Diagnostic accuracy of transvaginal ultrasonography and hysterosalpingography in the detection of uterine cavity pathologies among infertile women.

Background: Uterine cavity pathology may affect the endometrium or myometrium, resulting in distortion of the uterine cavity, and is responsible for 2%-5% of infertility. The methods for its assessment usually involve imaging modalities like pelvic ultrasonography, often transvaginal-(TVS), and hysterosalpingography-(HSG), with hysteroscopy-(HSC) as the gold standard. However, HSC is not readily available in resource-poor-settings. Purpose: To determine and compare the diagnostic accuracy of TVS and HSG in detecting uterine cavity pathology using HSC as a gold standard. Materials and Methods: A cross-sectional analytical study of consenting infertile women for evaluation of the uterine cavity using transvaginal-ultrasonography, hysterosalpingogram, and hysteroscopy. The primary-outcome-measures were the sensitivity, specificity, and accuracy of TVS and HSG in detecting uterine cavity abnormalities using HSG as the gold standard. Results: Eighty-eight participants were analysed for this study. The lesions confirmed on HSC were intrauterine-adhesions (43.1%), endometrial polyps (14.8%), submucous fibroids (18.2%), intrauterine-septum (13.6%), and cavity distortion (14.8%). The overall sensitivity with TVS was 57.7%, with a specificity of 97.6%, a positive-predictive-value (PPV) of 88.2%, and a negative-predictive-value (NPV) of 88.2%, giving a percentage-accuracy of 88.2%. In comparison, HSG had a sensitivity of 72.1%, a specificity of 99.4%, a PPV of 97.4%, and an NPV of 92.0%, giving an overall accuracy of 92.9%. The detection rates of TVS and HSG in this category were: fibroids (97.7% vs 89.8%; p = .0004) and adhesions (73.9% vs 87.5%; p = .0002), respectively. Conclusion: HSG appears to be the superior modality for detection of obliterative uterine cavity pathologies, while TVS is better suited for myometrium and endometrial lesions.

Effects of speculum lubrication on cervical smears for cervical cancer screening: A double blind randomized clinical trial.

BACKGROUND: Speculum lubrication may help to reduce the pain experienced during Pap-smear collection and hence increase uptake of cervical cancer screening and repeat testing, but there are fears of its interference with cytological results. AIM: To determine and compare the adequacy of cervical cytology smears and the mean pain scores of women undergoing cervical cancer screening with or without speculum lubrication. METHODS: This was a randomised controlled study of 132 women having cervical cancer screening at a tertiary hospital in Nigeria. Sixty-six participants were randomly assigned to the 'Gel' and 'No Gel' groups, respectively. Pap smears were collected from each participant with a lubricated speculum ('Gel group') or a non-lubricated speculum ('No Gel group'). The primary outcome measures were the proportion of women with unsatisfactory cervical cytology smears and the mean numeric rating scale pain scores, while the secondary outcome measures were the proportion of women who were willing to come for repeat testing and the cytological diagnosis of Pap-smear results. RESULTS: The baseline socio-demographic variables were similar in both groups. There was no significant difference in the proportion of unsatisfactory cervical smear results between the two groups (13.6% vs. 21.2%, p = 0.359). However, the mean pain scores were significantly lower in the gel group than in the no gel group (45.04 vs. 87.96; p<0.001). An equal proportion of the participants in each group (90.9% vs. 90.9%; p > 0.999) were willing to come for repeat cervical smears in the future. CONCLUSION: Speculum lubrication did not affect the adequacy of cervical smears but significantly reduced the pain experienced during pap smear collection. Also, it did not significantly affect the willingness to come for repeat cervical smears in the future. TRIAL REGISTRATION: The trial was registered with the Pan-African Clinical Trial Registry with a unique identification and registration number: PACTR2020077533364675.

Prophylactic tranexamic acid for reducing intraoperative blood loss during cesarean section in women at high risk of postpartum hemorrhage: A double-blind placebo randomized controlled trial.

