Manually Controlled, Continuous Infusion of Phenylephrine or Norepinephrine for Maintenance of Blood Pressure and Cardiac Output During Spinal Anesthesia for Cesarean Delivery: A Double-Blinded Randomized Study.

BACKGROUND: To counteract the vasoplegia induced by spinal anesthesia (SA) and maintain blood pressure (BP) during cesarean delivery, phenylephrine is currently recommended, but norepinephrine might offer superior preservation of cardiac output. We aimed to compare the hemodynamic effects of phenylephrine and norepinephrine administered by manually adjusted continuous infusion during elective cesarean delivery. METHODS: In this pragmatic, parallel-group, double-blind randomized controlled trial, 124 parturients scheduled for elective cesarean delivery under SA in a tertiary maternity in France, between February 2019 and December 2020, were randomized to receive norepinephrine at a starting rate of 0.05 µg·kg -1 ·min -1 (n = 62) or phenylephrine at a starting rate of 0.5 µg·kg -1 ·min -1 (n = 62). In both groups, the vasopressor infusion rate was then manually adjusted to maintain maternal systolic BP above 90% of the baseline value. The primary outcome, the change in cardiac index (CI) measured by thoracic bioreactance from SA to umbilical cord clamping, was analyzed through repeated measures analysis of variance and post hoc t tests. Secondary outcomes included maternal BP and neonatal outcomes. RESULTS: In the norepinephrine group, cardiac index was maintained between 90% and 100% of baseline from SA to umbilical cord clamping, whereas it was maintained at significantly lower values (81%-88%) in the phenylephrine group ( P = .001). The percentage of elapsed time with a mean maternal BP <65 mm Hg and with systolic BP <80% of the baseline value was higher in the phenylephrine group: 2.9% (7.3) vs 0.5% (1.8) (absolute risk difference [ARD], -2.4%; 95% confidence interval, -4.4 to -0.5; P = .012) and 8.5% (16.6) vs 2.3% (5.2) (ARD, -6.2%; 95% confidence interval, -10.6 to -1.8; P = .006). Excluding parturients with gestational diabetes, severe neonatal hypoglycemia was more common in the phenylephrine group at 19.6% (9/46) vs 4.1% (2/49) ( P = .02). The other neonatal outcomes did not differ significantly between the groups. CONCLUSIONS: When administered by manually adjusted infusion during SA for cesarean delivery, norepinephrine was associated with a higher CI; both infusions were effective for maintaining BP.

The role of parliamentarians in promoting self-care interventions for sexual and reproductive health and rights: applying COVID-19 lens in the Eastern Mediterranean region.

Innovative people-centered care modalities including self-care interventions offer an opportunity to ensure continuity of healthcare services during COVID-19 and in post-COVID-19, as well as contribute to the achievement of universal health coverage. Parliamentarians are uniquely positioned to promote self-care interventions for sexual and reproductive health and rights through their legislative, budget allocation, oversight, and advocacy roles. However, existing health systems governance challenges in the Eastern Mediterranean region such as weak institutions setups, fragmentation of health programs, and limitation of resources could impede parliamentarians' progress. To address these challenges, the following recommended actions should be considered: (1) promote the adaptation of sexual and reproductive health and rights service packages at primary healthcare level to integrate self-care interventions (2) govern innovative people-centered care channels including self-care interventions; and (3) engage in a dialogue with civil society and communities to meet needs, raise public awareness and generate demand.

Therapeutic Vaccines for HPV-Associated Cervical Malignancies: A Systematic Review.

