Acceptability and side-effects of Implanon in Switzerland: a retrospective study by the Implanon Swiss Study Group

Design A multicenter, retrospective study of the single-rod contraceptive implant, Implanon^® (NV Organon, Oss, The Netherlands), was carried out in Switzerland in 1183 women. Methods Assessments included duration of use, bleeding pattern, side-effects and subjective acceptability and satisfaction with the method. Results A total of 991 women (84%) had at least one follow-up visit and 306 (26%) had two visits with a mean duration between insertion and follow-up of 224 days (7.4 months) and 347 days (11.4 months), respectively. Implanon was removed prematurely in 235 women (24%), primarily because of side-effects (20%) and for family planning reasons (4%). Side-effects leading to discontinuation were mainly bleeding disturbances (45%), acne (12%) and other reasons (15%). The mean duration between insertion and removal for discontinuers was 280 days (9.2 months). Side-effects related to bleeding (visit 1) included infrequent bleeding (28%), amenorrhea (33%), prolonged bleeding (15%), and metromenorrhagia (frequent and heavy bleeding) (16%). Other reported side-effects at visit 1 included dizziness (12%), acne (11%), mood swings (8%) and headache (5%). The incidence of side-effects reported at visit 2 was generally comparable to that at visit 1. Conclusions The results of this study show that early discontinuation of implant use is primarily due to bleeding problems. Extensive counseling before implant insertion may help to prevent this. It is also important to develop an easy solution to successfully treating progestogen-induced bleeding disturbances.     

Swiss consensus guidelines for hysterectomy. Swiss Society of Gynecology and Obstetrics, Switzerland.

OBJECTIVE: The quality of the indication for hysterectomy is widely discussed at present. In early 1996, the committee for quality assurance of the Swiss Society of Gynecology and Obstetrics decided to set up nationally accepted guidelines for the indication of hysterectomy. METHODS: A modified Delphi approach was used. In a first step, general guidelines and actions prior to hysterectomy were defined. An expert panel of 17 Swiss gynecologists rated 74 frequent indications, twice for appropriateness (more benefits than risks for the patient), once for necessity (n = 34; procedure has to be offered or discussed with the patient), and outlined suggestions to be performed prior to hysterectomy. RESULTS: In a home rating round before the first panel met, there was an agreement rate of 48%. In 45% we observed neither agreement nor disagreement; in 7% we found disagreement. After the panel discussion 89% of experts agreed, 11% were indeterminate, and there was no disagreement. The necessity ratings showed agreement in 68% while 32% were indeterminate. The average median rating on a 1-9 point scale (1 = extremely inappropriate, 9 = extremely appropriate or necessary) was 5.4 over all single indications for appropriateness and 7.8 in single indications for necessity. After a second panel for consensus all panelists agreed on both appropriateness and necessity. CONCLUSION: The results of the appropriateness and necessity consensus presented in this paper reflect the findings of a 17 member Swiss panel. This joint effort by a medical society may be a step towards the direction of a peer controlled healthcare system.     

Acceptability of the diaphragm in Mombasa Kenya: a 6-month prospective study.

OBJECTIVES: If proven acceptable, safe and effective, the diaphragm could be used as a female-controlled method of preventing both sexually-transmitted infections (STIs) and pregnancy. This study's aim was to assess the acceptability and safety of the diaphragm among sexually-active women in Mombasa, Kenya. METHODS: We conducted a 6-month prospective study among female sex workers (FSWs), and women attending sexual and reproductive health services. Diaphragm acceptability was assessed using continuation rates and factors associated with acceptability. Safety evaluations included colposcopy findings and incidence of urinary tract infections (UTIs) and STIs. RESULTS: Half the 185 participants were FSWs who had less schooling and were less likely to be married than other women. After 6 months, 55% (56/102) of sexually-active women reported having used the diaphragm each sex act during the preceding month. Women liked using the diaphragm (95%, 104/109), and 96% (125/130) reported willingness to continue using it. Colposcopy did not reveal significantly more vaginal or cervical lesions. Use of the diaphragm was not associated with an increase in bacterial vaginosis or UTIs. A pregnancy rate of 12 per 100 women/years was observed. CONCLUSION: After 6 months of diaphragm use in this setting, continuation rates were sustained, user satisfaction was high and adverse effects were few.     

