed. INTERVENTION(S): Participants received questionnaires 3, 6, and 12 months after the initial D&C procedure with questions regarding menstrual pattern, conception, and reproductive outcome. MAIN OUTCOME MEASURE(S): Reproductive outcomes during the 12 months after the D&C procedure. RESULT(S): Outcomes were available for 149 women: 77 in the intervention group and 72 in the control group. The conception rates were, respectively, 71% (46/64) and 59.7% (40/67). There was no significant difference in the miscarriage, ongoing pregnancy, and live birth rates. The median times to conception were 5.5 and 7.1 months, respectively. CONCLUSION(S): Reproductive performance was similar in both groups although there was a significant difference in the prevalence of IUAs. Given the favorable reproductive outcome in this underpowered study and the fact that adhesiolysis was executed, no solid conclusion can be drawn. Future studies are needed to evaluate the effect of ACP gel on fertility and reproductive outcomes. CLINICAL TRIAL REGISTRATION NUMBER: NTR 3120.

Pessary or Progesterone to Prevent Preterm delivery in women with short cervical length: the Quadruple P randomised controlled trial.

BACKGROUND: Preterm birth is in quantity and in severity the most important topic in obstetric care in the developed world. Progestogens and cervical pessaries have been studied as potential preventive treatments with conflicting results. So far, no study has compared both treatments. METHODS/DESIGN: The Quadruple P study aims to compare the efficacy of vaginal progesterone and cervical pessary in the prevention of adverse perinatal outcome associated with preterm birth in asymptomatic women with a short cervix, in singleton and multiple pregnancies separately. It is a nationwide open-label multicentre randomized clinical trial (RCT) with a superiority design and will be accompanied by an economic analysis. Pregnant women undergoing the routine anomaly scan will be offered cervical length measurement between 18 and 22 weeks in a singleton and at 16-22 weeks in a multiple pregnancy. Women with a short cervix, defined as less than, or equal to 35 mm in a singleton and less than 38 mm in a multiple pregnancy, will be invited to participate in the study. Eligible women will be randomly allocated to receive either progesterone or a cervical pessary. Following randomization, the silicone cervical pessary will be placed during vaginal examination or 200 mg progesterone capsules will be daily self-administered vaginally. Both interventions will be continued until 36 weeks gestation or until delivery, whichever comes first. Primary outcome will be composite adverse perinatal outcome of perinatal mortality and perinatal morbidity including bronchopulmonary dysplasia, intraventricular haemorrhage grade III and IV, periventricular leukomalacia higher than grade I, necrotizing enterocolitis higher than stage I, Retinopathy of prematurity (ROP) or culture proven sepsis. These outcomes will be measured up until 10 weeks after the expected due date. Secondary outcomes will be, among others, time to delivery, preterm birth rate before 28, 32, 34 and 37 weeks, admission to neonatal intensive care unit, maternal morbidity, maternal admission days for threatened preterm labour and costs. DISCUSSION: This trial will provide evidence on whether vaginal progesterone or a cervical pessary is more effective in decreasing adverse perinatal outcome in both singletons and multiples. TRIAL REGISTRATION: Trial registration number: NTR 4414 . Date of registration January 29th 2014.

Oil-Based or Water-Based Contrast for Hysterosalpingography in Infertile Women.

BACKGROUND: Pregnancy rates among infertile women have been reported to increase after hysterosalpingography, but it is unclear whether the type of contrast medium used (oil-based or water-soluble contrast) influences this potential therapeutic effect. METHODS: We performed a multicenter, randomized trial in 27 hospitals in the Netherlands in which infertile women who were undergoing hysterosalpingography were randomly assigned to undergo this procedure with the use of oil-based or water-based contrast. Subsequently, couples received expectant management or the women underwent intrauterine insemination. The primary outcome was ongoing pregnancy within 6 months after randomization. Outcomes were analyzed according to the intention-to-treat principle. RESULTS: A total of 1119 women were randomly assigned to hysterosalpingography with oil contrast (557 women) or water contrast (562 women). A total of 220 of 554 women in the oil group (39.7%) and 161 of 554 women in the water group (29.1%) had an ongoing pregnancy (rate ratio, 1.37; 95% confidence interval [CI], 1.16 to 1.61; P<0.001), and 214 of 552 women in the oil group (38.8%) and 155 of 552 women in the water group (28.1%) had live births (rate ratio, 1.38; 95% CI, 1.17 to 1.64; P<0.001). Rates of adverse events were low and similar in the two groups. CONCLUSIONS: Rates of ongoing pregnancy and live births were higher among women who underwent hysterosalpingography with oil contrast than among women who underwent this procedure with water contrast. (Netherlands Trial Register number, NTR3270 .).

