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1.
Int Urogynecol J ; 32(7): 1727-1732, 2021 07.
Artigo em Inglês | MEDLINE | ID: mdl-33439282

RESUMO

INTRODUCTION AND HYPOTHESIS: To examine a common assumption that suturing of episiotomy, a straight performer-controlled incision, might be easier compared to repair of unpredictable spontaneous perineal tears. METHODS: Data for this study were collected prospectively, as part of a randomized controlled trial examining the outcomes of episiotomy avoidance. Suturing characteristics were compared between vaginal deliveries with episiotomy vs. spontaneous perineal tears. Primary outcomes included the duration of the repair, number of suture packs used for the repair, and subjective rating of suturing difficulty (rated from 1 to 5 by practitioner performing the suturing). RESULTS: Of 525 vaginal deliveries, episiotomy was performed in 165 (31.4%) of the cases, 59 of which (35.8%) were accompanied by additional vaginal tears. Spontaneous vaginal tears without episiotomy were noted in 272 deliveries (51.8%). Compared to spontaneous perineal tears, episiotomy performance was associated with an adverse effect on all three suturing characteristics in the overall cohort and in subgroup of non-operative deliveries. When comparing episiotomy only to second-degree tear suturing, in the subgroup of non-operative vaginal deliveries a higher rate of suturing duration < 10 min was noted in favor of spontaneous tears. However, in sub-analysis of vacuum-assisted deliveries, a benefit was noted in favor of the episiotomy-only group in terms of fewer suture packs and lower subjective difficulty. CONCLUSIONS: In women with non-operative vaginal delivery, suturing of spontaneous perineal tears was easier and shorter compared to episiotomy repair. This might be related to the unpredictable nature of perineal tears, which might be shorter and shallower compared to the standard episiotomy incision.


Assuntos
Lacerações , Complicações do Trabalho de Parto , Parto Obstétrico/efeitos adversos , Episiotomia/efeitos adversos , Feminino , Humanos , Lacerações/etiologia , Lacerações/cirurgia , Complicações do Trabalho de Parto/etiologia , Complicações do Trabalho de Parto/cirurgia , Períneo/lesões , Períneo/cirurgia , Gravidez , Suturas
2.
Arch Gynecol Obstet ; 303(3): 653-658, 2021 03.
Artigo em Inglês | MEDLINE | ID: mdl-32886235

