Reactogenicity, pregnancy outcomes, and SARS-CoV-2 infection following COVID-19 vaccination during pregnancy in Canada: A national prospective cohort study.

OBJECTIVE: To describe self-reported reactogenicity, pregnancy outcomes, and SARS-CoV-2 infection following COVID-19 vaccination during pregnancy. DESIGN: National, prospective cohort study. SETTING: Participants across Canada were enrolled from July 2021 until June 2022. POPULATION: Individuals pregnant during the COVID-19 pandemic, regardless of vaccination status, were included. METHODS: The Canadian COVID-19 Vaccine Registry for Pregnant and Lactating Individuals (COVERED) was advertised through traditional and social media. Surveys were administered at baseline, following each vaccine dose if vaccinated, pregnancy conclusion, and every two months for 14 months. Changes to pregnancy or vaccination status, SARS-CoV-2 infections, or significant health events were recorded. MAIN OUTCOME MEASURES: Reactogenicity (local and systemic adverse events, and serious adverse events) within 1 week post-vaccination, pregnancy and neonatal outcomes, and subsequent SARS-CoV-2 infection. RESULTS: Among 2868 participants who received 1-2 doses of a COVID-19 vaccine during pregnancy, adverse events described included: headache (19.5-33.9%), nausea (4.8-13.8%), fever (2.7-10.2%), and myalgia (33.4-42.2%). Reactogenicity was highest after the 2nd dose of vaccine in pregnancy. Compared to 1660 unvaccinated participants, there were no statistically significant differences in adverse pregnancy or infant outcomes, aside from an increased risk of NICU admission ≥ 24 h among the unvaccinated group. During follow-up, there was a higher rate of participant-reported SARS-CoV-2 infection in the unvaccinated compared to the vaccinated group (18[47.4%] vs. 786[27.3%]). CONCLUSIONS: Participant-reported reactogenicity was similar to reports from non-pregnant adults. There was no increase in adverse pregnancy and birth outcomes among vaccinated vs. unvaccinated participants and lower rates of SARS-CoV-2 infection were reported in vaccinated participants. TWEETABLE ABSTRACT: No significant increase in adverse pregnancy or infant outcomes among vaccinated versus unvaccinated pregnant women in Canada.

Congenital anomalies following antenatal exposure to dolutegravir: a Canadian surveillance study.

OBJECTIVE: Dolutegravir is recommended worldwide as a first-line antiretroviral therapy (ART) for individuals living with HIV. A recent study reported increased rates of neural tube defects in infants of dolutegravir-treated women. This study examined rates of congenital anomalies in infants born to women living with HIV (WLWH) in Canada. DESIGN: The Canadian Perinatal HIV Surveillance Programme captures surveillance data on pregnant WLWH and their babies and was analysed to examine the incidence of congenital anomalies. SETTING: Paediatric HIV clinics. POPULATION: Live-born infants born in Canada to WLWH between 2007 and 2017. METHODS: Data on mother-infant pairs, including maternal ART use at conception and during pregnancy, are collected by participating sites. MAIN OUTCOME MEASURES: Congenital anomalies. RESULTS: Of the 2423 WLWH, 85 (3.5%, 95% CI 2.85-4.36%) had non-chromosomal congenital anomalies. There was no evidence of a significant difference in rates of congenital anomalies between women who were on ART in their first trimester (3.9%, CI 1.7-7.6%) or later in the pregnancy (3.9%, 95% CI 2.6-5.6%). Four of the 80 (5.0%, 95% CI 1.4-12.3%) neonates born to WLWH on dolutegravir during the first trimester had congenital anomalies, none were neural tube defects (95% CI 0.00-3.10%). CONCLUSION: Despite recent evidence raising a safety concern, this analysis found no signal for increased congenital anomalies. TWEETABLE ABSTRACT: Five percent of the infants of Canadian women living with HIV on dolutegravir at conception had congenital anomalies; none had neural tube defects.

The Women and Children's Infectious Diseases Center: An integrated approach to congenital infectious diseases.

