Endometrial advancement after triggering with recombinant or urinary HCG: a randomized controlled pilot study

More than 3 days’ luteal endometrial advancement in IVF has been related with no pregnancies. This study assessed the effect of recombinant and urinary human chorionic gonadotrophin (recHCG and uHCG) when administered for final oocyte maturation on the advancement of endometrial histology. Thirty patients were randomized to receive either 250 μg recHCG or 10,000 IU uHCG in an antagonist/recombinant FSH protocol. Endometrial biopsy was performed on the day of oocyte retrieval. All specimens were evaluated according to Noyes’ criteria by one pathologist blinded to the allocation treatment groups. Single blastocyst transfer was performed. Overall, 13 patients in recHCG group and 14 patients in uHCG group underwent endometrial biopsy. The mean days of histological endometrial advancement were comparable between the two groups: 2.03 versus 2.17 days, respectively. Nevertheless more patients (69%, 9/13) had less than 3 days’ advanced endometrium in the recHCG arm as compared with 43% (6/14) patients in the uHCG group (OR 3.00, 95% CI 0.4–16.3). The delivery rate per patient was higher, although not significantly, in the recHCG group (38.5% versus 28.6%). Both recHCG and uHCG preparations induce advancement of endometrial maturation. Whether a subtle difference in endometrial maturation affects the reproductive outcome remains to be proven.     

Contribution of embryo cryopreservation to elective single embryo transfer in IVF-ICSI

Single embryo transfer is the best way to reduce the risk of multiple pregnancy in IVF-intracytoplasmic sperm injection (ICSI). Between June 2002 and December 2004, all patients (first cycle, female age <38 years) were offered the choice between having one (SET) or two (DET) embryos transferred. Among 493 couples, 428 had at least two good quality embryos, and among them, 32% opted for SET. The SET and DET populations were not comparable (patients in the SET group were younger and had more oocytes retrieved), and therefore a paired, case-control analysis was performed involving 130 SET couples and 130 DET couples, matched according to the female partners' ages and the numbers of embryos available. All of the SET patients, and 82% of the DET group, had at least one embryo cryopreserved, (3.9 versus 2.8 embryos). The option of SET was continued for the frozen-thawed embryo transfers. The pregnancy rate following embryo transfer was significantly lower after SET compared with DET for both fresh (27.6 versus 36.9%; P < 0.05) and frozen-thawed (14.4 versus 23.5%) embryos. However, the cumulative live birth rates following the transfer of fresh and frozen embryos were identical between the two groups (43 versus 45%), with a high prevalence of twins following DET (34 versus 0%).     

Laparoscopy versus laparotomy in endometrial cancer: first analysis of survival of a randomized prospective study

STUDY OBJECTIVE: Laparoscopy has been proved to be safe and reliable in staging of patients with endometrial cancer. It has definite advantages over laparotomy, but a comparable survival outcome is still to be verified in prospective randomized trials. DESIGN: Prospective, randomized clinical trial. SETTING: Department of Gynecology, Friedrich Schiller University, Jena, Germany. PATIENTS: One hundred twenty-two women with uterine cancer. INTERVENTIONS: Laparotomy and laparoscopy. MEASUREMENTS AND MAIN RESULTS: Sixty-three patients were allocated to the laparoscopy arm, and 59 were allocated to the laparotomy arm. Median follow-up for all patients was 44 months (range 5-96 months). Eight patients (12.6%) in the laparoscopy group had a recurrence versus five patients (8.5%) in the laparotomy group (p = .65). At median follow-up, disease-free survival (DFS) and overall survival (OS) in the laparoscopy group and laparotomy group were 87.4% versus 91.6% and 82.7% versus 86.5%, respectively. Cause-specific survival (CSS) was 90.5% in the laparoscopy group versus 94.9% in the laparotomy group. In patients with International Federation of Gynecology and Obstetrics stage I, DFS was 91.2% in the laparoscopy group versus 93.8% in the laparotomy group, OS was 86.5% versus 89.7%, and CSS was 93.4% versus 95.9%. CONCLUSION: Laparoscopic vaginal treatment of patients with endometrial cancer provides a survival outcome comparable with laparotomy. If these data are confirmed, laparoscopic procedures should be included in routine therapy for patients with endometrial cancer.     