BACKGROUND: Postpartum hemorrhage remains a leading cause of maternal mortality especially in developing countries. The majority of previous trials on the effectiveness of tranexamic acid in reducing blood loss were performed in low-risk women for postpartum hemorrhage. A recent Cochrane Systematic Review recommended that further research was needed to determine the effects of prophylactic tranexamic acid for preventing intraoperative blood loss in women at high risk of postpartum hemorrhage. OBJECTIVE: This study aimed to evaluate the effectiveness and safety of tranexamic acid in reducing intraoperative blood loss when given prior to cesarean delivery in women at high risk of postpartum hemorrhage. STUDY DESIGN: The study is a double-blind randomized controlled trial. METHODS: The study consisted of 200 term pregnant women and high-risk preterm pregnancies scheduled for lower-segment cesarean delivery at Enugu State University of Science and Technology, Teaching Hospital, Parklane, Enugu, Nigeria. The participants were randomized into two arms (intravenous 1 g of tranexamic acid or placebo) in a ratio of 1:1. The participants received either 1 g of tranexamic acid or placebo (20 mL of normal saline) intravenously at least 10 min prior to commencement of the surgery. The primary outcome measures were the mean intraoperative blood loss and hematocrit change 48 h postoperatively. RESULTS: The baseline sociodemographic characteristics were similar in both groups. The tranexamic acid group when compared to the placebo group showed significantly lower mean blood loss (442.94 ± 200.97 versus 801.28 ± 258.68 mL; p = 0.001), higher mean postoperative hemoglobin (10.39 + 0.96 versus 9.67 ± 0.86 g/dL; p = 0.001), lower incidence of postpartum hemorrhage (1.0% versus 19.0%; p = 0.001), and lower need for use of additional uterotonic agents after routine management of the third stage of labor (39.0% versus 68.0%; p = 0.001), respectively. However, there was no significant difference in the mean preoperative hemoglobin (11.24 ± 0.88 versus 11.15 ± 0.90 g/dL; p = 0.457), need for other surgical intervention for postpartum hemorrhage (p > 0.05), and reported side effect, respectively, between the two groups. CONCLUSION: Prophylactic administration of tranexamic acid significantly decreases postpartum blood loss, improves postpartum hemoglobin, decreases the need for additional uterotonics, and prevents postpartum hemorrhage following cesarean section in pregnant women at high risk of postpartum hemorrhage. Its routine use during cesarean section in high-risk women may be encouraged.The trial was registered in the Pan-African Clinical Trial Registry with approval number PACTR202107872851363.

A randomized controlled trial of rectal versus intramuscular diclofenac for post-operative analgesia after open myomectomy.

AIM: To determine the efficacy and safety of rectal versus intramuscularly administered Diclofenac in reducing post-operative pain in the first 24 h after open-myomectomy. METHODS: A single blind, placebo controlled randomized trial consisting of 90 consenting women that had open-abdominal-myomectomy. They were randomized into two-groups (rectal-group and intramuscular-group) of 45 women (1:1 ratio). Rectal-group received 75 mg of Diclofenac suppository 12 hourly for 24 h and placebo (3 ml of intramuscular injection-water) 12hourly for 24 h while intramuscular-group received intramuscular Diclofenac 75 mg 12 hourly for 24 h and placebo (Anusol suppository) 12 hourly for 24 h. Both groups received intramuscular Pentazocine 30 mg 6 hourly for 24 h as primary analgesic after myomectomy. Pain was assessed using a Ten-Point Visual-Analogue-Scale. Participants' satisfaction of the mode of the pain relief was assessed using the Likert-scale after 24 h. The primary outcome was the pain score using the visual-analogue-scale. The secondary outcome-measures were participants' satisfaction after 24 h of administration of the drugs, the need and frequency of rescue-analgesia and maternal-side-effects. RESULT: The baseline socio-demographic characteristics were similar in both groups. There was no statistically significant difference between both groups in pain assessment at 1 h post-myomectomy (p-value > 0.05). However, the pain assessments at 6, 12, 18 and 24 h post-myomectomy were statistically significant with more pain in intramuscular-group when compared to rectal-group. Majority of participants in rectal-group were both very satisfied (35.6 %) and satisfied (55.6 %) when compared to intramuscular-group (11.1 %) and (31,1%) respectively (p-value < 0.05). Also majority of the participants in intramuscular-group were dissatisfied (17.8 %) with none of the participant showing any form of dissatisfaction (p-value < 0.05). Majority of the participant in rectal-group had no drug side effects when compared with intramuscular-group. Epigastric discomfort was commoner in rectal-group while drowsiness was commoner in intramuscular-group. CONCLUSION: Rectal Diclofenac with intramuscular Pentazocine is significantly associated with better effectiveness in pain reduction and maternal satisfaction when compared with intramuscular Diclofenac and intramuscular Pentazocine following open-myomectomy. While epigastric discomfort was the commonest side-effect in rectal-group, drowsiness was commoner in intramuscular-group. TRIAL REGISTRATION: Pan-African-clinical-trial-registry (PACTR); PACTR202206556144219.