Congenital infectious diseases, transmitted during the course of pregnancy, are estimated to affect nearly one in every hundred births worldwide. These infections may be associated with fetal and infant adverse health outcomes, due to congenital malformations caused by in utero transmission of the infectious organism itself (as is the case with cytomegalovirus, toxoplasmosis, syphilis and Zika virus), or due to chronic infection in the infant (as is the case with human immunodeficiency virus [HIV] and hepatitis B and C). In addition, children who are exposed, yet uninfected, may still suffer from the consequences of exposure to infectious pathogens or to the drugs given to treat pregnant women and prevent in utero transmission (as may be the case with HIV infection).

Preventing transmission of bloodborne viruses from infected healthcare workers to patients: Summary of a new Canadian Guideline.

BACKGROUND: Although it is well documented that bloodborne viruses (BBVs), including human immunodeficiency virus (HIV), hepatitis C virus (HCV) and hepatitis B virus (HBV) have been transmitted from patients to healthcare workers (HCWs), there has also been reported transmission from HCWs to patients during the provision of health care. With remarkable progress in infection prevention, diagnosis tools, treatment regimens and major improvements in guideline development methodology, there was a need to develop an evidence-based guideline to replace the 1998 Canadian consensus document for managing HCWs infected with BBVs. PURPOSE: This article summarizes the Canadian Guideline on the Prevention of Transmission of Bloodborne Viruses from Infected Healthcare Workers in Healthcare Settings. METHODS: A Guideline Development Task Group was established and key questions developed to inform the guideline content. Systematic reviews were conducted to evaluate the risk of HCW-to-patient transmission of HIV, HCV and HBV. Environmental scans were used to provide information on Expert Review Panels, disclosure of a HCW's serologic status and lookback investigations. Federal, provincial and territorial partners and key stakeholder organizations were consulted on the Guideline. RESULTS: The risk of HCW-to-patient BBV transmission was found to be negligible, except during exposure-prone procedures, where there is a risk that injury to the HCW may result in exposure of a patient's open tissues to the HCW's blood. Risk of ensuing transmission and the rate of transmission varied by BBV, and were lowest with HIV and highest with HBV. The Guideline provides key content, including recommendations regarding criteria to determine if a procedure is an exposure-prone procedure, management of HCWs infected with a BBV, including considerations for the HCW's fitness for practice, Expert Review Panels, HCW disclosure obligations and right to privacy and lookback investigations. CONCLUSION: This new Guideline provides a pan-Canadian approach for managing HCWs infected with a BBV, with recommendations related to preventing HCW-to-patient transmission of BBVs during the provision of care.

A case series of third-trimester raltegravir initiation: Impact on maternal HIV-1 viral load and obstetrical outcomes.

OBJECTIVE: To describe the impact of initiating raltegravir (RAL)-containing combination antiretroviral therapy (cART) regimens on HIV viral load (VL) in pregnant women who have high or suboptimal VL suppression late in pregnancy. METHODS: HIV-infected pregnant women who started RAL-containing cART after 28 weeks' gestation from 2007 to 2013 were identified in two university hospital centres. RESULTS AND DISCUSSION: Eleven HIV-infected women started RAL at a median gestational age of 35.7 weeks (range 31.1 to 38.0 weeks). Indications for RAL initiation were late presentation in pregnancy (n=4) and suboptimal VL suppression secondary to poor adherence or viral resistance (n=7). Mean VL at the time of RAL initiation was 73,959 copies/mL (range <40 to 523,975 copies/mL). Patients received RAL for a median of 20 days (range one to 71 days). The mean decline in VL from the time of RAL initiation to delivery was 1.93 log, excluding one patient who received only one RAL dose and one patient with undetectable VL at the time of RAL initiation. After eight days on RAL, 50% of the women achieved a VL <1000 copies/mL (the threshold for recommended Caesarean section to reduce the risk for perinatal transmission). There were no cases of perinatal HIV transmission. CONCLUSION: The present study provides preliminary data to support the use of RAL-containing cART to expedite HIV-1 VL reduction in women who have a high VL or suboptimal VL suppression late in pregnancy, and to decrease the risk of HIV perinatal transmission while avoiding Caesarean section. Further assessment of RAL safety during pregnancy is warranted.