Cyst aspiration or GnRH antagonist administration for ovarian cysts detected at the start of fresh in vitro fertilization cycles*

The primary objective of this study is to investigate the effect of transvaginal ultrasonogram (TVUS)-guided cyst aspiration or gonadotropin releasing hormone antagonist (GnRH-ant) administration for the management of solitary ovarian cysts detected at the start of in vitro fertilization (IVF) cycles on the outcomes of the same cycles. This is a single-center, retrospective, cohort study of patients who had TVUS-guided cyst aspiration or GnRH-ant treatment for ovarian cysts detected at the start of IVF during a 5-year period. Four hundred and three patients met inclusion criteria: 41 (10.2%) underwent cyst aspiration and 362 (89.2%) were treated with GnRH-ant. There was no difference in the demographics or baseline IVF cycle characteristics of the two groups. Patients treated with GnRH-ant had a longer duration of ovarian stimulation (10.8?±?3.45 days versus 9.05?±?4.06 days, p?=?0.003) and required higher gonadotropin doses (3887.7?±?1097.8?IU versus 3293.7?±?990.5?IU; p?=?0.01) compared with the cyst aspiration group. There was no difference in the clinical pregnancy (43.9% versus 41.4%), spontaneous miscarriage (9.76% versus 8.01%) and live birth (34.1% versus 33.4%) rates between the groups. Our findings suggest that cyst aspiration is comparable to GnRH-ant administration for the management of solitary ovarian cysts detected at the start of IVF cycles.     

Resource utilization for ovarian cancer patients at the end of life: how much is too much?

OBJECTIVE: End-of-life (EOL) medical care consumes 10-12% of national health care expenditures and 27% of Medicare dollars annually. Studies suggest that hospice services decrease EOL expenditures by 25-40%. The goal of this study was to compare the total cost of hospital-based resources utilized in ovarian cancer patients during their last 60 days of life for those enrolled in hospice versus those not on hospice. METHODS: Study eligibility included patients who expired from ovarian cancer from 1999 to 2003. Medical records were reviewed for demographic data as well as treatment, response and recurrence rates, histologic type, grade and stage. Billing records were analyzed for costs of inpatient and outpatients visits, including radiologic, laboratory and pharmacy charges. Total cost of hospital resources was compared between patients managed on hospice for >10 days (hospice group) versus <10 days (non-hospice group) using the following methods: Mann-Whitney U, Kruskal-Wallis and Student's t tests. Overall survival was compared using Kaplan-Meier statistics. RESULTS: Of the 84 patients analyzed, 67 (79.8%) were in the non-hospice group and 17 (20.2%) were in the hospice group. Demographic, histologic and staging characteristics as well as platinum sensitivity were similar between the two groups before the last 60 days of life. Mean number of chemotherapy cycles before the study period was also similar (20.4 and 21.0, respectively). However, during the study period, the mean total cost per patient in the non-hospice group was dollar 59,319 versus dollar 15,164 in the hospice group (P = 0.0001). A significant difference in cost was noted for mean inpatient days (dollar 6584 vs. dollar 1629, P = 0.0007), radiology (dollar 6063 vs. dollar 2343, P = 0.003), laboratory (dollar 12,281 vs. dollar 2026, P = 0.0004) and pharmacy charges (dollar 13,650 vs. dollar 4465, P = 0.0017) as well as for treating physician per patient (dollar 112,707 vs. dollar 34,677, P = 0.04). Overall survival for the two groups was the same. CONCLUSIONS: Our findings demonstrate that there is a significant cost difference with no appreciable improvement in survival between ovarian cancer patients treated aggressively versus those enrolled in hospice at the EOL. These data suggest that earlier hospice enrollment is beneficial. Furthermore, cost variations between physicians and patients imply that education may be an important variable.     

Cryopreserved embryo transfer in an artificial cycle: is GnRH agonist down-regulation necessary?