Prevalence of intrauterine adhesions after the application of hyaluronic acid gel after dilatation and curettage in women with at least one previous curettage: short-term outcomes of a multicenter, prospective randomized controlled trial.

OBJECTIVE: To examine whether intrauterine application of auto-crosslinked hyaluronic acid (ACP) gel, after dilatation and curettage (D&C), reduces the incidence of intrauterine adhesions (IUAs). DESIGN: Multicenter; women and assessors blinded prospective randomized trial. SETTING: University and university-affiliated teaching hospitals. PATIENT(S): A total of 152 women with a miscarriage of <14 weeks with at least one previous D&C for miscarriage or termination of pregnancy. INTERVENTION(S): Women were randomly assigned to either D&C plus ACP gel (intervention group) or D&C alone (control group). A follow-up diagnostic hysteroscopy was scheduled 8-12 weeks after the D&C procedure. MAIN OUTCOME MEASURE(S): The primary outcome was the number of women with IUAs and the secondary outcome was the severity of IUAs. RESULT(S): Outcomes were available for 149 women: 77 in the intervention group and 72 in the control group. The IUAs were observed in 10 (13.0%) and 22 women (30.6%), respectively (relative risk, 0.43; 95% confidence interval 0.22-0.83). Mean adhesion score and the amount of moderate-to-severe IUAs were significantly lower in the intervention group according to the American Fertility Society (AFS) and European Society of Gynecological Endoscopy classifications systems of adhesions. CONCLUSION(S): Intrauterine application of ACP gel after D&C for miscarriage in women with at least one previous D&C seems to reduce the incidence and severity of IUAs but does not eliminate the process of adhesion formation completely. Future studies are needed to confirm our findings and to evaluate the effect of ACP gel on fertility and reproductive outcomes. CLINICAL TRIAL REGISTRATION NUMBER: NTR 3120.

Prevalence of intrauterine adhesions after termination of pregnancy: a systematic review.

OBJECTIVES: Termination of pregnancy (TOP) is one of the most performed interventions in women worldwide: approximately one in three women will have at least one TOP in their reproductive life. Intrauterine adhesions (IUAs) have been reported as a possible complication after TOP, but their prevalence has not been established, as women are not routinely evaluated. IUAs are associated with menstrual disturbances, infertility and obstetric complications. METHODS: We searched Ovid MEDLINE, Ovid EMBASE and CENTRAL from inception until November 2015 for studies evaluating women following TOP. We selected studies in which women were evaluated consecutively, independently of symptoms, by hysteroscopy or hysterosalpingography (HSG), for the presence of IUAs. RESULTS: After an extensive review of the literature, no studies were found that evaluated women after medical TOP and no randomised trials following surgical TOP. Only two prospective cohort studies were identified. In the first, IUAs were detected in 21.2% of women evaluated by hysteroscopy following first trimester surgical TOP; adhesions were moderate to severe in 48%. In the second, IUAs were detected in 16.2% of women evaluated by HSG after second trimester TOP by intra-amniotic prostaglandin induction followed by D&C; a pathologically wide internal cervical os was observed in 12%. CONCLUSIONS: This systematic review suggests a link between TOP and adhesion formation, but, according to the scientific literature and despite new diagnostic facilities, the relationship between the methods of TOP and IUA formation remains unclear. Nevertheless, the reported frequency is in accordance with that found in women following D&C for miscarriage. Further research is required.