OBJECTIF: Décrire les répercussions de l'amorce d'une antirétrovirothérapie prophylactique associative (ARPA) contenant du raltégravir (RAL) sur la charge virale (CV) du VIH chez les femmes enceintes dont la suppression de la CV est élevée ou sous-optimale en fin de grossesse. MÉTHODOLOGIE: Les chercheurs ont extrait le dossier des femmes enceintes infectées par le VIH qui avaient amorcé une ARAP contenant du RAL après 28 semaines de grossesse dans deux centres hospitaliers universitaires entre 2007 et 2013. RÉSULTATS ET EXPOSÉ: Onze femmes infectées ont entrepris un traitement de RAL à une médiane de 35,7 semaines de grossesse (plage de 31,1 à 38,0 semaines). Les indications pour entreprendre le RAL étaient une présentation tardive au suivi de grossesse (n=4) et une suppression sous-optimale de la CV en raison d'un mauvais respect du traitement ou d'une résistance virale (n=7). La CV moyenne au début du traitement au RAL était de 73 959 copies/mL (plage de moins de 40 copies/mL à 523 975 copies/mL). Les patientes ont pris du RAL pendant une médiane de 20 jours (plage de un à 71 jours). La diminution moyenne de la CV entre le début du RAL et l'accouchement était de 1,93 log, à l'exception d'une patiente qui n'a reçu qu'une dose de RAL et d'une patiente dont la CV n'était pas décelable au moment d'entreprendre le RAL. Au bout de huit jours de RAL, 50 % des femmes présentaient une CV inférieure à 1 000 copies/mL (le seuil pour recommander une césarienne afin de réduire le risque de transmission périnatale). Il n'y a d'ailleurs eu aucun cas de transmission périnatale du VIH. CONCLUSION: La présente étude fournit des données provisoires pour soutenir l'utilisation d'ARPA contenant du RAL afin d'accélérer la réduction de la CV du VIH-1 chez les femmes qui présentaient une CV élevée ou une suppression sous-optimale de leur CV pendant la grossesse, ainsi que pour réduire le risque de transmission périnatale du VIH tout en évitant une césarienne. Une évaluation plus approfondie de l'innocuité du RAL est justifiée pendant la grossesse.

[Training of residents in obstetrics and gynecology: Assessment of an educational program including formal lectures and practical sessions using simulators]. / Formation des internes de gynécologie obstétrique : évaluation d'un programme pédagogique intégrant cours théoriques et sessions pratiques sur simulateurs.

OBJECTIVES: Evaluate an educational program in the training of residents in gynecology-obstetrics (GO) with a theory session and a practical session on simulators and analyze their learning curve. METHODS: Single-center prospective study, at the university hospital (CHU). Two-day sessions were leaded in April and July 2013. An evaluation on obstetric and gynecological surgery simulator was available to all residents. Theoretical knowledge principles of obstetrics were evaluated early in the session and after formal lectures was taught to them. At the end of the first session, a satisfaction questionnaire was distributed to all participants. RESULTS: Twenty residents agreed to participate to the training sessions. Evaluation of theoretical knowledge: at the end of the session, the residents obtained a significant improvement in their score on 20 testing knowledge. Obstetrical simulator: a statistically significant improvement in scores on assessments simulator vaginal delivery between the first and second session. Subjectively, a larger increase feeling was seen after breech delivery simulation than for the cephalic vaginal delivery. However, the confidence level of the resident after breech delivery simulation has not been improved at the end of the second session. Simulation in gynecological surgery: a trend towards improvement in the time realized on the peg-transfer between the two sessions was noted. In the virtual simulation, no statistically significant differences showed, no improvement for in salpingectomy's time. Subjectively, the residents felt an increase in the precision of their gesture. Satisfaction: All residents have tried the whole program. They considered the pursuit of these sessions on simulators was necessary and even mandatory. CONCLUSION: The approach chosen by this structured educational program allowed a progression for the residents, both objectively and subjectively. This simulation program type for the resident's training would use this tool in assessing their skills and develop learning curves.

[Instrumental extractions using Thierry's spatulas: evaluation of the learning curve]. / Évaluation de la courbe d'apprentissage des extractions par spatules de Thierry.

