Maintenance darunavir/ritonavir monotherapy to prevent perinatal HIV transmission, ANRS-MIE 168 MONOGEST study.

OBJECTIVES: Because NRTIs can have fetal toxicities, we evaluated a perinatal NRTI-sparing strategy to prevent perinatal HIV transmission. Our primary objective was to determine the proportion maintaining a viral load (VL) of <50 copies/mL up to delivery on darunavir/ritonavir monotherapy, without requiring treatment intensification. METHODS: In a one-arm, multicentre Phase 2 clinical trial, eligible patients in the first trimester of pregnancy on ART with plasma VL < 50 copies/mL received maintenance monotherapy with darunavir/ritonavir, 600/100 mg twice daily. VL was monitored monthly. ART was intensified in the case of VL > 50 copies/mL. Neonates received nevirapine prophylaxis for 14 days. RESULTS: Of 89 patients switching to darunavir/ritonavir monotherapy, 4 miscarried before 22 weeks' gestation, 2 changed treatment for elevated liver enzymes without virological failure, and 83 were evaluable for the main outcome. Six had virological failure confirmed on a repeat sample (median VL = 193 copies/mL; range 78-644), including two before switching to monotherapy. In these six cases, ART was intensified with tenofovir disoproxil fumarate/emtricitabine. The success rate was 75/83, 90.4% (95% CI, 81.9%-95.7%) considering two patients with VL missing at delivery as failures, and 77/83, 92.8% (95% CI, 84.9%-97.3%) when considering them as successes since both had undetectable VL on darunavir/ritonavir throughout pregnancy. In ITT, the last available VL before delivery was <50 copies/mL in all of the patients. There was no case of perinatal HIV transmission. CONCLUSIONS: Darunavir/ritonavir maintenance monotherapy required intensification in nearly 10% of cases. This limits its widespread use, thus other regimens should be evaluated in order to limit exposure to antiretrovirals, particularly NRTIs, during pregnancy.

Faecal incontinence after first instrumental vaginal delivery using Thierry's spatulas.

OBJECTIVE: The purpose of this study is to estimate the prevalence of faecal incontinence after first vaginal delivery and to assess the impact of Thierry's spatulas-assisted delivery. METHODS: A prospective observational study of primiparas who underwent a vaginal delivery at term was conducted. Faecal incontinence was assessed at 2 and 6 months postpartum by a questionnaire (Wexner score >or=5 was considered significant). Univariate and multivariate analyses were performed. RESULTS: Five hundred thirty-eight women were recruited with undergoing 176 spatulas-assisted deliveries and 362 spontaneous vaginal deliveries. The response rate was 85.9% (2 months) and 80.5% (6 months). The prevalence of faecal incontinence was similar between the two groups at 2 months (14.3% and 9.7%). Episiotomy (odds ratio [OR] = 5.0) and maternal age over 35 years (OR = 4.1) were independently associated with faecal incontinence after adjustment. CONCLUSIONS: Anal symptoms are common after the first vaginal delivery. Thierry's spatulas do not increase the prevalence of faecal incontinence after delivery given that an episiotomy is performed.

Conservative versus active management in HELLP syndrome: results from a cohort study.

