Correlation between sponge biopsies and uterine cervical smears.
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OBJECTIVE: To determine whether the risk for uterine rupture is increased in women attempting vaginal birth after multiple cesarean deliveries. METHODS: We conducted a prospective multicenter observational study of women with prior cesarean delivery undergoing trial of labor and elective repeat operation. Maternal and perinatal outcomes were compared among women attempting vaginal birth after multiple cesarean deliveries and those with a single prior cesarean delivery. We also compared outcomes for women with multiple prior cesarean deliveries undergoing trial of labor with those electing repeat cesarean delivery. RESULTS: Uterine rupture occurred in 9 of 975 (0.9%) women with multiple prior cesarean compared with 115 of 16,915 (0.7%) women with a single prior operation (P = .37). Multivariable analysis confirmed that multiple prior cesarean delivery was not associated with an increased risk for uterine rupture. The rates of hysterectomy (0.6% versus 0.2%, P = .023) and transfusion (3.2% versus 1.6%, P < .001) were increased in women with multiple prior cesarean deliveries compared with women with a single prior cesarean delivery attempting trial of labor. Similarly, a composite of maternal morbidity was increased in women with multiple prior cesarean deliveries undergoing trial of labor compared with those having elective repeat cesarean delivery (odds ratio 1.41, 95% confidence interval 1.02-1.93). CONCLUSION: A history of multiple cesarean deliveries is not associated with an increased rate of uterine rupture in women attempting vaginal birth compared with those with a single prior operation. Maternal morbidity is increased with trial of labor after multiple cesarean deliveries, compared with elective repeat cesarean delivery, but the absolute risk for complications is small. Vaginal birth after multiple cesarean deliveries should remain an option for eligible women. LEVEL OF EVIDENCE: II-2.
The use of vaginal contraceptives reduces the risk of a woman's contracting sexually transmitted diseases (STDs). Almost two decades of laboratory data have established the virucidal and bactericidal characteristics of the spermicide nonoxynol-9; clinical trials, albeit limited, have confirmed its effectiveness. The use of spermicides in conjunction with mechanical barriers, such as the condom, diaphragm, contraceptive sponge and cervical cap, may provide optimal STD prophylaxis. Such information should be conveyed to women who are at risk of contracting or transmitting STDs.
The purpose of this study was to evaluate the safety, efficacy and acceptability of Lea's Shield, a new vaginal contraceptive barrier device, when used with either spermicidal or non-spermicidal lubricant. One-hundred-eighty-five (185) women enrolled at six centers. Half were randomized to use the device with spermicide and half with a non-spermicidal lubricant. To be eligible, volunteers had to be 18-40 years old (inclusive), in good health with regular menses, sexually active in an ongoing relationship and at risk for pregnancy, and willing to use Lea's Shield as their sole means of contraception for six months. Participants were seen at admission, one week, one month, three months and six months. Gross cumulative life table rates were calculated for pregnancy and others reasons for discontinuation. Adverse experiences and responses to an acceptability questionnaire were evaluated. One-hundred-eighty-two (182) volunteers contributed data to the analysis of safety and 146 to that of contraceptive efficacy. The unadjusted six-month life table pregnancy rate was 8.7 per 100 women for spermicide users and 12.9 for non-spermicide users (p = 0.287). After controlling for age, center, and frequent prior use of barrier methods, the adjusted six-month life table pregnancy rate was 5.6 for spermicide users and 9.3 for non-spermicide users (p = 0.086), indicating that use of spermicide lowered pregnancy rates, although not significantly, during typical use. For purposes of comparison, it is important to note that this study differed from the cap/diaphragm and sponge/ diaphragm studies in that a high percentage (84%) of volunteers were parous. For reasons that are unclear, pregnancy rates among parous women using barrier contraceptives tend to be higher than among nulliparous women. Indeed, in this study there were no pregnancies among nulliparous users of Lea's Shield. Standardization of parity of this study population on those of the cap/diaphragm and sponge/diaphragm studies suggests that unadjusted pregnancy rates for this device would have been considerably lower (2.2 and 2.9 per 100 users of spermicide and non-spermicide, respectively) had the study been done using the populations of earlier studies. Since no directly comparative study has been done, these figures provide a tentative estimate of the relative efficacy of Lea's Shield compared with the sponge, cap, and diaphragm. There were no serious adverse experiences attributed to the use of Lea's Shield. Acceptability was very good. Seventy-five percent (75%) of women responded to an end-of-study questionnaire; 87% of these reported that they would recommend Lea's Shield to a friend. Lea's Shield is a new vaginal contraceptive that does not require clinician fitting. Pregnancy rates in this study compare favorably with other studies of barrier contraceptive methods including the cervical cap, diaphragm, and sponge, even though this study was done with greater rigor and with a greater percentage of parous women than previous barrier studies. Lea's Shield appears to be safe and very acceptable to study volunteers.
