Evaluation of a follow-up customized strategy for women treated with methotrexate for an ectopic pregnancy: An observational study.

OBJECTIVE: To evaluate a follow-up customized strategy used in women treated with methotrexate for tubal ectopic pregnancy. STUDY DESIGN: This observational monocentric study took place from November 2009 to December 2015 in the emergency unit at La Conception University Hospital in Marseille, France. 440 women were treated by methotrexate for tubal ectopic pregnancy. Women were assigned in a classic follow up protocol with a weekly hCG evaluation (conventional protocol) if the drop in hCG between D1 and D4 was inferior to 20% or in an alternative follow up (streamlined protocol) with a hCG evaluation at one month. The main outcome measures were the success rate, the proportion of women requiring several methotrexate injections, and the mean number of consultations per women and duration of the follow-up. RESULTS: During this period, the success rate was 348/440 (79.1%). The rate of women requiring 1, 2, or 3 injections and of women lost to follow-up were comparable between the two protocols. The mean number of consultations per woman was 3.6 ± 1.33 vs. 5.95 ± 2.25 days (p < 0.0001), and the follow-up was 27.5 ± 12 vs. 28.1 ± 15.4 (p = 0.6) respectively in the conventional protocol group and the streamlined. CONCLUSION: Our customized strategy allows for a decrease in the number of consultations per woman without changing the success rate or the need for methotrexate injection. hCG count drop between D1 and D4 allows for the selection of a low-risk group that can benefit from appropriate aftercare.

Effect of laparoscopy by single-port endoscopic access in benign adnexal surgery: study protocol for a randomized controlled trial.

BACKGROUND: Laparoscopic surgery has become the preferred surgical approach due to a reduction in postoperative pain, better recovery, shorter hospitalization, and improved esthetic outcomes. Laparoscopic surgery with single-port laparoscopy (SPL) is a laparoscopic surgery technique that is based on making a single parietal incision using a single trocar specifically designed to allow introduction of several instruments. The level of evidence regarding the advantages of SPL in terms of postoperative pain has remained low despite several randomized studies. Adult patients exhibiting a surgical indication for an a priori benign ovarian pathology or for prophylactic purposes that can be performed by laparoscopy will be randomized to receive conventional laparoscopy (CL) or SPL. The aim of our study is to evaluate whether SPL offers advantages over CL in benign adnexal surgery. METHODS: The patients will be evaluated preoperatively to confirm their eligibility. The perioperative data up to 24 h after the intervention, as well as the postoperative data at day 7 and at one month from the intervention will be collected. The primary outcome for the study will be the postoperative pain at 24 h ± 2 h after the intervention. The pain will be assessed by a numeric rating scale of 0-10. Other outcomes will also be assessed, such as pain at other times, the consumption of analgesics, the operative time, perioperative bleeding, the number of additional trocars in the two groups, the incidence of laparoconversion, the esthetic criteria of the scar at one month, the incidence of complications, and the quality of life at one month. DISCUSSION: If our hypothesis is confirmed, this study will provide evidence that the use of SPL can decrease postoperative pain in adnexal surgery. The standard surgical treatment of this condition would thus be modified. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02739724 . Registered on 12 April 2016.

Outcome and Follow-up of Patients with Endometrial Carcinoma Diagnosed on Operative Hysteroscopic Resection Specimens.

AIM: To study outcomes of patients diagnosed with endometrial carcinoma (EC) after histological analysis of endometrial resections retrieved during operative hysteroscopy performed for a presumed benign lesion. PATIENTS AND METHODS: A retrospective study was conducted using medical records of patients who underwent operative hysteroscopy for a presumed benign lesion with a final diagnosis of EC between January 1994 and April 2014 in two tertiary academic centers. RESULTS: A total of 29 patients were selected. International federation of gynecology and obstetrics (FIGO) classification was distributed as follows: 16 stages IA, 7 stages IB, 4 stages II and 2 stages III. Peritoneal cytology was positive in one case (stage IIIA). Median follow-up was 4.2 years (range=0.3-20.51). Two deaths were observed and were attributed to endometrial cancer. CONCLUSION: Operative hysteroscopy does not appear to influence stage of EC nor cause retrograde seeding of EC for 27/29 (93%) patients. For 2 patients, the impact of operative hysteroscopy remains uncertain.

Risk of coexisting endometrial carcinoma in case of atypical endometrial hyperplasia diagnosed on total hysteroscopic resection.