The use of GnRH agonist downregulation in artificial endometrium priming cycles for cryopreserved embryo transfer was retrospectively investigated to establish whether higher live birth rates resulted. Six hundred and ninety-nine patients underwent 1129 artificial endometrium priming cycles for the transfer of cryopreserved embryos between 1 July 2009 and 1 June 2012. Hormonal supplementation with (group A, n = 280 cycles) or without (group B, n = 849 cycles) GnRH agonist co-treatment was given. Live birth rates were comparable between the two groups per started cycle (14.9% [41/275] in group A versus 15.1% [127/839] in group B) or per embryo transfer (17.5% [41/234] in group A versus 17.6% [127/723] in group B). After logistic regression analysis, the only variables that were significantly associated with live birth rates were day of embryo transfer (OR 0.69; 95% CI 0.48 to 0.98) for day 3 versus day 5 embryos, the number of embryos transferred (OR 2.13; 95% CI 1.58 to 2.86) for two embryos versus one embryo transferred and the endometrial thickness on the day of embryo transfer (OR 1.15; 95% CI 1.05 to 1.25). Live birth rates after cryopreserved embryo transfer in artificial cycles did not increase when a GnRH agonist was administered.     

Wound complications in patients with carcinoma of the vulva. Comparison between radical and modified vulvectomies

OBJECTIVE: To evaluate complications after different vulvectomies performed because of vulvar cancer. STUDY DESIGN: Retrospective analysis of 149 patients who underwent vulvectomy. RESULTS: Wound infections was found in 58%. Overweight, central or bilateral location of the tumor, and non-radical surgery were significant predictors of wound infections. Patients with a wound infection had more often wound breakdown (P<0.001), prolonged healing time (P<0.000), and lymphedema (P<0.001) than patients without infection. Antimicrobial prophylaxis did not prevent wound infection. Wound infections were found in 75% after radical en bloc vulvectomy (RV) and in 47% after modified vulvectomies (MV) (P<0.001). Also wound breakdown (47 versus 20%) (P<0.001) and lymphedema (48 versus 12%) (P<0.0001) were more common in RV group than in MV group. Lymphocysts were found in 7%, and showed no association with wound infection or type of operation. The mean hospital stay was 26 days in patients with wound infection and 12 days in patients without infection, 31 days in RV group and 12 days in MV group, respectively. CONCLUSIONS: Wound infections are major determinants for both acute and late complications. Postoperative complications reduce with increasing use of modified vulvectomies.     

Endoscopic treatment of endometriosis-associated infertility. Therapeutic, economic and social benefits.

In this report on the therapeutic results in patients with moderate and severe endometriosis treated by operative laser laparoscopy, we also present a comparative analysis of cost and duration of hospitalization and of convalescence in comparable patients treated by laparoscopy versus laparotomy. Sixty patients treated by the same surgeon with operative laser laparoscopy were followed for a period of at least one year to calculate cumulative pregnancy rates, monthly fecundity rates, and monthly probability of pregnancy. The mean duration of hospitalization and incapacitation as well as physician and hospital costs incurred by the laparoscopy treated patients were compared with those incurred by 60 patients with similar degrees of endometriosis but treated by microsurgery at laparotomy. In the laparoscopy group, 36 patients had stage III and 24, stage IV endometriosis. Monthly fecundity rates (6.7%), monthly probability of pregnancy (12.6%) and cumulative pregnancy rates (70.5%) did not differ between patients with stage III and IV disease. The total number of hospital days required by the 60 laparoscopy patients was 72 versus 258 for the laparotomy patients (P less than .001). The total number of days' incapacitation for laparoscopy patients was 216 versus 1,284 for the laparotomy group (P less than .001). The total cost of medical care was $223,260 for the laparoscopy group and $424,500 for the laparotomy group (P less than .001). Our results validate the therapeutic efficacy of operative laparoscopy in the treatment of moderate and severe endometriosis and confirm the substantial economic and social benefits of laparoscopy surgery over laparotomy.     

A prospective randomized study comparing aspiration only with aspiration and flushing for transvaginal ultrasound-directed oocyte recovery.

