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1.
J Gynecol Obstet Hum Reprod ; 53(6): 102775, 2024 Mar 21.
Article in English | MEDLINE | ID: mdl-38521409

ABSTRACT

INTRODUCTION: In 2017, the French public health authority HAS published new guidelines for the management of newborns at risk of early bacterial neonatal infection. These guidelines were based on ante- and intrapartum risk factors and clinical monitoring. In January 2021, we implemented a new protocol based on these guidelines in our tertiary maternity unit. OBJECTIVES: To assess the impact of the protocol implemented on neonates' antibiotic prescriptions. METHOD: An "old protocol" group comprising newborns hospitalized between July 1, 2020 and December 31, 2020, was compared to a "new protocol" group formed between January 14, 2021 and July 13, 2021. Data were collected on infectious risk factors, antibiotic prescriptions, and emergency room visits within 2 weeks for an infection or suspected infection. RESULTS: The "old protocol" population comprised 1565 children and the "new protocol" population 1513. Antibiotic therapy was prescribed for 29 newborns (1.85 %) in the old protocol group versus 15 (0.99 %) in the new one (p = 0.05). The median duration was 5 days and 2 days respectively (p = 0.08). With the new protocol, newborns in category B were about 20 times more likely (p = 0.01), and those in category C about 54 times more likely (p = 0.005) to have an infection than those classified in categories N or A. CONCLUSION: This study demonstrates that clinical monitoring criteria enable reduced use and duration of antibiotic therapy and are reliable.

3.
Biomark Res ; 12(1): 25, 2024 Feb 14.
Article in English | MEDLINE | ID: mdl-38355595

ABSTRACT

In recent decades, preterm birth (PTB) has become a significant research focus in the healthcare field, as it is a leading cause of neonatal mortality worldwide. Using five independent study cohorts including 1290 vaginal samples from 561 pregnant women who delivered at term (n = 1029) or prematurely (n = 261), we analysed vaginal metagenomics data for precise microbiome structure characterization. Then, a deep neural network (DNN) was trained to predict term birth (TB) and PTB with an accuracy of 84.10% and an area under the receiver operating characteristic curve (AUROC) of 0.875 ± 0.11. During a benchmarking process, we demonstrated that our DL model outperformed seven currently used machine learning algorithms. Finally, our results indicate that overall diversity of the vaginal microbiota should be taken in account to predict PTB and not specific species. This artificial-intelligence based strategy should be highly helpful for clinicians in predicting preterm birth risk, allowing personalized assistance to address various health issues. DeepMPTB is open source and free for academic use. It is licensed under a GNU Affero General Public License 3.0 and is available at https://deepmptb.streamlit.app/ . Source code is available at https://github.com/oschakoory/DeepMPTB and can be easily installed using Docker ( https://www.docker.com/ ).

4.
Clin Chem Lab Med ; 62(6): 1101-1108, 2024 May 27.
Article in English | MEDLINE | ID: mdl-38278625

ABSTRACT

OBJECTIVES: The objective of our study was to evaluate serum CX3CL1/Fractalkine, a monocyte/macrophage chemoattractant expressed in cytotrophoblasts and decidual cells, as a predictive biomarker for the occurrence of preterm premature rupture of membranes (PPROM). METHODS: A case-control study of 438 pregnancies including 82 PPROM cases and 64 preterm labor with intact membranes cases with blood samples collected at first trimester, second trimester and delivery was conducted. The predictive ability of CX3CL1 and maternal risk factors for the occurrence of PPROM was assessed by receiver operating characteristic curve analysis. A second, independent cohort was prospectively constituted to confirm the case-control study results. RESULTS: First trimester CX3CL1 was significantly increased in PPROM cases when compared to matched controls. Multivariate regression analysis highlighted a significant difference for CX3CL1 measured during the first trimester (p<0.001). Alone, CX3CL1 predicts PPROM with a 90 % sensitivity and a specificity around 40 %. The area under the receiver operating characteristic curve for PPROM prediction were 0.64 (95% confidence interval: 0.57-0.71) for first trimester CX3CL1, and 0.61 (95% confidence interval: 0.54-0.68) for maternal risk factors (body mass index<18.5 kg/m2, nulliparity, tobacco use and the absence of high school diploma). The combination of CX3CL1 and maternal risk factors significantly improved the area under the curve: 0.72 (95% confidence interval: 0.66-0.79) (p<0.001). The results were confirmed on a second independent cohort. CONCLUSIONS: CX3CL1 is a promising blood biomarker in the early (first trimester) prediction of PPROM.


