Wide genital hiatus is a risk factor for recurrence following anterior vaginal repair

Objective

To determine if a wide genital hiatus is a risk factor for recurrence of anterior vaginal wall prolapse following anterior vaginal repair.

Methods

A retrospective cohort study was performed on patients who had undergone an anterior vaginal wall repair. Patients were placed into 1 of 2 groups: wide genital hiatus (≥ 5 cm) or normal genital hiatus (< 5 cm). The wide genital hiatus group (n = 35) was compared with the normal genital hiatus group (n = 30) for surgical failure.

Results

There were no significant differences between the 2 groups in demographic data, additional operative procedures, or apical suspensions. The rate of postoperative anterior vaginal wall prolapse was greater in patients with a wide genital hiatus compared with those with a normal genital hiatus (34.3% vs 10% respectively; odds ratio 4.7 [95% confidence interval, 1.0-24.1]; P = 0.02).

Conclusion

The rate of recurrent anterior vaginal wall prolapse is higher in patients with a wide genital hiatus.     

Phase II trial of cetuximab in the treatment of persistent or recurrent squamous or non-squamous cell carcinoma of the cervix: a Gynecologic Oncology Group study

Purpose

The Gynecologic Oncology Group (GOG) conducted a phase II trial to assess the efficacy and tolerability of the anti-EGFR antibody cetuximab, in persistent or recurrent carcinoma of the cervix.

Patients and methods

Eligible patients had cervical cancer, measurable disease, and GOG performance status ≤ 2. Treatment consisted of cetuximab 400 mg/m² initial dose followed by 250 mg/m² weekly until disease progression or prohibitive toxicity. The primary endpoints were progression-free survival (PFS) at 6 months and response. The study used a 2-stage group sequential design.

Results

Thirty-eight patients were entered with 3 exclusions, leaving 35 evaluable for analysis. Thirty-one patients (88.6%) received prior radiation as well as either 1 (n = 25, 71.4%) or 2 (n = 10) prior cytotoxic regimens. Twenty-four patients (68.6%) had a squamous cell carcinoma. Grade 3 adverse events possibly related to cetuximab included dermatologic (n = 5), GI (n = 4), anemia (n = 2), constitutional (n = 3), infection (n = 2), vascular (n = 2), pain (n = 2), and pulmonary, neurological, vomiting and metabolic (n = 1 each). No clinical responses were detected. Five patients (14.3%; two-sided 90% CI, 5.8% to 30%) survived without progression for at least 6 months. The median PFS and overall survival (OS) times were 1.97 and 6.7 months, respectively. In this study, all patients with PFS at 6 months harbored tumors with squamous cell histology.

Conclusion

Cetuximab is well tolerated but has limited activity in this population. Cetuximab activity may be limited to patients with squamous cell histology.     

Vulvar intraepithelial neoplasia (VIN 2/3): Comparing clinical outcomes and evaluating risk factors for recurrence

Objective

To evaluate demographic and clinical characteristics associated with the development of vulvar intraepithelial neoplasia (VIN 2/3), and factors associated with recurrence.

Methods

A retrospective chart review of 303 patients with VIN 2/3 evaluated at a single institution between 1993 and 2011 was performed. Medical records were reviewed for demographic information, risk factors, treatment type, pathologic diagnosis, and recurrence/outcome information.

Results

Median age at diagnosis was 47 years (range 14-87). 40% of patients reported current tobacco use and 26% reported previous use. Primary treatment included excision (n = 176, 59%), laser ablation (n = 40, 13%), imiquimod (n = 22, 7.4%), excision with laser (n = 24, 8.1%), excision with imiquimod (n = 10, 3.4%), and laser with imiquimod (n = 3, 1.0%). 92 patients (62.6%) were noted to have positive margins, which was associated with larger tumor size (p = 0.004). 87 patients (28.7%) developed recurrent disease, which was associated with smoking (p < 0.001), larger lesion size (p = 0.016), and positive margins (p = 0.005). On univariate analysis, higher rates of recurrence were associated with laser ablation (45.0%) compared with excision (26%) or imiquimod (13.6%) (p = 0.018). However, on multivariate analysis of recurrence-free survival (RFS) these therapies were equivalent when used individually, but the use of excision plus laser had an adverse impact on RFS (p < 0.001). 7 patients (2.3%) recurred with invasive disease a median of 109 months (range 12-327) from initial VIN 2/3 diagnosis.