RESUMO

PURPOSE: To evaluate the effect around nurses' shift change and on-call physicians' shift change on obstetrical outcomes. METHODS: A retrospective study of women who had an attempt of labor in a single-medical center, January 2006-December 2017. Obstetrical outcomes were compared between the time around nurses' shift change (6:00-8:00, 14:00-16:00, and 22:00-00:00) to the rest of the day, and between the time around on-call physicians' shift change (6:00-8:00, 14:00-16:00) to the rest of the day. RESULTS: 32,861 women were included, 7826 deliveries occurred during nurses' shift-change, and 25,035 deliveries occurred during the rest of the day. The groups had similar general and obstetrical characteristics, with no statistical difference in cesarean delivery rate (10% vs. 9.8%, P = 0.45) (Table 1). Nurses' shift change had no measurable effect on obstetrical outcomes, including induction of labor, preterm labor, 5-min-Apgar score and cord pH value, except PPH which was less likely to occur during nurses' shift change period (3.8% vs. 4.4%, P = 0.045) (Table 2). From 32,861 deliveries, 5155 deliveries occurred during on-call physicians' shift-change, and 27,706 deliveries occurred during the rest of the day. Induction\augmentation of labor and epidural analgesia were less likely to happen during on-call physicians' shift change (34.4% vs. 38%, P < 0.0001, 59.6% vs. 61.8%, P = 0.003, respectively) (Table 3). The two groups had similar obstetrical outcomes, without statistical difference in cesarean delivery rate (10% vs. 9.8%, P = 0.63) (Table 4). Table 1 General and obstetric characteristics of women giving birth during the time of nurses shift change versus during the rest of the day Variable Change of nurses shifts (n = 7826) All other hours of the day (n = 25,035) P value Maternal age, y 30.3 ± 5.1 30.2 ± 5.2 0.09 Gestational age at birth (weeks) 39.7 ± 1.09 39.8 ± 1.10 0.55 Nulliparity 2077 (35%) 7067 (37%) 0.01 Induction\augmentation of labor 2905 (37) 9368 (38) 0.62 Epidural analgesia 4746 (61) 15,396 (62) 0.16 Neonatal birth weight, g 3340 ± 422 3330 ± 423 0.06 Data is presented as mean ± S.D or N (%) Table 2 Maternal and neonatal adverse outcomes of women giving birth during the time of nurses shift change versus during the rest of the day Variable (%) Change of nurses shifts (n = 7826) All other hours of the day (n = 25,035) P value Vacuum assisted delivery 615 (7.9) 2002 (8.0) 0.69 Cesarean delivery 788 (10) 2443 (9.8) 0.45 Postpartum hemorrhage 294 (3.8) 1089 (4.4) 0.045 Third- and fourth-degree perineal laceration 106 (1.4) 372 (1.5%) 0.51 5-min Apgar score < 7 39 (0.5) 139 (0.6) 0.65 Umbilical pH < 7.2 170 (23) 580 (23) 0.96 Prolonged second stage 190 (2.5) 559 (2.2) 0.22 Maternal and fetal composite adverse outcome* 1309 (16.7%) 4219 (16.9%) 1.00 Data is presented as N (%) *Maternal and fetal composite adverse outcome was defined as the presence of any of the following: vacuum delivery, CD, prolonged second stage, postpartum hemorrhage, third and fourth degree perineal laceration, 5-min Apgar score < 7 and umbilical cord pH < 7.2 Table 3 General and obstetric characteristics of women giving birth during the time of the on-call physicians shift change versus during the rest of the day Variable Change of physicians shifts (n = 5155) All other hours of the day (n = 27,706) P value Maternal age, years 30.3 ± 5.1 30.2 ± 5.2 0.38 Gestational age at birth (weeks) 39.8 ± 1.09 39.8 ± 1.10 0.95 Nulliparity (%) 1303 (33.4) 7841 (37) < 0.0001 Induction\augmentation of labor (%) 1769 (34.3) 10,504 (38) < 0.0001 Epidural analgesia (%) 3067 (59.6) 17,075 (61.8) 0.003 Neonatal birth weight (gr) 3345 ± 416 3330 ± 424 0.019 Data is presented as mean ± S.D or N (%) Table 4 Maternal and neonatal adverse outcomes of women giving birth during the time of physicians on-call shift change versus during the rest of the day Variable (%) Change of physicians shifts (n = 5155) All other hours of the day (n = 27,706) P value Vacuum assisted delivery 397 (7.7) 2220 (8.0) 0.45 Cesarean delivery 517 (10.0) 2714 (9.8) 0.63 Postpartum hemorrhage 209 (4.1) 1174 (4.3) 0.54 Third- and fourth-degree perineal laceration 67 (1.3) 411 (1.5) 0.31 5-min Apgar score < 7 22 (0.5) 156 (0.6) 0.30 Umbilical pH < 7.2 94 (20.3) 656 (23.3) 0.15 Prolonged second stage 127 (2.5%) 622 (2.3%) 0.36 Maternal and fetal composite adverse outcome* 852 (16.5%) 4676 (16.9%) 1.00 Data is presented as N (%) *Maternal and fetal composite adverse outcome was defined as the presence of any of the following: vacuum delivery, CD, prolonged second stage, postpartum hemorrhage, third and fourth degree perineal laceration, 5-min Apgar score < 7 and umbilical cord pH < 7.2 CONCLUSION: Nurses' shift change and on-call physicians' shift change does not appear to be associated with an increase in adverse maternal or neonatal outcomes.


Assuntos
Parto Obstétrico , Enfermeiras e Enfermeiros/psicologia , Médicos/psicologia , Jornada de Trabalho em Turnos/psicologia , Adulto , Peso ao Nascer , Feminino , Humanos , Recém-Nascido , Trabalho de Parto , Obstetrícia , Paridade , Gravidez , Complicações na Gravidez/epidemiologia , Resultado da Gravidez/epidemiologia , Estudos Retrospectivos
3.
Int Urogynecol J ; 31(11): 2377-2385, 2020 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-32448935

RESUMO

INTRODUCTION AND HYPOTHESIS: The objective of this trial was to evaluate whether avoidance of episiotomy can decrease the risk of advanced perineal tears. METHODS: In this randomized (1:1) parallel-group superiority trial, primiparous women underwent randomization into "avoidance of episiotomy" (the study group in which episiotomy was allowed only in cases of fetal distress) or "standard care." The primary outcome was the incidence of advanced (3rd- and 4th-degree) perineal tears. RESULTS: The participants were randomized into "standard care" (n = 337) vs. "no episiotomy" (n = 339) groups, not differing in any demographic or obstetric characteristics. Episiotomy rates were significantly lower in the study group (19.6%) compared with the standard care group (29.8%, p = 0.004). Five (1.5%) advanced tears were diagnosed in the study group vs. ten = 3.0% in the controls, yielding an odds ratio of 0.50 (95% CI 0.17-1.50) in favor of the "no episiotomy" group (p = 0.296). No differences were noted in any secondary outcomes. By per protocol analysis (omitting cases in which episiotomy was performed for indications other than fetal distress in the study group), a trend to decreased risk of advanced tears in the study group was noted (p = 0.0956). By per protocol analyses, no severe tears were noted in the 53 vacuum deliveries in the study group vs. 4/65 (6.2%) tears in the controls (p = 0.126). CONCLUSIONS: Since decreased use of episiotomy was not associated with higher rates of severe tears or any other adverse outcomes, we believe this procedure can be avoided in spontaneous as well as vacuum-assisted deliveries. Trial registration no. NCT02356237.