Subject(s)
Biomarkers , Chemokine CX3CL1 , Fetal Membranes, Premature Rupture , Humans , Female , Pregnancy , Chemokine CX3CL1/blood , Fetal Membranes, Premature Rupture/blood , Fetal Membranes, Premature Rupture/diagnosis , Biomarkers/blood , Adult , Case-Control Studies , ROC Curve , Pregnancy Trimester, First/blood , Risk Factors
5.
Article in French | MEDLINE | ID: mdl-38296107

ABSTRACT

AIM: To describe pregnancy outcome of kidney transplant patients till 1 year postpartum. METHODS: This retrospective, monocentric study included 15 kidney transplant patients who presented 18 pregnancies, between January 2000 and January 2020. For each of them, we searched for possible obstetrical, fetal and renal complications and we evaluated renal function before, during and after pregnancy. RESULTS: The live birth rate was 84% (16/19) with an average gestational age at delivery of 37 weeks of gestation. The rate of prematurity was 50% (8/16), gestational diabetes was 16.6% (3/18) and preeclampsia was 27.7% (5/18). Cesarean section was performed in 61.1% (11/18) of cases including, 81.8% (9/11) unplanned surgery. The average birth weight was 2635 grams and 37.5% (6/16) of the newborn were small for gestational age. All patients had stable renal function before conception of pregnancy. We noticed two acute graft rejection during pregnancy with only one resulting in graft loss. Four patients had a reduced graft function in 12months of the postpartum. CONCLUSION: Risk of maternal, fetal and renal complications remained high in kidney transplant recipients. Pregnancy should be carefully planned in transplanted women associated with adequate follow-up according to clinical guidelines (normal renal function and blood pressure without proteinuria before pregnancy, no recent graft rejection, period of one year after transplant respected and no teratogenic treatment in the month before pregnancy).

6.
J Matern Fetal Neonatal Med ; 36(2): 2266092, 2023 Dec.
Article in English | MEDLINE | ID: mdl-37840223

ABSTRACT

OBJECTIVES: The current recommended treatment for severe fetal anemia is in utero transfusion (IUT). During this procedure, the evaluation of the necessary volume of transfused blood is based on regular measurement of fetal hemoglobin (FHb) concentration. The gold standard measurement is performed in the biology laboratory. A rapid medical test such as HemoCue® is an effective way to predict FHb concentration. It would reduce the time to obtain results and therefore the procedure duration. To evaluate the accuracy of HemoCue® to measure FHb during IUT, we compared Hb levels obtained by HemoCue® and by our biology laboratory. METHODS: This retrospective study involved all pregnant women who had undergone an IUT in the university hospital of Clermont-Ferrand, France, during the period from 1 January 2010 to 6 June 2021. The FHb level was evaluated by two methods, a rapid medical test, HemoCue®, and a standard method in the biology laboratory. RESULTS: We obtained 244 pairs of results from HemoCue® and our laboratory, of 90 IUT procedures. The correlation between the two sets of results was excellent, with Lin's concordance correlation coefficient of 0.979. However, we established that the measurements were not significantly modified by IUT number, puncture time, cause of fetal anemia, estimated fetal weight, gestational age, and delay between two IUT or middle cerebral artery peak systolic velocity values. CONCLUSION: Our results allowed to extend the relevance of FHb measurements by HemoCue® during IUT.


