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Introduction: Treatment of pregnancy‐associated breast cancer is complex, as providers try to balance risks to the pregnant person and the developing fetus. Given increased case fatality and increasing incidence, there is a pressing need understand the efficacy and safety of different treatment regimens in this population; however, pregnant and lactating people have traditionally been excluded from participating in randomized controlled trials (RCTs). Given recent efforts to expand the inclusion criteria for oncology RCTs, this study aimed to review the inclusion/exclusion criteria of current breast cancer RCTs to assess what proportion of trials permitted enrollment of pregnant and lactating persons. Material and methods: We conducted a comprehensive search of ClinicalTrials.gov in January 2022 to identify interventional studies of breast cancer in adults that were actively recruiting. The primary outcomes were the exclusion of pregnant and lactating people. Results: The search identified 1706 studies, of which 1451 met eligibility criteria. Overall, 69.4% and 54.8% of studies excluded pregnant and lactating people, respectively. The exclusion of pregnant and lactating persons differed by study characteristics but extended across all trial designs, locations, phases and interventions. Exclusion of pregnant and lactating persons was most common in trials where the intervention was biological (86.3%), drug (83.5%) or radiation (81.5%). Conclusions: The exclusion of pregnant and lactating people from clinical trials contributes to evidence gaps in how to treat this population. A paradigm shift is needed that focuses on how research can be used to protect pregnant people from future harms, instead of protecting pregnant people from research‐related risks. [ABSTRACT FROM AUTHOR]

Introduction: Children born to mothers with gestational diabetes mellitus (GDM) are at risk of metabolic disturbances such as diabetes mellitus and overweight. However, few have examined the outcome of children whose mothers were at risk of GDM. The aim of the study was to investigate how mothers' risk of developing GDM affects physical health and neurodevelopment of the children at 7 years of age. Material and methods: This is a secondary analysis of a follow‐up study of a multicenter randomized controlled trial including 855 pregnant women, carried out at St. Olavs Hospital, Trondheim University Hospital, and Stavanger University Hospital in Norway from 2007 to 2009. Risk factors for developing GDM included age >40 years, diabetes in near family, previous child with birthweight ≥4500 g and pre‐pregnancy body mass index (BMI) ≥25 kg/m2. Data on GDM risk factors were available for 750 women, who were divided into a risk group if they had one or more risk factors for developing GDM (n = 238) and a no risk (n = 512) group. At 7 years of age, 72 children born to mothers in the risk group and 194 children born to mothers in the no risk group participated. The children's height, weight and physical activity were reported by their parents. Neurodevelopmental outcomes were assessed by using the Five‐to‐Fifteen questionnaire, which includes motor skills, executive functions, perception, memory, language, social skills, and emotional/behavioral problems. Results: Most women had only one risk factor for GDM, and pre‐pregnancy overweight was the most prevalent risk factor. Children of mothers in the risk group had higher birthweight and length. At the 7‐year follow‐up, they had a higher weight and BMI, and the odds ratio of being overweight was 3.0 (95% confidence interval 1.1–8.3). There was no group difference in the children's physical activity and their neurodevelopmental outcomes were similar. Conclusions: We found higher BMI and increased risk of overweight in children born to mothers with one or more risk factors for developing GDM. A focus on preventing pre‐pregnancy overweight should be encouraged. [ABSTRACT FROM AUTHOR]