Conclusions

This large cohort of women with VIN 2/3 further delineates the demographic and clinical factors associated with VIN 2/3. High rates of recurrence were noted and found to be associated with smoking, larger lesion size, and positive margins. While higher rates of recurrence were found among those treated with laser ablation, it was not inferior with respect to RFS when used alone, but the use of laser with excision was associated with decreased RFS. Our findings provide hypothesis-generating material for further research in the management of VIN2/3.     

Fertility sparing surgery for treatment of early-stage cervical cancer: open vs. robotic radical trachelectomy

Objective

To compare the open versus robotic surgical approaches and provide surgical outcome data on patients who have undergone radical trachelectomy (RT).

Methods

We identified patients who underwent open (ORT) or robotic radical trachelectomy (RRT) between September 2005 and June 2011. Tumor characteristics, perioperative, operative and obstetrical outcomes were analyzed.

Results

Thirty-seven patients with early stage cervical cancer that desired future fertility underwent attempted radical trachelectomy, and 32 patients (20 with 1B1, 11 with 1A2, and 5 with 1A1 with LVSI/poorly differentiated histology) had successful completion of RT. Five (1 open/4 robotic) underwent conversion to radical hysterectomy secondary to close (< 5 mm) endocervical margin (p = 0.08). The median age at diagnosis was 28.9 years (range; 21.4-37.2), 70% were nulliparous, and 9 had a visible lesion. Twenty-five patients (68%) underwent ORT and 12 (32%) underwent RRT. RRT was associated with less blood loss (62.5 mL vs. 300 mL, p = 0.0001) and decreased length of postoperative stay (1 vs. 4 days, p < 0.001), with no difference in operative time or histopathologic outcomes. Twenty-three patients (62%) had no residual cervical disease on final pathology. Common long-term morbidities were irregular menstrual bleeding or amenorrhea (25%), cerclage erosion (13%), or cervical stenosis (9%). Although there was a higher rate of conversion to hysterectomy in the robotic surgery cohort, rates of serious morbidities among the cohorts were comparable (robotic: 33% vs. open: 24%, p = 0.70). Eleven (36%) patients are actively attempting pregnancy and three have achieved pregnancy. The median time of follow up is 17.0 months (range 0.30-64.9 months). There are no documented recurrences.

Conclusions

RRT results in less blood loss and decreased length of hospital stay with no compromise in histopathologic outcomes.     

Effect of chemotherapy delays and dose reductions on progression free and overall survival in the treatment of epithelial ovarian cancer

Introduction

Hematologic, gastrointestinal, and neurologic complications are common side effects of the platinum and taxane-based chemotherapy used in the primary treatment of epithelial ovarian cancer (EOC). These side effects and the impact of the resultant chemotherapy dose modification on disease free interval have not been extensively studied. The goal of this study was to determine the effect of chemotherapy delays and dose reductions on progression free survival (PFS) and overall survival (OS).

Methods

A review of patients with primary epithelial ovarian, peritoneal, and fallopian tube carcinoma treated between 1/2000 and 12/2007 was performed. Inclusion criteria were advanced stage disease and first line chemotherapy with a platinum and taxane regimen. Cox proportional hazard models were used to determine the effect of chemotherapy reductions and delays on PFS and OS.

Results

One hundred and fifty seven patients met the inclusion criteria. Patients were divided into four groups: no delays or reductions (48%), delay only (27%), reduction only (8%), and both delay and reduction (18%). The mean number of delays/reductions per patient was 1.1 (range = 0-5) and therapy was delayed a mean of 8 days. The most common reasons for delays/reductions were neutropenia (n = 51), thrombocytopenia (n = 45), and neuropathy (n = 18). There were no differences detected in PFS or OS between groups.

Conclusions

There were no differences detected in survival between patients who required dose adjustments and treatment delays and those who did not. The lack of association between survival and chemotherapy alterations suggests that in specific circumstances patients with advanced ovarian cancer should have individualized treatment plans.     

Complications of mid-urethral slings for treatment of stress urinary incontinence

Objective

To compare the incidence of complications associated with the use of retropubic tension-free vaginal tape (TVT) and transobturator tension-free vaginal tape (TVT-O) for the management of stress urinary incontinence (SUI).