Subject(s)
Anemia , Fetal Diseases , Humans , Female , Pregnancy , Fetal Hemoglobin/analysis , Retrospective Studies , Anemia/diagnosis , Anemia/therapy , Fetal Diseases/diagnosis , Fetal Diseases/therapy , Blood Transfusion , Blood Transfusion, Intrauterine , Hemoglobins/analysis
7.
Clin Chim Acta ; 551: 117594, 2023 Nov 01.
Article in English | MEDLINE | ID: mdl-37832906

ABSTRACT

PURPOSE: Cytogenetic analysis provides important information for prenatal decision-making and genetic counseling. Optical genome mapping (OGM) has demonstrated its performances in retrospective studies. In our prospective study, we assessed the quality of DNA obtained from cultures of amniotic fluid (AF) and chorionic villi (CV) and evaluated the ability of OGM to detect all clinically relevant aberrations identified by standard methods. METHODS: A total of 37 prenatal samples from pregnancies with a fetal anomaly on ultrasound were analyzed prospectively by OGM between January 1, 2021 and June 31, 2022. OGM results were interpreted blindly and compared to the results obtained by standard techniques. RESULTS: OGM results were interpretable in 92% of samples. We observed 100% concordance between OGM and karyotype and/or chromosomal microarray results. In addition, OGM identified a median of 30 small (<100 kb) structural variations per case with the involvement of 12 OMIM genes, of which 3 were OMIM morbid genes. CONCLUSION: This prospective study showed OGM performed well in detecting genomic alterations in cell cultures from prenatal samples. The place of OGM in relation to CMA or exome sequencing remains to be defined in order to optimize the prenatal diagnostic procedure.


Subject(s)
Chromosome Aberrations , Prenatal Diagnosis , Pregnancy , Female , Humans , Prospective Studies , Retrospective Studies , Karyotyping , Cytogenetic Analysis , Chromosome Mapping
8.
Ann Biol Clin (Paris) ; 81(4): 388-394, 2023 10 20.
Article in French | MEDLINE | ID: mdl-37864444

ABSTRACT

A threshold of 50 µg fecal calprotectin per g stool sample (µg/g) is commonly used to diagnose chronic inflammatory bowel disease in adult patients and children over 4 years of age. In younger children, fecal calprotectin values are physiologically increased. For the first time, the objective of our study was to establish reference ranges in newborns for the measurement of meconium calprotectin with an automated assay (Liaison® XL, DiaSorin). A prospective study was conducted in 2022 in the Maternity Unit of the Clermont-Ferrand University Hospital, with the inclusion of full-term newborns without intestinal involvement. The quantitative automated Liaison® XL calprotectin assay was assessed on a panel of meconium samples. In our cohort of 132 term neonates, calprotectin values ranged from 21 to 855 µg/g of meconium (2,5th to 97.5th percentile) and the median value was 194 µg/g. In our cohort, only sex-related differences were observed for calprotectin values. No significant differences were found for the other factors studied (maternal or neonatal). Because of inter-individual variability, a sequential measurement of newborn calprotectin from meconium should be considered.


Subject(s)
Leukocyte L1 Antigen Complex , Meconium , Adult , Child , Humans , Infant, Newborn , Female , Pregnancy , Prospective Studies , Feces , Immunoassay , Biomarkers
9.
J Clin Med ; 12(17)2023 Sep 01.
Article in English | MEDLINE | ID: mdl-37685773

