Irritable bowel syndrome worsens faecal incontinence after primary repair of major obstetric anal sphincter injuries.

AIM: Obstetric anal sphincter injuries (OASIS) occur in approximately 3%-6% of vaginal deliveries and are the leading risk factor for late-onset faecal incontinence, which is an underdiagnosed pathology. The aim of this work was to use a validated scoring system to quantify the effect of irritable bowel syndrome (IBS) on the severity of faecal incontinence symptoms after primary repair of major OASIS (Grade IIIb-IV). METHOD: A prospective cohort study was performed on all women who underwent primary repair of major OASIS over a 6-year period. They were assessed with ultrasonography within 12 weeks. Two control groups (who did not have OASIS) were women who underwent elective caesarean section and primigravid women. Questionnaires were sent at least 12 months after delivery, or at first consultation for primigravids, which generated the main outcome measures: Cleveland Clinic faecal incontinence severity scores and the presence of IBS based on Rome III criteria. RESULTS: There was a total of 211 patients included in the three groups and the mean follow-up time was 26 months after sphincter repair. Ultrasonographic sphincter defects were detected in 37% but did not affect the faecal incontinence score (p = 0.47), except in patients with IBS. Within each group, patients with IBS had significantly worse faecal incontinence than those without. Women with both OASIS and IBS had the most severe faecal incontinence scores. CONCLUSION: OASIS has a limited negative effect on faecal incontinence, independent of whether residual ultrasonographic sphincter defects are present. However, the presence of IBS has a significant compounding effect on faecal incontinence in OASIS patients. The effect of IBS on faecal incontinence is also notable in caesarean section patients and primigravids, suggesting that IBS is an independent risk-factor that should have its place in predelivery assessment and counselling.

Evaluation of a new, low-dose levonorgestrel intrauterine contraceptive system over 5 years of use.

OBJECTIVE: To evaluate the efficacy and safety of a new, low-dose levonorgestrel intrauterine contraceptive system (LNG-IUS 12) for up to 5 years of use. STUDY DESIGN: In this Phase III study, 2885 nulliparous and parous women aged 18-35 years were randomized to LNG-IUS 8 or LNG-IUS 12 for 3 years. After 3 years, women using LNG-IUS 12 could continue for up to 2 additional years (5 years total). The primary outcome was occurrence of pregnancy (Pearl Index). Secondary outcomes included safety, bleeding, dysmenorrhea, discontinuations, and user satisfaction. RESULTS: From August 2007 through May 2008, out of 2885 women who were enrolled, 1453 were randomized to LNG-IUS 12. Placement was attempted in 1452/1453 (full analysis set). Mean age at baseline was 27.1 years; 39.5% were nulliparous. The cumulative 5-year Pearl Index (PI) was 0.29; the 5-year cumulative failure rate was 1.4%. The 5-year PI for ectopic pregnancy was 0.18. Over 5 years, 55.3% of women reported study drug-related treatment-emergent adverse events (TEAEs). Crude incidences of pelvic inflammatory disease, uterine perforation, and complete/partial LNG-IUS 12 expulsion were 0.6%, 0.2%, and 3.7%, respectively. Women using LNG-IUS 12 generally experienced less frequent bleeding over time. The incidence of amenorrhea during the last 90-day reference interval (end of Year 5) was 22.6%. Overall, 870 (59.9%) and 550 (37.9%) women completed 3 and 5 years of treatment, respectively; 77.8% of women who entered the extension phase completed 5 years of use. Over 5 years, 22.6% discontinued due to TEAEs, including 13 women who discontinued due to pregnancy; 76 discontinued due to bleeding problems including amenorrhea; and 163 discontinued due to desire for pregnancy, 71.2% of whom conceived within 12 months. CONCLUSION: In this study including parous and nulliparous women, LNG-IUS 12 was highly effective over 5 years of use and associated with a favorable safety profile. LNG-IUS 12 offers women a low-dose contraceptive option for up to 5 years.

A Phase III, single-arm study of LNG-IUS 8, a low-dose levonorgestrel intrauterine contraceptive system (total content 13.5mg) in postmenarcheal adolescents.