Introduction: Cesarean scar defect (CSD) is a long‐term outcome of cesarean section (CS) and associated with numerous gynecological and obstetric problems. Previous studies indicate that infection may be a risk factor for CSD. Adjunctive azithromycin was shown to reduce the risk of postoperative infection in patients undergoing non‐elective primary cesarean delivery in labor or after the rupture of membranes compared with standard antibiotic prophylaxis. This study investigated the protective effect of adjunctive azithromycin in combination with single‐dose cephalosporin against CSD in women undergoing non‐elective cesarean delivery. Material and methods: A randomized, double‐blind, controlled clinical trial was conducted in a University hospital in Shanghai, China. A total of 242 women who underwent their first non‐elective CS were randomly assigned to receive 1500 mg cefuroxime sodium plus 500 mg intravenous azithromycin (n = 121; experimental group) or 1500 mg cefuroxime sodium plus a placebo (n = 121; placebo group). The primary outcome was CSD prevalence, as determined by transvaginal ultrasound and saline infusion sonohysterography within 6 months of delivery. Secondary outcomes were changes in infectious indicators (eg hypersensitive C‐reactive protein and procalcitonin), postoperative morbidity, and use of postoperative antibiotics. We also examined the operative procedure, pathogenic microorganism cultures, and fetal outcomes. Outcomes were compared between groups with the chi‐squared test, Fisher's exact test, or Student's t test. Results: Between May 2018 and May 2021, 121 women were randomized to each arm. Because the sonographic follow up was disrupted by the coronavirus disease 2019 pandemic and strict management policies, we merged the follow‐up time points (6 weeks and 6 months) into a single time period (6 weeks to 6 months); 104 and 108 women in the experimental and placebo groups, respectively, completed the first sonographic follow up. CSD was diagnosed by sonography in 34/104 (32.7%) and 50/108 (46.3%) patients in the experimental and placebo groups, respectively (relative risk 0.71, 95% confidence interval 0.50–0.99; p = 0.043). Characteristics of CSD and short‐term infection outcomes did not differ between groups. Conclusions: A single dose of intravenous 500 mg azithromycin adjunctive to single‐dose cefuroxime prophylaxis significantly reduced the incidence of CSD in women undergoing non‐elective CS. [ABSTRACT FROM AUTHOR]

Introduction: The transfusion rate in hysterectomies for benign pathology is almost 3%. However, despite the strong interest in reducing intraoperative bleeding, limited evidence is available regarding the technical aspects concerning uterine vessel management during a total laparoscopic hysterectomy (TLH). Uterine artery (UA) closure in TLH can be performed at the origin from the internal iliac artery or at the uterus level (UL). However, low‐quality evidence is available regarding the superiority of one method over the other. Material and methods: We performed a single‐blind randomized (1:1) controlled trial (NCT04156932) between December 2019 and August 2020. One hundred and eighty women undergoing TLH for benign gynecological diseases were randomized to TLH with UA closure at the origin from the internal iliac artery (n = 90), performed at the beginning of the procedure by putting two clips per side at the origin, vs closure at the UL (n = 90). Intraoperative blood loss estimated from suction devices was the primary outcome. Secondary end points were perioperative outcomes, the conversion rate from one technique to the other, and complication rates with 4 months of follow up. Results: Uterine artery closure at the origin was completed in all 90 patients (0%), whereas closure at the UL was converted to closure at the origin in 11 cases (12.2%; p < 0.001); failures were mainly associated with the presence of endometriosis (81.8% [9/11] vs 10.1% [8/79]; p < 0.001). In the intention‐to‐treat analysis, the intraoperative blood loss was higher in the group assigned to the closure at the UL (108.5 mL) than in the group with closure at the origin (69.3 mL); the mean difference was 39.2 mL (95% CI 13.47–64.93 mL; p = 0.003). Other perioperative outcomes and complications rates did not differ. Conclusions: Uterine artery closure at the origin reduces intraoperative blood loss during a TLH and appears to be more reproducible than closure at the UL without higher complication rates. However, the absent translation in clinical benefits impedes the support of a clinical superiority in all women. Closure at the origin may provide clinical advantages in the presence of severe preoperative anemia or pelvic anatomic distortion. [ABSTRACT FROM AUTHOR]

