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1.
Article in French | MEDLINE | ID: mdl-38734234

ABSTRACT

INTRODUCTION: Preterm premature rupture of membranes (PPROM) is the main cause of premature delivery, complicating 1-3% of all pregnancies. Conventional hospitalization (CH) is the most frequent mode of follow-up, but homecare (HC) seems to be an alternative. OBJECTIVES: Study of the impact of the monitoring mode on the duration of the latency period and on the latency ratio after PPROM, and analysis of the risk factors modifying this ratio. METHODS: This was a bicentric retrospective cohort study here-abouts including patients who presented a PPROM between 24 and 36weeks of gestation from 2016 to 2018. Patients had a follow-up in HC at Lille University Hospital center (UHC) and in CH at Nantes UHC according to two different follow-up protocols. The latency ratio corresponded to the real latency period divided by the latency period to theoretical term. RESULTS: We included 154 patients: 102 in HC and 52 in CH. The mean latency period was significantly higher in HC: 36.9±21.8 days, corresponding to an 85.5±23.7% latency ratio versus 20.2±12 days, corresponding to an 66.9±29.8% latency ratio in CH (P<0.001). The latency ratio in CH was correlated with term at PPROM (P=0.001). CONCLUSIONS: The duration of the latency period seems prolonged for PPROM followed by HC management versus CH in selected populations. This study suggests a benefit to HC in stable patients.

2.
Transfus Med Rev ; 38(1): 150778, 2024 01.
Article in English | MEDLINE | ID: mdl-37925226

ABSTRACT

Anti-D alloimmunization in the first trimester of pregnancy has long been the subject of prevention with anti-D immunoglobulins during events at risk of fetomaternal hemorrhage. Although the efficacy of preventing anti-D alloimmunization by an injection of immunoglobulin at 28 weeks of gestation (WG) is obvious, the literature provides little evidence of the effectiveness before 12+6 WG and several countries have modified their recommendations. In the presumed absence of a difference in alloimmunization risk between early and late prevention, our objective was to evaluate and compare the cost of treatment for 3 alloimmunization prevention strategies in France, the United Kingdom, and the Netherlands. This was a single-center retrospective study. Our target population included all women who received anti-D immunoglobulins (Rhophylac) in the first trimester of pregnancy before 12+6 WG at Nantes University Hospital in 2018 (N = 356). Within the target population, 2 other populations were constituted based on British (N = 145) and Dutch (N = 142) clinical practice guidelines (CPG). These 3 populations were analyzed for the comparative cost of treatment for prevention from a health system perspective. The average cost of Rhophylac alloimmunization prevention for 1 episode was €117.8 from a health system perspective. The total cost attributed to prevention in 2018 at Nantes University Hospital (N = 356) was €41,931.4 according to this perspective. If the UK CPG or Dutch CPG had been applied to the Nantes target population, a saving of around 60% would have been achieved. At the national level, the cost according to the health system perspective specifically attributable to induced abortion (N estimated = 26,916) could represent a total cost of €3,170,704. This study highlighted the high cost of the French prevention strategy in the first trimester of pregnancy compared with British or Dutch strategies. The modification of our practices would allow substantial financial savings to the French health system but would also avoid the nonrecommended exposure to a blood product at this term, would allow a faster medical management and a relief of the care system.


Subject(s)
Anemia, Hemolytic, Autoimmune , Rh Isoimmunization , Pregnancy , Female , Humans , Pregnancy Trimester, First , Rho(D) Immune Globulin/therapeutic use , Retrospective Studies , Rh Isoimmunization/prevention & control , Anemia, Hemolytic, Autoimmune/drug therapy
3.
J Surg Educ ; 81(2): 182-192, 2024 Feb.
Article in English | MEDLINE | ID: mdl-38160113

ABSTRACT

BACKGROUND: Surgical residents in France lack a clear pedagogical framework for achieving autonomy in the operating room. The progressive acquisition of surgical autonomy is a determining factor in the confidence of operators for their future independent practice. Currently, there is no autonomy scale commonly used in Europe. The objective of this study is to identify existing tools for quantifying the autonomy of residents and the factors that influence it. MATERIALS AND METHODS: We conducted a qualitative systematic review following the recommendations of the Systematic Review Without Meta-Analysis (SWiM) guidelines. Publications were extracted from the MEDLINE (PubMed), EMBASE, and PSYCINFO databases. All publications without date restrictions up to July 2022 were identified. RESULTS: Among the 231 identified publications, 21 met the inclusion criteria. Seventeen publications used a graded autonomy assessment tool by the student and/or the teacher, while 4 used evaluations by an observing third party. We found 8 different autonomy scales, with the Zwisch Scale representing 57.1% of the cases. Factors influencing autonomy were diverse, including the work context, experience, and gender of the resident and their teacher. DISCUSSION: We found heterogeneity in the tools used to "measure" the autonomy of a resident in the operating room. The SIMPL tool or the Zwisch Scale appear to be the most frequently used tools. The relationship between autonomy, performance, confidence, and knowledge may require multidimensional tools that encompass various areas of competence, but this could make their daily application more challenging. The factors influencing autonomy are numerous; and understanding them would improve teaching in the operating room. There is a significant lack of data on surgical autonomy in France, as well as a lack of evaluation in the field of gynecology-obstetrics worldwide.