Cardiomyopathy in pregnancy: a retrospective study.

Women with dilated cardiomyopathies (DCM) have traditionally been advised not to attempt to carry pregnancies. This is largely based on data derived from studies of the course of peripartum cardiomyopathy (PPCM) and it is not clear that this extrapolation is appropriate. Our objective was to compare maternal and obstetric outcomes of pregnancies in women with preexisting DCM to women with PPCM. A 10-year retrospective comparative cohort study was undertaken of women between the ages of 15 and 40 discharged from two university medical centers with the diagnosis of cardiomyopathy (CM). Patients were included in the study if CM was diagnosed prior to pregnancy (DCM group) or if CM developed during pregnancy or within 5 months postpartum (PPCM group), and follow-up data was available. Thirty-one subjects were included in the study. Twenty-three women with the diagnosis of PPCM were compared with 8 women with DCM of other etiologies. There were no significant differences in maternal age, race, parity, tobacco or other substance use, or other risk factors between the two groups. Maternal outcomes in the PPCM group were significantly worse than in the DCM group, with three maternal deaths and four women undergoing heart transplants (p = 0.05). In the DCM group, one woman with a prepregnancy ejection fraction of 16% underwent transplantation after termination of pregnancy for genetic indications. None of the other women in the DCM group had a significant decline in cardiac status. Infant outcomes in both groups were uniformly good. PPCM represents an acute, evolving insult to the pregnant or postpartum woman. The prognosis of this condition should not be used for counseling women with DCM considering pregnancy. Women with stable DCM may do well during pregnancy without significant deterioration in their cardiac status.     

Delivery after previous cesarean: a risk evaluation. Swiss Working Group of Obstetric and Gynecologic Institutions

OBJECTIVE: To examine the risks of vaginal delivery after previous cesarean and to find criteria to help decide whether a trial of labor or an elective repeat cesarean should be preferred. METHODS: We evaluated 29,046 deliveries after previous cesarean registered in a pooled database of 457,825 deliveries used to assess quality control in gynecology and obstetrics departments in Switzerland. RESULTS: Among the 17,613 trial-of-labor cases logged (attempt rate 60.64%), the success rate was 73.73% (65.56% after inducing labor and 75.06% after the spontaneous onset of labor). The following complications were significantly more frequent in the previous-cesarean group: maternal febrile episodes (relative risk [RR] 2.77; 95% confidence interval [CI] 2.52, 3.05), thromboembolic events (RR 2.81; CI 2.23, 3.55), bleeding due to placenta previa during pregnancy (RR 2.06; CI 1.70, 2.49), uterine rupture (92 cases; RR 42.18; CI 31.09, 57.24), and perinatal mortality (118 cases, including six associated with uterine rupture; RR 1.33; CI 1.10, 1.62). The postcesarean group also showed a 0.28% rate of peripartum hysterectomy (81 cases; RR 6.07; CI 4.71, 7.83). There was one maternal death in the group, compared with 14 maternal deaths in the group without previous cesarean (no statistical significance). The risk of uterine rupture for patients with previous cesareans was elevated in the trial-of-labor group compared with the group without trial of labor (RR 2.07; CI 1.29, 3.30), but all other maternal risks, including peripartum hysterectomy (RR 0.36; CI 0.23, 0.56), were lower. When comparing the women having a trial of labor, the 70 with uterine rupture more often had induced labor (24.29% compared with 13.92% in the nonrupture group; P = .013), had epidural anesthesia (24.29% compared with 8.44%; P < .001), had an abnormal fetal heart rate tracing (32.86% compared with 8.53%; P < .001), and had failure to progress (21.43% compared with 7.98%; P = .001). CONCLUSION: A history of cesarean delivery significantly elevates the risks for mother and child in future deliveries. Nonetheless, a trial of labor after previous cesarean is safe. Induction of labor, epidural anesthesia, failure to progress, and abnormal fetal heart rate pattern are all associated with failure of a trial of labor and uterine rupture.     