Methods

In a cross-sectional study, 1081 patients were treated for SUI via mid-urethral slings, and the outcomes of those treated via TVT and those treated via TVT-O were compared. Patients who suffered from recurrent or mixed urinary incontinence were excluded.

Results

Group 1 included patients treated via TVT (n = 207) and group 2 included those treated with TVT-O (n = 570). There was a higher incidence of bladder perforation (5.4% versus 0.6%; P = 0.001) and hematoma formation (9.1% versus 1.5%; P = 0.001) in group 1 than in group 2. Compared with group 1, there was higher incidence of vaginal wall perforation in group 2 (0.0% versus 3.8%, P = 0.044). The rate of intraoperative complications was not related to patient age, body mass index, or parity. Of the patients who did not leak urine during a cough test 1 month after surgery, 90.9% still had a negative cough test at the long-term follow-up.

Conclusion

TVT-O was superior to TVT with regard to the incidence of bladder perforation and hematoma formation, but it resulted in more vaginal wall injuries.     

Impact of smoking on perioperative pulmonary and upper respiratory complications after laparoscopic gynecologic surgery

Objective

To determine the impact of smoking on the rate of pulmonary and upper respiratory complications following laparoscopic gynecologic surgery.

Methods

We retrospectively identified all patients who underwent laparoscopic gynecologic surgery at one institution between January 2000 and January 2009. Pulmonary and upper respiratory complications were defined as atelectasis, pneumonia, upper respiratory infection, acute respiratory failure, hypoxemia, pneumothorax, or pneumomediastinum occurring within 30 days after surgery

Results

Nine hundred three patients underwent attempt at laparoscopic surgery. Fifty-four were excluded because of conversion to laparotomy and 31 because of insufficient data. Of the 818 patients included, 356 (43%) had cancer. A total of 576 (70%) patients were never smokers, 156 (19%) were past smokers, and 86 (10%) were current smokers (smoked within 6 weeks before surgery). These three groups were similar with regard to median body mass index, operative time, and length of hospital stay. Compared to never and past smokers, current smokers were more likely to undergo high-complexity laparoscopic procedures (10.4%, 15.4%, and 19.8%, respectively; p = 0.015) and had younger median age 49 years, 51 years, and 46 years, respectively; p = 0.035. Nineteen (2.3%) patients experienced pulmonary complications — symptomatic atelectasis (n = 9), pneumonia (n = 5), acute respiratory failure (n = 2), hypoxemia (n = 1), pneumomediastinum (n = 1), and pneumothorax (n = 2). The rate of pulmonary complications was 2.1% (12 of 564 patients) in never smokers, 4.5% (7 of 156 patients) in past smokers, and zero in current smokers.

Conclusion

In this cohort, smoking history did not appear to impact postoperative pulmonary and upper respiratory complications. In smokers scheduled for operative procedures, laparoscopy should be considered when feasible.     

Effect of intra-abdominal instillation of lidocaine during minor laparoscopic procedures

Objective

To assess the effect of intraperitoneal instillation of lidocaine on postoperative pain after minor gynecological laparoscopic surgery.

Method

A prospective, double-blind, placebo-controlled clinical trial of 75 patients undergoing gynecological laparoscopy randomized to receive intraperitoneal instillation of either 120 mg of lidocaine (n = 60) or normal saline (n = 15) at the end of surgery. Postoperative pain was evaluated by Wong-Baker Faces Pain Rating Scale (WBFS) score at 15 minutes and at 1, 2, 4, 12, and 24 hours postoperatively.

Results

The WBFS score was lower for the lidocaine group than for the control group at 1, 2, and 4 hours after surgery (P = 0.023). There was no difference in WBFS scores between the 2 groups at 15 minutes (P = 0.46), 12 hours (P = 0.13), and 24 hours (P = 0.07) after surgery.

Conclusion

Intraperitoneal instillation of lidocaine was effective in reducing postoperative pain after minor gynecological laparoscopic procedures.     

Micropapillary pattern in serous borderline ovarian tumors: does it matter?

Objective

To evaluate the clinical and prognostic impact of micropapillary pattern in patients with serous borderline ovarian tumors (SBOT).

Methods

We retrospectively assessed 130 consecutive patients with typical (n = 97, 74.6%) or micropapillary (n = 33, 25.4%) SBOT. Clinicopathologic factors and outcomes were compared between these two groups.