Introduction: The aim of this study was to compare childbirth experiences and experience of labor pain in primiparous women who had received high‐ vs low‐dose oxytocin for augmentation of delayed labor. Material and methods: A multicenter, parallel, double‐blind randomized controlled trial took place in six Swedish labor wards. Inclusion criteria were healthy primiparous women at term with uncomplicated singleton pregnancies, cephalic fetal presentation, spontaneous onset of labor, confirmed delayed labor progress and ruptured membranes. The randomized controlled trial compared high‐ vs low‐dose oxytocin used for augmentation of a delayed labor progress. The Childbirth Experience Questionnaire version 2 (CEQ2) was sent to the women 1 month after birth. The CEQ2 consists of 22 items in four domains: Own capacity, Perceived safety, Professional support and Participation. In addition, labor pain was reported with a visual analog scale (VAS) 2 hours postpartum and 1 month after birth. The main outcome was the childbirth experience measured with the four domains of the CEQ2. The clinical trial number is NCT01587625. Results: The CEQ2 was sent to 1203 women, and a total of 1008 women (83.8%) answered the questionnaire. The four domains of childbirth experience were scored similarly in the high‐ and low‐dose oxytocin groups of women: Own capacity (P =.36), Perceived safety (P =.44), Professional support (P =.84), Participation (P =.49). VAS scores of labor pain were reported as similar in both oxytocin dosage groups. Labor pain was scored higher 1 month after birth compared with 2 hours postpartum. There was an association between childbirth experiences and mode of birth in both the high‐ and low‐dose oxytocin groups. Conclusions: Different dosage of oxytocin for augmentation of delayed labor did not affect women's childbirth experiences assessed through CEQ2 1 month after birth, or pain assessment 2 hours or 1 month after birth. [ABSTRACT FROM AUTHOR]

Introduction: Vitamin D deficiency is common in pregnancy, especially in obese women. Lifestyle intervention could potentially result in higher levels of vitamin D. We therefore aimed to study the effect of lifestyle intervention during pregnancy on serum levels of 25-hydroxyvitamin D (25(OH)D).Material and Methods: A total of 360 obese women were randomized before gestational age 14 weeks to lifestyle intervention (diet and exercise) or routine clinical follow up (controls). Clinical outcomes and levels of 25(OH)D were determined three times: At gestational age 12-15 weeks (baseline), gestational age 28-30 weeks and 6 months postpartum.Results: A total of 304 (84%) women completed the intervention study and 238 (66%) attended postpartum follow up. Vitamin D levels were similar in the two groups at baseline. At gestational age 28-30 weeks and 6 months postpartum, 25(OH)D levels were significantly higher in the intervention group than in controls (75.6 vs 66.8 nmol/L, P = 0.009) and (54.8 vs 43.1 nmol/L, P = 0.013), respectively. Concurrently, vitamin D deficiency (25-hydroxyvitamin D <50 nmol/L) was less frequent in the intervention group than in controls: 15 vs 25% (P = 0.038) at gestational age 28-30 and 45 vs 63% (P = 0.011) 6 months postpartum, respectively.Conclusions: Lifestyle intervention during pregnancy was associated with significantly increased vitamin D levels in late pregnancy and postpartum compared with controls. [ABSTRACT FROM AUTHOR]

Introduction: The beneficial effects of physical activity during pregnancy for the mother and offspring have been reported by several studies but there are conflicting results concerning the possible effect of physical activity on the course of labor and risk of cesarean delivery. This study presents secondary analyses from the Norwegian Fit for Delivery randomized controlled trial, aiming at studying the effect of a lifestyle intervention including group exercise classes, as well as the possible influence of physical activity level in late pregnancy, on labor outcomes.Material and Methods: Healthy nulliparous women with singleton pregnancy were randomized to an intervention group, n = 303 (dietary counseling and twice-weekly exercise classes) or a control group, n = 303 (standard care). The participants were analyzed both by randomization and as a cohort comparing women with lowest (quartile 1, 0 metabolic equivalent of task-hours moderate-to-vigorous physical activity/week) (n = 140) vs. highest (quartile 4, ≥16 metabolic equivalent of task-hours moderate-to-vigorous physical activity/week) (n = 131) physical activity level in late pregnancy, assessed with the International Physical Activity Questionnaire.Result: The intervention group had a longer first stage of labor compared with the control group (293 ± 202 min vs. 257 ± 181 min, p = 0.030). No differences between the randomization groups were seen for time spent in second stage of labor, prolonged labor or mode of delivery. In the total sample, women with the highest physical activity level had lower odds ratio (OR) of acute cesarean delivery (OR 0.33, 95% CI 0.11-0.97, p = 0.044) than did those with the lowest physical activity-level.Conclusion: A significantly longer first stage of labor was observed in the intervention group than in the control group. A high physical activity level in late pregnancy was associated with lower odds of acute cesarean delivery compared with a low physical activity level. [ABSTRACT FROM AUTHOR]