IMPORTANCE: Despite widespread prophylactic vaccination, cervical cancer continues to be a major health problem with considerable mortality. Currently, therapeutic vaccines for HPV-associated cervical malignancies are being evaluated as a potential complement to the standard treatment. OBJECTIVE: The present systematic review was conducted on randomized controlled trials (RCTs) to investigate the effects of therapeutic vaccines on the treatment of patients with cervical cancer and cervical intraepithelial neoplasia (CIN) of Grades 2 and 3. EVIDENCE REVIEW: The PubMed, Embase, and Cochrane Central Register of Controlled Trials databases were searched. Only articles in English published up until 31 January 2024 were selected. Also, reference lists of the selected original papers and recent review articles were manually searched for additional sources. Data on study characteristics were extracted from the selected articles. Data on outcomes of interest were synthesized, and vaccine efficacy endpoints (histological lesion regression, clinical response, and overall survival) were selected as the basis for grouping the studies. FINDINGS: After screening 831 articles, nine RCTs with 800 participants were included, of which seven studies with 677 participants involved CIN2 and CIN3 and examined lesion regression to ≤CIN1 as the efficacy endpoint. Results of two of these studies were deemed to have a high risk of bias, and another one did not contain statistical analyses. Results of the other four studies were quantitively synthesized, and the pooling of p-values revealed a significant difference between the vaccine and placebo groups in terms of lesion regression (p-values of 0.135, 0.049, and 0.034 in RCTs, yielding a combined p-value of 0.010). The certainty of the evidence was rated as moderate. Patients with advanced cervical cancers were studied in two RCTs with 123 participants. Clinical response and overall survival were taken as endpoints, and the results were reported as not significant. The certainty of the evidence of these results was rated as very low, mainly due to the very small number of events. All studies reported good tolerance for the vaccines. CONCLUSIONS AND RELEVANCE: The results indicate the potential for therapeutic vaccines in the regression of CIN2 and CIN3 lesions. Moreover, a potential gap in evidence is identified regarding the very low number of RCTs in patients with advanced cervical cancer.

The European Trauma Course: Transforming systems through training.

The European Trauma Course (ETC) exemplifies an innovative approach to multispecialty trauma education. This initiative was started as a collaborative effort among the European Society for Emergency Medicine, the European Society for Trauma and Emergency Surgery, and the European Society of Anaesthesiology under the auspices of the European Resuscitation Council. With the robust support of these societies, the project has evolved into the independent European Trauma Course Organisation. Over the past 15 years, the ETC has transcended traditional training by integrating team dynamics and non-technical skills into a scenario-based simulation course, helping to shape trauma care practice and education. A distinctive feature of the ETC is its training of doctors and allied healthcare professionals, fostering a collaborative and holistic approach to trauma care. The ETC stands out for its unique team-teaching approach, which has gained widespread recognition as the standard for in-hospital trauma care training not only in Europe but also beyond. Since its inception ETC has expanded geographically from Finland to Sudan and from Brazil to the Emirates, training nearly 20,000 healthcare professionals and shaping trauma care practice and education across 25 countries. Experiencing exponential growth, the ETC continues to evolve, reflecting its unmet demand in trauma team education. This review examines the evolution of the ETC, its innovative team-teaching methodology, national implementation strategies, current status, and future challenges. It highlights its impact on trauma care, team training, and the effect on other life support courses in various countries.

Pelvic Floor Muscle Training for Urinary Incontinence with or without Biofeedback or Electrostimulation in Women: A Systematic Review.

To determine the effectiveness of pelvic floor muscle training (PFMT) with or without biofeedback or electrostimulation in reducing urinary incontinence and pelvic floor muscle con-traction in non-pregnant women with urinary incontinence. METHODS: The following electronic databases were searched: PubMed, Cochrane Central, ClinicalTrials.gov, EU Clinical Trials Register, and sources from NICE, FDA, EMA, and SMC (articles only in English, 2000-2021). Search terms were: urinary incontinence, pelvic floor muscle training or exercises, biofeedback, electrostimulation. We used the PRISMA statement (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) for this systematic review. Relevant articles were selected, data were extracted, and quality was assessed. Data were extracted in predesigned form, followed by narrative synthesis. RESULTS: Following the search, 15 RCTs were retrieved using the strict inclusion and exclusion criteria, assessing 2441 non-pregnant women with urinary incontinence. Of the 15 studies, 7 were low risk, 5 were medium risk, and 3 were high-risk studies. Of the 2441 patients, 970 were in PFMT, 69 were in extracorporeal magnetic innervation (ExMi) or with PFMT + BF, 30 were in electrostimulation (ES), 21 were in whole body vibration training (WBVT), 23 were in pelvic floor muscle + abdominal muscle therapy (PFM + AMT), 326 were in PFMT + biofeedback, 93 were in vaginal cones (VC), 362 were in PFMT + education, 318 were in education, and 229 were in control groups. The most often measures employed were pad tests, bladder diary, and questionnaire on the quality of life. Stress, urge and mixed urinary incontinence were studied. In all RCT, PFMT significantly reduced urinary incontinence, essentially SIU and MUI, when compared with the control group before and after treatment. Overall, out of 997 PFMT or PFMT + education patients, 504 patients (50.5%) showed improvement in urinary incontinence, and 218 became continent (21.8%) (negative pad test). In total, 62% of patients significantly reduced their urinary incontinence or cured it and improved their pelvic floor muscle contraction. All other physiotherapist techniques also significantly reduced urinary leakages, e.g., vaginal cones, biofeedback, ExMI, and WBVT when compared with the control group. There were no significant differences between these methods in reducing the severity of urinary incontinence. CONCLUSION: PFMT alone or with bio-feedback or electrostimulation was effective in reducing urinary incontinence and improving pelvic floor muscle contraction. PFMT when compared with other interventions such as bio-feedback, VC, and WBVT did not show significant differences but was superior to the control group. RCT studies with similar parameters used for measuring the outcomes need to be included.