OBJECTIVES: To determine the learning curve of fetal extractions with Thierry's spatulas. PATIENTS AND METHODS: Single-center prospective study following the progress of six residents in obstetrics and gynecology in learning fetal extractions by Thierry's spatulas. The instrumental extractions procedures performed by the residents were evaluated by the senior obstetrician on call according to a validated scoring rubric. In parallel, the residents would fill out a questionnaire on their own perception of their abilities at the time of the procedure. RESULTS: The six residents participated in 160 extractions using Thierry's spatulas between November and May 2011. Sixty-three (39.6%) were evaluated, i.e. an average number of 12±6 extractions per resident. After validating respectively 0, 1, 2 or 3 semesters, the mean global assessment scores (graded out of 5) obtained by the residents were 3.54, 3.18, 4.43 and 4.61. The overall average score was significantly higher when the resident participated in more than 20 extractions before the studied extraction (4.0 vs. 3.7, P<0.001). After attending more than 20 extractions, no resident had obtained the maximum evaluation score of 5/5 nor was deemed capable of performing extractions without supervision. DISCUSSION AND CONCLUSIONS: Learning extractions with Thierry's spatulas, including an objective assessment by senior doctors and a self-assessment by the residents, is a constant process over the first six months of training. Specific training simulator should be developed to enable students to achieve a threshold number of extractions, ensuring the safety of the procedure in the birthing rooms.

[Impact of a training workshop on residents and senior registrar skill in diagnosis and repair of anal sphincter and rectal mucosae obstetrical injuries]. / Impact d'un atelier de formation au diagnostic et à la réparation des lésions obstétricales du sphincter anal et de la muqueuse rectale sur les compétences des internes et chefs de clinique.

OBJECTIVE: To evaluate the impact of a training workshop on residents and senior registrar skill in repair of anal sphincter and rectal mucosae obstetrical injury. MATERIAL AND METHODS: Residents and senior registrar practical and theoretical knowledge were evaluated by a questionnaire sent, using AGOF (association des gynécologues-obstétriciens en formation) mailing list. This questionnaire includes questions about epidemiology, risk factors and sutures types. Scores were compared according to the participation or not at the workshop. RESULTS: There were 106 residents or senior registrar (48.4%) in the workshop group and 113 (51.6%) in the control group. Scores were significantly higher in the workshop group than in the control group for theoretical knowledge (4.1 vs. 3.7), practical knowledge (17.6 vs. 15.9) and global scores (21.7 vs. 19.7). There was no difference according to the participation before or after the third residency semester. Residents global scores were statistically higher in the workshop group compared to the control group (21.8 vs. 19.5) but there was no significant difference between the senior registrar of the two group. Participants in the workshop group estimate themselves significantly more efficient than in the control group concerning anal sphincter injury repair and rectal mucosae repair. CONCLUSION: A training workshop seems to improve the theoretical and practical skill. LEVEL OF EVIDENCE: 4.

Normal serum concentrations of anti-Mullerian hormone in a population of fertile women in their first trimester of pregnancy.

BACKGROUND: Anti-Müllerian hormone (AMH) levels are used to evaluate the ovarian reserve. AMH serum concentrations have recently been studied among women attending fertility centers, and among women with regular menstrual cycles but normative values have not been established among fertile women: the objective of this study was to establish those values. METHODS: This prospective cross-sectional study included 340 healthy fertile women attending a single centre, aged between 15 and 50 years. The women were all in the first trimester of pregnancy, had no serious medical history and attended the abortion service of the University Hospital of Nice, France. Serum AMH was measured using a second-generation AMH enzyme-linked immunosorbent assay. RESULTS: Median AMH concentration was 2.42 ng/ml (25-75 percentiles 1.19-4.12). The relationship between AMH concentration and age was best fitted by a polynomial function. Serum AMH values rose until age 29 years and then showed a significant decline (R(2)= 0.289, P < 0.001). Normative values for serum AMH were established in different age groups between 15 and 50 years. CONCLUSIONS: We established the normative values for serum AMH in a population of French fertile women in their first trimester of pregnancy.

[Pregnancy with Implanon: a report on three cases]. / Grossesse sous Implanon : une « enquête ¼ à propos de trois cas.

We explored the potential causes associated with pregnancies occurring in patients using an etonogestrel contraceptive implant (Implanon). Three cases of treatment failure were reported where no predisposing factors were found (i.e. Body Mass Index, hepatic inducing therapy). Etonogestrel plasmatic detection was positive in two cases whereas in the third case with negative endocrinological makers, neither palpation nor ultrasonography identified the device. Therefore, true contraceptive failure can be considered in two of the reported cases. Furthermore, pregnancies associated with Implanon use warrant additional attention including notification to drug monitoring centers and Organon SA.