Subject(s)
Internship and Residency , Operating Rooms , Professional Autonomy , Humans , Clinical Competence , General Surgery/education , Mental Processes
4.
J Clin Med ; 12(18)2023 Sep 18.
Article in English | MEDLINE | ID: mdl-37762978

ABSTRACT

Adrenal necrosis is a rare but serious cause of abdominal pain of thrombotic origin during pregnancy. There is often a delay in diagnosis and treatment. The objective was to specify the clinical and paraclinical signs suggestive of adrenal necrosis, making it possible to improve the delay in diagnostic. The secondary objective was to establish a multidisciplinary protocol regarding management. This is a case report of pregnant women with a radiological diagnosis of adrenal gland necrosis. In parallel, we carried out a systematic review in the same period. We studied these patients' clinical, biological and radiological data. We included eight patients with a computed tomography scan diagnosis of adrenal necrosis and fifteen articles in the literature describing twenty-four cases. All the patients presented with the same symptoms. The treatment was based on curative anticoagulation. The diagnosis of adrenal gland necrosis is worth suggesting in view of the array of sudden morphine-resistant abdominal pain associated with a biological inflammatory syndrome. The diagnosis is based on the computed tomography scan. Three to six months of curative anticoagulation is recommended as well as a thrombophilia and endocrinological assessment to rule out adrenal insufficiency.

5.
J Clin Med ; 11(19)2022 Sep 20.
Article in English | MEDLINE | ID: mdl-36233372

ABSTRACT

Background: The COVID-19 pandemic has shaken the world by imposing unprecedented health measures, including in the postpartum period. Objectives: We aim to assess the impact of maternal isolation in the immediate postpartum period on the rate of postpartum depression (PPD) in a tertiary center. Study Design: We conducted a prospective cohort study, between 22 April and 29 October 2020, using anonymous questionnaires on 265 participants (129 during lockdown and 135 outside). The Edinburgh Postnatal Depression Scale (EPDS) was used as screening for PPD. We used a univariate logistic regression model to analyze the association between risk factors and PPD. Results: There was no difference between the two groups for PPD assessed by an EPDS score >10.5 on day 30 and/or day 60 (23.1% vs. 29.3%, p = 0.661) but on day 3 it was higher (31% vs. 17.8%, p = 0.015) during the lockdown period and partners were more impacted psychologically (48.3% vs. 10.5%, p < 0.001). Parity ≥1 was a protective factor for PPD (OR = 0.2, 95% CI [0.1−0.6], p = 0.003). Risk factors of PPD were: history of psychological abuses (OR = 6.4, CI 95% [1.1−37.6], p = 0.04), stressful life event (OR = 4.5, CI 95% [1.6−12.6], p = 0.004), and bad birth experience (OR = 5.1, CI 95% [1.4−17.8], p = 0.012). Conclusion: Maternal isolation in the immediate postpartum period is associated with an increased rate of moderate to severe symptoms of postpartum blues. The well-known long-term consequences of PPD must be balanced against the expected benefits of partner's restrictive access to maternity ward.

6.
J Gynecol Obstet Hum Reprod ; 51(8): 102434, 2022 Oct.
Article in English | MEDLINE | ID: mdl-35768063

ABSTRACT

OBJECTIVE: To implement a vaginal delivery of the second twin simulation program for obstetric and gynecology residents, to reduce maternal-fetal mortality in the management of twin pregnancies in the delivery room. DESIGN: A prospective education program. The session consisted of a theoretical part, a practical part on a mannequin and an evaluation. The model was designed in a simple and reproducible way. The simulation evaluation was done at several levels according to the validated Kirkpatrick model. SETTING: A tertiary level university maternity hospital. PARTICIPANTS: Ten obstetric and gynecology residents participated. RESULTS: The resident's personal feelings about their ability to perform the maneuvers increased significantly after participation in the simulation session. Their technical skills in performing the maneuvers were assessed in a second step. The majority of the participants considered the model realistic and the session useful. All agreed that the simulation was an essential part of their learning process. CONCLUSION: A simulated vaginal delivery of the second twin session allows residents to be safely trained in these obstetrical maneuvers, which can be difficult to teach and perform.