Antivirals for prevention of hepatitis B virus mother-to-child transmission in human immunodeficiency virus positive pregnant women co-infected with hepatitis B virus.

BACKGROUND: Hepatitis B virus (HBV)-human Immunodeficiency virus (HIV) co-infection promotes an aggressive disease course of HBV infection. In the only available non-Cochrane systematic review on antiviral therapy during pregnancy for prevention of mother-to-child transmission of HBV, none of the women studied had HBV-HIV co-infection but were either HBV- or HIV-seropositive. Treatment of HBV alone may develop HIV-strains that are resistant to non-nucleoside reverse transcriptase inhibitors. Accordingly, co-treatment of the HIV infection is recommended. OBJECTIVES: To evaluate the benefits and harms of tenofovir-based antiviral combination regimens versus placebo, tenofovir alone, or non-tenofovir-based antiviral regimen either alone or in combination with HBV for the prevention of mother-to-child transmission of HBV in HIV-positive pregnant women co-infected with HBV. SEARCH METHODS: We searched the Cochrane Hepato-Biliary Group Controlled Trials Register, Cochrane Central Register of Controlled Trials, MEDLINE Ovid, Embase Ovid, LILACS (Bireme), Science Citation Index Expanded (Web of Science), and Conference Proceedings Citation Index-Science (Web of Science) on 30 January 2023. We manually searched the reference lists of included trials, searched on-line trial registries, and contacted experts in the field and pharmaceutical companies for any further potential trials. SELECTION CRITERIA: We aimed to include randomised clinical trials comparing tenofovir-based antiviral combination regimens (anti-HIV regimen with lopinavir-ritonavir therapy, or any other antiviral therapy, and two drugs with activity against HBV, specifically, tenofovir alafenamide (TAF) or tenofovir disoproxil fumarate (TDF), plus lamivudine or emtricitabine) with placebo alone, or tenofovir alone, or non-tenofovir-based antiviral regimen (zidovudine, lamivudine, telbivudine, emtricitabine, entecavir, lopinavir-ritonavir, or any other antiviral therapy) either alone or in combination with at least two other antivirals. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane. Primary outcomes included all-cause infant mortality, proportion of infants with serious adverse events, proportion of infants with HBV mother-to-child transmission, all-cause maternal mortality, and proportion of mothers with serious adverse events. Secondary outcomes included proportion of infants with adverse events not considered serious, proportion of mothers with detectable HBV DNA (deoxyribonucleic acid) (before delivery), maternal hepatitis B e antigen (HBeAg) to HBe-antibody seroconversion (before delivery) and maternal adverse events not considered serious. We used RevMan Web to carry out analyses and presented results, where feasible, using a random-effects model and risk ratios (RR) with 95% confidence intervals (CIs). We performed sensitivity analysis. We assessed risk of bias using predefined domains, assessed the certainty of the evidence using GRADE, controlled risk of random errors with Trial Sequential Analysis, and presented outcome results in a summary of findings table. MAIN RESULTS: Five completed trials were included, of which four trials contributed data to one or more of the outcomes. They included a total of 533 participants randomised to tenofovir-based antiviral combination regimens (196 participants) versus control (337 participants). The control groups received non-tenofovir-based antiviral regimens either as zidovudine alone (three trials) or as a combination of zidovudine, lamivudine and lopinavir-ritonavir (five trials). None of the trials used placebo or tenofovir alone. All trials were at unclear risk of bias. Four trials used intention-to-treat analyses. In the remaining trial, two participants in the intervention group and two in the control group were lost to follow-up. However, the outcomes of these four participants were not described. Tenofovir-based antiviral combination regimen versus control We are very uncertain about the effect of a tenofovir-based antiviral combination regimen versus control on all-cause infant mortality (RR 2.24, 95% CI 0.72 to 6.96; participants = 132; trials = 1; very low-certainty evidence); proportion of infants with serious adverse events (RR 1.76, 95% CI 1.27 to 2.43; participants = 132; trials = 1; very low-certainty evidence), and proportion of mothers with serious adverse events (RR 0.90, 95% CI 0.62 to 1.32; participants = 262; trials = 2; very low-certainty evidence). No trial reported data on the proportion of infants with HBV mother-to-child transmission and all-cause maternal mortality. We are also very uncertain about the effect of tenofovir-based antiviral combination regimens versus control on the proportion of infants with adverse events not considered serious (RR 0.94, 95% CI 0.06 to 13.68; participants = 31; trials = 1; very low-certainty evidence), and proportion of mothers with detectable HBV DNA (before delivery) (RR 0.66, 95% CI 0.42 to 1.02; participants = 169; trials = 2; very low-certainty evidence). No trial reported data on maternal hepatitis B e antigen (HBeAg) to HBe-antibody seroconversion (before delivery) and maternal adverse events not considered serious. All trials received support from industry. AUTHORS' CONCLUSIONS: We do not know what the effects of tenofovir-based antiviral combination regimens are on all-cause infant mortality, proportion of infants with serious adverse events and proportion of mothers with serious adverse events, proportion of infants with adverse events not considered serious, and proportion of mothers with detectable HBV DNA before delivery because the certainty of evidence was very low. Only one or two trials, with insufficient power, contributed data for analyses. We lack randomised clinical trials at low risk of systematic and random errors, and fully reporting all-cause infant mortality, serious adverse events and reporting on clinical and laboratory outcomes, such as infants with HBV mother-to-child transmission, all-cause maternal mortality, maternal hepatitis B e antigen (HBeAg) to HBe-antibody seroconversion before delivery and maternal adverse events not considered serious.