ABSTRACT

We conducted a prospective double-blind study to compare two vaginal diagnostic methods in singleton pregnancies with threatened preterm labor (TPL) at the University Hospital of Clermont-Ferrand (France) from August 2018 to December 2020. Our main objective was to compare the diagnostic capacity at admission, in terms of positive predictive value (PPV) and negative predictive value (NPV), of Premaquick® (combined detection of IL-6/total IGFBP-1/native IGFBP-1) and QuikCheck fFN™ (fetal fibronectin) for delivery within 7 days in cases of TPL. We included 193 patients. Premaquick® had a sensitivity close to 89%, equivalent to QuikCheck fFN™, but a higher statistical specificity of 49.5% against 38.6% for QuikCheck fFN™. We found no superiority of Premaquick® over QuickCheck fFN™ in terms of PPV (6.6% vs. 7.9%), with NPV being equivalent in predicting childbirth within 7 days in cases of TPL (98.6% vs. 98.9%). Nevertheless, the combination of positive native and total IGFBP-1 and the combination of all three positive markers were associated with a higher PPV. Our results, though non-significant, support this combined multiple-biomarker approach to improve testing in terms of predictive values.

10.
Gynecol Obstet Fertil Senol ; 51(10): 448-454, 2023 10.
Article in French | MEDLINE | ID: mdl-37634804

ABSTRACT

OBJECTIVES: The Shock Index (SI) is used in emergency medicine to assess the severity of active bleeding and in the postpartum context for postpartum haemorrhage (PPH). We investigated the diagnostic value of haemodynamic parameters (SI, heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP) and mean arterial pressure (MAP)) in predicting subsequent use of uterotonic sulprostone treatment. METHODS: This was a retrospective study including parturients with PPH ≥ 500mL between January 2017 and December 2018. Hemodynamic parameters at the diagnosis of PPH were compared according to whether the patient required subsequent sulprostone treatment (sulprostone(+) group) or not (sulprostone(-) group). RESULTS: We included in the analysis 147 patients. The SI was significantly higher in the sulprostone(+) group (0.92±0.28 vs. 0.83±0.22; p=0.04). The SBP (107.2±17.5 vs. 113.8±17.7mmHg; p=0.03), DBP (56.8±12,2 vs. 61.5±13,2mmHg; p=0.04), MAP (73.6±12.6 vs. 78.5±13.4mmHg; p=0.03) were significantly lower in the same group. No difference between AUC of these parameters to predict the use of sulprostone was found (AUC between 0.59 and 0.61). No significant difference was found for the HR between the two groups. CONCLUSION: The diagnostic value of SI appeared to be low and similar to other haemodynamic parameters in predicting the use of sulprostone.


Subject(s)
Postpartum Hemorrhage , Shock , Female , Humans , Postpartum Hemorrhage/diagnosis , Postpartum Hemorrhage/therapy , Retrospective Studies , Dinoprostone , Shock/diagnosis , Shock/drug therapy
12.
Am J Obstet Gynecol ; 229(5): 542.e1-542.e14, 2023 11.
Article in English | MEDLINE | ID: mdl-37209893