OBJECTIVE: To evaluate the rate of coexisting endometrial carcinoma or atypical endometrial hyperplasia (AEH) residue in patients who had a total hysteroscopic resection with diagnosis of AEH and without suspicious lesions detected during hysteroscopy. STUDY DESIGN: This retrospective bicentric study included patients diagnosed with AEH on hysteroscopic resection products, and who subsequently underwent secondary hysterectomy. Cases of hysteroscopic appearance suggesting an endometrial carcinoma were excluded. Histopathological results of hysterectomy specimen determined the persistence or absence of AEH and the possible presence of coexisting endometrial carcinoma. RESULTS: Thirty-two patients were selected. Histopathological analysis of hysterectomy specimens diagnosed an absence of AEH in 24/32 (75%) subjects, an AEH residue in 6/32 (18.8%) subjects and a coexisting endometrial carcinoma in 2/32 (6.2%) subjects. CONCLUSION: The risk of missing an endometrial carcinoma in patients diagnosed with AEH based on total hysterocopic resection is low when there is no suspicious hysteroscopic aspect, but this risk cannot be entirely excluded. Total hysteroscopic resection may be a possible alternative to hysterectomy in patients with AEH who refuse hysterectomy or are a high surgical risk. These patients require a close and long term follow-up due to the risks of residual lesion.

Is intrapartum intravenous zidovudine for prevention of mother-to-child HIV-1 transmission still useful in the combination antiretroviral therapy era?

BACKGROUND: Intrapartum intravenous zidovudine (ZDV) prophylaxis is a long-standing component of prevention of mother-to-child transmission (MTCT) of human immunodeficiency virus (HIV) in high-resource countries. In some recent guidelines, intravenous ZDV is no longer systematically recommended for mothers receiving combination antiretroviral therapy (cART) with low viral load. We evaluated the impact of intravenous ZDV according to viral load and obstetrical conditions. METHODS: All HIV-1-infected women delivering between 1 January 1997 and 31 December 2010 in the French Perinatal Cohort (ANRS-EPF) were analyzed if they received ART during pregnancy and did not breastfeed. We identified maternal and obstetrical characteristics related to lack of intravenous ZDV and compared its association with MTCT rate and other infant parameters, according to various risk factors. RESULTS: Intravenous ZDV was used in 95.2% of the 11 538 deliveries. Older age, multiparity, and preterm and vaginal delivery were associated with lack of intravenous ZDV (n = 554). In women who delivered with viral load ≥1000 copies/mL, the overall MTCT rate was higher without than with intravenous ZDV (7.5% vs 2.9%; P = .01); however, there was no such difference when the neonate received postnatal intensification therapy. Among them, 77% of women who had viral load <400 copies/mL, there was no difference in MTCT rate (0% without intravenous ZDV vs 0.6% with intravenous ZDV; P = .17). Intravenous ZDV was not associated with increased short-term hematological toxicity or lactate level. CONCLUSIONS: Intravenous ZDV remains an effective tool to reduce transmission in cases of virological failure, even in cART-treated women. However, for the vast majority of women with low viral loads at delivery, in the absence of obstetrical risk factors, systematic intravenous ZDV appears to be unnecessary.

Salpingectomy for ectopic pregnancy by transumbilical single-site laparoscopy with the SILS system.

OBJECTIVE: To evaluate the feasibility in everyday practice and the advantages of salpingectomy for ectopic pregnancy by single-incision laparoscopic surgery with the SILS system. STUDY DESIGN: This single-center prospective observational study included 37 women requiring salpingectomy for ectopic pregnancy who underwent single-incision laparoscopic salpingectomy with the SILS system. Information about feasibility and intra- and post-operative data were collected. The data for these patients were compared with those of a control group of 40 women treated by standard laparoscopy. RESULTS: Thirty-six (97%) patients were treated successfully with the SILS system. After laparoscopic confirmation of the ectopic pregnancy, salpingectomy was performed with bipolar forceps and scissors. In one case, conversion to classic laparoscopy was performed because SILS was not feasible. Compared with the control group, operative time was longer (50 ± 35 vs 35 ± 30 min, p=0.001) but duration of hospitalization shorter with single-site laparoscopy (1.5 ± 1.5 vs 2.3 ± 1.5 days, p=0.02). CONCLUSIONS: Laparoscopic salpingectomy for ectopic pregnancy appears to be feasible in everyday practice by single-incision laparoscopic surgery with the SILS system and appears to reduce the duration of hospitalization. Larger series are necessary to confirm this conclusion.