Randomized control trial on effectiveness and safety of direct trocar versus Veress needle entry techniques in obese women during diagnostic laparoscopy.

PURPOSE: To determine the benefits and safety of direct trocar insertion versus Veress needle technique in obese women undertaking diagnostic laparoscopy procedures. METHODS: Randomized-controlled trial on 135 obese women undergoing diagnostic laparoscopy and dye test for infertility was conducted. Women were randomly assigned to either direct trocar access (n = 68) or Veress needle access (n = 67) before achieving pneumoperitoneum. The same surgeon executed the laparoscopic techniques with a single-puncture technique. The primary outcome measures included total length of the procedure and incidence of any complications, while the mean laparoscopic entry time, volume of CO2 required, and total of tries needed to attain successful entry were secondary outcomes. Intention-to-treat principle was applied to analysis. RESULTS: Women in both groups had similar socio-demographic and clinical characteristics and none were lost to follow-up. The overall length of the procedure was significantly lesser in the direct trocar group compared to the Veress needle group (9.9 ± 6.0 vs 16.7 ± 4.7 min; p < 0.001). No significant differences occurred in other outcomes including mean entry time, volume of CO2 used, number of attempts for successful entry, and major/minor complications (p > 0.05). CONCLUSIONS: Direct trocar technique may be an effective alternative to Veress needle for pneumoperitoneum in obese women for diagnostic laparoscopy. It has a comparable rapid laparoscopic entry time but a significantly lower duration of the procedure and shorter exposure to anesthesia. Both methods are equally effective as there was no significant difference in the complications recorded. A greater sample trial may be essential for more corroborative substantiation. CLINICAL TRIAL REGISTRATION: PACTR201510000999192.

Combined insulin-like growth factor binding protein-1/interleukin-6 (Premaquick) versus fetal fibronectin for predicting preterm delivery among women with preterm contractions.

OBJECTIVES: To compare accuracy between Premaquick (combined test for native insulin-like growth factor binding protein-1 (IGFBP-1), total IGFBP-1, and interleukin-6) and fetal fibronectin (Ffn) in predicting preterm delivery. METHODS: Prospective study among women at 28-36+6 gestational weeks with threatened preterm labor attending Federal Medical Center, Owerri, Nigeria, from August 2017 to February 2019. Cervico-vaginal fluids were collected and tested by Premaquick and Ffn tests. The women were followed for 14 days. Sensitivity, specificity, and negative (NPV) and positive (PPV) predictive value for delivery were compared between the tests. RESULTS: Among 213 women assessed for eligibility, 183 were enrolled and 175 completed the study. The sensitivity, specificity, PPV, NPV, and accuracy of the Premaquick versus Ffn tests were, respectively, 96.3% versus 51.9%, 97.6% versus 98.4%, 89.7% versus 87.5%, 99.2% versus 90.3% and 97.3% versus 90.0% for preterm delivery within 14 days. Ffn had higher specificity (98.5% vs 97.8%; P>0.99), but Premaquick had higher PPV (92.7% vs 90.9%; P>0.99). CONCLUSION: Both tests seem to have high utility in predicting preterm delivery, but Premaquick showed higher accuracy in terms of sensitivity and PPV. Premaquick might be a feasible alternative to Ffn for predicting preterm delivery among symptomatic women in a low-income setting.