Pluridisciplinary management of women with postpartum hemorrhage is mandatory in order to precisely assess initial seriousness, to maintain hemodynamic parameters and to confirm the cause of bleeding. Embolization should be offered only after exploration of the uterine cavity, inspection of the vagina, cervix and perineum and failure of uterotonic drugs. Embolization should be carried out in an angiography suite under constant monitoring of the patient by the anesthesiologist. Indications to perform arterial embolization include uterine atony particularly following a vaginal delivery, cervico-uterine hemorrhage, cervicovaginal lacerations (previously repaired or if surgical repair has failed) and vaginal thrombus, particularly in case of associated coagulopathy. Arterial embolization is effective in about 85% of cases. Placenta acccreta can also be successfully managed with arterial embolization as an alternative to hysterectomy. Unilateral femoral approach allows selective study of both internal iliac arteries and branches. Selective embolization of both uterine arteries should be ideally performed. In case of spasm or difficult catheterization, embolization of the anterior division of both internal iliac arteries should be considered. In case of bleeding from the cervico-vaginal region, selective evaluation and embolization of cervicovaginal branches should be performed. In case of failure or recurrence of bleeding, ovarian and round ligament arteries should be evaluated. In most cases, resorbable gelatin sponge pledgets should be used to perform embolization. The use of microcatheters and non resorbable embolization agents should be considered by trained interventional radiologists in case of placenta accreta or vascular lesions. After embolization, the patient should be transferred to the intensive care unit for further observation in order to offer emergent surgical procedure or another session of embolization in case of recurrence of bleeding.
Pluridisciplinary management of women with postpartum hemorrhage is mandatory in order to precisely assess initial seriousness, to maintain hemodynamic parameters and to confirm the cause of bleeding. Embolization should be offered only after exploration of the uterine cavity, inspection of the vagina, cervix and perineum and failure of uterotonic drugs. Embolization should be carried out in an angiography suite under constant monitoring of the patient by the anesthesiologist. Indications to perform arterial embolization include uterine atony particularly following a vaginal delivery, cervico-uterine hemorrhage, cervicovaginal lacerations (previously repaired or if surgical repair has failed) and vaginal thrombus, particularly in case of associated coagulopathy. Arterial embolization is effective in about 85% of cases. Placenta acccreta can also be successfully managed with arterial embolization as an alternative to hysterectomy. Unilateral femoral approach allows selective study of both internal iliac arteries and branches. Selective embolization of both uterine arteries should be ideally performed. In case of spasm or difficult catheterization, embolization of the anterior division of both internal iliac arteries should be considered. In case of bleeding from the cervico-vaginal region, selective evaluation and embolization of cervicovaginal branches should be performed. In case of failure or recurrence of bleeding, ovarian and round ligament arteries should be evaluated. In most cases, resorbable gelatin sponge pledgets should be used to perform embolization. The use of microcatheters and non resorbable embolization agents should be considered by trained interventional radiologists in case of placenta accreta or vascular lesions. After embolization, the patient should be transferred to the intensive care unit for further observation in order to offer emergent surgical procedure or another session of embolization in case of recurrence of bleeding.
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AIMS: To examine why anatomical correction of a cystocele may cause stress incontinence in a patient with no prior history of this condition. METHODS: The study group consisted of 5 patients, aged 45-63 years, with stress incontinence induced by supporting a cystocele with a pessary. The patients were otherwise continent. Testing was performed in a semirecumbent sitting position under perineal ultrasound control. The patients were asked to strain and cough before and after supporting the bladder neck with both sponge-holding forceps and a ring pessary. RESULTS: In all 5 patients, urine loss on stress was noted with bladder base support by forceps and pessary insertion. With both, asymmetrical downward stretching of the vagina and bladder base was observed. When the cystocele was allowed to balloon outwards, the asymmetrical pattern converted to a symmetrical 'funnelling' of the anterior and posterior walls of bladder neck. CONCLUSION: This study appears to support the hypothesis that, in addition to urethral narrowing, a ballooning cystocele may restore urethral closure by removing laxity from the vaginal hammock. Correction of a cystocele may cause incontinence by removing a fortuitous, but abnormal compensatory mechanism.
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A 5-year-old girl referred to our division for evaluation of persisting foul-smelling brown vaginal discharge with pruritus for over 2 years, not corresponding to antibiotic therapy. Transabdominal ultrasound identified a heterogeneous mass intensely fixed in the upper third of vaginal wall. Vaginography revealed a filling defect in the upper part of vagina, confirming the diagnosis of an intravaginal foreign body. The foreign body was grasped and removed by traction; it turned out to be a thin double-wrapped piece of sponge. Psychological assessment of the girl was undertaken, in order to illuminate the potential of an underlying emotional and behavioural problem and revealed the existence of psychological disturbances mostly affecting social competence and adaptiveness.