A randomized controlled trial is a prospective, comparative, quantitative study/experiment performed under controlled conditions with random allocation of interventions to comparison groups. The randomized controlled trial is the most rigorous and robust research method of determining whether a cause-effect relation exists between an intervention and an outcome. High-quality evidence can be generated by performing an randomized controlled trial when evaluating the effectiveness and safety of an intervention. Furthermore, randomized controlled trials yield themselves well to systematic review and meta-analysis providing a solid base for synthesizing evidence generated by such studies. Evidence-based clinical practice improves patient outcomes and safety, and is generally cost-effective. Therefore, randomized controlled trials are becoming increasingly popular in all areas of clinical medicine including perinatology. However, designing and conducting an randomized controlled trial, analyzing data, interpreting findings and disseminating results can be challenging as there are several practicalities to be considered. In this review, we provide simple descriptive guidance on planning, conducting, analyzing and reporting randomized controlled trials. [ABSTRACT FROM AUTHOR]

Introduction: Progesterone is becoming universally accepted for preventing recurrent spontaneous preterm delivery. There is, however, poor consensus on the effective types and doses of progesterone to be used. Despite the encouraging available research, the role of oral micronized progesterone has not yet been thoroughly investigated.Material and Methods: We randomized 212 singleton pregnancies with past history of spontaneous preterm delivery at <37 weeks, into a progesterone group (receiving 100 mg oral micronized progesterone, six-hourly, starting at 14-18 weeks until 37 weeks or delivery) and an identical placebo group. The rate of spontaneous preterm delivery was the primary outcome. Secondary outcomes included gestational age at birth and admission to neonatal intensive care units.Results: The progesterone group delivered at a later gestational age, and needed longer tocolysis-to-delivery intervals (35.4 weeks vs. 33.9 weeks, p = 0.01, and 87 days vs. 36 days, p < 0.001, respectively). The relative risk of spontaneous preterm delivery was 0.7 (95% confidence interval 0.54-0.92, p = 0.01), and the number needed-to-treat to prevent one case of spontaneous preterm delivery was 5 (95% confidence interval 3-20). The two groups had similar rates of operative delivery and postpartum complications. Progesterone was associated with mild maternal dizziness (29.1% vs. 9.8%, p = 0.002), somnolence (41.6% vs. 19.7%, p = 0.002), and vaginal dryness (20.8% vs. 8.7%, p = 0.03), lower neonatal mortality rates (7.3% vs. 25.2%, p < 0.001), and shorter neonatal intensive care unit admissions (p = 0.008).Conclusion: Oral micronized progesterone is effective in preventing spontaneous preterm delivery. The additional advantages of oral administration, affordability, and high safety profile make it worth recommending, at least for further research. [ABSTRACT FROM AUTHOR]

Introduction: There is documented concern that cerclage may cause cervical stenosis or changes to the cervical mucus, which may reduce fertility. The aim of this study is to determine whether placement of a preconception abdominal cerclage affects fertility.Material and Methods: This was a planned subgroup analysis of a randomized controlled trial comparing abdominal cerclage, high vaginal cerclage or low vaginal cerclage. Women with a history of previous second-trimester miscarriage or preterm birth despite having a low vaginal cerclage, presenting to specialist preterm birth services in the UK, were eligible for inclusion. Only women randomized before conception were included in this analysis. Women randomized to abdominal cerclage had the surgery performed before conception (abdominal group). Women randomized to high or low transvaginal cerclage received it in the subsequent pregnancy (control group).Results: Abdominal cerclage was performed in 19 women and transvaginal cerclage in 48 women. Overall, there was no statistically significant difference between time to conception between the two groups (hazard ratio 1.34; 95% confidence interval 0.72-2.50, p = 0.35). Rates of conception at 6, 12, and 18 months were similar - 37% in abdominal group vs. 35% in control group at 6 months (relative risk 1.04; 95% confidence interval 0.52-2.10; p = 0.91); 58% in abdominal group vs. 42% in control group at 12 months (relative risk 1.39; 95% confidence interval 0.84-2.31, p = 0.21); 74% in abdominal group vs. 56% in control group at 18 months (relative risk 1.31; 95% confidence interval 0.91-1.89; p = 0.15).Conclusion: This subgroup analysis of randomized data indicates that abdominal cerclage does not affect fertility rates. [ABSTRACT FROM AUTHOR]