A double-blind, randomized controlled trial of the use of a 50:50 mixture of nitrous oxide/oxygen in legal abortions.

BACKGROUND: The study was conducted to evaluate the effectiveness of oxygen/nitrous oxide (O(2)/N(2)O) in elective abortions by vacuum aspiration with paracervical block and intravenous paracetamol. DESIGN: This single-center double-blinded randomized study tested O(2)/N(2)O (n=36) and placebo (air, n=36) for additional analgesia in elective abortions with paracervical block and intravenous paracetamol. We assessed intra- and postoperative pain according to both a visual analogic scale rated from 0 to 10 and postoperative analgesic requirements. RESULTS: Mean (±SD) intraoperative, immediate postoperative and late postoperative pain did not differ significantly for patients with O(2)/N(2)O and with air [3.4±2.6 vs. 3.7±3.05 (p=.75), 1.89±2.4 vs. 1.56±2.03 (p=.78), 0.5±0.8 vs. 0.75±1.2 (p=.45)]. The number of patients with scores for low (0-4), moderate (4-7) and severe (7-10) intraoperative, immediate postoperative and late postoperative pain did not differ significantly between the groups. Total adverse effects were significantly higher in the O(2)/N(2)O group [35/180 (19.4%) vs. 18/180 (10%), p=.01]. CONCLUSION: O(2)/N(2)O did not reduce intraoperative or postoperative pain in elective abortions by vacuum aspiration with paracervical analgesia and intravenous paracetamol, and its adverse effect rate was substantial.

Cornual resection for interstitial pregnancy by laparoendoscopic single-site surgery.

OBJECTIVE: To present two cases of interstitial pregnancy treated successfully by use of laparoendoscopic single-site surgery (LESS). DESIGN: Case series. SETTING: Department of obstetrics and gynecology at a tertiary health care facility. PATIENT(S): Two women with interstitial pregnancy requiring surgical treatment. INTERVENTION(S): Laparoscopy by use of LESS with the single-incision laparoscopic surgery (SILS) system. MAIN OUTCOME MEASURE(S): Feasibility of LESS with the SILS system. RESULT(S): Two patients were treated successfully by use of LESS with the SILS system. After laparoscopic confirmation of the interstitial pregnancy, a cornual resection was performed with bipolar forceps and scissors for the first patient and with an automatic stapler for the second. CONCLUSION(S): Laparoscopic treatment of interstitial pregnancy by use of LESS seems feasible. Larger series are necessary to confirm these findings.

Plasma creatine phosphokinase level may predict successful treatment after a single injection of methotrexate for ectopic pregnancy.

Our finding that creatine phosphokinase level was significantly higher in women successfully treated for ectopic pregnancy with only a single injection of methotrexate suggests that this indicator predicts this outcome.

Hysteroscopic tubal sterilization (essure) in women with an intrauterine device.

STUDY OBJECTIVE: To evaluate the feasibility and effectiveness of hysteroscopic tubal sterilization in women with an intrauterine device (IUD). DESIGN: Prospective observational study (Canadian Task Force classification II-2). SETTING: University hospital. PATIENTS: From January 2005 through January 2006, all women with an IUD who came for a hysteroscopic tubal sterilization consultation were selected to participate. INTERVENTIONS: Hysteroscopic tubal sterilization in women with IUD. MEASUREMENTS AND MAIN RESULTS: Feasibility of the procedure, localization of microinserts, and tubal occlusion evaluated by hysterography. Hysteroscopic tubal sterilization was performed in 6 patients. Hysterography showed correct placement of microinserts and bilateral tubal occlusion in all patients. CONCLUSION: Hysteroscopic tubal sterilization in women with an IUD appears to be a feasible and effective procedure.

Comparison of ropivacaine and lidocaine for paracervical block during surgical abortion.