Diagnosis and Management of Pregnant Women With Placental Abruption and Neonatal Outcomes.

Background Placenta abruptio (PA) remains a serious materno-fetal complication. According to progress realized in maternal-fetal medicine, we aimed to evaluate the diagnosis and management of PA and neonatal outcomes. Methods We conducted a retrospective study that involved all the patients that were diagnosed with PA in a tertiary maternity hospital between 2006 and 2013. Data were analyzed to determine mean and standard deviation and statistically analyzed using the Chi-square test. Results In total, 201 patients were diagnosed with PA out of 35184 deliveries (0.56%). The mean age of patients was 30 years and most of them were multiparous (56.2%). Thirty-six out of 201 patients (17.9%) smoked tobacco or consumed alcohol during the pregnancy. Three patients came from their homes. Twenty-eight patients had preeclampsia and 105 presented with high blood pressure. Furthermore, 117 patients presented metrorrhagia (58.2%) and 39% of patients exhibited abdominal pain. We reported fetal heart rate abnormalities in 57% of the cases. Ultrasound examination revealed PA in only 48 patients (23.9%). One hundred eighty out of 201 patients (84.6%) underwent an emergency caesarean section. One hundred sixty-seven fetuses were born prematurely. Thirteen out of 201 fetuses died, and 98 newborns needed neonatal resuscitation. In total, 31 fetuses had an umbilical artery (UA) with pH ≤ 7 (31/188). The mean time for delivery was 18.7 min. However, UA pH did not differ when the delivery time was shorter (p = 0.09). Seventy-six percent of cases came from their homes. The mean UA pH was significantly lower for PA cases who came from their homes compared to hospitalized women (p = 0.0015). Histological examination of the placenta confirmed the diagnosis in 71 out of 148 cases (47.9%). The mean duration of hospital stay of the newborns was 17 days. Conclusion PA remains a serious materno-fetal emergency with a bad fetal prognosis for many newborns. Many fetuses either died or exhibited severe acidosis. Clinical signs and radiological images of PA are absent in many cases. There was more fetal acidosis for mothers who came from their homes at the time of delivery. We recommend that the delivery should not be delayed and a cesarean section must be the preferred mode of delivery. Pregnant women with vascular and metabolic diseases should be carefully monitored and informed on the risk of PA.

Maternal-Fetal Implications of SARS CoV-2 Infection during Pregnancy, Viral, Serological Analyses of Placenta and Cord Blood.

OBJECTIVE: There are few data on the maternal-fetal transmission of SARS-CoV-2 and its outcomes. This study aimed to evaluate pregnancy outcomes of pregnant women infected by SARS-CoV-2, to detect SARS-CoV-2 in placenta and different newborns' samples and search antibodies in cord blood. METHODS: This was a prospective study of pregnant women diagnosed with SARS-CoV-2 infection from May 2020 to May 2021. At delivery, the placentas were investigated for SARS-CoV-2 using RT-PCR, cord blood. Mothers' blood samples were tested by SARS-CoV-2 serology. PCR of nasopharyngeal, anal and gastric swabs (NPSs) of newborns was performed according to pediatric indications. RESULTS: Among 3626 pregnant women presenting at maternity to deliver, 45 mothers had COVID-19 during their pregnancy or at delivery (32 ± 4.8 years). Most of them were multiparous and in the third trimester. There were 35 (77%) women who remained in ambulatory, while 10 (22%) were hospitalized for severe pneumonia, digestive symptoms, and/or fetal tachycardia. Thirty-eight delivered vaginally, and 7 had a cesarean delivery with normal Apgar scores (9 ± 1.6 at 5 min) and umbilical artery pH (7.22 ± 0.08). Two mothers required ICU admission after cesarean section for fetal and maternal distress. Of the 46 newborns, 6 were premature births (13%) and 5 IUGR (intra-uterine growth restriction,11%). RT-PCR SARS-CoV-2 was positive for 1/30 placental, and 1/33 neonatal anal swabs and negative in all other cases and in gastric swabs. SARS-CoV-2 IgG was positive in 20/41 cord blood samples (49%) and their mothers' samples. IgM was negative in the 23 cord blood samples. CONCLUSIONS: Pregnancy outcomes in women diagnosed with COVID-19 during their pregnancy were favorable in most cases. However, some women with severe clinical forms required hospitalization and ICU admission. Preterm births and intrauterine growth retardations were relatively frequent. Vaginal delivery was possible in most cases. SARS-CoV-2 IgG antibodies were positive and elevated in most cord blood samples of newborns. They are possibly of maternal origin, suggesting a probable mechanism of fetal protection against SARS-CoV-2 infection. No SARS-CoV-2 IgM was found in the cord blood samples. Detection of SARS-CoV-2 in placenta is rare.