Subject(s)
Gynecology , Internship and Residency , Obstetrics , Clinical Competence , Delivery, Obstetric/education , Female , Gynecology/education , Hospitals, Maternity , Humans , Obstetrics/education , Pregnancy , Prospective Studies , Universities
7.
J Gynecol Obstet Hum Reprod ; 51(1): 102239, 2022 Jan.
Article in English | MEDLINE | ID: mdl-34624512

ABSTRACT

INTRODUCTION: The breech presentation represents 4,7% of deliveries at term. There is a method of external cephalic version (ECV) performed from 36 weeks of gestation. French guidelines for the clinical practice of ECV were published in 2020. OBJECTIVE: To evaluate the national practices of ECV in French maternity units, especially on the use of tocolysis, 1 year after publication of the French clinical recommendations guidelines by the French national college of obstetricians and gynecologists (CNGOF). METHODS: Data self-reported for this national descriptive study were collected from March to May 2021 by an online questionnaire distributed to all French maternities. The 25 items of the questionnaire collected information of maternity units, the general practice of ECV, use or not of tocolysis for ECV attempt and the relevance of a prospective study. RESULTS: Of the 517 French maternity units, 150 (29%) responded to the online survey.  95,3% systematically performed ECV. A Kleihauer test was routinely performed in 71 units (49.7%). A tocolysis was associated with ECV attempt in 52.4% of cases. The drugs used were intravenous atosiban (30,7%), mainly in levels 2b and 3 maternity units, intravenous salbutamol (24%), other mode of administration of salbutamol (14,7%) and oral nifedipine (22,6%) mainly in levels 1 and 2a maternity units. Adverse effects were described in 20%, mainly with the use of salbutamol (73,3%). CONCLUSIONS: 52.4% of the French maternity units surveyed used tocolysis for the ECV attempt, although it is systematically recommended. The choice of tocolytic drug differed according to the maternity units.


Subject(s)
Breech Presentation/therapy , Version, Fetal/methods , Breech Presentation/physiopathology , Female , France , Humans , Obstetrics and Gynecology Department, Hospital/organization & administration , Obstetrics and Gynecology Department, Hospital/statistics & numerical data , Pregnancy , Prospective Studies , Surveys and Questionnaires , Tocolytic Agents/administration & dosage , Version, Fetal/standards , Version, Fetal/statistics & numerical data
8.
Diagnostics (Basel) ; 11(7)2021 Jul 15.
Article in English | MEDLINE | ID: mdl-34359357

ABSTRACT

BACKGROUND: Endometrial cancer is the most common pelvic gynecological cancer in France. The most frequent symptom is post-menopausal bleeding and is one of the primary reasons for consultation in gynecological emergencies. The treatment is very codified and consists of a surgical intervention for anatomopathological analysis. The latter is frequently reassuring. These interventions are often performed in mild situations and there is currently no element to be sufficiently reassuring to avoid surgery. This study aims to explore the sensitivity of an innovative marker: Human Epididymis 4 (HE4) in the diagnosis approach of endometrial cancer in case of postmenopausal bleedings. METHODS: This is a prospective multicenter diagnostic study with three centers involved. Inclusion criteria are any patient with post-menopausal bleeding who is to undergo hysteroscopy, endometrial biopsy, or endometrial resection. In accordance with the recommendations for the management of post-menopausal bleedings, the medical conduct consists of performing a clinical examination, an ultrasound and, in general, even in case of paraclinical examination reassuring, an anatomopathological analysis. This pathological analysis can be obtained in several ways: biopsy, hysteroscopy-curettage (which is the most frequently performed surgery), and hysterectomy. Our protocol consists of taking a blood sample from each woman who will undergo one of the interventions mentioned above. The dosage of HE4 and CA125 requires the withdrawal of an additional heparinized tube during the preoperative assessment usually performed. This research is therefore classified as non-interventional. The primary outcome is to evaluate the sensitivity of the HE4 marker in patients with postmenopausal bleeding in the diagnosis of endometrial cancer. The secondary outcomes are other parameters (specificity, VPP, VPN) of HE4, Evaluating the diagnostic capabilities of the CA125 marker alone and associated with HE4, as well as those of the REM and REM-B algorithms. We aim to include 100 patients over a period of one year in three centers. DISCUSSION: As of now, there is no biological marker used in routine practice in the diagnosis of endometrial cancer. The ultimate goal of HE4 in endometrial cancer is to avoid surgery for those who are identified as non-sick. This study is the precursor of others for use in routine practice, HE4 would represent a great help to diagnosis if our study demonstrates it as reliable in the management of these patients and avoid many unnecessary and risky surgeries.