Diagnostic value of Chorioquick for detecting chorioamnionitis in women with premature rupture of membranes.

OBJECTIVE: To determine the accuracy of a semi-quantitative interleukin-6 (IL-6) vaginal secretion rapid test (Chorioquick) for detecting chorioamnionitis in women with premature rupture of membranes (PROM). METHODS: A prospective cohort study in five tertiary hospitals in Nigeria involved women with confirmed PROM at term and preterm PROM with or without suspected chorioamnionitis from August 1, 2017, to October 31, 2018. Cervicovaginal fluid samples were tested for chorioamnionitis using the Chorioquick test. Samples were repeated at decision to deliver. The test was considered positive if at least the indicator 'IL-6 low' of the three Chorioquick biomarkers (low, medium, high) was positive, or negative if none of the biomarkers were positive. Chorioamnionitis was histologically confirmed post-delivery using three tissue samples. Primary outcome measures were sensitivity, specificity, and accuracy. RESULTS: Of 73 women, on histological confirmation, 39 were true positive and 29 were true negative (for chorioamnionitis) to the Chorioquick test at repeat assessment. Overall, the Chorioquick test had a sensitivity of 97.5% (95% confidence interval [CI] 85.3-99.9), specificity 87.9% (70.9-96.0), and accuracy 93.2% (79.5-99.1). Sub-group analysis of women <37 weeks of pregnancy showed a sensitivity of 100.0% (95% CI 83.4-100.0), specificity of 91.3% (70.5-98.5), and accuracy of 95.8% (82.5-99.5). Triple positive samples were 100.0% specific in all gestations. CONCLUSION: Chorioquick showed favorable utility for detecting chorioamnionitis in PROM and could be a reliable, non-invasive rapid tool in a real-world clinical setting.

Palliative interventions for controlling vaginal bleeding in advanced cervical cancer.

BACKGROUND: This is an updated version of the original Cochrane review published in Issue 5, 2015.Cervical cancer is the fourth most common cancer among women worldwide, with estimated 569,847 new diagnoses and 311,365 deaths per year. However, incidence and stage at diagnosis vary greatly between geographic areas and are largely dependent on the availability of a robust population screening programme. For example, in Nigeria, advanced-stage disease at presentation is common (86% to 89.3% of new cases), whereas in the UK, only 21.9% of women present with International Federation of Gynaecology and Obstetrics (FIGO) stage II+ disease. Women with advanced cancer of the cervix often need palliation for distressing symptoms, such as vaginal bleeding. Vaginal bleeding can be life threatening in advanced disease, with an incidence ranging from 0.7% to 100%. Bleeding is the immediate cause of death in 6% of women with cervical cancer and its management often poses a challenge.Thus, vaginal bleeding remains a common consequence of advanced cervical cancer. Currently, there is no systematic review that addresses palliative interventions for controlling vaginal bleeding caused by advanced cervical cancer. A systematic evaluation of the available palliative interventions is needed to inform decision-making. OBJECTIVES: To evaluate the efficacy and safety of tranexamic acid, vaginal packing (with or without formalin-soaked packs), interventional radiology or other interventions compared with radiotherapy for palliative treatment of vaginal bleeding in women with advanced cervical cancer. SEARCH METHODS: The search for the original review was run in 23 March 2015, and subsequent searches for this update were run 21 March 2018. We searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2018, Issue 3) in the Cochrane Library; MEDLINE via Ovid to March week 2, 2018; and Embase via Ovid to March week 12, 2018. We also searched registers of clinical trials, abstracts of scientific meetings and reference lists of review articles, and contacted experts in the field. We handsearched citation lists of relevant studies. SELECTION CRITERIA: We searched for randomised and non-randomised comparative studies that evaluated the efficacy and safety of tranexamic acid, vaginal packing (with or without formalin-soaked packs), interventional radiology or other interventions compared with radiotherapy techniques for palliative treatment of vaginal bleeding in women with advanced cervical cancer (with or without metastasis), irrespective of publication status, year of publication or language in the review. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed whether potentially relevant studies met the inclusion criteria. We found no studies for inclusion and, therefore, we analysed no data. MAIN RESULTS: The search strategy identified 1522 unique references of which we excluded 1330 on the basis of title and abstract. We retrieved the remaining 22 articles in full, but none satisfied the inclusion criteria. We identified only observational data from single-arm studies of women treated with formalin-soaked packs, interventional radiology or radiotherapy techniques for palliative control of vaginal bleeding in women with cervical cancer. AUTHORS' CONCLUSIONS: Since the last version of this review we found no new studies. There is no evidence from controlled trials to support or refute the use of any of the proposed interventions compared with radiotherapy. Therefore, the choice of intervention will be based on local resources. Radiotherapy techniques for managing vaginal bleeding are not readily available in resource-poor settings, where advanced cases of cervical cancer are predominant. Thus, this systematic review identified the need for a randomised controlled trial assessing the benefits and risks of palliative treatments for vaginal bleeding in women with advanced cervical cancer.