ABSTRACT

BACKGROUND: Many questions remain about the appropriate use of intrauterine balloon devices in postpartum hemorrhage after vaginal delivery refractory to first-line uterotonics. Available data suggest that early use of intrauterine balloon tamponade might be beneficial. OBJECTIVE: This study aimed to compare the effect of intrauterine balloon tamponade used in combination with second-line uterotonics vs intrauterine balloon tamponade used after the failure of second-line uterotonic treatment on the rate of severe postpartum hemorrhage in women with postpartum hemorrhage after vaginal delivery refractory to first-line uterotonics. STUDY DESIGN: This multicenter, randomized, controlled, parallel-group, nonblinded trial was conducted at 18 hospitals and enrolled 403 women who had just given birth vaginally at 35 to 42 weeks of gestation. The inclusion criteria were a postpartum hemorrhage refractory to first-line uterotonics (oxytocin) and requiring a second-line uterotonic treatment with sulprostone (E1 prostaglandin). In the study group, the sulprostone infusion was combined with intrauterine tamponade by an ebb balloon performed within 15 minutes of randomization. In the control group, the sulprostone infusion was started alone within 15 minutes of randomization, and if bleeding persisted 30 minutes after the start of sulprostone infusion, intrauterine tamponade using the ebb balloon was performed. In both groups, if the bleeding persisted 30 minutes after the insertion of the balloon, an emergency radiological or surgical invasive procedure was performed. The primary outcome was the proportion of women who either received ≥3 units of packed red blood cells or had a calculated peripartum blood loss of >1000 mL. The prespecified secondary outcomes were the proportions of women who had a calculated blood loss of ≥1500 mL, any transfusion, an invasive procedure and women who were transferred to the intensive care unit. The analysis of the primary outcome with the triangular test was performed sequentially throughout the trial period. RESULTS: At the eighth interim analysis, the independent data monitoring committee concluded that the incidence of the primary outcome did not differ between the 2 groups and stopped inclusions. After 11 women were excluded because they met an exclusion criterion or withdrew their consent, 199 and 193 women remained in the study and control groups, respectively, for the intention-to-treat analysis. The women's baseline characteristics were similar in both groups. Peripartum hematocrit level change, which was needed for the calculation of the primary outcome, was missing for 4 women in the study group and 2 women in the control group. The primary outcome occurred in 131 of 195 women (67.2%) in the study group and 142 of 191 women (74.3%) in the control group (risk ratio, 0.90; 95% confidence interval, 0.79-1.03). The groups did not differ substantially for rates of calculated peripartum blood loss pf ≥1500 mL, any transfusion, invasive procedure, and admission to an intensive care unit. Endometritis occurred in 5 women (2.7%) in the study group and none in the control group (P=.06). CONCLUSION: The early use of intrauterine balloon tamponade did not reduce the incidence of severe postpartum hemorrhage compared with its use after the failure of second-line uterotonic treatment and before recourse to invasive procedures.


Subject(s)
Balloon Occlusion , Postpartum Hemorrhage , Uterine Balloon Tamponade , Pregnancy , Female , Humans , Postpartum Hemorrhage/etiology , Delivery, Obstetric/adverse effects , Delivery, Obstetric/methods , Oxytocin , Uterine Balloon Tamponade/adverse effects
13.
BMJ Open ; 13(4): e058282, 2023 04 17.
Article in English | MEDLINE | ID: mdl-37068892

ABSTRACT

INTRODUCTION: It remains uncertain whether the most appropriate management for women with an unfavourable cervix after 24 hours of cervical ripening is repeating the ripening procedure or proceeding directly to induction by oxytocin. No adequately powered trial has compared these strategies. We hypothesise that induction of labour with oxytocin among women who have just undergone an ineffective first ripening procedure is not associated with a higher risk of caesarean delivery than a repeated cervical ripening with prostaglandins. METHODS AND ANALYSIS: We will conduct a multicentre, non-inferiority, open-label, randomised controlled trial aimed at comparing labour induction by oxytocin with a second cervical ripening that uses prostaglandins (slow-release vaginal dinoprostone; oral misoprostol 25 µg; dinoprostone vaginal gel 2 mg). Women (n=1494) randomised in a 1:1 ratio in 10 French maternity units must be ≥18 years with a singleton fetus in vertex presentation, at a term from ≥37+0 weeks of gestation, and have just completed a 24-hour cervical ripening procedure by any method (pharmacological or mechanical) with a Bishop score ≤6. Exclusion criteria comprise being in labour, having more than 3 contractions per 10 min, or a prior caesarean delivery or a history of uterine surgery, or a fetus with antenatally suspected severe congenital abnormalities or a non-reassuring fetal heart rate. The primary endpoint will be the caesarean delivery rate, regardless of indication. Secondary outcomes concern delivery, perinatal morbidity, maternal satisfaction and health economic evaluations. The nature of the assessed procedures prevents masking the study investigators and patients to group assignment. ETHICS AND DISSEMINATION: All participants will provide written informed consent. The ethics committee 'Comité de Protection des Personnes Ile de France VII' approved this study on 2 April 2021 (No 2021-000989-15). Study findings will be submitted for publication and presented at relevant conferences. TRIAL REGISTRATION NUMBER: NCT04949633.


