Intrapartum cardiotocography -- the dilemma of interpretational variation.

OBJECTIVE: To evaluate and compare interobserver variation in interpretation of intrapartum cardiotocograms. SUBJECTS: Fifteen senior (experience >4 years) and 16 junior (experience < or =4 years) obstetricians from 10 delivery units. DESIGN: Thirty-one obstetricians interpreted intrapartum cardiotocographic (CTG) readings from 22 parturients. METHODS: Inter-observer agreement in CTG interpretation and decision-making was assessed via proportions of agreement (Pa), with 95% confidence intervals (CI). MAIN OUTCOME MEASURES: The level of inter-observer agreement was analyzed by calculating Pa values for CTG baseline, variability, early, variable and late decelerations, uterine tonus, power of contractions, hypertonus and clinical decision. RESULTS: In assessments of normal cases the Pa were acceptable or good (0.63-0.82) as regards all CTG interpretation elements except for the power of contractions (0.24), but in assessments of abnormal cases the Pa values were lower (0.18-0.60). As regards clinical decisions, a higher Pa was found in cases without recommendation for intervention (0.63, 95% CI 0.62-0.64) than in cases with such recommendation (0.55, 95% CI 0.54-0.56). The Pa in the abnormal cases was better among senior than among junior obstetricians. CONCLUSIONS: Inter-observer variation in interpretation of abnormal CTG readings and recommendations for intervention is relatively wide. To improve reliability, uniform classification and standardized training in CTG interpretation are needed, as well as increased use of computerized CTG.

Feminine life-course of Estonian women born in 1937-47: a questionnaire survey.

BACKGROUND: This study describes reproductive health, use of contraception, age at menopause, the prevalence of climacteric complaints, and hormone replacement therapy among Estonian women born in 1937-47. METHODS: A sample of 800 Estonian women born in 1937-47 was composed at random from the Estonian population registry in 1997. A postal questionnaire was sent to all participants. RESULTS: Curettage before menopause (16.6%, 95%CI=13.5-20.0) and hysterectomy (11.7, 95%CI =9.0-14.8) were the most common gynecological operations. 66.7% (95%CI =62.5-70.6) of women had never used contraception, with the most popular method of contraception being intrauterine device (19.9%, 95%CI = 16.6-23.6). About three quarters of the respondents had had induced abortions, with 30.4% (95%CI =26.5-34.4) having had three or more abortions. After exclusion of women with surgical menopause (57 cases, 10.6%, 95% CI=8.1-13.5), women who were unable to assess the time of menopause (17 cases, 3.2%, 95%CI=1.8-5.0), and those who were still menstruating (73 cases, 13.6%, 95%CI = 10.8-16.8), the average age of menopause (based on 388 study subjects) was 50.3 (95%CI =49.9-50.6) years. The prevalence of climacteric complaints was as follows: hot flushes 51.0% (95%CI =46.7-55.3), night sweats 44.1% (95%CI =39.9-48.4%), depression/irritability 35.6% (95%CI =31.5-39.8), bleeding problems 10.1% (95%CI=7.6-12.9). Hormone replacement therapy was currently being used by 8 respondents (1.5%, 95%CI=0.6-2.9). Previous hormone replacement therapy use was reported by 4 (0.7%, 95% CI =0.2 2.9) of the women. CONCLUSIONS: The feminine life-course of women born in Estonia in 1937-47 is characterized by a high number of induced abortions and hysterectomies, and relatively little contraceptive use. Hormone replacement therapy use is very low.

A double blind, randomized trial on augmentation of labour with a combination of intravenous propranolol and oxytocin versus oxytocin only.

OBJECTIVE: To compare the combination of intravenous propranolol and oxytocin with oxytocin only in augmentation of labour. STUDY DESIGN: A prospective randomized double-blind study in an obstetric department of a large university hospital in Finland. A total of 107 parturients with arrested first stage of labour owing to inadequate uterine contractility were randomized to receive intravenously once or twice a 2 mg dose of propranolol or placebo combined with oxytocin infusion. The main outcome measure was the effect of intravenous propranolol on the frequency of Caesarean section among parturients with arrested labour. The secondary outcome measures were the duration of labour, the required dosage of oxytocin, CTG readings, neonatal outcome and maternal and cord plasma levels of beta-adrenoceptor-binding component of propranolol. Categorial variables between the groups were compared using Chi square and Fisher's exact tests. Continuous variables were compared using the Mann-Whitney U-test and Student's t-test. RESULTS: No reduction in Caesarean section rate was found in the propranolol group. Seventy-three percent of the parturients in the propranolol group and 85% in the placebo group had spontaneous vaginal delivery, RR=0.86 (95% CI 0.70-1.05). The percentage proportion of the augmented part of labour was significantly shorter in the propranolol group than in the placebo group. No differences in the required oxytocin dosage or CTG pathology were found between the groups. Propranolol was found to be safe for the neonates. The concentrations of its beta-adrenoceptor-binding component after a 2mg intravenous dose were quite similar in parturients and neonates at the time of delivery. The active drug component crossed placental barriers with an average neonate umbilical artery/parturient venous plasma ratio of 0.7. After a 4 mg dose the active drug concentrations in parturients were rather similar to those measured after 2 mg dose, whereas in neonates there were signs of drug accumulation. No picture could be obtained from the kinetics of the beta-adrenoceptor-binding component of propranolol from the data. CONCLUSIONS: Propranolol (2 or 4 mg i.v.) combined with oxytocin, as treatment for arrested labour did not affect the Caesarean section rate compared with placebo plus oxytocin. The percentage proportion of the augmented part of labour was significantly shorter after propranolol. Propranolol was safe for the neonates and can be used as an additional medication among parturients with arrested labour.