OBJECTIVE: To compare aspiration only with aspiration and flushing of ovarian follicles during transvaginal ultrasound (US)-directed oocyte recovery. DESIGN: Prospective randomized study. PATIENTS: One hundred patients who were undergoing an in vitro fertilization (IVF) treatment cycle. INTERVENTIONS: All patients underwent pituitary desensitization before the administration of gonadotropins. Monitoring of ovarian stimulation and the criteria for the administration of human chorionic gonadotropin were similar in both groups. In patients in whom aspiration alone was used, each follicle was aspirated until it was empty. The US probe was then rotated until every drop of follicular fluid had been aspirated before the next follicle was aspirated and the procedure repeated. For patients who had aspiration and flushing, each follicle was aspirated and then flushed up to a maximum of six times before moving to the next follicle. In both groups, all follicles greater than 10 mm were aspirated. RESULTS: The indication for IVF and mean age of the patients were comparable in the two groups. There were no significant differences between the aspiration and the aspiration and flushing groups in terms of the number of oocytes retrieved (11 versus 9), the oocyte recovery rates (77.5% versus 77.0%), the fertilization rates (55.6% versus 60.0%), the number of embryos transferred (2 versus 2), or the number of clinical pregnancies (12 versus 13). The time taken for oocyte recovery was significantly shorter (15 versus 30 minutes, P less than 0.00001), and the dose of pethidine required significantly less (50 mg versus 100 mg, P less than 0.00001) in the aspiration only group. CONCLUSIONS: Aspiration alone produces comparable oocyte recovery rates as aspiration and flushing while significantly reducing the length of the procedure and the dose of analgesia required. Aspiration alone suffices for virtually all cases during transvaginal US-directed oocyte recovery.     

Conservative management of placenta previa: A cost-benefit analysis

Thirty-eight gravid patients with placenta previa were managed according to either an inpatient expectant or an outpatient expectant approach. The inpatient expectant group showed significant improvement in outcome by several measures when compared with the outpatient expectant group. These included mean obstetric gestational age at delivery (35.3 versus 32.4 weeks), mean neonatal Dubowitz (35.7 versus 33.3 weeks), mean neonatal weight (2442 versus 1824 gm), neonatal morbidity (24% versus 74%), mean neonatal hospital days (21.2 versus 32.8 days), and neonatal hospital costs (nearly a 3:1 ratio). There were two cases of neonatal death in the outpatient expectant group and none in the inpatient expectant group. Mean maternal hospital days and hospital costs were significantly higher in the inpatient expectant group. However, overall hospital costs for maternal-neonatal pairs were 69% higher in the outpatient expectant group. The implications of these findings are discussed.     

Surgical morbidity associated with radical trachelectomy and radical hysterectomy

OBJECTIVES: To examine intra-operative, short and longer term morbidity associated with Radical Trachelectomy (RT) within our cohort of patients, compared with conventional Radical Hysterectomy (RH). METHODS: A retrospective case note review comprising 29 RT and 50 RH patients. Patients who required adjuvant treatment were excluded. Operative data, short-term and long-term complications were recorded. Long-term problems were included only if they had been of persistent nature. RESULTS: The median age and follow up period for the RH group were 40 years and 60 months and for RT group 30.5 years and 25 months. There were significant differences between RH and RT groups in median operative time (260 versus 187 min), blood loss (1000 versus 400 ml), transfusion requirement (75% versus 12%), analgesic requirement (8 versus 3.5 days) and hospital stay (11 versus 6 days). Bladder hypotonia requiring prolonged catheterisation was more frequent in RH group (P = 0.004). There was no apparent difference in psychosexual problems between the two groups (17 versus 16%). Complications of deep dyspareunia (P = 0.009), excessive vaginal discharge (P = 0.01), and upper thigh parasthesia (P = 0.05) were noted to be significantly higher in the RT group. Specific problems encountered in the RT group included; dysmenorrhea (24%), irregular menstruation (17%), recurrent candidiasis (14%), cervical suture problems (14%), isthmic stenosis (10%) and prolonged amenorrhea (7%). CONCLUSION: RT is associated with less operative and short-term morbidity compared with conventional RH. In addition to specific complications associated with RT, in our experience, there are long-term morbidities that are not as commonly observed in RH.     