OBJECTIVE: HELLP syndrome exposes to severe maternal and fetal complications. Prompt delivery is thus recommended after 34 weeks of gestation, or earlier in case of nonreassuring maternofetal conditions. However, no consensus has been raised in the treatment of HELLP syndrome occurring before 34 weeks of gestation, when both maternal and fetal conditions are stable: it remains still unclear whether an active attitude should be prioritized over expectant management. Herein, we aimed to compare mother and child outcomes according to the type of obstetrical management, either active or conservative. STUDY DESIGN: Retrospective and multicenter study involving two tertiary care units. In Center A, obstetrical attitude consisted in expectant management: all women received full antenatal betamethasone therapy and pregnancy was prolonged until maternal or fetal follow up indicated delivery. In Center B, management was active: all deliveries were initiated within 48 hours following diagnosis. RESULTS: From 2003 to 2011, 118 patients were included (87 in Center A, 31 in Center B). Both groups of patients were similar regarding maternal and fetal features at baseline. Active management led to increased risks of post-partum hemorrhage (relative risks (RR) = 5.38, 95%CI: 1.2-24.06) and neonatal morbidity including respiratory distress syndrome (RR = 3.1, 95%CI: 1.4-7.1), sepsis (RR = 2.5, 95%CI: 1.1-6.0), necrotizing enterocolitis (RR = 4.8, 95%CI: 1.1-21.2), intracerebral hemorrhage (RR = 5.4, 95%CI: 2.1-13.6), and blood transfusion (RR = 6.1, 95%CI: 1.7-21.7). CONCLUSIONS: Conservative management may be beneficial for both mother and newborn in patients with stable HELLP syndrome. Identification of maternal and fetal specific prognostic factors would allow a better stratification of women with HELLP syndrome according to illness progressive potential, resulting in a more personalized management.

Finally an evidence-based indication for injectable phloroglucinol!

BACKGROUND: While phloroglucinol is widely prescribed in European countries for its antispasmodic properties, recent high quality data failed to demonstrate its superiority to placebo in alleviating abdominal pain. Rumors suggest that injectable presentation of phloroglucinol may erase povidone-iodine stains. We thus aimed to evaluate its efficacy in this new indication. METHODS: In this double-blind, controlled trial, we randomly assigned 9 squares of fabric obtained from common white coat to receive injectable phloroglucinol (experimental arm), stain remover (active control arm) or water (placebo arm). The primary efficacy endpoint was the change in stain intensity 10 min after the intervention. RESULTS: In placebo and active control arms, povidone-iodine stains remained unchanged 10 min after treatment application. In contrast, the stain disappeared completely in the experimental arm. CONCLUSION: Injectable phloroglucinol was more effective than usual stain remover and water to remove povidone-iodine stains from white coats.

Management of persistent occiput posterior position: a substantial role of instrumental rotation in the setting of failed manual rotation.

INTRODUCTION: To compare the maternal and neonatal outcomes associated with Instrumental Rotation (IR) to operative vaginal delivery in occiput posterior (OP) position with Thierry's spatulas (TS), in the setting of failed manual rotation (MR). STUDY DESIGN: We led a prospective observational cohort study in a tertiary referral hospital in Toulouse, France. All women presenting in labor with persistent OP position at full cervical dilatation and who delivered vaginally after failed MR and with IR or OP assisted delivery were included from January 2014 to December 2015. The main outcomes measured were maternal morbidity parameters including episiotomy rate, incidence and severity of perineal lacerations, perineal hematomas and postpartum hemorrhage. Severe perineal tears corresponded to third and fourth degree lacerations. Fetal morbidity outcomes comprised neonatal Apgar scores, acidemia, fetal injuries, birth trauma and neonatal intensive care unit admissions. RESULTS: Among 9762 women, 910 (9.3%) presented with persistent OP position at full cervical dilatation and 222 deliveries were enrolled. Of 111 attempted IR, 97 were successful (87.4%). The incidence of anal sphincter injuries was significantly reduced after IR attempt (1.8% vs. 12.6%; p < 0.002). Both groups were similar regarding most fetal outcomes and no birth trauma occurred in our study population. In a multivariable logistic regression analysis, OP operative delivery was a significant risk factor of severe perineal lacerations (OR = 9.5; 95% CI: 2.05-44.05). CONCLUSION: Our results support the use of IR in order to reduce perineal morbidity associated with OP assisted delivery, in the setting of a failed manual rotation.

Vaginal evisceration: an unexpected complication of conization.