Acceptability of suction curettage and mifepristone abortion in the United States: a prospective comparison study

OBJECTIVE: We sought to compare the acceptability of suction curettage abortion with that of medical abortion with mifepristone and misoprostol in American women. STUDY DESIGN: We performed a prospective, serially enrolled, cohort analysis. The study population consisted of 152 subjects receiving mifepristone and misoprostol and 174 subjects undergoing suction curettage abortion aged > or =18 years with intrauterine pregnancies of up to 63 days' estimated gestation. Questionnaires regarding expectations and experiences were administered before the abortion and at the 2-week follow-up visit. RESULTS: Subjects undergoing medical abortions reported significantly greater satisfaction than those undergoing surgical abortions (mean rank, 121 vs 149; P <.01) but were no more likely to recommend the method they had just experienced to a friend (97% vs 93.3%). If a future abortion was required, however, 41.7% of subjects undergoing surgical abortions indicated they would opt for a medical abortion, whereas only 8.6% of subjects receiving medical abortions would choose a surgical abortion (P <.001). Failure of the abortion decreased satisfaction in the medical group and increased the likelihood of choosing a surgical abortion for a subsequent procedure (P <.001). Surgical subjects who experienced more anxiety than expected during the abortion were more likely to choose a medical procedure for a subsequent abortion (P <.01). CONCLUSION: Women receiving mifepristone and misoprostol were more satisfied with their method and more likely to choose the same method again than were subjects undergoing surgical abortion. Failure of a medical abortion and increased anxiety during surgical abortion were associated with preference for the alternative technique in a future procedure.     

A long-term study of the efficacy and acceptability of a single-rod hormonal contraceptive implant (Implanon) in healthy women in China.

OBJECTIVE: To investigate the contraceptive efficacy, cycle control and acceptability of Implanon, a new single-rod, progestogen-only contraceptive implant. METHODS: In a non-comparative, open, multicenter study, a contraceptive implant containing the progestogen etonogestrel was inserted into 200 healthy women. The study duration was 2 years, with an optional extension up to 4 years. RESULTS: Women were exposed to Implanon for 644.6 woman-years. There were no pregnancies during the study. Per 90-day reference period, the median number of bleeding-spotting days ranged between 18 and 21 and the median number of bleeding-spotting episodes was two. The mean overall incidence of prolonged bleeding fell markedly during the study, from 69% in the first reference period to 26% in the 16th period. The most common adverse events were related to disturbed bleeding pattern and amenorrhea. Heavy or prolonged bleeding caused 18 subjects to withdraw from the study. Only a few subjects discontinued the study early due to irregular bleeding (2%) or amenorrhea (2%). A slight increase in mean body weight was observed. The implant was removed in an average time of 2.9 min. CONCLUSIONS: Implanon demonstrated excellent contraceptive efficacy for 4 years of use and was well tolerated. The incidences of prolonged bleeding and amenorrhea both fell markedly with continued implant use. Because of its single-rod design, Implanon was quickly removed with few complications and proved to be a highly acceptable method of contraception.     

Endometrioid carcinoma of the ovary: a retrospective study

Summary. Thirty-nine women with endometrioid carcinoma of the ovary were studied for factors relating to their presentation, treatment and survival. Nine of the women (23%) had a concomitant adenocarcinoma of the endometrium at the time of presentation. There were no significant differences in age at presentation or menopausal status between the two groups. The actuarial 5-year survival for women with endometrioid carcinoma of the ovary alone was 43%, 95% confidence interval (CI) 24% to 62% (stage 180%, CI45% to 100%, stage II62%, CI27% to 97%, and stage III 21%, CI 0% to 42%). The 5-year survival for women with concomitant endometrial tumours was 62.5% (CI 28.5% to 96.5%). The difference in the overall survival rate between the two groups was not significant.     