Embryo pooling: a promising strategy for managing insufficient number of embryos in preimplantation genetic diagnosis

This retrospective study evaluated the embryo pooling strategy for managing insufficient number of embryos in preimplantation genetic diagnosis (PGD) through serial vitrification of cleavage-stage embryos from consecutive cycles, and simultaneous blastocysts biopsy in combination with blastocysts obtained in ultimate fresh cycle. A retrospective analysis of the cumulative pregnancy rate of 68 patients underwent cleavage-stage embryos accumulation (Embryo Pooling Group) and 94 patients underwent one stimulation cycle (Control Group) over a 2-year period were conducted. The blastocyst formation rate was comparable between the consecutive cycles and the ultimate cycle in embryo pooling group (56.0 versus 62.0%, p?=?.078). No significant difference existed between twice-vitrified and once-vitrified warmed blastocysts with respect to implantation rate (50.8 versus 46.3%, p?=?.658). The implantation rate and cumulative pregnancy rate of embryo pooling group were 49.0 and 67.6%, respectively, which were statistically comparable to the corresponding values of 48.9 and 73.4% obtained in control group. Our study suggests that in patients undergoing ICSI-PGD who do not reach enough embryos in a single stimulation cycle, pooling embryos from consecutive ovarian stimulation cycles is a promising strategy, which can render a cumulative pregnancy rate comparable to those patients who only require one stimulation cycle.     

Antibiotic therapy in preterm premature rupture of membranes: Are seven days necessary? A preliminary,randomized clinical trial

OBJECTIVE: The purpose of this study was to determine whether 3 days of broad-spectrum antibiotic therapy, which is intended to prolong latency in patients with preterm premature rupture of membranes, is comparable to 7 days of therapy. STUDY DESIGN: Patients with preterm premature rupture of membranes at three separate study sites were asked to participate in this intent-to-treat, prospective, randomized trial. They were assigned randomly to either 3 or 7 days of ampicillin-sulbactam (3 g intravenously every 6 hours). The primary outcome of interest was the latency period from membrane rupture to delivery. RESULTS: Forty-two individuals were enrolled in each group. No difference was noted in the latency interval between the two groups (3 days, 214 +/- 225 hours, vs 7 days, 229 +/- 218 hours). A significantly higher number of patients in the 3-day group completed therapy (80.1% vs 47.6%, P =.003). No other parameters were significantly different between the two groups. No adverse events or trends were noted in either group. CONCLUSION: There appears to be no difference in the latency period between 3 and 7 days of ampicillin-sulbactam antibiotic therapy. More patients are needed to exclude a type II error.     

A protocol for managing severe preeclampsia in the second trimester

One hundred nine patients with severe preeclampsia in the second trimester were studied. Pregnancy termination was recommended for those with gestational age less than or equal to 24 weeks (n = 25), whereas expectant management with aggressive maternal and fetal monitoring was recommended for those with gestational age greater than 24 but less than or equal to 27 weeks (n = 84). Ten of the 25 women in the early pregnancy group accepted termination and 15 elected to continue the pregnancy. The overall perinatal survival in the latter 15 patients was 6.7%, and maternal complications developed in six patients. Thirty of the 84 patients in the late second-trimester group had immediate delivery, and 54 had expectant management. The average length of pregnancy prolongation in the expectant group was 13.2 days (range, 4 to 28 days). Compared with the immediate delivery group, the expectant management group had significantly higher perinatal survival (76.4% versus 35%), significantly higher birth weights (880 versus 709 gm), and a lower incidence of neonatal complications. There were no differences between the two groups with regard to maternal complications. Expectant management with aggressive monitoring of maternal and fetal status at a perinatal center improves perinatal outcome in patients with severe preeclampsia with gestational age greater than 24 but less than or equal to 27 weeks.     

Application of the cavitron ultrasonic surgical aspirator (CUSA) for gynecological laparoscopic surgery using the rabbit as an animal model.