Results

There were no significant between-group differences in age, menopausal status, parity, body mass index, cancer antigen 125 concentration, tumor size, tumor rupture, positive cytology, ovarian surface involvement, retrieved lymph nodes, use of laparoscopy, fertility-sparing and ovary-sparing procedures, complete staging and restaging, and adjuvant chemotherapy. However, the incidences of advanced stage (II-III) tumors (10.3% vs 36.4%, P = 0.001), microinvasion (2.1% vs 15.2%, P = 0.012), peritoneal implants (8.3% vs 33.4%, P < 0.001), and lymph node involvement (0% vs 21.2%, P < 0.001) were significantly higher in patients with micropapillary than with typical SBOT. Five patients with typical (5.2%) and three with micropapillary (9.1%) SBOT had recurrent disease (P = 0.418), and one patient (3%) in micropapillary SBOT group died due to the disease (P = 0.254). The 5-year disease-free survival (DFS) rates for patients with typical and micropapillary SBOT were 96% and 86%, respectively (P = 0.148). All three patients with micropapillary SBOT who had recurrence had peritoneal implants (one noninvasive and two invasive). Multivariate analysis showed that peritoneal implant was the only significant factor related to DFS (P = 0.002).

Conclusions

Because micropapillary SBOT was significantly associated with peritoneal implants, especially invasive implants, and lymph node involvement, complete staging procedures, including lymph node dissection, are recommended. However, micropapillary SBOT itself was not significantly associated with DFS. Peritoneal implant was the only factor independently associated with tumor recurrence.     

Increased complication rates associated with laparoscopic surgery among patients with genital tuberculosis

Objective

To compare the complications and surgical difficulties encountered during laparoscopy between women diagnosed with and without genital tuberculosis (TB).

Methods

Retrospective review of the records of women diagnosed with and without genital TB who underwent laparoscopy primarily for infertility and chronic pelvic pain from January 2006 through July 2009. Genital TB was diagnosed by laboratory studies and endoscopic findings.

Results

A total of 313 women were included in the study: 87 (27.8%) with genital TB and 226 (72.2%) without. Laparoscopy was performed in 48 (55.2%) patients with genital TB and 19 (8.4%) without; laparoscopy with hysteroscopy was performed in 39 (44.8%) with the disease and 132 (58.4%) without. Although individual complication rates were all higher in the genital TB group, significant differences were seen for inability to see the pelvis (10.3% vs 1.3%, P = 0.027), excessive bleeding requiring transfusion (2.3% vs 0%, P = 0.045), and peritonitis (8.0% vs 1.8%, P = 0.037). Other complications encountered were inability to create pneumoperitoneum, bladder injury, trocar site discharge, and need for laparotomy.

Conclusion

Laparoscopic surgery may be associated with increased complication rates in patients with genital TB compared with those without the disease.     

Vaginal intraepithelial neoplasia (VAIN) after radiation therapy for gynecologic malignancies: a clinically recalcitrant entity

Objectives

Vaginal dysplasia is associated with prior radiation therapy (RT) for gynecologic malignancies. We reviewed our institution's experience with VAIN in patients who were treated with radiation therapy for a gynecologic malignancy.

Methods

A retrospective review of patients treated for VAIN was performed. All cases of patients followed and treated for VAIN after radiation therapy were identified (n = 10), along with a cohort of patients with VAIN who did not have radiation therapy (n = 23).

Results

Mean follow-up after initial diagnosis of VAIN was 37.6 months (range: 12 to 72). Cytologic screening events after diagnosis of VAIN (n = 105) showed that patients with prior RT were more than twice as likely to have recurrent dysplasia (OR 3.625, 95% CI = from 1.454 to 9.0376) after treatment. Of patients who recurred, the mean time to first recurrence was 12.3 months in cases and 15.3 months in controls, which was not statistically significant (p = 0.31). Screening practices at our institution ranged from 3 month to 12 month intervals. 3 patients in the RT group and 1 patient in the control group developed invasive squamous cell cancer of the vagina.

Conclusions

Vaginal dysplasia after radiation therapy is more refractory to treatment than dysplasia not associated with radiation therapy, more likely to recur after surgical and ablative therapy, and may also be more likely to progress to invasive cancer. These data support the need for further study to determine the optimal follow-up screening interval and whether aggressive surgical or ablative treatment stems disease progression in this clinical scenario.     

Surgical staging for endometrial cancer in the elderly - is there a role for lymphadenectomy?