Good perinatal outcome in selective vaginal breech delivery at term.

BACKGROUND AND AIM: To compare perinatal outcome in groups of planned vaginal breech delivery, elective cesarean section with the fetus in breech presentation, and planned vaginal delivery with the fetus in cephalic presentation in a university hospital with a tradition of managing breech deliveries by the vaginal route. METHODS: A cohort study from a 7-year period 1995-2002, including 590 planned vaginal deliveries with a term (> 37 weeks) singleton fetus in breech presentation, 396 elective cesarean sections with a term singleton fetus in breech presentation, and 590 control women intending vaginal delivery with a singleton term fetus in cephalic presentation. RESULTS: The Apgar scores were lower in the group of planned vaginal breech delivery, but in other outcome measures there were no significant intergroup differences. The overall neonatal morbidity was small (1.2% vs. 0.5% vs. 0.3% in the respective study groups) if compared to a recently published randomized multicenter study. CONCLUSIONS: Selective vaginal breech deliveries may be safely undertaken in units having a tradition of vaginal breech deliveries.

Effects of ospemifene and raloxifene on hormonal status, lipids, genital tract, and tolerability in postmenopausal women.

OBJECTIVE: To compare ospemifene and raloxifene regarding their effects on hormones, lipids, genital tract, and tolerability in postmenopausal women. DESIGN: A randomized, double-blind study in which 118 healthy postmenopausal women received 30 (n = 29), 60 (n = 30), or 90 mg (n = 30) of ospemifene or 60 mg (n = 29) of raloxifene for 3 months. RESULTS: There were no significant differences in the baseline characteristics between study groups. In comparison with raloxifene, follicle-stimulating hormone levels decreased significantly more in the 90-mg ospemifene group and sex hormone-binding globulin levels increased more in all ospemifene groups. Total cholesterol and low-density lipoprotein cholesterol levels decreased more in raloxifene than in ospemifene groups, although the difference in low-density lipoprotein cholesterol between 90-mg ospemifene and raloxifene was not significant. Endometrial thickness did not change in any study group and endometrial biopsies showed atrophy in the majority of subjects at 3 months. All ospemifene groups demonstrated a clear estrogenic effect on the vaginal epithelium, as seen in Pap smears. This was in sharp contrast to the raloxifene group, which had no effect on the vaginal epithelium. Kupperman index decreased in all study groups during treatment. The adverse events were mild, mainly single cases, and no clustering of events was observed. There were no clinically significant abnormal findings in laboratory safety parameters. CONCLUSIONS: Ospemifene, at the dose of 90 mg/day, was more estrogenic than raloxifene, as shown by changes in serum follicle-stimulating hormone and sex hormone-binding globulin levels. Neither agent stimulated endometrium, but in contrast to raloxifene, ospemifene had a clear estrogenic effect in the vagina. Further studies with ospemifene are needed in subjects with vaginal atrophy.

Blinding decreased recruitment in a prevention trial of postmenopausal hormone therapy.

PURPOSE: To compare the effect of blind design (active drug and placebo) and nonblind design (active drug and no treatment) on recruitment. SETTING: A primary prevention trial with postmenopausal hormone therapy in Estonia. METHODS: Women who were eligible and willing to participate on the basis of the questionnaire survey were randomized into blind and nonblind groups. Recruitment rates are based on record keeping, and reasons for participating were requested in the first-year follow-up. RESULTS: The recruitment was 30% higher in the nonblind group: of the 4,295 women invited, 37% (95% confidence interval CI=35-39%) in the blind group and 48% (95% CI=46-49%) in the nonblind group were recruited. In both groups, once randomized, most of the losses were women who did not attend the first clinical examination: 49% (blind; 95% CI=47-51%) and 40% (nonblind; 95% CI=38-42%). The rest were found ineligible or lost their interest during clinical examinations. The reasons for joining the trial were relatively similar in the two groups. CONCLUSIONS: Blinding decreased women's interest in joining a long-term preventive trial. Women's reasons for joining the trial were not influenced by blinding.

Skin contamination by oestradiol gel--a remarkable source of error in plasma oestradiol measurements during percutaneous hormone replacement therapy.