9.
J Gynecol Obstet Hum Reprod ; 50(7): 102107, 2021 Sep.
Article in English | MEDLINE | ID: mdl-33705991

ABSTRACT

INTRODUCTION: Initially dispensed in specialized simulation centers, simulation training has recently begun to take place directly in healthcare facilities, that is, in situ. The objective of this study is to assess the effect of training by in situ simulation in obstetrics. MATERIAL AND METHODS: The training program, dispensed over a 2-day period, took place in maternity units of the members of the Pays de la Loire perinatal network, Réseau Sécurité Naissance (Network Safety Birth). All participants received a learner satisfaction questionnaire to complete (5-point Likert-like scales). Then, at least 6 months later, each maternity ward received a general questionnaire to assess the effect of the training, as well as a second questionnaire specific to each institution, about the areas for improvement proposed by the teaching team after debriefings. RESULTS: The 14 establishments included in our study returned 375 satisfaction questionnaires. In all, 91.1 % were very satisfied and reported that the training met their expectations, and 99.7 % thought the program would have an impact on their professional practice. More than 94 % of the learners wanted more simulation sessions. Among the 14 facilities, 9 (64.3 %) returned their evaluation questionnaires. In 44.4 % of cases, they reported improvement in team cohesion and in team communication, while the others reported these elements remained stable. All maternity units reported that the training had a positive impact on their team, and that they would be interested in new training program with in situ simulation. DISCUSSION: Most participants clearly appreciated this training. In situ simulation training also led to the identification of areas for improvements, many of them accomplished, through the drafting of protocols or material modifications aimed at improving staff practices and therefore global patient care. There are many ways by which these training programs can be made sustainable, including the development of a new training program of in situ simulation or the creation of onsite simulation sessions on demand or by the professionals at each institution. CONCLUSION: This survey demonstrated the enthusiasm of healthcare professionals about in situ simulation. Moreover, overall improvement in team communication and cohesion was reported in the medium term (evaluation at more than 6 months). The interest of continuing these training sessions appears undeniable.


Subject(s)
Health Personnel/education , Obstetrics/education , Simulation Training/standards , Teaching/standards , Adult , Clinical Competence/standards , Clinical Competence/statistics & numerical data , Education, Professional/methods , Education, Professional/standards , Education, Professional/statistics & numerical data , Female , Humans , Male , Simulation Training/methods , Simulation Training/statistics & numerical data , Surveys and Questionnaires , Teaching/statistics & numerical data
10.
Clin Chim Acta ; 515: 27-36, 2021 Apr.
Article in English | MEDLINE | ID: mdl-33388311

ABSTRACT

INTRODUCTION: Endometrial cancer, one of the most frequent pelvic gynecologic cancer worldwide, currently has no biomarker used to assess it in daily practice. Nonetheless, human epididymis 4 (HE4) appears to offer the best prospects, alone or combined with CA125. This study sought to systematically review the work on HE4 from the first publications in 2008 until now. MATERIAL AND METHODS: Two independent reviewers searched the PubMed database with the terms "HE4″, "endometrial cancer", "endometrial carcinoma", and HE4 or human epididymis protein 4. Only original clinical research articles and meta-analyses, published in English, were included, with literature reviews and case reports excluded. RESULTS: Studies were organized into 3 categories: diagnosis, prognosis, and recurrence/survival. Overall we identified 117 articles dealing with HE4 and endometrial cancer and selected 52 relevant texts: 46 articles, 6 meta-analyses. The sensitivity of HE4 for the diagnosis of endometrial cancer varied from 44.2% to 91% and its specificity from 65.5 to 100%, versus 24.1 to 71.5% and from 65.6 to 100% for CA125. Two meta-analyses of their combination produced areas under the curve (AUC): 0.83 and 0.86. Two available algorithms - the REM (risk of endometrial malignancy) and REM-B (risk of endometrial malignancy associated with BMI) scores - require more study. HE4 is also strongly associated with prognostic factors such as myometrial invasion, tumor grade, FIGO stage, and lymph node involvement. It also predicts recurrence and can serve as a monitoring tool, as reported by a 2018 meta-analysis with a hazard ratio of 2.15 (P < 0.001). CONCLUSION: HE4, alone or associated with CA125, appears to be an important tool in the management of endometrial cancer, initially for diagnosis, but for assessing prognosis and survival. Other prospective and multicenter studies are necessary to confirm these hopes and be able to recommend the use of HE4 in regular practice.