Subject(s)
Abortifacient Agents, Nonsteroidal , Labor, Induced , Oxytocics , Female , Humans , Pregnancy , Cervical Ripening , Cervix Uteri , Dinoprostone/therapeutic use , Labor, Induced/methods , Multicenter Studies as Topic , Oxytocin/therapeutic use , Prostaglandins/therapeutic use , Equivalence Trials as Topic
14.
J Clin Med ; 12(8)2023 Apr 21.
Article in English | MEDLINE | ID: mdl-37109371

ABSTRACT

We conducted a retrospective case-control study in patients presenting a perineal tear (second degree or higher) or episiotomy complicated by wound breakdown during maternity stay to identify risk factors associated with wound breakdown in early postpartum with a view to improving the quality of care. We collected ante- and intrapartum characteristics and outcomes at the postpartum visit. In all, 84 cases and 249 control subjects were included. In univariate analysis, primiparity, absence of history of vaginal delivery, a longer second phase of labour, instrumental delivery, and a higher degree of laceration emerged as risk factors for early perineal suture breakdown postpartum. Gestational diabetes, peripartum fever, streptococcus B, and suture technique did not emerge as risk factors for perineal breakdown. Multivariate analysis confirmed that instrumental delivery (OR = 2.18 [1.07; 4.41], p = 0.03) and a longer second phase of labour (OR = 1.72 [1.23; 2.42], p = 0.001) were risk factors for early perineal suture breakdown.

15.
J Clin Med ; 12(4)2023 Feb 14.
Article in English | MEDLINE | ID: mdl-36836056

ABSTRACT

We set out to identify factors of non-compliance with a protocol for the oral administration of misoprostol 25 µg (Angusta®) every 2 h (up to eight tablets), for the induction of labor (IOL). We conducted a retrospective study on IOL at term, on singleton pregnancies from 2019 to 2021, in a university hospital. The study included 195 patients, comprising 144 compliant protocols. Pain was statistically more frequent in the non-compliance group (92.2% vs. 62.5%, p < 0.001), and when a midwife was unavailable (15.7% vs. 0.7%, p < 0.001). A multivariable analysis found factors of good response (defined as going into labor before the administration of the median number of tablets, i.e., six) to be an indication for PROM (OR: 12.03, 95% CI: 5.42-26.71), and gestational age at induction (OR: 1.54, 95% CI: 1.19-2.01), independently of BMI, initial Bishop score, and parity. Patients with pain who were able to follow the protocol delivered 9 h earlier than patients with pain who interrupted the protocol and 16 h earlier than patients who experienced no pain. We identified two key elements that favored compliance: (i) providing the next tablet in advance; and (ii) offering patients early epidural analgesia when in pain in order to continue the protocol and go into labor promptly.

16.
Int J Mol Sci ; 24(4)2023 Feb 17.
Article in English | MEDLINE | ID: mdl-36835482

ABSTRACT

At the feto-maternal interface, fetal membranes (FM) play a crucial role throughout pregnancy. FM rupture at term implicates different sterile inflammation mechanisms including pathways activated by the transmembrane glycoprotein receptor for advanced glycation end-products (RAGE) belonging to the immunoglobulin superfamily. As the protein kinase CK2 is also implicated in the inflammation process, we aimed to characterize the expressions of RAGE and the protein kinase CK2 as a candidate regulator of RAGE expression. The amnion and choriodecidua were collected from FM explants and/or primary amniotic epithelial cells throughout pregnancy and at term in spontaneous labor (TIL) or term without labor (TNL). The mRNA and protein expressions of RAGE and the CK2α, CK2α', and CK2ß subunits were investigated using reverse transcription quantitative polymerase chain reaction and Western blot assays. Their cellular localizations were determined with microscopic analyses, and the CK2 activity level was measured. RAGE and the CK2α, CK2α', and CK2ß subunits were expressed in both FM layers throughout pregnancy. At term, RAGE was overexpressed in the amnion from the TNL samples, whereas the CK2 subunits were expressed at the same level in the different groups (amnion/choriodecidua/amniocytes, TIL/TNL), without modification of the CK2 activity level and immunolocalization. This work paves the way for future experiments regarding the regulation of RAGE expression by CK2 phosphorylation.