Risk-reducing bilateral salpingo-oophorectomy in women with BRCA1 or BRCA2 mutations.

BACKGROUND: The presence of deleterious mutations in breast cancer 1 gene (BRCA1) or breast cancer 2 gene (BRCA2) significantly increases the risk of developing some cancers, such as breast and high-grade serous cancer (HGSC) of ovarian, tubal and peritoneal origin. Risk-reducing salpingo-oophorectomy (RRSO) is usually recommended to BRCA1 or BRCA2 carriers after completion of childbearing. Despite prior systematic reviews and meta-analyses on the role of RRSO in reducing the mortality and incidence of breast, HGSC and other cancers, RRSO is still an area of debate and it is unclear whether RRSO differs in effectiveness by type of mutation carried. OBJECTIVES: To assess the benefits and harms of RRSO in women with BRCA1 or BRCA2 mutations. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2017, Issue 7) in The Cochrane Library, MEDLINE Ovid, Embase Ovid and trial registries, with no language restrictions up to July 2017. We handsearched abstracts of scientific meetings and other relevant publications. SELECTION CRITERIA: We included non-randomised trials (NRS), prospective and retrospective cohort studies, and case series that used statistical adjustment for baseline case mix using multivariable analyses comparing RRSO versus no RRSO in women without a previous or coexisting breast, ovarian or fallopian tube malignancy, in women with or without hysterectomy, and in women with a risk-reducing mastectomy (RRM) before, with or after RRSO. DATA COLLECTION AND ANALYSIS: We extracted data and performed meta-analyses of hazard ratios (HR) for time-to-event variables and risk ratios (RR) for dichotomous outcomes, with 95% confidence intervals (CI). To assess bias in the studies, we used the ROBINS-I 'Risk of bias' assessment tool. We quantified inconsistency between studies by estimating the I2 statistic. We used random-effects models to calculate pooled effect estimates. MAIN RESULTS: We included 10 cohort studies, comprising 8087 participants (2936 (36%) surgical participants and 5151 (64%) control participants who were BRCA1 or BRCA2 mutation carriers. All the studies compared RRSO with or without RRM versus no RRSO (surveillance). The certainty of evidence by GRADE assessment was very low due to serious risk of bias. Nine studies, including 7927 women, were included in the meta-analyses. The median follow-up period ranged from 0.5 to 27.4 years. MAIN OUTCOMES: overall survival was longer with RRSO compared with no RRSO (HR 0.32, 95% CI 0.19 to 0.54; P < 0.001; 3 studies, 2548 women; very low-certainty evidence). HGSC cancer mortality (HR 0.06, 95% CI 0.02 to 0.17; I² = 69%; P < 0.0001; 3 studies, 2534 women; very low-certainty evidence) and breast cancer mortality (HR 0.58, 95% CI 0.39 to 0.88; I² = 65%; P = 0.009; 7 studies, 7198 women; very low-certainty evidence) were lower with RRSO compared with no RRSO. None of the studies reported bone fracture incidence. There was a difference in favour of RRSO compared with no RRSO in terms of ovarian cancer risk perception quality of life (MD 15.40, 95% CI 8.76 to 22.04; P < 0.00001; 1 study; very low-certainty evidence). None of the studies reported adverse events.Subgroup analyses for main outcomes: meta-analysis showed an increase in overall survival among women who had RRSO versus women without RRSO who were BRCA1 mutation carriers (HR 0.30, 95% CI 0.17 to 0.52; P < 0001; I² = 23%; 3 studies; very low-certainty evidence) and BRCA2 mutation carriers (HR 0.44, 95% CI 0.23 to 0.85; P = 0.01; I² = 0%; 2 studies; very low-certainty evidence). The meta-analysis showed a decrease in HGSC cancer mortality among women with RRSO versus no