Subject(s)
Endometrial Neoplasms , Ovarian Neoplasms , Biomarkers, Tumor , CA-125 Antigen , Endometrial Neoplasms/diagnosis , Female , Humans , Neoplasm Recurrence, Local , Prospective Studies , Proteins
11.
Int Urogynecol J ; 32(4): 975-991, 2021 04.
Article in English | MEDLINE | ID: mdl-32918592

ABSTRACT

INTRODUCTION AND HYPOTHESIS: Sacropexy is a reference surgical treatment for pelvic organ prolapse in women. The great variability in surgical techniques for this procedure is a source of bias that complicates analysis of the results of trials assessing it. Using the French guidelines issued in 2016 by the SCGP, AFU, SIFUD-PP, and CNGOF as a reference, we sought to inventory the surgical practices of the surgeons who perform these procedures. METHODS: In November 2018, a questionnaire about the technical aspects of this procedure was distributed by email to the French physicians performing it. It was distributed to members of several professional societies (CNGOF, SCGP, and SIFUD) and to gynecologists practicing in clinics owned by the ELSAN group. RESULTS: Of the 273 responders, 92% reported that they perform most operations laparoscopically. Overall, 83% of gynecologic surgeons used polypropylene prostheses (mesh); 38% routinely placed a posterior mesh, while the rest did so only in cases of clinical rectocele with anorectal symptoms. A concomitant hysterectomy was performed by 51% of respondents when the uterus was bulky and/or associated with substantial uterine prolapse. Finally, half the surgeons suggested the placement of a suburethral sling for women with stress urinary incontinence. CONCLUSIONS: Although practices are largely consistent with the most recent guidelines, surgical techniques vary widely between surgeons, both in France and internationally.


Subject(s)
Pelvic Organ Prolapse , Suburethral Slings , Female , France , Gynecologic Surgical Procedures , Humans , Pelvic Organ Prolapse/surgery , Surgical Mesh
12.
J Gynecol Obstet Hum Reprod ; 50(7): 102033, 2021 Sep.
Article in English | MEDLINE | ID: mdl-33301980

ABSTRACT

INTRODUCTION: The purpose of this study is to assess the angiographic incidence of uterine arteriovenous fistula (UAVF) in women referred for a high ultrasonographic suspicion in a postabortion setting and to evaluate the safety, efficacy and impact on further fertility of uterine artery embolization (UAE) in this indication. MATERIALS AND METHODS: A monocentric retrospective study of 31patients managed by uterine artery embolization for suspected UAVF after spontaneous or induced first trimester abortion. The diagnosis of UAVF was confirmed when an early venous drainage was identified on the angiogram. Technical success was defined as complete exclusion of the vascular lesion. Clinical success was defined as the absence of bleeding during the clinical follow-up and during the surgery in case of hysteroscopic resection. Information about further fertility was gathered by phone calls to the patients. RESULTS: The mean age of the patients was 30.8 (±6.0) years. The diagnosis of UAVF was angiographically confirmed in 6 patients (19.4 %). Angiographic findings of retained product of conception (RPOC) with varying degrees of vascularity were observed in remaining patients. The technical success rate of UAE was 100 %, mostly through a proximal and bilateral embolization using a resorbable agent (27/31 patients, 87.1 %). The clinical success rate of UAE was 100 % in the group treated by a single UAE. We did not notice any bleeding during the surgery in the group of patients who needed a further hysteroscopic resection. 14 patients led at least one subsequent pregnancy to term without any difficulty. CONCLUSION: UAVF is a rare condition. We supposed it may constitute the ultimate stage in the natural history of the retained products of conception with "marked vascularity". UAE seems to be an effective and safe first-line treatment.


Subject(s)
Abortion, Induced/adverse effects , Angiography/methods , Arteriovenous Fistula/diagnosis , Embolization, Therapeutic/methods , Uterus/diagnostic imaging , Abortion, Induced/methods , Adult , Angiography/statistics & numerical data , Arteriovenous Fistula/diagnostic imaging , Embolization, Therapeutic/statistics & numerical data , Female , Humans , Pregnancy , Retrospective Studies , Uterus/abnormalities
13.
J Perinat Med ; 49(2): 119-126, 2021 Feb 23.
Article in English | MEDLINE | ID: mdl-33001855

ABSTRACT

OBJECTIVES: Preterm labour is the leading cause of hospitalization during pregnancy. In France, it results in more than 60,000 births before 37 weeks of gestation every year. Recent studies suggest that detection of placental α-microglobulin-1 (PAMG-1) in vaginal secretions among women presenting symptoms of preterm labour with intact membranes has good predictive value for the onset of spontaneous preterm delivery within 7 days. The test is especially interesting, in that the repetition of antenatal corticosteroids for foetal lung maturation is no longer recommended in France and the effect of the initial administration is most beneficial in the 24 h to 7 days afterwards. METHODS: We included all studies listed in PubMed and clinicaltrials.gov with the terms "PAMG-1" and either "preterm labor" or "preterm labour", while excluding all studies on the subject of "rupture of the membranes" from 2000 through 2017. Ten studies were thus included. RESULTS: In women who had both the PAMG-1 and foetal fibronectin test, the PAMG-1 test was statistically superior to the measurement of cervical length for positive predictive value (p<0.0074), negative predictive value (p=0.0169) and specificity (p<0.001) for the prediction of spontaneous preterm delivery within 7 days. CONCLUSIONS: The use of PAMG-1 may make it possible to target the women at risk with a shortened cervix on ultrasound (<25 mm) those with an imminent preterm delivery and therefore to adapt management, especially the administration of antenatal corticosteroid therapy.