OBJECTIVE: To study the potential application of the cavitron ultrasonic surgical aspirator (CUSA) in gynecological laparoscopic surgery using a rabbit animal model. DESIGN: Twenty-six rabbits were prospectively randomized into two groups. Laparoscopically directed standard injuries were made on the randomly assigned horn and sidewall in all animals with the CUSA. Contralateral injuries were made with a contact neodymium-yttrium aluminum garnet (Nd:YAG) laser in group 1 and with bipolar cautery in group 2. Adhesion and inflammation scores were assessed for two animals in each group at 24, 48, and 72 hours, and seven animals in each group at 14 days. SETTING: University animal research facility. MAIN OUTCOME MEASURES: Adhesion and inflammation scores were compared between animals in the CUSA versus Nd:YAG study and the CUSA versus bipolar cautery at 14 days. RESULTS: No significant difference in uterine or sidewall adhesion scores was noted between the CUSA versus Nd:YAG or the CUSA versus bipolar cautery. Bipolar cautery produced significantly less inflammation on the uterine horn compared with the CUSA (3.0 +/- 0.2 versus 5.3 +/- 0.7, P = 0.0001), but no difference in sidewall inflammation was noted between the CUSA compared with bipolar cautery. No difference in inflammation was observed between the CUSA and the Nd:YAG laser. CONCLUSIONS: The bipolar cautery appears to be preferable to the CUSA for coagulation of uterine lesions, although dissection of the uterus is not possible with bipolar cautery. The CUSA and the Nd:YAG appear to be comparable for uterine horn dissection. Because the CUSA causes similar adhesion formation and tissue inflammation at the sidewall when compared with the Nd:YAG laser and bipolar cautery and may be less likely to damage blood vessels, ureters, or other collagen-rich tissues, the CUSA may represent a promising new surgical tool for laparoscopically directed peritoneal dissection.     

Laparoscopic-assisted vaginal vs. abdominal surgery in patients with endometrial cancer stage 1

BACKGROUND: The development of new diagnostic and surgical methods has brought a differentiated approach to the surgery of endometrial cancer. The aim of this study was to verify the peri- and postoperative differences between laparoscopic and open procedures. METHODS: In the period from January 1995 to August 2001 a total of 86 patients were treated for endometrial cancer stage 1. Of these, 28 patients were treated by laparoscopic-assisted vaginal hysterectomy (LAVH) and bilateral salpingo-oophorectomy (BSO), while 58 patients were treated by total abdominal hysterectomy (TAH) and BSO. The two patient groups were comparable in all aspects. RESULTS: The average hospital stay in the LAVH group was 2.7 days compared to 5.4 days for the TAH group. There were fewer complications in the LAVH group (7%) compared to the laparotomy group (14%). CONCLUSIONS: Laparoscopic-assisted vaginal hysterectomy seems to be acceptable in the treatment of stage 1 endometrial carcinoma.     

Embryo quality in controlled ovarian stimulation for in vitro fertilization in young poor responders

This retrospective matched case control study was conducted to evaluate the effects of poor ovarian response in a group of young women (20–30 years) on embryos quality in controlled ovarian hyperstimulation (COH) for in vitro fertilization. Thirty-nine young patients with poor ovarian response (≤5 oocytes on retrieval) were enrolled and compared to age- and date-matched controls. Maximal Estradiol levels, number of oocytes aspirated, number of M2 oocytes and number of fertilized oocytes were significantly lower in the study group compared to controls. Implantation rate and rate of good quality embryos transferred of the study group and control were comparable (15.3 versus 16.3% and 62 versus 67.2%, respectively). Additionally, clinical pregnancy rate per transfer and delivery rate per transfer were also comparable (26.6 versus 35.8% and 23.3 versus 30.7%, respectively). The rate of cycles with no transfer, however, was 23.07% in the study group compared to zero cycles with no transfer in the control group. We conclude that young poor responders may still have reasonable proportion of good quality embryos when compared to controls. This results in comparable implantation rate and clinical pregnancy rate. Cycle transfer cancelation, however, represents a true barrier for achieving pregnancy.     