Background. Large loop excision of the transformation zone (LLETZ) is routinely performed for the management of high grade intracervical neoplasia (CIN). Several uncommon complications have been described, including postoperative peritonitis, pseudoaneurysm of uterine artery, and bowel fistula. We report a unique case of postoperative vaginal evisceration and the subsequent management. Case. A 73-years-old woman underwent LLETZ for high grade CIN. On postoperative day 3, she was admitted for small bowel evisceration through the vagina. Surgical management was based on combined laparoscopic and transvaginal approach and consisted in bowel inspection and reinstatement, peritoneal washing, and dehiscence repair. Conclusions. Vaginal evisceration is a rare but potentially serious complication of pelvic surgery. This case report is to make clinicians aware of such complication following LLETZ and its management.

Instrumental delivery: clinical practice guidelines from the French College of Gynaecologists and Obstetricians.

Routine use of a partograph is associated with a reduction in the use of forceps, but is not associated with a reduction in the use of vacuum extraction (Level A). Early artificial rupture of the membranes, associated with oxytocin perfusion, does not reduce the number of operative vaginal deliveries (Level A), but does increase the rate of fetal heart rate abnormalities (Level B). Early correction of lack of progress in dilatation by oxytocin perfusion can reduce the number of operative vaginal deliveries (Level B). The use of low-concentration epidural infusions of bupivacaine potentiated by morphinomimetics reduces the number of operative interventions compared with larger doses (Level A). Placement of an epidural before 3-cm dilatation does not increase the number of operative vaginal deliveries (Level A). Posterior positions of the fetus result in more operative vaginal deliveries (Level B). Manual rotation of the fetus from a posterior position to an anterior position may reduce the number of operative deliveries (Level C). Walking during labour is not associated with a reduction in the number of operative vaginal deliveries (Level A). Continuous support of the parturient by a midwife or partner/family member during labour reduces the number of operative vaginal deliveries (Level A). Under epidural analgesia, delayed pushing (2h after full dilatation) reduces the number of difficult operative vaginal deliveries (Level A). Ultrasound is recommended if there is any clinical doubt about the presentation of the fetus (Level B). The available scientific data are insufficient to contra-indicate attempted midoperative delivery (professional consensus). The duration of the operative intervention is slightly shorter with forceps than with a vacuum extractor (Level C). Nonetheless, the urgency of operative delivery is not a reason to choose one instrument over another (professional consensus). The cup-shaped vacuum extractor seems to be the instrument of choice for operative deliveries of fetuses in a cephalic transverse position, and may also be preferred for fetuses in a posterior position (professional consensus). Vacuum extraction deliveries fail more often than forceps deliveries (Level B). Overall, immediate maternal complications are more common for forceps deliveries than vacuum extraction deliveries (Level B). Compared with forceps, operative vaginal delivery using a vacuum extractor appears to reduce the number of episiotomies (Level B), first- and second-degree perineal lesions, and damage to the anal sphincter (Level B). Among the long-term complications, the rate of urinary incontinence is similar following forceps, vacuum extraction and spontaneous vaginal deliveries (Level B). Anal incontinence is more common following forceps delivery (Level B). Persistent anal incontinence has a similar prevalence regardless of the mode of delivery (caesarean or vaginal, instrumental or non-instrumental), suggesting the involvement of other factors (Level B). Rates of immediate neonatal mortality and morbidity are similar for forceps and vacuum extraction deliveries (Level B). It appears that difficult instrumental delivery may lead to psychological sequelae that may result in a decision not to have more children (Level C). The rates of neonatal convulsions, intracranial haemorrhage and jaundice do not differ between forceps and vacuum extraction deliveries (Levels B and C). Rapid sequence induction with a Sellick manoeuvre (pressure to the cricoid cartilage) and tracheal intubation with a balloon catheter is recommended for any general anaesthesia (Level B). Training must ensure that obstetricians can identify indications and contra-indications, choose the appropriate instrument, use the instruments correctly, and know the principles of quality control applied to operative vaginal delivery. Nowadays, traditional training can be accompanied by simulations. Training should be individualized and extended for some students.