Assuntos
Lacerações , Complicações do Trabalho de Parto , Episiotomia/efeitos adversos , Feminino , Humanos , Incidência , Razão de Chances , Períneo/lesões , Gravidez
4.
Arch Gynecol Obstet ; 299(3): 635-644, 2019 03.
Artigo em Inglês | MEDLINE | ID: mdl-30564929

RESUMO

PURPOSE: To assess whether there is an association between predicted fetal macrosomia and adverse outcomes in macrosomic newborns (> 4000 g), based on a sonographic evaluation up to 2 weeks prior to delivery. METHODS: A retrospective cohort study of 3098 mothers of macrosomic babies who were delivered at our institution (2000-2015). We compared the management and outcomes of women with predicted fetal macrosomia with that of women with unknown fetal macrosomia. The primary outcomes were cesarean section (CS) rate and postpartum hemorrhage. Secondary outcomes were composite maternal and neonatal outcomes and birth injuries. RESULTS: In 601 (19.4%) women fetal macrosomia was predicted, and in 2497 (80.6%) women, fetal macrosomia was unknown. CS rate was more than 3.5 times higher in the group of predicted macrosomia (47.2% vs. 12.7%, P < 0.001) than those with unpredicted macrosomia; not only due to non-progressive labor, but for non-reassuring heart rate as well. However, predicted fetal macrosomia reduced the risk of postpartum hemorrhage (aOR 0.5, 95% CI 0.2-1.0), maternal (aOR 0.3, 95% CI 0.2-0.5) and neonatal composite adverse outcomes (aOR 0.7 95% CI 0.6-0.9). It was also associated with increased risk for induction of labor, episiotomy, 3rd- or 4th-degree tears and a longer maternal hospitalization. Birth injuries and shoulder dystocia were not different between the groups. CONCLUSIONS: Antepartum CS was found to be associated with predicted fetal macrosomia. Moreover, a planned CS due to macrosomia was associated with reduced risk for postpartum hemorrhage, maternal and neonatal outcome, even for babies with a mean birth weight < 4500 g.


Assuntos
Macrossomia Fetal/diagnóstico , Cuidado Pré-Natal/métodos , Adulto , Estudos de Coortes , Feminino , Macrossomia Fetal/terapia , Humanos , Recém-Nascido , Gravidez , Complicações na Gravidez , Estudos Retrospectivos
5.
Arch Gynecol Obstet ; 300(2): 293-297, 2019 08.
Artigo em Inglês | MEDLINE | ID: mdl-31069489

RESUMO

OBJECTIVE: To assess the association of the attendant of the parturient (husband or mother or both), on labor duration, mode of delivery, maternal and neonatal complications. STUDY DESIGN: A retrospective cohort study, over a 4-year period, of women admitted to the delivery room accompanied by their husband, their mother or both. Medical records were reviewed for demographic, medical and obstetrical history. RESULTS: Overall, 3029 patients were included, 2192 were accompanied by their husband; 127 were accompanied by their mother and 710 were accompanied by both. Women accompanied by their husbands were significantly older and more likely to be multiparous than women accompanied by their mother (30.2 years vs. 27.8 years, P < 0.001 and 60% vs. 48.8%, P = 0.02, respectively). Compared to women supported during labor by their mothers, women supported only by their husbands spent less hours in the delivery room (from admission to delivery) (11.1 h vs. 13.7 h, P = 0.02). While the nature of the attendant had no influence on the mode of delivery among nulliparous women (p = 0.13), multiparous women supported by the mothers had a significantly higher rate of cesarean delivery compared to those supported only by their husband or by both (OR = 2.07, 95% CI = [1.317-3.246], P = 0.002, OR = 3.33, 95% CI = [1.623-6.849], P = 0.001, respectively). CONCLUSIONS: Women supported by their mothers during labor have a longer second stage of labor, a decreased rate of vaginal delivery and an increased risk for cesarean delivery compared to women supported by their husbands. Future large prospective studies are needed to confirm our observation and to find causative affect.