Multiple square sutures for postpartum hemorrhage: results and hysteroscopic assessment.

OBJECTIVE: The purpose of this study was to evaluate the efficiency and morbidity of multiple square sutures in severe postpartum hemorrhage. STUDY DESIGN: A retrospective study encompassed 30 multiple square sutures that were performed for severe postpartum hemorrhage in 26,605 deliveries in a tertiary maternity center. The main outcome measures were the ability to stop hemorrhage and the assessment of the uterine cavity by hysteroscopy at 3 months. RESULTS: Multiple square sutures stopped postpartum hemorrhage in 28 of 30 cases (93%). Twenty women underwent hysteroscopy after multiple square sutures. Eight women (40%) did not have intrauterine adhesions. Nine women (45%) had thin and localized intrauterine adhesions that were removed easily by the tip of the hysteroscope; 2 women had moderate intrauterine adhesions that were resected. One patient had endometritis followed by severe intrauterine adhesions. CONCLUSION: Multiple square sutures are effective and safe for the control of severe postpartum hemorrhage and for uterine conservation in most cases. Although some patients had moderate or severe adhesions, a normal uterine cavity or minimal intrauterine adhesions that were removed easily were the most frequent findings at hysteroscopy. A prospective study may be helpful to compare the safety and efficiency of square and brace sutures.

Diagnosis and management of placenta previa and low placental implantation.

Objective: To evaluate the migration of low-placental implantation (LPI) during the third trimester of pregnancy and its effect on delivery and post-partum hemorrhage.Methods: We conducted a retrospective study at a level 3 maternity center including all cases of placenta previa (PP) and LPI between 1998 and 2014. The distance (d) between cervical internal os (CIO) and placental edge (PE) were measured by vaginal ultrasonography in the third trimester of pregnancy at 32 and 3 weeks after. We analyzed CIO-PE distance, volume of post-partum hemorrhage, delivery decision, and mode of delivery using Kruskall-Wallis test.Results: In total, 319 patients presented with PP or LPI. All complete PP (121) and 90.6% (58 of 64) of the placentas less than 1 cm from the CIO did not migrate. Among the 138 placentas with an initial CIO-PE d greater than 1 cm, only 17 (12.3%) did not migrate above 2 cm. The patients for whom the decision to perform a cesarean section (C-section) was retained and realized had a CIO-PE d significantly lower than those who delivered vaginally (p < .001). The patients who delivered by C-section had a lower CIO-PE d when an emergency C-section was performed, specifically for hemorrhage (p < .001). The mean volume of hemorrhage was significantly higher for patients with a CIO-PE d less than 2 cm.Conclusion: Complete PP and the majority of the placentas less than 1 cm from the CIO did not migrate. Above 1 cm, the majority of the placentas migrated three to four weeks later. For the placentas less than 1 cm from the CIO, a significant risk of hemorrhage at delivery was observed. Thus, prophylactic cesarean section is required for CIO-PE distances <1 cm. For distances between 1 and 2 cm, the volume of blood loss tends to be more important than for distances >3 cm without statistical significance. A vaginal delivery could be tried after information of patients.

Cervical cancer complicating pregnancy: implications of laparoscopic lymphadenectomy.