[Learning use of spatulas: risks of perineal injuries and newborns morbidity]. / Risques néonataux et périnéaux liés à l'apprentissage des spatules.

OBJECTIVES: To examine the acute neonatal and maternal perineal morbidity due to resident training on spatulas assisted deliveries. MATERIAL AND METHODS: We conducted a retrospective observational study of succesful spatulas-assisted deliveries at Nice University Hospital between January2003 and December2006. We performed univariate analysis and logistic regression to assess risk of severe perineal injuries, vaginal laceration and newborn hospitalization according to operator status, controlling for confounders. RESULTS: Among 1004 deliveries, 86.4% were performed by residents. No significant difference was found on incidence of severe perineal tears between the 872 extractions performed by residents and the 132 performed by an attending physician (6.9% versus 7.9% p=0.706; OR=0.86 IC95% [0.41-1.81]), but extraction performed by young residents were associated to more severe perineal tears than those performed by senior residents (8.0% versus 4.5% p=0.035; OR=2.10 IC95% [1.16-3.77]). There was no difference between groups concerning newborn morbidity and hospitalisation in special care units (6.4% versus 9.8% p=0.149; OR=1.49 IC95% [0.73-304]). CONCLUSION: According to our data, training of resident do not increase the incidence of severe perineal injuries, neonatal complications and hospitalisation linked to spatulas assisted delivery.

[Delivery of emergency contraception to minors in French pharmacies]. / Délivrance de la contraception d'urgence aux mineures dans les pharmacies françaises.

OBJECTIVE: The goal of this work was to evaluate the application in French pharmacies of the decree n 2002-39 relating to the delivery of the emergency contraception to minors. PATIENTS AND METHODS: Four selected minors carried out an anonymous investigation in 53 randomised pharmacies in the town of Nice (south of France). RESULTS: The cost-free delivery of the emergency oral contraception was refused to minors by 37.7% of pharmacies. DISCUSSION AND CONCLUSION: Our article highlights the remaining problems, five years after the decree, with the delivery of the emergency contraception. It seems necessary to explain to all the professionals of information, drugs delivery and treatments relating to the contraception or abortive methods the importance of their roles and the respect of their legal obligations.

[Influence of mode of delivery in term breech presentation on the Apgar score and transfer in neonatal care unit. Results of the management of 568 singleton pregnancies in a level III French maternity]. / Influence de la voie d'accouchement dans la présentation du siège à terme sur le score d'Apgar et les transferts en néonatologie. Résultats de la prise en charge de 568 grossesses singleton dans une maternité française de niveau III.

OBJECTIVES: The aim of our study was to define the influence of mode of delivery in term breech presentation on the Apgar score and transfert in neonatal care unit using our university hospital protocol. MATERIAL AND METHOD: We conducted a retrospective study. The study included 568 singleton term pregnancies during the period January 1996 to December 2005. The main selection criteria were Apgar score and transfert in neonatal care unit. RESULTS: Analysis of the Apgar scores at 1.5 and 10min and transfer in neonatal care unit do not show any statistical difference. CONCLUSION: The absence of a difference in neonatal prognosis is to allow vaginal delivery to be carried out. To carry on with the teaching of obstetrical manoeuvres makes it possible to avoid pointless surgical intervention and a bad maternofoetal prognosis in the event of an unexpected breech presentation.

[Minors' request for voluntary termination of pregnancy. A study of their motivations and influences at the CHU of Nice]. / Demandes d'IVG des mineures. Etude de leurs motivations et influences menée au CHU de Nice.

OBJECTIVE: The goal of this work was to determine the influences exerted on minors during a request for voluntary termination of pregnancy (TOP). PATIENTS AND METHODS: We made a retrospective descriptive study at the Centre Hospitalier Universitaire (CHU) of Nice. Two hundred (and) four minor patients were included, from January 1st 2003 to December 31st 2004. RESULTS: In the majority of cases, the entourage (sexual partner or parents) who are informed of the request for TOP support the patient in her choice. In more than 56% of cases, the parents are not informed of the request for TOP. DISCUSSION AND CONCLUSION: It seems, for minors, that it is the need for conforming to the existing social model which motivates the majority of the requests for TOP.