BACKGROUND: The study was conducted to compare the effectiveness of ropivacaine and lidocaine as paracervical analgesia for elective abortion by vacuum aspiration. STUDY DESIGN: This single-center double-blinded randomized study tested two different agents for paracervical analgesia in elective abortions: lidocaine (n=57) or ropivacaine (n=57). We assessed intra- and postoperative pain according to both a visual analogical scale rated from 0 to 10 and postoperative analgesic requirements. RESULTS: Mean intraoperative pain was significantly lower in the ropivacaine group (5.23+/-2.72 vs. 4.18+/-2.77, p=.048.). There was no significant difference in mean assessed pain at the end of the intervention or at 2 or 4 h afterward. The rate of subjects requiring additional postoperative analgesia did not differ significantly between the lidocaine and ropivacaine groups [8/59 (13.5%) vs. 6/59 (10.1%), p=.33]. DISCUSSION: Intraoperative pain appears to be less with ropivacaine than with lidocaine. Nonetheless, the clinical difference was slight, as was therefore the benefit of using ropivacaine for paracervical block in elective abortions.

Complications of vaginal myomectomy by posterior colpotomy.

OBJECTIVE: To evaluate the morbidity of vaginal myomectomy by posterior colpotomy. STUDY DESIGN: From January 1, 1994, through December 31, 2003, 108 patients in our department underwent a vaginal myomectomy procedure by posterior colpotomy. This study assessed the intra-operative (conversion to laparotomy, organ injury, hemorrhage) and post-operative (hematoma, abscess) complications as well as the risk factors for conversion to laparotomy. RESULTS: There were 27 intra- or post-operative complications (25%), 17 (15.7%) of which concerned conversion to laparotomy necessary for successful myomectomy. One case involved rectal injury (0.9%), three hemorrhages (2.8%), one hematoma (0.9%) and five abscesses (4.7%). The mean weight of fibromas was significantly higher in the group of patients undergoing laparotomy (19 cases) than in the vaginal-myomectomy-only group (89 cases) (270+/-197 g versus 181+/-143 g, p=0.02). Similarly, the fibroma size measured by ultrasound was higher in the laparotomy group than in the vaginal-myomectomy-only group, but this difference was not significant (82.6+/-27.1 mm versus 73.7+/-21.8 mm, p=0.13). CONCLUSIONS: The principal risk of vaginal myomectomy is that it will require conversion to laparotomy. The risk of pelvic abscess also appears greater in myomectomy than in other procedures. However, apart from the risk of conversion to laparotomy, vaginal morbidity is lower with this procedure. Vaginal myomectomy is a useful alternative to laparotomy for specific indications.

Twin pregnancy as a risk factor for mother-to-child transmission of HIV-1: trends over 20 years.

OBJECTIVE: We investigated whether twin pregnancies were at increased risk of mother-to-child HIV-1 transmission (MTCT), in comparison with singletons. METHODS: Among HIV-1 infected women enrolled in the French Perinatal HIV Cohort (n = 9262), we studied the association between twin deliveries and MTCT rate according to three time periods (pre-1994, 1994-1996, 1997-2004) and the effect of birth order. The mother was considered to have transmitted if at least one of the twins was infected. Univariate and multivariate analyses of risk factors for MTCT were performed for deliveries in the periods up to 1996. RESULTS: Overall, 2.1% (192/9262) of all the deliveries were twins. The rate of prematurity was greater in twins than in singletons (54% and 13%, respectively). Up to 1996 the rate of MTCT of HIV-1 was 28.3% (15/53) in twin pregnancies, versus 13.5% (414/3077) in singletons [odds ratio (OR), 2.5; 95% confidence interval (CI), 1.4-4.7; P = 0.002; adjusted OR, 2.3: 95% CI, 1.1-2.3; P = 0.03). In the period from 1997 to 2003, MTCT was low and did not differ between twins (1.0%) and singletons (1.8%; P = 1.0). Overall, the transmission rate for the first-born child was threefold that for the second-born child (14/164, 8.5% versus 4/164, 2.4%; P = 0.008). CONCLUSION: Twin pregnancies were at increased risk of transmission, but in the era of HAART this risk was reduced for twins, as well as singletons. Management of multiple pregnancies should take into account the risks of premature rupture of the membranes and preterm delivery.

[Invasive cervical cancer treatment costs in France]. / Coût de la prise en charge du cancer invasif du col de l'utérus en France.