Objectives

We sought to evaluate the effect of systematic lymphadenectomy (LND) on endometrial cancer-specific survival in an elderly population.

Methods

Data were obtained from the Surveillance, Epidemiology, and End Results (SEER) program from 1988 to 2006. Women who underwent primary hysterectomy for non-serous, non-clear cell endometrial carcinoma were included. Women were stratified by age (< 70, 70-79, and ≥ 80) and disease-specific survival (DSS) was analyzed via the Kaplan-Meier method and stratified by postoperative grade. Cohorts were compared using the log-rank test. In a simulated population, the disease-specific survival of women with pre-operative grade 1 endometrial carcinoma was calculated using a weighted average survival accounting for those upgraded at final pathology.

Results

Endometrial cancer was identified in 5759 women ≥ 80 years old. Disease specific survival at 5 years for the LND and no LND groups was 93.4% and 94.5% (p = 0.36) for grade 1, 84.4% and 85% (p = 0.97) for grade 2, and 65.9% and 60.9% (p = 0.002) for grade 3. In the simulated pre-operative grade 1 group, 5 year disease-specific survival (DSS) was 91% in the LND group and 92% in the no LND group.

Conclusion

In women older than 80, systematic lymphadenectomy is associated with improved DSS for high grade, but similar DSS for low grade endometrial cancer, consistent with what is seen with younger women. As there is no clear survival benefit to lymphadenectomy in elderly women presenting with low grade disease, the surgeon should carefully weigh the surgical risks and benefits in this patient population, which may be at higher risk for morbidity.     

A study of 579 pregnant women with premature rupture of membranes at term

Objective

To determine the best management for women with premature rupture of membranes at term.

Method

In 2008, 579 women admitted to Peking University First Hospital for premature rupture of membranes (PROM) at term were allocated to one of 3 groups. Group 1 (n = 292) consisted of those whose labor began spontaneously within 12 hours of PROM; group 2 (n = 234), of those whose labor did not begin within 12 hours of PROM and were induced with oxytocin; and group 3 (n = 53), of those who accepted a cesarean delivery immediately after PROM was diagnosed. The χ² test was used to compare the rates of intrauterine and neonatal infection in these 3 groups.

Results

Compared with the intrauterine and neonatal infection rates for group 1 (3.4% and 13.7%) and group 3 (1.9% and 3.8%), the corresponding rates were higher for group 2 (10.7% and 21.8%) (P < 0.05). In group 2, 76.5% of the women began labor within 24 hours of induction and 92.7% of these within 12 hours.

Conclusion

In women at term, induction should be performed immediately after PROM is diagnosed, as it is likely to fail when labor does not begin within 12 hours of oxytocin administration.     

Bone turnover and maternal 25(OH) vitamin D3 levels during pregnancy and the postpartum period: should routine vitamin D supplementation be increased in pregnant women?

Objective

To investigate the relationship between 25(OH) vitamin D3 levels and maternal bone turnover during pregnancy and lactation.

Study design

Thirty pregnant women and 30 healthy non-pregnant controls were included the study. The pregnant women were examined in the 12th, 25th and 32nd gestational weeks and 6 weeks after delivery. The controls were examined once. Serum concentrations of 25(OH) vitamin D3, parathyroid hormone (PTH), cross-linked C-terminal telopeptide of type I collagen (CTX), calcium, and phosphate were measured.

Results

In the 32nd week and the postpartum period, 25(OH) vitamin D3 deficiency rates were 13.3% and 33.3%, respectively. Serum 25(OH) vitamin D3 levels were below the detection limit in 10% and 33%, respectively, of the same subjects. In the control group, rates of 25(OH) vitamin D3 deficiency and “below detection limit” were 30% and 23%, respectively. While 25(OH) vitamin D3 and CTX levels were not correlated to each other in the first trimester, a negative correlation was found in the 2nd and 3rd trimesters and the postpartum period between 25(OH) vitamin D3 and CTX levels (r = −0.472, p = 0.048; r = −0.893, p < 0.0001, r = −0.881, p < 0.001, respectively). No correlation between 25(OH) vitamin D3 and CTX levels was found in controls.

Conclusion

We consider that 25(OH) vitamin D3 supplementation of women could both decrease maternal bone resorption and lead to enhanced bone mass in offspring during later life. Since women are prone to 25(OH) vitamin D3 insufficiency, we suggest higher doses of 25(OH) vitamin D3 should be given to pregnant subjects.     