RRSO who were BRCA1 mutation carriers (HR 0.10, 95% CI 0.02 to 0.41; I² = 54%; P = 0.001; 2 studies; very low-certainty evidence), but uncertain for BRCA2 mutation carriers due to low frequency of HGSC cancer deaths in BRCA2 mutation carriers. There was a decrease in breast cancer mortality among women with RRSO versus no RRSO who were BRCA1 mutation carriers (HR 0.45, 95% CI 0.30 to 0.67; I² = 0%; P < 0.0001; 4 studies; very low-certainty evidence), but not for BRCA2 mutation carriers (HR 0.88, 95% CI 0.42 to 1.87; I² = 63%; P = 0.75; 3 studies; very low-certainty evidence). One study showed a difference in favour of RRSO versus no RRSO in improving quality of life for ovarian cancer risk perception in women who were BRCA1 mutation carriers (MD 10.70, 95% CI 2.45 to 18.95; P = 0.01; 98 women; very low-certainty evidence) and BRCA2 mutation carriers (MD 13.00, 95% CI 3.59 to 22.41; P = 0.007; very low-certainty evidence). Data from one study showed a difference in favour of RRSO and RRM versus no RRSO in increasing overall survival (HR 0.14, 95% CI 0.02 to 0.98; P = 0.0001; I² = 0%; low-certainty evidence), but no difference for breast cancer mortality (HR 0.78, 95% CI 0.51 to 1.19; P = 0.25; very low-certainty evidence). The risk estimates for breast cancer mortality according to age at RRSO (50 years of age or less versus more than 50 years) was not protective and did not differ for BRCA1 (HR 0.85, 95% CI 0.64 to 1.11; I² = 16%; P = 0.23; very low-certainty evidence) and BRCA2 carriers (HR 0.88, 95% CI 0.42 to 1.87; I² = 63%; P = 0.75; very low-certainty evidence). AUTHORS' CONCLUSIONS: There is very low-certainty evidence that RRSO may increase overall survival and lower HGSC and breast cancer mortality for BRCA1 and BRCA2 carriers. Very low-certainty evidence suggests that RRSO reduces the risk of death from HGSC and breast cancer in women with BRCA1 mutations. Evidence for the effect of RRSO on HGSC and breast cancer in BRCA2 carriers was very uncertain due to low numbers. These results should be interpreted with caution due to questionable study designs, risk of bias profiles, and very low-certainty evidence. We cannot draw any conclusions regarding bone fracture incidence, quality of life, or severe adverse events for RRSO, or for effects of RRSO based on type and age at risk-reducing surgery. Further research on these outcomes is warranted to explore differential effects for BRCA1 or BRCA2 mutations.

Spontaneous Synchronous Tubal Pregnancy with Prior Successful in Vitro Fertilization and Embryo Transfer. A Case Report.

BACKGROUND: Synchronous (bilateral) ectopic preg- nancy is a very rare gynecological entity resulting in most cases from assisted reproduction techniques. Al- though few cases of bilater- al ectopic pregnancy have been reported in Nigeria, spontaneous bilateral tubal pregnancy in a woman with a diagnosis of bilateral tubal blockage and prior success- ful in vitro fertilization and embryo transfer (IVF-E T) is paradoxically rare and, to the best of our knowledge, has not been reported in Nigeria. CASE: A 37-year-old Nigerian woman presented with ruptured ectopic pregnancy associated with hemoperito- neum with previous diagnosis of bilateral tubal blockage and prior successful IVF-ET She subsequently under- went a laparotomy and the diagnosis of bilateral tubal pregnancy was made during surgery and confirmed by histology. Bilateral salpingectomy was done. CONCLUSION: This was the first case of spontaneous bilateral tubal pregnancy in a woman with previous di- agnosis of bilateral tubal blockage and prior successful IVF-ET in Nigeria. There is no evidence-based guideline presently available on the management of bilateral ectopic pregnancy.