PURPOSE: We report the detailed technique and results of transvaginal extraction of the intact laparoscopic radical nephrectomy specimen. MATERIALS AND METHODS: Since June 2000, 10 select female patients with a median age of 67 years underwent transvaginal extraction of the intact specimen after laparoscopic radical nephrectomy. In 5 patients open surgery had previously been performed on the uterus, including transabdominal hysterectomy in 2 and cesarean section in 3. Laparoscopic nephrectomy was performed via the transperitoneal and retroperitoneal approach in 5 cases each. After completion of the primary laparoscopic procedure a sponge stick was externally inserted into the sterile prepared vagina and tautly positioned in the posterior fornix. Laparoscopically a transverse posterior colpotomy was created at the apex of the tented up posterior fornix and the drawstring of the entrapped specimen was delivered into the vagina. After laparoscopic exit was completed the patient was placed in the supine lithotomy position. The specimen was extracted intact via the vagina and the posterior colpotomy incision was repaired transvaginally. Patients were mailed a linear scale analog questionnaire to assess various aspects of recovery with responses graded from 0--no pain and/or change to 10--severe pain and/or change. RESULTS: Vaginal extraction was successful in all 10 patients. Median operative time for the vaginal extraction procedure was 35 minutes. Blood loss was minimal. Median tumor size was 3.6 cm. (range 2.4 to 7.4) and median specimen weight was 327 gm. (range 152 to 484). No intraoperative complications occurred. Postoperatively blood spotting via the vagina in 1 patient resolved spontaneously. Postoperative questionnaires revealed excellent patient satisfaction and convalescence. CONCLUSIONS: Vaginal extraction is an efficacious and minimally morbid technique for removing the intact entrapped specimen after laparoscopic radical nephrectomy. It has now become our preferred technique of intact specimen extraction in appropriate female patients.
OBJECTIVE: The purpose of this study was to determine which factors influence the likelihood of successful trial of labor (TOL) after 1 previous cesarean delivery (CD). STUDY DESIGN: We performed a multicenter 4-year prospective observational study (1999-2002) of all women with previous CD undergoing TOL. Women with term singleton pregnancies with 1 previous low transverse CD or unknown incision were included for analysis. RESULTS: Fourteen thousand five hundred twenty-nine women underwent TOL, with 10,690 (73.6%) achieving successful VBAC. Women with previous vaginal birth had an 86.6% success rate compared with 60.9% in women without such a history (odds ratio [OR] 4.2; 95% CI 3.8-4.5; P < .001). TOL success rates were affected by previous indication for CD, need for induction or augmentation, cervical dilation on admission, birth weight, race, and maternal body mass index. Multivariate logistic regression analysis identified as predictive of TOL success: previous vaginal delivery (OR 3.9; 95% CI 3.6-4.3), previous indication not being dystocia (CPD/FTP) (OR 1.7; 95% CI 1.5-1.8), spontaneous labor (OR 1.6; 95% CI 1.5-1.8), birth weight <4000 g (OR 2.0; 95% CI 1.8-2.3), and Caucasian race (OR 1.8, 95% CI 1.6-1.9) (all P < .001). The overall TOL success rate in obese women (BMI > or = 30) was lower (68.4%) than in nonobese women (79.6%) (P < .001), and when combined with induction and lack of previous vaginal delivery, successful VBAC occurred in only 44.2% of cases. CONCLUSION: Previous vaginal delivery including previous VBAC is the greatest predictor for successful TOL. Previous indication as dystocia, need for labor induction, or a maternal BMI > or = 30 significantly lowers success rates.
Studies were undertaken to detect a possible reporting or diagnostic bias that might have affected the results of previous epidemiologic investigations of toxic shock syndrome (TSS). The methods used in this reassessment of initial findings regarding TSS epidemiology (which were obtained through passive- and active-surveillance systems) included record review and analysis of discharge diagnoses. Results obtained with both the latter methods confirmed the broad outlines of the descriptive epidemiology of TSS. Some recent studies have focused on nonmenstrual cases of TSS and on risk factors for the development of TSS. Key findings include the more frequent isolation from nonmenstrual TSS cases of Staphylococcus aureus strains not producing TSS toxin 1 and a higher case-fatality rate for cases in men and for "non-vaginal" cases in women than for vaginal cases (defined as menstrual, postpartum, vaginal nonmenstrual, and contraceptive cases). Studies of the relation between tampon use and TSS suggest that both the degree of absorbency and the chemical composition of the tampon are involved; however, the mechanism by which tampons increase the risk of TSS remains unknown. Contraceptive sponges and diaphragms may be linked to an increased risk of nonmenstrual TSS, whereas oral contraceptives may play a protective role; these possibilities require further study.