OBJECTIVE: To assess the safety profile of the low-dose levonorgestrel intrauterine system (LNG-IUS) total content 13.5mg (average approximate release rate 8µg/24h over the first year; LNG-IUS 8; Jaydess®) in adolescents. STUDY DESIGN: In a Phase III study in 36 European centers, 304 healthy nulliparous or parous postmenarcheal adolescents (12-17years) received LNG-IUS 8 for 12months. The primary outcome was the incidence of treatment-emergent adverse events (TEAEs). Secondary outcomes included: serious TEAEs, adverse events of special interest, overall user satisfaction, discontinuation rate at 12months, and Pearl Index. RESULTS: LNG-IUS 8 placement was successful in 303/304 participants (99.7%). Overall, 82.6% of participants reported TEAEs, and serious TEAEs and serious study drug-related TEAEs were reported by 7.6% and 1.0% of participants, respectively. No cases of pelvic inflammatory disease, ectopic pregnancy, or uterine perforation were reported. No pregnancies were reported during the 12-month study. At Month 12/study end, the overall user satisfaction rate was 83.9%. Overall, 51 participants (16.8%) prematurely discontinued the study before 12months; 13.8% of participants discontinued owing to TEAEs. CONCLUSIONS: No new or unexpected safety events were associated with the low-dose LNG-IUS 8. The safety profile of LNG-IUS 8 in adolescents was consistent with that previously reported in adults. The high overall user-satisfaction rate at study end and the low discontinuation rate over 12months demonstrate that LNG-IUS 8 is a highly acceptable contraceptive method among adolescents. IMPLICATIONS: This study is the first to assess the low-dose levonorgestrel intrauterine system LNG-IUS 8 (average approximate release rate 8µg/24h over the first year and total content 13.5mg) specifically in females<18years of age and confirms the safety and efficacy of LNG-IUS 8 in an adolescent population.

Understanding the barriers and myths limiting the use of intrauterine contraception in nulliparous women: results of a survey of European/Canadian healthcare providers.

OBJECTIVES: To evaluate healthcare providers' (HCPs') knowledge, attitudes and beliefs regarding intrauterine contraception (IUC). STUDY DESIGN: HCPs in eight European countries and Canada who saw at least 20 women per month for contraception completed an online questionnaire. Responses were evaluated by country. RESULTS: In total, 1103 HCPs completed the survey: 633 obstetrician-gynecologists, 335 general practitioners and 135 family planning clinicians (physician, midwife or nurse). When respondents in different countries were asked to report their three main barriers to considering IUC, predominant concerns were nulliparity (34-69%) and pelvic inflammatory disease (PID; 14-83%) for women in general, and insertion difficulty (25-83%), PID (17-83%), insertion pain (7-60%) and infertility (6-55%) for nulliparous women. In addition, 4-59% of HCPs reported that they never proactively include IUC in contraceptive counseling for a nulliparous woman, regardless of her age. Furthermore, only 30-61% of respondents correctly identified that, in the World Health Organization medical eligibility criteria for IUC, nulliparity is category 2 (benefits outweigh risks). CONCLUSIONS: HCPs in Europe and Canada have clear gaps in their knowledge regarding IUC and misplaced concerns persist, particularly regarding use of IUC in nulliparous women; the predominant misconceptions are about PID, insertion difficulty and insertion pain. Further education on the evidence is needed so that IUC is recognized as being suitable for young and nulliparous women and is included in contraceptive counseling.

[IVF surrogacy after embryo transfer abroad. Dilemmas of pregnancy follow-up]. / Draagmoederschap na ivf in het buitenland: dilemma's bij de begeleiding.

A 43-year-old female, gravida 3, para 2, who was 9 weeks pregnant, presented herself as a surrogate mother for a 33-year-old couple at our outpatient clinic in Heerlen, the Netherlands, for pregnancy follow-up. As she had not passed the selection procedure in the Netherlands (VU University Medical Center, Amsterdam), IVF using the gametes of the prospective parents and embryo transfer was performed in Belgium. We discussed the management of possible problems and complications during pregnancy and delivery. After an uneventful pregnancy and delivery a healthy boy was taken home by the donor couple. In the Netherlands, high-tech surrogate motherhood under strict non-commercial conditions has been accepted by law since 1997. Since the inclusion criteria are very strict, some couples seem to find a way to have their wish fulfilled abroad. Uniformity of the IVF surrogacy legislation in Europe is necessary to discourage this practice. When this situation occurs nevertheless, it is important that doctors involved know how to handle the (often unknown) medical, ethical, legal, emotional and psychosocial aspects associated with high-tech IVF-surrogacy.

Non-commercial surrogacy: an account of patient management in the first Dutch Centre for IVF Surrogacy, from 1997 to 2004.

BACKGROUND: Surrogacy was prohibited in the Netherlands until 1994, at which time the Dutch law was changed from the general prohibition of surrogacy to the prohibition of commercial surrogacy. This paper describes the results from the first and only Dutch Centre for Non-commercial IVF Surrogacy between 1997 and 2004. METHODS: A prospective study was conducted of all intended parents, and surrogate mothers and their partners (if present), in which medical, psychological and legal aspects of patient selection were assessed by questionnaires and interviews developed for this study. RESULTS: More than 500 couples enquired about surrogacy by telephone or e-mail. More than 200 couples applied for surrogacy in the Centre, of which, after extensive screening, 35 couples actually entered the IVF programme and 24 completed the treatment, resulting in 16 children being born to 13 women. Recommendations for non-commercial surrogacy are given, including abandoning the 1-year waiting period before adoption, currently dictated by law, avoiding a period of unnecessary psychological distress. CONCLUSIONS: Our study has shown that non-commercial IVF surrogacy is feasible, with good results in terms of pregnancy outcome and psychological outcome for all parents, and with no legal problems relating to the adoption procedures arising. The extensive screening of medical, psychological and legal aspects was a key element in helping to ensure the safety and success of the procedure.