Palliative interventions for controlling vaginal bleeding in advanced cervical cancer.

BACKGROUND: Cervical cancer is the second most common cancer among women worldwide, with around 500,000 new diagnoses and 273,000 deaths per year. However, incidence and stage at diagnosis vary greatly between geographic areas and are largely dependent on the availability of a robust population screening programme. For example, in Nigeria, advanced-stage disease at presentation is common (86% to 89.3% of new cases), whereas in the UK, only 21.9% of women present with International Federation of Gynaecology and Obstetrics (FIGO) stage II+ disease. Women with advanced cancer of the cervix often need palliation for distressing symptoms, such as vaginal bleeding. Vaginal bleeding can be life threatening in advanced disease, with an incidence ranging from 0.7% to 100%. Bleeding is the immediate cause of death in 6% of women with cervical cancer and its management often poses a challenge.Thus, vaginal bleeding remains a common consequence of advanced cervical cancer. Currently, there is no systematic review that addresses palliative interventions for controlling vaginal bleeding caused by advanced cervical cancer. A systematic evaluation of the available palliative interventions is needed, to inform decision-making. OBJECTIVES: To evaluate the efficacy and safety of tranexamic acid, vaginal packing (with or without formalin-soaked packs), interventional radiology or other interventions compared with radiotherapy for palliative treatment of vaginal bleeding in women with advanced cervical cancer. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), Issue 2, 2015; the Cochrane Gynaecological Cancer Group Trials Register; MEDLINE from 1980 to March week 3, 2015 and EMBASE from 1980 to February week 12, 2015. We also searched registers of clinical trials, abstracts of scientific meetings and reference lists of review articles and contacted experts in the field. We handsearched citation lists of relevant studies. SELECTION CRITERIA: We searched for randomised and non-randomised comparative studies that evaluated the efficacy and safety of tranexamic acid, vaginal packing (with or without formalin-soaked packs), interventional radiology or other interventions compared with radiotherapy techniques for palliative treatment of vaginal bleeding in women with advanced cervical cancer (with or without metastasis), irrespective of publication status, year of publication or language in the review. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed whether potentially relevant studies met the inclusion criteria. We found no studies were identified for inclusion and, therefore, we analysed no data. MAIN RESULTS: The search strategy identified 1335 unique references of which 1160 were excluded on the basis of title and abstract. We retrieved the remaining 22 articles in full, but none satisfied the inclusion criteria. We identified only observational data from single-arm studies of women treated with formalin-soaked packs, interventional radiology or radiotherapy techniques for palliative control of vaginal bleeding in women with cervical cancer. AUTHORS' CONCLUSIONS: There is no evidence from controlled trials to support or refute the use of any of the proposed interventions compared with radiotherapy. Therefore, the choice of intervention will be based on local resources. Radiotherapy techniques for managing vaginal bleeding are not readily available in resource-poor settings, where advanced cases of cervical cancer are predominant. Thus, this systematic review identified the need for a randomised controlled trial assessing the benefits and risks of palliative treatments for vaginal bleeding in women with advanced cervical cancer.

Adult granulosa cell tumor associated with endometrial carcinoma: a case report.

INTRODUCTION: If strict criteria for the diagnosis of carcinoma are used and all patients with granulosa cell tumors are considered, the best estimate of the incidence of associated endometrial carcinomas is under 5%. In patients with granulosa cell tumors, estrogen-dependent endometrial cancers are rarely found, and most of these endometrial cancers are well-differentiated endometrioid adenocarcinomas that carry a good prognosis when detected early. CASE PRESENTATION: We report the case of a 65-year-old post-menopausal Nigerian woman of the Igbo tribe with an adult granulosa cell tumor that was initially treated as endometrial carcinoma. She underwent a total abdominal hysterectomy and a bilateral salpingo-oophorectomy after histopathologic confirmation of a well-differentiated granulosa cell tumor of the ovary and a nuclear grade 1 adenocarcinoma of the endometrium (International Federation of Obstetricians and Gynecologists stage 1B). She had a good post-operative recovery and was discharged 10 days after treatment. CONCLUSION: The association between adult granulosa cell tumors of the ovary and endometrial carcinomas is rare. A high index of suspicion as well as good imaging and histopathologic analyses are important in making this diagnosis.