Subject(s)
Insulin-Like Growth Factor Binding Protein 1/metabolism , Obstetric Labor, Premature/diagnosis , Biomarkers/metabolism , Cervix Uteri/diagnostic imaging , Female , Fibronectins/metabolism , Humans , Obstetric Labor, Premature/metabolism , Pregnancy , Ultrasonography, Prenatal , Vaginal Smears
14.
BMC Pregnancy Childbirth ; 20(1): 442, 2020 Aug 03.
Article in English | MEDLINE | ID: mdl-32746802

ABSTRACT

BACKGROUND: Threatened preterm delivery (TPD) is the leading cause of inpatient admissions during pregnancy. The ability to predict the risk of imminent preterm delivery is thus a major priority in obstetrics. The aim of our study is to assess the diagnostic performance of the test to detect the placental alpha microglobulin 1 (PAMG-1) for the prediction of delivery within 7 days in women with TPD. METHODS: This is a prospective multicenter diagnostic study. Inclusion criteria are singleton pregnancy, gestational age between 24 + 0 and 33 + 6 weeks inclusive, cervical measurement 25 mm or less assessed by transvaginal ultrasound (with or without uterine contractions), clinically intact membranes and cervical dilatation < 3 cm assessed by digital examination. According to the current protocol, when a women presents with TPD and the diagnosis is confirmed by transvaginal ultrasound, a vaginal sample to test for genital infection is performed. At the same time, the midwife will perform the PartoSure® test. To perform this analysis, a sample of cervicovaginal secretions is taken with the vaginal swab furnished in the test kit. The primary outcome is the specificity of the PartoSure® test of women who gave birth more than 7 days after their hospitalization for TPD. The secondary outcomes are the sensitivity, PPV, and NPV of the Partosure® test and the factors associated with false positives (with a univariate logistic regression model). Starting with the hypothesis of an anticipated specificity of 89%, if we want to estimate this specificity with a confidence interval of ± 5%, we will require 151 women who do not give birth within 7 days. We therefore decided to include 400 women over a period of two years to have a larger number of events (deliveries within 7 days). DISCUSSION: The different tests already used such as fetal fibronectin and phIGFBP-1, are not sufficiently relevant to recommend their use in daily practice. The different studies of PAMG-1 described above thus provide support for the use of this substance, tested by PartoSure®. Nonetheless, other larger studies are necessary to validate its use in daily practice and our study could answer this question. TRIAL REGISTRATION: NCT03401255 (January 15, 2018).


Subject(s)
Cervix Uteri/chemistry , Insulin-Like Growth Factor Binding Protein 1/analysis , Premature Birth/diagnosis , Female , France , Hospitals , Humans , Pregnancy , Prospective Studies , Risk Assessment/methods , Sensitivity and Specificity , Vagina/diagnostic imaging
15.
Trials ; 21(1): 522, 2020 Jun 12.
Article in English | MEDLINE | ID: mdl-32532310

ABSTRACT

BACKGROUND: Perineal pain due to episiotomy is commonly reported and can be severe enough to disturb the mother-infant dyad during the postpartum period. Its incidence at day 7 postpartum varies from 63% to 74%. Recent studies have investigated the analgesic efficacy of perineal infiltration of ropivacaine after episiotomy but have only focused on the immediate postpartum period (at 24 and 48 h after birth). Large, adequately powered, multicenter, randomized controlled trials are required to evaluate the impact of ropivacaine infiltration on perineal pain and mid- and long-term quality of life before the widespread use of ropivacaine to prevent perineal pain after episiotomy can be recommended. METHODS/DESIGN: The ROPISIO study is a two-center, randomized, double-blind, placebo-controlled trial being conducted in La Roche sur Yon and Nantes, France. It will involve 272 women with vaginal singleton delivery and mediolateral episiotomy at term (≥ 37 weeks). Perineal infiltration (ropivacaine 75 mg or placebo) will be administrated just after vaginal birth and before episiotomy repair. The primary outcome will be the analgesic efficacy at day 7 postpartum (midterm), defined by the Numeric Pain Rating Scale (NPRS) strictly superior to 3/10 on the perineal repair area. Secondary outcomes will be the analgesic efficacy (NPRS) and the impact of pain on daily behavior, on the quality of life (36-item Short Form Health Survey), on the occurrence of symptoms of postpartum depression (Edinburgh Postnatal Depression Scale), and on sexual health (Female Sexual Function Index) at 3 and 6 months (long-term) using validated online questionnaires. This study will have 90% power to show approximately 30% relative risk reduction in the incidence of perineal pain at day 7, from 70.0% to 50.0%. DISCUSSION: Ropivacaine is a promising candidate drug, inexpensive, and easy to administer, and it would be suitable to include in the routine management of deliveries in labor ward. This study will investigate if perineal ropivacaine infiltration just after birth can reduce mid- and long-term postpartum pain and increase quality of life in women with mediolateral episiotomy. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03084549. Registered on 14 April 2017.