Retinoids are effective suppressors of the phenotypic development of cancer in many animal systems, whether the process is initiated by chemical, physical or viral carcinogens. Cases of cervical intraepithelial neoplasia are excellent for studying the effectiveness of retinoids as chemopreventive agents because the process can be closely followed by serial colposcopic and pathologic (cytology or biopsy) means and changes in the condition safely monitored. We have previously conducted a phase I study of trans-retinoic acid (Tretinoin) given topically by a collagen sponge and cervical cap. A dose of 0.372% was selected for phase II trial. We have treated 20 patients with topical retinoic acid, and a complete response with total regression of disease was obtained in 50%. Systemic and cervical side effects were mild and vaginal side effects moderate but tolerable. These results provide a clinical basis for a randomized, double-blind phase III study to definitely answer the question of whether retinoic acid is an effective chemopreventive agent for cervical cancer.
A small clinical trial evaluated the safety and effectiveness of intravaginal sponges containing metronidazole for the treatment of bacterial vaginosis (BV). Twenty women were treated with sponges containing 250 mg metronidazole (two sponges per day for two days), and 32 were treated with sponges containing 1,000 mg metronidazole (one sponge per day for three days). After four weeks there was a significantly higher cure rate (P less than .10) for women using the higher-dose sponge (88.0% vs. 57.1%). Although not significantly different (P greater than .10), the rates of side effects and complications were somewhat more frequent for women using the higher-dose sponge. Additional clinical trials are being conducted to further evaluate the 1,000-mg-metronidazole sponge for the treatment of BV.
OBJECTIVE: In an effort to reduce shoulder dystocia incidence and morbidity, some obstetricians use prophylactic maternal hip hyperflexion (McRoberts maneuver), with the hope of facilitating delivery and decreasing the traction needed for delivery. The objective of this study was to evaluate whether the delivery force is reduced with the prophylactic McRoberts maneuver in a prospective, objective manner. STUDY DESIGN: Between April 2002 and July 2003, we randomly assigned multiparous women with term, cephalic singleton gestations to delivery in the lithotomy or McRoberts position. A single physician used a force-measuring system that consisted of a custom glove with force sensors to record the amount of force that was exerted on the fetal head. The primary outcomes of the study were peak force (pounds; highest force needed to accomplish entire delivery), peak force for delivery of anterior shoulder (pounds), and peak force rate (pounds per second; the duration required to reach the peak force). RESULTS: The peak force was not different between the patients in the lithotomy position (n=13) versus the McRoberts position (n=14; 7.2 +/- 0.8 lbs vs 8.0 +/- 0.7 lbs; P = .5). The peak force for delivery of the anterior shoulder (6.7 +/- 0.8 lbs vs 7.1 +/- 0.7 lbs; P = .7) and peak force rate (32.3 +/- 7.0 lbs/sec vs 29.1 +/- 3.5 lbs/sec; P = .7) were not different between the patients in the lithotomy position versus the McRoberts position, respectively. There was no difference between the groups for gestational age, birth weight, incidence of diabetes mellitus, or operative vaginal delivery. The subjective degree of difficulty of the delivery correlated with the peak force (R2 = 0.53; P = .001). CONCLUSION: The use of the McRoberts maneuver before clinical diagnosis of shoulder dystocia provides no reduction in the force that is used in traction on the fetal head during vaginal delivery in multiparous patients. The acceptance of this maneuver to be used prophylactically requires re-evaluation.
OBJECTIVE: Epidural anesthesia (EA) is used in 80% of vaginal deliveries and is linked to neonatal and maternal trauma. Our objectives were to determine (1) whether EA affected clinician-applied force on the fetus and (2) whether this force influenced perineal trauma. STUDY DESIGN: After informed consent, multiparas with term, cephalic, singletons were delivered by 1 physician wearing a sensor-equipped glove to record force exerted on the fetal head. Those with EA were compared with those without for delivery force parameters. Regression analysis was used to identify predictors of vaginal laceration. RESULTS: The force required for delivery was greater in patients with EA (n = 27) than without (n = 5) (P < .01). Clinical parameters, including birth weight (P = .31) were similar between the groups. Clinician force was similar in those with no versus first- versus second-degree laceration (P = .5). Only birth weight was predictive of laceration (P = .02). CONCLUSION: Epidural use resulted in greater clinician force required for vaginal delivery of the fetus in multiparas, but this force was not associated with perineal trauma.