Conclusions on the effect of metformin on circulating anti-Müllerian hormone ( AMH) levels in women with polycystic ovary syndrome ( PCOS) are ambiguous. We performed a secondary analysis of a randomized, double-blind, placebo-controlled cross-over trial. Fifty-six women with hyperandrogenemic PCOS were included. Each woman served as her own control receiving a daily dose of either 1700 mg metformin or placebo for 6 months. After a 3-month wash-out period they received the opposite treatment. The decrease in AMH from a median of 49.5 to 46.9 pmol/L after 6 months on metformin was overall not significant ( p = 0.81), nor were changes in obese women (from 49.5 to 38.2 pmol/L; p = 0.53). Comparing individual metformin/placebo AMH values, a small absolute decrease of 9.3 pmol/L ( p = 0.03) was observed in obese women after 6 months relative to baseline, suggesting a trend towards decreasing values after metformin treatment, mainly in obese women. [ABSTRACT FROM AUTHOR]

Objective To assess the effect of bilateral ultrasound-guided transversus abdominis plane block with ropivacaine compared with placebo as part of a multimodal analgesic regimen. Design A randomized, double-blind, placebo-controlled trial following the CONSORT criteria. Setting Hvidovre University Hospital. Patients Forty-six women scheduled for total abdominal hysterectomy. Intervention Women received either ropivacaine 0.75%, 20 mL ( n = 24) or 0.9% saline, 20 mL ( n = 24) in the transversus abdominis plane on each side. Main outcome measures Primary outcome was the 24-h postoperative morphine consumption. Secondary outcomes were pain scores at rest and during coughing, postoperative nausea and vomiting at 1, 2, 4, 6, 8, and 24 h, and time to first mobilization. Results There was no difference in the mean 24-h postoperative morphine consumption between the two groups ( p = 0.733). The ropivacaine group had significantly lower median pain scores at 1 h ( p = 0.008) and 2 h ( p = 0.027) postoperatively at rest and at 8 h ( p = 0.028) during coughing. There was no significant difference in other secondary outcomes. Conclusion There was no reduction in 24-h morphine consumption when using an ultrasound-guided transversus abdominis plane block in women undergoing total abdominal hysterectomy. As part of a multimodal regimen the transversus abdominis plane block showed some effect on pain scores at rest only in the early postoperative period. [ABSTRACT FROM AUTHOR]

Objectives To assess the effect and safety of moderate-to-vigorous resistance exercise during pregnancy. Design Randomized controlled study. Setting Two antenatal clinics in Gothenburg, Sweden. Population Ninety-two healthy pregnant women. Methods The intervention was administered during gestational weeks 14-25. The intervention group received supervised resistance exercise twice a week, performed at an activity level equivalent to within moderate-to-vigorous ( n = 51). The control group received generalized exercise recommendation, a home-based training program and a telephone follow up ( n = 41). Main outcome measures Health-related quality of life, physical strength, pain, weight, blood pressure, functional status, activity level, and perinatal data. Results Functional status deteriorated during the intervention in both groups and pain increased. Significant differences between the groups were obtained only for birthweight. Newborns delivered by women who underwent resistance exercise during pregnancy were significantly heavier than those born to control women; 3561 (±452) g vs. 3251 (±437) g ( p = 0.02), a difference that disappeared when adjustment was made for gestational age ( p = 0.059). Both groups showed normal health-related quality of life, blood pressure, and perinatal data. Conclusions These findings indicate that supervised, moderate-to-vigorous resistance exercise does not jeopardize the health status of healthy pregnant women or the fetus during pregnancy, but instead appears to be an appropriate form of exercise in healthy pregnancy. [ABSTRACT FROM AUTHOR]