Subject(s)
Casein Kinase II , Extraembryonic Membranes , Protein Processing, Post-Translational , Receptor for Advanced Glycation End Products , Humans , Casein Kinase II/metabolism , Extraembryonic Membranes/metabolism , Phosphorylation , Receptor for Advanced Glycation End Products/metabolism
17.
Article in English | MEDLINE | ID: mdl-36573918

ABSTRACT

Background: Gestational diabetes (GD) is associated with an increase in maternal and fetal morbidity. The risk factors involved have been clearly identified but no prevention strategies have yet provided robust evidence of their efficacy. Myoinositol has insulin sensitization properties and is of potential interest in the treatment of the disorder. Aim: The aim of this work was to assess the efficacy of myoinositol supplementation during pregnancy to prevent GD in patients with known risk factors. Method: A systematic literature review was performed on studies comparing the effects of myoinositol supplementation and placebo on the occurrence of GD in at-risk pregnant women. The main judgement criterion was diagnosis of GD between 24 and 28 gestational weeks by an oral glucose tolerance test. The secondary judgement criteria were the occurrence of maternal fetal complications and the need to initiate insulin treatment to manage GD. Results: Nine studies were included in the meta-analysis. The results showed a significantly higher risk of GD in patients on placebo than in those receiving myoinositol (RR â€‹= â€‹2.58, CI 95%: 1.68 to 3.97, p â€‹< â€‹0.0001) but wide variations between studies (I2 â€‹= â€‹71.94%, p â€‹< â€‹0.001). And the risk of prematurity was significantly greater in the children of mothers on placebo (RR: 2.15, IC 95%: 1.32 to 3.20, p â€‹= â€‹0.002). Conclusion: Myoinositol supplementation taken from the beginning of pregnancy reduces the incidence of GD and could be of interest at a dose of 4 â€‹g/day as a prevention strategy for patients with identified risk factors.

18.
PLoS One ; 17(10): e0275129, 2022.
Article in English | MEDLINE | ID: mdl-36260615

ABSTRACT

INTRODUCTION: This trial evaluates whether daily low-dose aspirin initiated before 16 weeks of gestation can reduce preeclampsia and fetal growth restriction in nulliparous women identified by first-trimester uterine artery Dopplers as at high risk of preeclampsia. METHODS: This randomized, blinded, placebo-controlled, parallel-group trial took place in 17 French obstetric departments providing antenatal care. Pregnant nulliparous women aged ≥ 18 years with a singleton pregnancy at a gestational age < 16 weeks of gestation with a lowest pulsatility index ≥ 1.7 or a bilateral protodiastolic notching for both uterine arteries on an ultrasound performed between 11+0 and 13+6 weeks by a certified sonographer were randomized at a 1:1 ratio to 160 mg of low-dose aspirin or to placebo to be taken daily from inclusion to their 34th week of gestation. The main outcome was preeclampsia or a birthweight ≤ 5th percentile. Other outcomes included preeclampsia, severe preeclampsia, preterm preeclampsia, preterm delivery before 34 weeks, mode of delivery, type of anesthesia, birthweight ≤ 5th percentile and perinatal death. RESULTS: The trial was interrupted due to recruiting difficulties. Between June 2012 and June 2016, 1104 women were randomized, two withdrew consent, and two had terminations of pregnancies. Preeclampsia or a birthweight ≤ 5th percentile occurred in 88 (16.0%) women in the low-dose aspirin group and in 79 (14.4%) in the placebo group (proportion difference 1.6 [-2.6; 5.9] p = 0.45). The two groups did not differ significantly for the secondary outcomes. CONCLUSION: Low-dose aspirin was not associated with a lower rate of either preeclampsia or birthweight ≤ 5th percentile in women identified by their first-trimester uterine artery Doppler as at high risk of preeclampsia. TRIAL REGISTRATION: (NCT0172946).