Endometrioid carcinoma of the ovary: a retrospective study

Thirty-nine women with endometrioid carcinoma of the ovary were studied for factors relating to their presentation, treatment and survival. Nine of the women (23%) had a concomitant adenocarcinoma of the endometrium at the time of presentation. There were no significant differences in age at presentation or menopausal status between the two groups. The actuarial 5-year survival for women with endometrioid carcinoma of the ovary alone was 43%, 95% confidence interval (CI) 24% to 62% (stage I 80%, CI 45% to 100%, stage II 62%, CI 27% to 97%, and stage III 21%, CI 0% to 42%). The 5-year survival for women with concomitant endometrial tumours was 62.5% (CI 28.5% to 96.5%). The difference in the overall survival rate between the two groups was not significant.     

Pregnancy and the Ehlers-Danlos syndrome: a retrospective study in a Dutch population

BACKGROUND: The study was carried out to assess the course and outcome of pregnancies in women with the Ehlers-Danlos syndrome, with the aim of developing guidelines for assessment of risk and counseling, and for providing optimum medical and obstetric care. METHODS: A retrospective study based on data collected from members of the Dutch Association of Ehlers-Danlos patients. Pregnancies and neonatal outcomes of the affected mothers were compared with those of the nonaffected mothers who delivered an infant with Ehlers-Danlos syndrome. RESULTS: In a group of 46 women with Ehlers-Danlos syndrome, 128 pregnancies beyond 24 weeks gestation were evaluated and compared with 43 pregnancies of 33 nonaffected women. The main maternal complications consisted of pelvic pain and instability (26% vs. 7%). One bowel rupture was reported in a woman with Ehlers-Danlos syndrome type IV. Preterm delivery occurred in 21% of the affected mothers compared with 40% of the nonaffected women with an affected infant; the women with Ehlers-Danlos syndrome experienced postpartum hemorrhage (19% vs. 7%) and complicated perineal wounds (8% vs. 0%) more often than the unaffected women. The floppy infant syndrome was diagnosed in 13% of the affected infants and did not occur in the nonaffected neonates. CONCLUSION: Pregnancy is generally well-tolerated in women with Ehlers-Danlos syndrome, with favorable maternal and neonatal outcomes. In Ehlers-Danlos syndrome type IV it may be associated with severe maternal complications. Preconceptional counseling concerning specific possible complications and a multidisciplinary approach are recommended.     

Maternal obesity and pregnancy: a retrospective study

Objectives

to establish the incidence of obesity in the pregnant population in a large city in the North West of England, identify links between obesity and social deprivation, and compare outcomes of pregnancy in obese and non-obese women.

Design

retrospective cohort study using maternal records.

Setting

largest maternity hospital in Europe.

Participants

8176 women who gave birth at the study hospital in 2006.

Findings

data showed that 17.7% of women were clinically obese. Obesity rates increased with advancing age. The incidence of pre-eclampsia, gestational diabetes, induction of labour, caesarean section and fetal macrosomia was significantly higher amongst the obese population. No relationship was found between obesity and social deprivation.

Conclusions

this study ascertained the exact incidence of maternal obesity in the local area and showed the increased risks associated with obesity and pregnancy.

Implications for practice

this study supports the need for a shared-care approach to antenatal care and that obese women should give birth in consultant-led units. The support of a named midwife should be available to these women throughout the childbearing experience, and preconception care advocated.     