We appraised the methodology, execution and quality of the five published meta-analyses that are based on the five randomized controlled trials which compared cardiotocography ( CTG)+ ST analysis to cardiotocography. The meta-analyses contained errors, either created de novo in handling of original data or from a failure to recognize essential differences among the randomized controlled trials, particularly in their inclusion criteria and outcome parameters. No meta-analysis contained complete and relevant data from all five randomized controlled trials. We believe that one randomized controlled trial excluded in two of the meta-analyses should have been included, whereas one randomized controlled trial that was included in all meta-analyses, should have been excluded. After correction of the uncovered errors and exclusion of the randomized controlled trial that we deemed inappropriate, our new meta-analysis showed that CTG+ ST monitoring significantly reduces the fetal scalp blood sampling usage (risk ratio 0.64; 95% confidence interval 0.47-0.88), total operative delivery rate (0.93; 0.88-0.99) and metabolic acidosis rate (0.61; 0.41-0.91). [ABSTRACT FROM AUTHOR]

We reappraised the five randomized controlled trials that compared cardiotocography plus ECG ST interval analysis ( CTG+ ST) vs. cardiotocography. The numbers enrolled ranged from 5681 (Dutch randomized controlled trial) to 799 (French randomized controlled trial). The Swedish randomized controlled trial ( n = 5049) was the only trial adequately powered to show a difference in metabolic acidosis, and the Plymouth randomized controlled trial ( n = 2434) was only powered to show a difference in operative delivery for fetal distress. There were considerable differences in study design: the French randomized controlled trial used different inclusion criteria, and the Finnish randomized controlled trial ( n = 1483) used a different metabolic acidosis definition. In the CTG+ ST study arms, the larger Plymouth, Swedish and Dutch trials showed lower operative delivery and metabolic acidosis rates, whereas the smaller Finnish and French trials showed minor differences in operative delivery and higher metabolic acidosis rates. We conclude that the differences in outcomes are likely due to the considerable differences in study design and size. This will enhance heterogeneity effects in any subsequent meta-analysis. [ABSTRACT FROM AUTHOR]

Objective Pelvic girdle pain ( PGP) is a disabling condition affecting 30% of pregnant women. The aim of this study was to investigate the efficacy of craniosacral therapy as an adjunct to standard treatment compared with standard treatment alone for PGP during pregnancy. Design Randomized, multicenter, single blind, controlled trial. Setting University hospital, a private clinic and 26 maternity care centers in Gothenburg, Sweden. Population A total of 123 pregnant women with PGP. Methods Participants were randomly assigned to standard treatment (control group, n = 60) or standard treatment plus craniosacral therapy (intervention group, n = 63). Main outcome measures Primary outcome measures: pain intensity (visual analog scale 0-100 mm) and sick leave. Secondary outcomes: function (Oswestry Disability Index), health-related quality of life (European Quality of Life measure), unpleasantness of pain (visual analog scale), and assessment of the severity of PGP by an independent examiner. Results Between-group differences for morning pain, symptom-free women and function in the last treatment week were in favor of the intervention group. Visual analog scale median was 27 mm (95% confidence interval 24.6-35.9) vs. 35 mm (95% confidence interval 33.5-45.7) ( p = 0.017) and the function disability index was 40 (range 34-46) vs. 48 (range 40-56) ( p = 0.016). Conclusions Lower morning pain intensity and less deteriorated function was seen after craniosacral therapy in conjunction with standard treatment compared with standard treatment alone, but no effects regarding evening pain and sick-leave. Treatment effects were small and clinically questionable and conclusions should be drawn carefully. Further studies are warranted before recommending craniosacral therapy for PGP. [ABSTRACT FROM AUTHOR]