OBJECTIVE: To define a strategy for lymph node staging in cervical carcinoma complicating pregnancy. MATERIAL AND METHODS: Eight patients undergoing laparoscopic pelvic (+/-para-aortic) lymphadenectomy during pregnancy (12 to 32 weeks of gestation) between 1994 and 2006 were included. The FIGO stage of cervical cancer was IB1 for five women, IB2 for two women, and IIIA for one woman. The histological type was squamous in five cases and adenocarcinoma in three cases. RESULTS: All of the laparoscopic procedures were successful; there was no mortality, morbidity, or conversion. There were no complications for either mother or child related to the general anesthesia. The mean number of lymph nodes removed was 18 (range 11-28). The pelvic lymph nodes were not invaded in 5 patients (4 IB1, 1 IB2). Cancer treatment was delayed for four out of five patients until after fetal extraction. One patient aborted after a radical trachelectomy. All patients without lymph node metastasis were alive without recurrence at a mean follow-up time of 64+/-39 months. Lymph nodes were involved in three patients (IB1, IB2, IIIA). These patients died from recurrence of the disease. Seven patients out of eight reached fetal maturity and gave birth by caesarean section to healthy babies. CONCLUSION: Laparoscopic lymphadenectomy during pregnancy is a safe and effective procedure for lymph node staging in cervical cancer. Laparoscopic pelvic lymphadenectomy can be performed in any trimester of pregnancy. Because the number of patients in this study was small, the safety of the laparoscopic procedures should be confirmed by future studies. Pregnant women who do not have lymph node metastasis may benefit from either delayed cancer treatment after fetal extraction or immediate conservative treatment for early stage cancers. The prognosis is poor for patients with lymph node metastasis, and therefore, these patients should have input into the therapeutic process.

Information for patients undergoing a prenatal diagnosis.

OBJECTIVES: Lack of information is a frequent complaint with regard to physicians dealing with prenatal diagnosis (PD). The aim of the study was to find out how information on PD was perceived by patients and if they considered that they had been correctly informed by their physicians. METHODS: We conducted a prospective study in Lariboisière Hospital (Paris) with 86 patients undergoing prenatal diagnosis between 2001 and 2003. A 23-item questionnaire was given to patients after delivery or termination of pregnancy (TP). RESULTS: Fifty patients out of 86 answered the questionnaire. Twelve patients out of 50 underwent a TP. Information on foetal anomaly was insufficient for 11 patients out of 50 (22%). Some patients found the information too technical; others would like to see photos to illustrate the anomalies and the possible surgical repairs to be performed. Information was insufficient for one in four patients concerning maternal serum screening for Down's syndrome. Information before amniocentesis was considered sufficient by 9 out of 10 patients. Information on the risks of TP was not given or not understood by 10 out of 12 patients. CONCLUSION: Information on prenatal diagnosis could be improved by using simple and accessible language, supported by written documents and photos for certain anomalies. More information should be given in cases of abstract anomalies and should be adapted to the social, ethnic and cultural background of the patient.

Operative hysteroscopy versus vacuum aspiration for incomplete spontaneous abortion (HY-PER): study protocol for a randomized controlled trial.

BACKGROUND: Incomplete spontaneous abortions are defined by the intrauterine retention of the products of conception after their incomplete or partial expulsion. This condition may be managed by expectant care, medical treatment or surgery. Vacuum aspiration is currently the standard surgical treatment in most centers. However, operative hysteroscopy has the advantage over vacuum aspiration of allowing the direct visualization of the retained conception product, facilitating its elective removal while limiting surgical complications. Inadequately powered retrospective studies reported subsequent fertility to be higher in patients treated by operative hysteroscopy than in those treated by vacuum aspiration. These data require confirmation in a randomized controlled trial comparing fertility rates between women undergoing hysteroscopy and those undergoing vacuum aspiration for incomplete spontaneous abortion. METHODS: After providing written informed consent, 572 women with incomplete spontaneous abortion recruited from 15 centers across France will undergo randomization by a centralized computer system for treatment by either vacuum aspiration or operative hysteroscopy. Patients will not be informed of the type of treatment that they receive and will be cared for during their hospital stay in accordance with standard practices at each center. The patients will be monitored for pregnancy or adverse effects by a telephone conversation or questionnaire sent by e-mail or post over a period of two years. In cases of complications, failure of the intervention or diagnosis of uterine cavity disease, patient care will be left to the discretion of the medical center team. DISCUSSION: If our hypothesis is confirmed, this study will provide evidence that the use of operative hysteroscopy can increase the number of pregnancies continuing beyond 22 weeks of gestation in the two-year period following incomplete spontaneous abortion without increasing the incidence of morbidity and peri- and postoperative complications. The standard surgical treatment of this condition would thus be modified. This study would therefore have a large effect on the surgical management of incomplete spontaneous abortion. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02201732 ; registered on 17 July 2014.