Subject(s)
Anesthetics, Local/therapeutic use , Episiotomy/adverse effects , Pain/drug therapy , Perineum/injuries , Ropivacaine/therapeutic use , Clinical Trials, Phase III as Topic , Double-Blind Method , Female , France , Humans , Multicenter Studies as Topic , Pain/etiology , Pain Measurement , Postpartum Period , Quality of Life , Randomized Controlled Trials as Topic
17.
Cureus ; 12(3): e7191, 2020 Mar 06.
Article in English | MEDLINE | ID: mdl-32269871

ABSTRACT

The rudimentary horn of uterus is an extremely rare malformation and potentially serious obstetric entity, threatening maternal and fetal outcome. Diagnostic sonography of early pregnancy in a non-communicating rudimentary horn is difficult but important. We report a case of ruptured non-communicating rudimentary horn with unicornuate uterus at 12 weeks' gestation, where diagnosis is made before surgery. Excision of the rudimentary horn and ipsilateral salpingectomy (to prevent a further ectopic tubal gestation), conserving the ovary, is the recommended surgical procedure for patients desiring to maintain their fertility potential. The subsequent obstetric prognosis is reassuring. Diagnostic imaging examinations of the reproductive system after this treatment showed no negative effect from surgery on subsequent fertility and there was no reported case of uterine rupture during subsequent pregnancy in the remaining unicornuate uterus after rudimentary horn excision. Future pregnancies will require extremely close monitoring and a caesarean section is highly recommended.

18.
PLoS One ; 15(2): e0228213, 2020.
Article in English | MEDLINE | ID: mdl-32074108

ABSTRACT

INTRODUCTION: Previous studies of fetal effects have suggested that intrahepatic cholestasis of pregnancy is associated with a higher rate of adverse neonatal outcomes including preterm birth, neonatal respiratory distress syndrome, meconium-stained amniotic fluid, neonatal intensive care unit admission, and stillbirth. The objective was to compare the neonatal and maternal consequences in pregnancies affected by intrahepatic cholestasis and normal pregnancies. MATERIAL AND METHODS: This case-control study compares pregnancies affected by intrahepatic cholestasis (pruritus and bile acid ≥ 10 µmol/L) with low-risk pregnancies managed between December 2006 and December 2014 at a French university hospital center. RESULTS: There were 83 (59.3%) cases of mild cholestasis (10≤ BA ≤39 µmol/L), 46 (32.8%) of moderate cholestasis (40≤ BA ≤99 µmol/L), and 11 (7.9%) of severe cholestasis (BA ≥100 µmol/L). No in utero fetal deaths occurred in the 140 women with cholestasis or the 560 controls analyzed. The rate of respiratory distress syndrome was higher in neonates of women with intrahepatic cholestasis (17.1% vs. 4.6%, P<0.001; crude OR 4.46 (CI95% 2.49-8.03)). This risk was also significant after adjustment for gestational age at birth and mode of delivery, adjusted OR 2.56 (CI95%1.26-5.18). The postpartum hemorrhage rate was twice as high among the case mothers (25% versus 14.1% for controls, P = 0.002). CONCLUSION: After adjustment on the confounding factors we found a higher rate of respiratory distress syndrome and neonatal morbidity among neonates of the cholestasis group.


Subject(s)
Cholestasis, Intrahepatic/diagnosis , Pregnancy Outcome , Adult , Bile Acids and Salts/analysis , Case-Control Studies , Cholestasis, Intrahepatic/pathology , Female , Gestational Age , Hemorrhage/epidemiology , Humans , Infant , Infant, Newborn , Intensive Care Units, Neonatal , Odds Ratio , Perinatal Mortality , Postpartum Period , Pregnancy , Respiratory Distress Syndrome, Newborn/diagnosis , Risk Factors , Severity of Illness Index
19.
J Matern Fetal Neonatal Med ; 33(15): 2561-2569, 2020 Aug.
Article in English | MEDLINE | ID: mdl-30513035