OBJECTIVES: To study the consequence of skin contamination by oestradiol gel on circulating plasma oestradiol levels. METHODS: We studied ten healthy, hysterectomized postmenopausal women who had used percutaneous oestradiol gel for at least 2 years. After wash-out period percutaneous dose of 1.5 mg 17beta-oestradiol was administered once a day in the evening. The gel was applied with a bare or gloved hand to an arm or thigh according to the schedule. Blood samples for assay of plasma oestradiol concentrations were collected from both cubital veins 12 h after gel administration, at baseline and every time after using the gel, for 2 weeks. RESULTS: Plasma oestradiol concentrations were significantly higher in the gel-contaminated samples: in the cubital vein of the gel-applying arm and in the cubital vein of the forearm on which the gel had been spread. CONCLUSIONS: Skin contamination by topical 17beta-oestradiol can distort plasma oestradiol measurements by giving much higher oestradiol concentrations than in reality there are in the systemic circulation. This has an important meaning when tailoring individual oestrogen therapy.

Oral ascorbic acid increases plasma oestradiol during postmenopausal hormone replacement therapy.

OBJECTIVES: To study the possible interaction between ascorbic acid (AA) and oestradiol (E2) in postmenopausal women on hormone replacement therapy (HRT). METHODS: We studied 25 healthy postmenopausal women who had used percutaneous E2 gel at same dose for 10-12 months, at which time the plasma E2 concentrations were stabilized. The subjects were treated with 1000 mg of AA daily for 3 months and blood samples for assay of AA and E2 were taken at 0, 1 and 3 months. RESULTS: After 1 month of AA treatment, there was an overall increase of 20.8% in E2 levels in the group as a whole. Greater responses were seen in two subgroups. In women with initially the lowest plasma concentrations of AA (<70 micromol/l), there was an increase of 55% in plasma E2 levels which was close to significance (P=0.063). In another subgroup with initially the lowest E2 levels (<0.20 nmol/l) there was a marked and significant increase (from 0.13 to 0.26 nmol/l) in plasma E2 concentrations (P=0.028). CONCLUSIONS: Our results support early findings that AA may interact with oestrogen therapy. Possible interaction of AA with E2 at the level of antioxidation is discussed.

Self-adjusted postmenopausal hormone replacement therapy: effects on the biological and immunological profile of FSH and correlation to climacteric symptoms.

OBJECTIVE: The purpose of the present study was to evaluate the hormonal profile of patients of postmenopausal age during estrogen replacement therapy (ERT) with special reference to the serum levels of biologically active FSH (B-FSH) in a self-adjusted ERT model. DESIGN: The hormonal values found have been correlated to climateric symptoms reported by the patients (scored by the Kupperman menopausal index (KI)). METHODS: B-FSH was measured using an assay based on a cell system transfected permanently with FSH receptor cDNA. All women (n=32) applied estradiol percutaneously using 1 mg estradiol-17beta (E(2)) as an initial dose and were encouraged to increase the daily dose until they felt comfortable according to a specific scheme. Twelve of the 32 women were hysterectomized and treated, accordingly, with ERT only; 20 women received megestrol acetate monthly for 10 days. RESULTS: The initial average KI was 30 (range 10-54). A high degree of correlation (r=0.83; P<0.001) was observed between B-FSH and immunologically active FSH (I-FSH). Serum I-FSH and E(2) correlated negatively (r=-0.21; P<0.001); similarly, a negative correlation (r=-0.15; P<0.01) was observed between serum B-FSH and E(2) levels. Serum I-FSH and KI showed modest but significant positive correlation (r=0.13; P<0.01); a somewhat higher degree of correlation (r=0.19; P<0.005) was observed when B-FSH and KI were compared. E(2) showed positive correlation to serum sex-hormone binding globulin levels (r=0.22; P<0.001). CONCLUSIONS: This study shows that the transdermal self-adjusted hormone replacement therapy (HRT) model introduced is suitable for studies on endocrine changes during postmenopausal ERT. The finding of poor correlation between serum E(2) levels and KI emphasizes the importance of hormonal measurements during postmenopausal HRT.

Peripherally administered sufentanil inhibits pain perception after postpartum tubal ligation.

The clinical effectiveness of locally administered opioids is still under discussion; in particular, the potency of morphine in settings other than intra-articular arthroscopy has been questioned. We developed another pain model, postpartum resection of the fallopian tubes for sterilisation, in which each patient serves as her own control when one side is infiltrated with the active drug (in this study sufentanil 5 mg) and the contralateral side with normal saline. In the control group both sides are infiltrated with plain saline. After 30 min from the end of anaesthesia onwards, 26 out of 30 patients observed significant pain relief on the side of the sufentanil infiltration, which in 11 patients lasted until the end of the observation period 24 h postoperatively; no difference was observed in the control group. In our pain model with a high assay sensitivity, the infiltration of one side with the lipophilic test drug, sufentanil, caused local analgesia in primarily non-inflamed tissue. The use of each patient as her own control excluded inter-subject bias.