Objective: This study examined the use of a Video Doctor plus provider cueing to promote provider advice and smoking cessation outcomes in pregnancy.Design: A randomized clinical trial was conducted from 2006 to 2008.Setting: Five community prenatal clinics in the San Francisco Bay Area of the United States.Participants: A total of 410 pregnant patients completed screening for behavioral risks including tobacco use in the past 30 days. Pregnant smokers (n = 42) were randomized regardless of their intention to quit smoking.Methods: Participants were assigned to either usual care or intervention. Intervention participants received 15-minute Video Doctor sessions plus provider cueing, at baseline and one month, prior to their routine prenatal visit. The Video Doctor delivered interactive tailored messages, an educational worksheet for participants, and a cueing sheet for providers.Main Outcome Measures: Receipt of advice from the provider and 30-day smoking abstinence, both by self-report.Results: Intervention participants were more likely to receive provider advice on tobacco use at both prenatal visits during the intervention period (60.9 vs. 15.8%, p = 0.003). The intervention yielded a significantly greater decrease in the number of days smoked and in cigarettes smoked per day. The 30-day abstinence rate at two months post baseline was 2.5 times greater in the intervention group; the difference was not significant (26.1 vs. 10.5%, p = 0.12).Conclusions: The Video Doctor plus provider cueing is an efficacious adjunct to routine prenatal care by promoting provider advice and smoking reduction among pregnant smokers. [ABSTRACT FROM AUTHOR]

Objective. To evaluate changes in sexual health and psychological well-being one year after subtotal and total hysterectomies. Design. Prospective randomized controlled trial. Material and methods. One hundred and thirty-two premenopausal patients scheduled for hysterectomy without planned oophorectomy for benign disorders and without a history of cervical dysplasia or symptomatic prolapse were randomized to total (n = 66) or subtotal hysterectomy (n = 66). The McCoy Female Sexuality Questionnaire was used to evaluate changes in sexual health and the Psychological General Well-Being index was used to evaluate changes in psychological well-being. Differences in outcome before and one year after the hysterectomy were calculated for each individual, and changes compared between the groups. Results. Women who had subtotal hysterectomy (SH) reported a significantly greater positive change in frequency of orgasm and sexual pleasure as compared with women who had total hysterectomy (TH) (mean values ± standard deviation (SD), orgasm: SH: 0.4 ± 1.1; TH: -0.2 ± 0.9, p = 0.012, sexual enjoyment: SH 0.3 ± 1.5; TH: -0.3 ± 1.3, p = 0.039). There was a significantly greater general health gain for the women who underwent subtotal hysterectomy as compared with total hysterectomy (mean values ± SD SH: 1.2 ± 2.3; TH: 0.3 ± 1.6, p = 0.03). The total score did not show a difference. Conclusions. Women undergoing subtotal hysterectomy experience a greater positive change in the frequency of orgasm and extent of sexual pleasure after surgery than women undergoing total hysterectomy, but the results must be interpreted with caution. [ABSTRACT FROM AUTHOR]

Objective. The purpose of this study was to evaluate the changes in lower abdominal pain and back pain among women with menorrhagia treated by hysterectomy or levonorgestrel-releasing intrauterine system (LNG-IUS). Design. A randomized controlled trial. Setting. Five university hospitals in Finland. Sample. A total of 236 women, aged 35–49 years. Methods. Women were randomly assigned to treatment by hysterectomy ( n = 117) or LNG-IUS ( n = 119). Main outcome measures. Frequency and intensity of lower abdominal pain and back pain were evaluated by questionnaires at baseline and after 6 months, 12 months and 5 years. Results. By six months, women in both groups had less frequent back pain than before treatment ( p < 0.001). Lower abdominal pain decreased only in the hysterectomy group ( p = 0.02) with significant differences between the groups. Between 12 months and 5 years, frequency of lower abdominal pain ( p = 0.05) and back pain ( p = 0.002) decreased more in the LNG-IUS group than in the hysterectomy group. Between baseline and five years, the lower abdominal pain score (including frequency and intensity of pain) decreased in both groups ( p < 0.001, p = 0.01). Back pain score decreased only in the LNG-IUS group and the difference between the groups was significant ( p = 0.02). However, some women experienced more pain after both treatments than before treatment. In multivariate analyses, LNG-IUS use was associated with a decrease in lower abdominal pain and back pain. Conclusions. In the treatment of menorrhagia, both hysterectomy and LNG-IUS decrease lower abdominal pain. LNG-IUS use, but not hysterectomy, has beneficial effects on back pain. [ABSTRACT FROM AUTHOR]