A simple procedure to prevent chronic vaginal colpotomy wound bleeding after laparoscopically assisted vaginal hysterectomy

Objective

To determine whether injecting the colpotomy wound with diluted vasopressin decreases vaginal bleeding after laparoscopically assisted vaginal hysterectomy (LAVH).

Methods

In this prospective controlled study 100 patients who underwent LAVH from July 1, 2005 to June 30, 2007, were randomized to receive an injection of vasopressin (n = 50) or normal saline (n = 50) solution in the colpotomy wound.

Results

In the vasopressin group, bleeding from the colpotomy wound occurred for more than 7 days in 9 patients (18%), and none was bleeding after 1 month; in the control group, the corresponding values were 29 (58%) and 2 (4%). Compared with the study group, the control group had a significantly higher rate of chronic bleeding from the colpotomy wound for more than 7 days and for more than 14 days after LAVH (P < 0.001 for both).

Conclusion

Infiltrating the colpotomy wound with diluted vasopressin was found to prevent chronic vaginal bleeding, which frequently occurs following LAVH.     

A randomised controlled trial testing the feasibility and efficacy of a physical activity behavioural change intervention in managing fatigue with gynaecological cancer survivors

Objective

To determine the feasibility and efficacy of a physical activity behavioural change intervention in managing cancer-related fatigue among gynaecological cancer survivors during and post anti-cancer treatments.

Methods

A two arm, single blind, randomised controlled trial was conducted within the Northern Ireland regional Cancer Centre. Thirty three sedentary gynaecological cancer survivors (stage I-III; ≤ 3 years post diagnosis), experiencing cancer-related fatigue (mild-severe) took part. Participants were randomly assigned to a behavioural change, moderate intensity physical activity intervention (n = 16) or a Contact Control group (n = 17). The primary outcome was fatigue (Multidimensional Fatigue Symptom Inventory—Short Form and Functional Assessment in Chronic Illness Therapy—Fatigue subscale). Secondary outcomes included quality of life, physical functioning, positive and negative affect, depression, body composition, sleep dysfunction and self-reported physical activity. Feasibility was assessed based on the recruitment rate, programme and physical activity adherence and participants' programme evaluation, including optional focus groups (n = 16).

Results

Twenty five percent of eligible women took part (33/134). Participants were 8.7 (SD = 9.1) months post diagnosis, with a mean age of 53 (SD = 10.3) years. The majority of the sample had a diagnosis of ovarian (n = 12) or endometrial cancer (n = 11). Significant differences favouring the intervention group were observed for fatigue at 12 weeks and 6 months follow-up (12 week: mean difference = −11.06; 95% confidence interval (CI) = −21.89 to − 0.23; effect size (d) = 0.13; p = 0.046; 6 month: mean difference = −19.48; 95% CI = − 19.67 to − 19.15; effect size (d) = 0.20; p = 0.01). A mean of 10 calls (SD = 1.2 calls) were delivered to the Physical Activity Group, and 10 (SD = 1.6 calls) to the CC group. The intervention was positively perceived based on exit questionnaire and focus group findings.

Conclusions

A physical activity behavioural change intervention for gynaecological cancer survivors is feasible in terms of participants' programme adherence and evaluation, and the intervention demonstrates improvements in fatigue. However, confirmation in the form of a larger fully powered RCT is warranted.     

Efficacy of intermittent preventive treatment with sulfadoxine-pyrimethamine on placental parasitemia in pregnant women in midwestern Nigeria

Objective

To assess the effect of intermittent preventive treatment with sulfadoxine and pyrimethamine (IPT-SP) on placental parasitemia and maternal and perinatal outcome.

Methods

We compared placental malaria parasitemia during pregnancy and pregnancy outcome in 2 groups of women receiving antenatal care at University of Benin Teaching Hospital. One group was prophylactically treated with IPT-SP and the other was not treated.

Results

The parasitemia rates for peripheral, placental, and cord blood were 11.9%, 11.4%, and 2.7% in the IPT-SP group (n = 370) and 19.1%, 22.6%, and 6.2% in the control group (n = 371) (P = 0.006, P = 0.002, and P = 0.02, respectively). The treatment reduced the odds of placental parasitemia by 37% (OR 0.63; 95% CI, 0.48-0.81). Peripheral (P = 0.002) and placental (P = 0.001) parasitemia were significantly reduced in the subgroup of women who took 2 or 3 doses of SP. Fewer women (16.2%) in the IPT-SP group than the control group (23.7%) had symptomatic malaria. Anemia at delivery was significantly lower in the IPT-SP group (10.8 vs 1.6%). The risks of abortion, preterm delivery, and low birth weight were also significantly lower in the IPT-SP group.