TVT-O treatment of stress urinary incontinence: immediate and one-year results

OBJECTIVE: To compare one-year results between the classic retropupubic (TVT) and the in-out transobturator approaches (TVT-O) of tension-free vaginal tape for the treatment of stress urinary incontinence (SUI). PATIENTS AND METHODS: The first 82 patients operated for SUI by TVT-O in our institution were included in the analysis. Patients were evaluated at 1 and 12 months. The global satisfaction rate was assessed at 12 months by a self-reported questionnaire. Results were compared to those of the first 124 patients operated of SUI by TVT in the same institution and by the same surgeons between 1996 and 1999. RESULTS: Except a younger mean age in the TVT-O group (57 versus 60 years), no other preoperative parameter was significantly different between the TVT and the TVT-O groups. The mean operating time was shorter in the TVT-O group (15 versus 30 minutes, P<0.001). No intraoperative complication occurred. The rate of bladder perforation was significantly lower in the TVT-O group (0 versus 8.8%, P=0.004). The rate of post-voiding residual less than 100 ml was higher in the TVT-O group (88 versus 61%, P<0.001). In the TVT-O group, 40% of patients had postoperative inguinal pain (mean=9 days, range 2-15 days). After 12 months from TVT-O, 85% of patients were completely dry, 6% had de novo over bladder activity, and 93.5% of patients were satisfied with the treatment they received. The 12-month results were not significantly different between the TVT and the TVT-O groups. DISCUSSION AND CONCLUSION: With a follow-up of 12 months, TVT-O is as efficient as TVT and has a lower risk of bladder injury, a cut by half operating time, and less postoperative dysuria.     

Extra-amniotic Foley catheter and prostaglandin E(2) gel for cervical ripening at term gestation.

OBJECTIVE: This study evaluated the efficacy of intravaginal prostaglandin E(2) gel in comparison with that of a Foley catheter for cervical ripening and induction of labor. STUDY DESIGN: Consecutive patients with unfavorable cervix requiring preinduction cervical ripening and induction of labor at term gestation were asked to participate in the study. One hundred and two patients were assigned to treatment with intravaginal prostaglandin E(2) gel (group 1) and 122 patients underwent the placement of an intracervical Foley catheter (group 2). After a maximum of three applications of intravaginal prostaglandin E(2) gel (18h) or after 18h from Foley catheter insertion oxytocin was administered to patients not in active labor. Labor profiles and pregnancy and neonatal outcome were compared between groups. RESULTS: The groups were comparable in term of demographic characteristics, indications for induction of labor, Bishop score at admission. The induction to labor time and the induction to delivery time were similar between groups. The cesarean sections rate was higher in group 1 than in group 2 (26.5 versus 14.7%, P<0.05). This remained significant when the analysis was restricted to nulliparous patients (32.3 versus 14.2%). The incidence of urinary tract infections, chorioamnionitis, and febrile morbidity was similar between groups. CONCLUSION: For preinduction cervical ripening, the Foley catheter is a valid alternative to the application of intravaginal prostaglandin E(2) gel and it is associated with a lower cesarean rate in nulliparous women.     

Comparison of One-Step Versus Two-Step Screening for Diagnosis of GDM in Indian Population: A Randomized Controlled Trial

Objective

To compare the incidence, maternal and fetal outcomes of gestational diabetes mellitus using one step versus two steps as a screening procedure.

Methodology

A prospective randomized trial involving screening of 1000 pregnant women for gestational diabetes mellitus was conducted. Women were divided in two groups (500 each). Group A comprised of patients screened with two-step approach (ACOG recommendation), and group B comprised of women screened by one-step method (IADPSG criteria). Women diagnosed with ‘gestational diabetes’ were followed in an antenatal clinic, and incidence of GDM and maternal and fetal outcome between two groups were analyzed using SPSS.

Results

The incidence of GDM was almost double using one-step versus two-step approach which was 19.2 and 11.8%, respectively. Maternal outcomes were comparable in both the groups except the risk of preterm delivery which was 2.5 times more in group A than group B (odds ratio = 2.43 95% CI 1.01–5.79). Further, fetal outcomes were also comparable except neonatal hypoglycemia which was seen in 29.31% in group A versus 7.4% in group B. In the group B, 15 patients (15.8%) with GDM (based on FBS ≥ 92 mg/dl at first ANC visit) showed clinical symptoms and blood sugars in hypoglycemic range on MNT requiring resumption of normal diet.

Conclusion

The incidence of GDM using IADPSG criteria was almost double versus ACOG criteria. Maternal and fetal outcomes were comparable except in 15.8% women diagnosed as GDM (using FBS ≥ 92 mg/dl at first ANC visit as per IADPSG) and suffered from hypoglycemia. A large trial is being proposed before these criteria are adopted.