Subject(s)
Pre-Eclampsia , Uterine Artery , Infant, Newborn , Female , Pregnancy , Humans , Male , Uterine Artery/diagnostic imaging , Pre-Eclampsia/prevention & control , Pre-Eclampsia/drug therapy , Birth Weight , Aspirin/therapeutic use , Pregnancy Trimester, First
19.
J Clin Med ; 11(14)2022 Jul 20.
Article in English | MEDLINE | ID: mdl-35887980

ABSTRACT

BACKGROUND: In France, more than 20% of women require induction of labor (IOL), which can be psychologically and emotionally challenging for patients. It is important to assess how they feel about their IOL experiences. Our aim was to cross-culturally adapt and evaluate the psychometric properties of a French version of the EXIT to assess women's experiences of IOL. METHODS: The EXIT was cross-culturally adapted by conducting forward and backward translations following international guidelines. A cross-sectional study was conducted to assess the psychometric properties of the ten French EXIT items: data completeness, factor analysis, internal consistency, score distribution, floor and ceiling effects, inter-subscale correlations, convergent validity, and test-retest reliability. RESULTS: The EXIT was successfully cross-culturally adapted to the French context and any IOL method. The results obtained from 163 patients requiring IOL showed good acceptability. Exploratory factor analysis resulted in a three-factor solution with subscales reflecting the experiential aspects of time taken to give birth, discomfort with IOL, and subsequent contractions. Good internal consistency (Cronbach's alpha or Spearman correlation coefficients ranging from 0.55 to 0.84) and good test-retest reliability (intraclass correlation coefficients ranging from 0.66 to 0.85) for the three identified subscales were found. CONCLUSIONS: The ten-item French EXIT is a valid and reliable instrument for the self-assessment of women's experiences of IOL in the three weeks following delivery for any method of IOL used. As a patient-reported outcome measure, it would allow the comparison of experiential outcomes across IOL studies in order to include women's preferences in decisions regarding their care.

20.
J Gynecol Obstet Hum Reprod ; 51(8): 102441, 2022 Oct.
Article in English | MEDLINE | ID: mdl-35843538

ABSTRACT

Background The best methods of labour induction have still been controversial because of an increased risk of uterine rupture, especially in exposed women of labour induction with prostaglandins. We here attempted to determine, after Dinoprostone Vaginal Insert, previous cesarean women (exposed women), compared with nulliparous women (non-exposed women), are more likely 1) to have the dilated cervix (up to 3 cm or more), and 2) to require cesarean after cervix being dilated 3 cm or more. Methods This retrospective observational study included 43 exposed women and 188 non exposed women . A propensity score was calculated to balance the background differences including age, BMI, Bishop. Main findings Exposed women were significantly less likely to reach 3 cm of cervix dilation than non exposed women (62.8 and 67.6% [study] vs. 83 and 81.3% [control] before and after propensy score analysis, respectively (p < 0.05)). However exposed women were significantly less likely to require cesarean than non exposed women (4.9 vs. 17.2% p = 0.03) after inverse probability of treatment weighting once 3 cm dilation was reached. Conclusion After Dinoprostone Vaginal Insert, women with scarred uterus were less likely to reach 3 cm of cervix dilation but once 3 cm of dilation was achieved, they were less likely to require cesarean.


Subject(s)
Cervical Ripening , Dinoprostone , Case-Control Studies , Cesarean Section , Dilatation , Dinoprostone/adverse effects , Female , Humans , Pregnancy , Retrospective Studies
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