Acute pyelonephritis in pregnancy: a retrospective study

OBJECTIVE: To examine the incidence, risk factors, microbial pathogens, and pregnancy outcomes of pregnant women with acute antepartum pyelonephritis. METHODS: Among all pregnant women admitted to Patan Hospital, Nepal from 14 April 2004 to 13 April 2005, pregnant women with acute pyelonephritis were retrospectively studied. Furthermore, the pregnancy outcomes of these women were compared with those of the general obstetric population received at our hospital during the same time period. RESULTS: Of 7034 pregnant women delivered at our hospital, 94 cases of acute antepartum pyelonephritis were diagnosed during the study period (incidence: 1.3%). Maternal mean age for the infection was 22 +/- 3.41 years. Acute pyelonephritis was most frequently occurred in nulliparous women (75%), and in the second trimester (60%). Of 94 cases, 62 (65.95%) showed positive urine culture, with the predominating organism Escherichia coli in 81% (50 of 62) of cases. E. coli was found most sensitive to nitrofurantoin (82.1% of cases), followed by ceftriaxone (81.55% of cases), gentamicin (77.01% of cases), ofloxacin (60.57% of cases), and ciprofloxacin (59% of cases). The incidences of low-birthweight babies (14%) and preterm babies (7.81%) in the cases with acute antepartum pyelonephritis were not significantly different compared to that of all births in our hospital during the same period (13% and 8%, respectively; P > 0.05). CONCLUSIONS: Acute pyelonephritis requiring admission to hospital most frequently occurs in nulliparous women, and in the second trimester. The predominating organism responsible for acute pyelonephritis is E. coli. Ceftriaxone, because of its safety and negligible side-effect, should be the drug of choice for acute antepartum pyelonephritis.     

Adhesions and pelvic pain: a retrospective study

Retrospective review of 100 consecutive laparoscopies for chronic pelvic pain and 88 for infertility was undertaken. Twenty-six of the 100 (26%) chronic pelvic pain patients and 34 of the 88 (39%) infertility patients exhibited pelvic adhesions as the only abnormal finding. Patients in each group with findings of pelvic adhesions were compared with respect to symptomatology, density of adhesions, and locations of adhesions. Only four of the 34 infertility patients in whom pelvic adhesions were found complained of pain. Comparison of the chronic pelvic pain patients and the asymptomatic infertility patients did not reveal a significant difference in the density or the location of adhesions. These findings question the role of pelvic adhesions as a cause of chronic pelvic pain.     

Adverse obstetric outcome in women with a history of infertility: a retrospective study.

Women with a history of infertility are associated with a higher incidence of adverse pregnancy outcome. This retrospective study reviewed 105 women with a known history of infertility; of these 105 women, 77 (73%) conceived spontaneously and 28 (27%) had assisted conception. Our finding confirms higher perinatal complications; relative ratios (RR) for pre-eclampsia was 4.6 (95% CI=2.1-9.9), intrauterine growth restriction 4.8 (95% CI=1.9-12.0), gestational diabetes 1.8 (95% CI=0.5-5.8), pre-term premature rupture of membrane 2.3 (95% CI=0.6-8.8) and pre-term labour 2.6 (95% CI=1.1-5.9). We postulate that women with a history of infertility are at high risk of such obstetric complications and may benefit from intensified antenatal care.     

Abnormal cervicovaginal cytology in women with lupus: a retrospective cohort study.

OBJECTIVE: The aim of this study was to review Pap smear reports in women with systemic lupus erythematosus and compare them to a large control population. METHODS: Pap smear results of 29 women with a diagnosis of lupus seen consecutively were compared to those of a control population of 747 women attending the gynecology clinic at the same medical center during the same year. Records of lupus patients were reviewed to obtain clinical data. Fisher's exact test and chi(2) analysis were used to determine statistical significance, as appropriate. RESULTS: Of 29 women with lupus, 1/29 had high-grade squamous intraepithelial lesions (HGSIL) and 6/29 had low-grade squamous intraepithelial lesions (LGSIL). The control population of 747 women had 9/747 with HGSIL and 63/747 with LGSIL. chi(2) and Fisher's exact tests showed that the lupus population had a statistically significant increase in Pap smear reports of dysplasia compared to the control group (P < 0.021 for HGSIL/LGSIL combined, P < 0.036 for LGSIL alone). Examination of serial Pap smear results revealed that 45% of the lupus patients had cervical dysplasia at some time. CONCLUSION: Women with lupus have an increased prevalence of cervical dysplasia. Serial observation revealed dysplastic cytologies in nearly half of the patients, suggesting that this may be a more common problem than previously reported. Serial prospective studies are needed to assess better the risk of premalignant cervical lesions in lupus.