The objective of this study was to estimate the direct costs of invasive cervical cancer (ICC) management to the French national health insurance system the 1st year after ICC diagnosis. A retrospective survey was conducted in three centres in 2005, including 42 patients admitted for ICC between 2001-2003. Medical records were examined for data relating to treatments and to determine the management costs. To estimate the annual cost of ICC management in France, data were extrapolated to the general population. The number of new ICC cases in France was estimated at 3,247 in 2003. The mean hospitalisation cost increased with ICC severity at diagnosis: 9,164 euros for stage I, 15,999 euros for stage II, 22,697 euros for stage III, and 26,886 euros for stage IV. The annual cost associated with the medical management of ICC patients was estimated at 43,862,125 euros (sensitivity range 32,973,461 euros-54,748,422 euros) corresponding to a mean patient cost of 13,509 euros. Recent HPV vaccination studies have shown 100 % for a quadrivalent (6,11,16,18) HPV vaccine against HPV-induced carcinoma in situ (FIGO stage 0/CIN3), a precursor lesion that may develop into ICC. Thus, it is expected that this vaccine will significantly reduce the socio-economic burden associated with this disease.

In situ methotrexate injection for treatment of recurrent endometriotic cysts.

OBJECTIVE: Ovarian endometrioma recurrence is frequent. Conventional treatment of ovarian endometrioma is by surgical cystectomy. We proposed an alternative medical treatment for recurrent ovarian endometrioma: cyst aspiration followed by in situ methotrexate injection. STUDY DESIGN: From January 2002 to May 2003, 14 patients with recurrent homolateral ovarian endometrioma underwent transvaginal ultrasound guided cyst puncture and aspiration followed by methotrexate injection, whilst under general anasthesia. Recurrence rate during follow up was evaluated. RESULTS: No complication was reported. After a mean follow up of 20+/-5 month (min: 13, max: 29), four recurrences were diagnosed (28.6%). Two asymptomatic recurrences were not treated and two painful recurrences underwent a second cyst drainage with methotrexate injection. CONCLUSIONS: In situ methotrexate injection is a simple, effective and an interesting alternative to surgical treatment in women with recurrent homolateral ovarian endometrioma.

Management of placenta accreta: morbidity and outcome.

OBJECTIVE: The aim of the study was to evaluate our results in the management of placenta accreta. STUDY DESIGN: In a retrospective study we reviewed cases of placenta accreta diagnosed in two university teaching hospitals between 1993 and 2003. For a subgroup of patients a conservative approach was attempted. In this procedure placenta was left in place until spontaneous resorption. RESULTS: Fifty cases (0.12%) of placenta accreta were observed in 41, 119 deliveries during the study period. Of the 50 cases, 24 patients (48%) were managed by the standard approach and 26 patients (52%) underwent conservative treatment. Additional surgical or medical treatment was performed in 35 of the 50 patients (70%). There was no maternal death. Overall hysterectomy rate was 40%, 10 patients were transferred to intensive care unit (20%), 7 had fever (14%), 5 had endometritis (10%) and 19 patients had blood transfusion (38%). Conservative treatment did not lead to hysterectomy in 21 cases (80.7%) and failed in 5 (19.3%). During the follow-up period, 3 women had successful pregnancy. CONCLUSION: Analysis of management of placenta accreta shows that for a subgroup of selected patients a conservative approach could preserve subsequent fertility without evident increase in morbidity.

Value of laparoscopic assistance for vaginal hysterectomy with prophylactic bilateral oophorectomy.

OBJECTIVE: This study was undertaken to compare morbidity for women undergoing laparoscopy-assisted vaginal hysterectomy with bilateral oophorectomy (LAVHO) and vaginal hysterectomy with bilateral oophorectomy without laparoscopic assistance (VHO). STUDY DESIGN: Between April 1, 2002, and February 1, 2004, a prospective randomized study at Marseille University Hospital (La Conception) included 48 patients who underwent a hysterectomy with prophylactic bilateral oophorectomy for benign uterine conditions. These patients were allocated to 2 groups (LAVHO vs VHO). The study variables were duration of surgery and of hospitalization and surgical and postoperative complications. RESULTS: There was no significant difference in the duration of surgery between the LAVHO and VHO groups (100.2 +/- 27.9 vs 83.9 +/- 34.6, P = .08). The rate of complications was significantly higher in the LAVHO group (13/24 [54.1%] vs 6/24 [25%], P = .039). CONCLUSION: The overall complication rate was higher with LAVHO than VHO. It thus appears that laparoscopic assistance is not useful in performing vaginal hysterectomies with prophylactic bilateral oophorectomies in patients without other related disorders (endometriosis, adhesions, adnexal anomalies).