ABSTRACT

Introduction: The incidence of fetal goiters is reported to be around 1 per 40,000 births. The risk of complications is first of all obstetric, directly related to goiter size, but it may also affect longer term fetal and child development, depending on whether the goiter is due to hypo- or hyperthyroidism. Management is multidisciplinary, but not yet consensual and not always optimal by either endocrinologists or obstetricians.Objectives: The principal objective of this retrospective study was to analyze the data that enabled the physicians to assess whether the goiter was hypo- or hyperthyroid and then to analyze the obstetric practices used in the Pays de Loire network to describe in detail the tools used to diagnose and characterize the goiters and the management chosen in these cases. The secondary objectives are to assess, in our small cohort, the effectiveness of the in utero treatments provided, based on the examination of the children at birth and their outcome at 6 months of life, and to suggest a strategy for monitoring these women at risk that takes current guidelines into consideration.Materials and methods: This multicenter retrospective study covers a 6-year period and focused on the prenatal diagnosis centers (CPDPN) of the Pays de Loire perinatal network: in Nantes, Angers, and Le Mans. The network is responsible for around 42,000 births a year, and the study included 17 women, for a prevalence of 1 per 15,000 births.Results: Ten of the 17 fetuses had a hypothyroid goiter, 4 a hyperthyroid goiter, and 3 normal thyroid findings on fetal blood sample (FBS). For four women, these goiters were secondary to fetal dyshormonogenesis, for 9 more to Graves disease with TSH receptor antibodies (TRAb), and for four women to thyrotoxicosis at the start of pregnancy, managed by synthetic antithyroid drugs. Two newborns had severe complications associated with maternal transmission of Graves disease (TRAb positive at birth): one with exophthalmos and one with neonatal tachycardia. The other 14 had normal psychomotor development at 6 months, based on a clinical examination by a pediatric endocrinologist; only one child was lost to follow-up.Conclusion: Together, ultrasound and multidisciplinary expertise (of an endocrinologist and an obstetrician experienced with this disease) remain the best means for avoiding, or otherwise for accurately characterizing fetal goiter. An ultrasound diagnostic score, of the type proposed by Luton et al. in 2009, may make it possible to homogenize practices and thus to defer or delay the - currently too common - performance of invasive FBS procedures, which must remain rare in this management to limit comorbidities. A threshold TRAb value (>5 IU/l) makes it possible to define this group of women as at risk of fetal and neonatal hyperthyroidism and thus requiring close monitoring. The value of prenatal intra-amniotic thyroxine treatment for hypothyroid goiters (including dyshormonogenesis) remains to be demonstrated.


Subject(s)
Goiter , Hyperthyroidism , Pregnancy Complications , Antithyroid Agents , Child , Female , Fetus , Goiter/diagnosis , Goiter/epidemiology , Humans , Infant, Newborn , Male , Pregnancy , Prenatal Diagnosis , Retrospective Studies
20.
Acta Obstet Gynecol Scand ; 99(3): 391-398, 2020 03.
Article in English | MEDLINE | ID: mdl-31630398

ABSTRACT

INTRODUCTION: Approximately 4% of singleton pregnancies at term are in breech presentation. External cephalic version (ECV) can reduce the risks of noncephalic birth and cesarean delivery, but this maneuver can be painful. Our aim was to analyze the effect of administering inhaled nitrous oxide for analgesia on the ECV success rate. MATERIAL AND METHODS: This prospective, randomized, single-blind, controlled trial included women with singleton pregnancies in breech presentation at term who were referred for ECV in a tertiary care center. Women were assigned according to a balanced (1:1) restricted randomization design to inhale either nitrous oxide (N2 O) in a 50:50 mix with oxygen or medical air during the procedure. The main outcomes reported are the ECV success rate, degree of pain, adverse event rate, and women's satisfaction. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01948115. RESULTS: The study included 150 women (nitrous oxide group: n = 74; medical air: n = 76). Inhaled nitrous oxide was not associated with a higher ECV success rate than medical air (24.3 vs 19.7%, P = 0.51). Among parous women (n = 34 in each group), the ECV success rate appeared higher in the nitrous oxide group, respectively 47.1% (n = 16) vs 23.5% (n = 8) (P = 0.042). Neither the median pain level nor adverse event rates differed significantly in women with inhaled nitrous oxide compared with medical air. CONCLUSIONS: Use of an equimolar mixture of oxygen and nitrous oxide during ECV appears safe. Although it does not seem to change the overall success rate, it may increase success in parous women.


Subject(s)
Anesthetics, Inhalation/administration & dosage , Breech Presentation , Nitrous Oxide/administration & dosage , Version, Fetal , Adult , Female , Humans , Pain Measurement , Pregnancy , Prospective Studies , Single-Blind Method , Treatment Outcome
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