Conclusion

IPT-SP is effective in preventing placental parasitemia, and reduces rates of malaria, maternal anemia, abortion, preterm delivery and low birth weight among pregnant women.     

The effect of “breathable” panty liners on the female lower genital tract

Objective

To evaluate whether the use of “breathable” panty liners (BPLs) alters the normal vaginal flora, increases the incidence of bacterial vaginosis and/or vaginal candidiasis, or causes vulvar irritation.

Methods

A randomized controlled trial assessed the vaginal ecosystem of women without complaints of vaginal discharge. The study group (n = 53) wore BPLs for 10-12 hours each day for 75 consecutive days, whereas the control group (n = 54) wore only their usual underwear. At each of 6 visits during 3 menstrual cycles, participants underwent gynecologic examination with colposcopic evaluation and pH measurement, in addition to assessment of vaginal microbial flora, intensity of inflammatory processes, and presence of vaginal candidiasis/bacterial vaginosis in Gram-stained smears.

Results

After 75 consecutive days of BPL use, 40/44 (90.9%) and 42/44 (95.5%) women reported no complaints of vaginal discharge or vulvar itching/burning, respectively. There was no significant difference between the study group and the control group with regard to positive vaginal fungus cultures (5/44 [11.4%] vs 8/50 [16.0%]; P = 0.7848) or bacterial vaginosis (3/44 [6.8%] vs 2/50 [4.0%]; P = 0.7974) at the end of the study period.

Conclusion

After 75 days of BPL use, there was no significant increase in vulvovaginal candidiasis, bacterial vaginosis, vulvovaginal irritation, or vulvovaginal inflammation.     

Efficacy of peripartum antiviral treatment for hepatic failure due to hepatitis B virus

Objective

To investigate the efficacy of oral nucleosides in preventing hepatic failure during pregnancy (HFP) caused by hepatitis B virus (HBV) infection.

Methods

Besides receiving standard treatment, 70 women with HFP caused by HBV infection joined a study group (n = 40) or a control group (n = 30) according to their preference. In the study group, 14 women were given lamivudine in the third trimester and an antiviral treatment was continued postpartum. The 26 remaining patients were treated postpartum only, with lamivudine (n = 16) or entecavir (n = 10).

Results

In the study group, the values for serum HBV DNA and hepatitis B envelope antigen were markedly lower at 1 and 2 months than they were at baseline (P < 0.001 and P < 0.001, respectively). Moreover, the HBV DNA values at 1 and 2 months were significantly lower in the study than in the control group (P < 0.05). Overall mortality and incidence of intrauterine infection were also significantly lower in the study group (P < 0.05). No newborns had any apparent abnormalities in either group.

Conclusion

Treatment with nucleosides suppressed the replication of HBV DNA and led to biochemical improvement. It also reduced maternal mortality and safely decreased mother-to-child HBV transmission.     

Pulse methotrexate versus pulse actinomycin D in the treatment of low-risk gestational trophoblastic neoplasia

Objective

To compare the efficacy of methotrexate and actinomycin D as single agents in first-line chemotherapy for women with low-risk gestational trophoblastic neoplasia (LR-GTN).

Methods

A total of 131 women with LR-GTN were randomized to receive a weekly pulsed dose of 30 mg/m² of methotrexate intramuscularly (n = 81) or a pulsed intravenous bolus of 1.25 mg/m² of actinomycin D every 2 weeks (n = 50). An additional cycle was administered as consolidation treatment following normalization of the serum level of β-human chorionic gonadotropin (< 5 IU/L).

Results

Complete remission was achieved in 48.14% of patients in the methotrexate group and 90.00% in the actinomycin D group (P < 0.001). The mean number of treatment cycles needed to achieve response was lower in the actinomycin D group (4.8 vs 6.8). The risk of treatment failure was 26.4 greater with methotrexate than with actinomycin D (95% confidence interval, 5.7-22.6; P < 0.001).

Conclusion

Actinomycin D may be a better option than methotrexate as a first-line chemotherapy agent for patients with LR-GTN.