Assuntos
Cesárea/métodos , Salas de Parto/normas , Parto Obstétrico/métodos , Trabalho de Parto/fisiologia , Adulto , Feminino , Humanos , Recém-Nascido , Gravidez , Estudos Retrospectivos
6.
Int Urogynecol J ; 29(3): 415-423, 2018 03.
Artigo em Inglês | MEDLINE | ID: mdl-28932882

RESUMO

INTRODUCTION AND HYPOTHESIS: The objective of this trial was to evaluate whether avoiding episiotomy can decrease the risk of advanced perineal tears. MATERIAL AND METHODS: In this randomized (1:1) parallel-group superiority trial, primiparous women underwent randomization into standard care (155 cases) vs. no episiotomy (154 cases) groups. The primary endpoint was the incidence of advanced (3rd- and 4th-degree) perineal tears. Secondary outcomes included perineal integrity, suturing characteristics, second-stage duration, incidence of postpartum hemorrhage, neonatal variables, and various postpartum symptoms 2 days and 2 months after delivery. RESULTS: At prespecified 1-year interim analysis, the groups did not differ in terms of baseline demographic and obstetric characteristics. Six advanced perineal tears (3.9%) were diagnosed in the standard care group vs. two in no episiotomy group (1.3%), yielding a calculated odds ratio (OR) of 0.33 [95% confidence interval (CI) 0.06-1.65). Unexpectedly, rates of episiotomy performance also did not significantly vary between groups: 26.5% (41 cases) vs. 21.4% (33 cases), respectively, p = 0.35. No significant differences were noted in any secondary outcomes. CONCLUSIONS: No difference in the rates of advanced perineal tears was found between groups; however, the main limitation of our study was unexpectedly high rates of episiotomy in the nonepisiotomy group. Thus, the main conclusion is that investigator monitoring and education should be continuously practiced throughout the trial duration, stressing the importance of adherence to the protocol.


Assuntos
Canal Anal/lesões , Episiotomia/estatística & dados numéricos , Lacerações/prevenção & controle , Complicações do Trabalho de Parto/prevenção & controle , Períneo/lesões , Adulto , Episiotomia/efeitos adversos , Feminino , Humanos , Análise de Intenção de Tratamento , Segunda Fase do Trabalho de Parto , Lacerações/classificação , Lacerações/epidemiologia , Lacerações/etiologia , Complicações do Trabalho de Parto/classificação , Complicações do Trabalho de Parto/epidemiologia , Complicações do Trabalho de Parto/etiologia , Razão de Chances , Hemorragia Pós-Parto/epidemiologia , Gravidez , Fatores de Tempo , Adulto Jovem
8.
Int J Gynaecol Obstet ; 166(2): 886-890, 2024 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-38477600

RESUMO

OBJECTIVE: Recently, two randomized controlled trials compared removal of cervical ripening balloon (CRB) after 6 versus 12 h. Their results showed similar Bishop score changes in both groups and a shorter time to delivery in the 6-h group. Neither of the studies was powered to show difference in mode of delivery. The aim of this study was to compare mode of delivery when the CRB was removed after 6 versus 12 h. METHODS: A historical control study comparing induction of labor with a CRB between two time periods, one in which the CRB was removed after 12 h (12-h group), and the other in which it was removed after 6 h (6-h group). We included term pregnancies with a singleton fetus in vertex presentation. We excluded patients with a previous cesarean delivery, failed ripening with prostaglandins prior to CRB insertion, and any contraindication for vaginal delivery. The primary outcome was mode of delivery. Secondary outcomes included delivery within 24 h and other maternal and neonatal outcomes. RESULTS: We included 1704 patients, 914 in the 12-h group, and 717 in the 6-h group. Removal after 6 h was associated with a lower rate of cesarean and instrumental deliveries (28.6% vs 22.5%, and 12% vs 6.2%, respectively) and a higher rate of vaginal delivery within 24 h. All differences were statistically significant. CONCLUSION: Removing a cervical ripening balloon after 6 rather than 12 h is associated with reduced cesarean and instrumental delivery rates, and should be considered as a reasonable, and potentially superior alternative in labor induction protocols with intracervical ripening balloon.


Assuntos
Maturidade Cervical , Cesárea , Trabalho de Parto Induzido , Humanos , Feminino , Gravidez , Trabalho de Parto Induzido/métodos , Adulto , Estudos Retrospectivos , Fatores de Tempo , Cesárea/estatística & dados numéricos , Parto Obstétrico/métodos , Resultado da Gravidez
9.
J Gynecol Obstet Hum Reprod ; 53(8): 102810, 2024 Jun 05.
Artigo em Inglês | MEDLINE | ID: mdl-38849116

RESUMO

PURPOSE: To compare mode of delivery and maternal and neonatal outcomes using cervical ripening balloon (CRB) for induction of labor (IOL) in nulliparous patients vs. those undergoing first trial of labor after cesarean (TOLAC). METHODS: Retrospective cohort study including data from two tertiary medical centers. Included were all patients with a singleton pregnancy and a gestational age > 37+0 weeks and no prior vaginal birth undergoing IOL with CRB. Nulliparous patients (nulliparous group) were compared to patients with one prior cesarean delivery (CD) and no prior vaginal delivery (TOLAC group). Patients who withdrew consent for trial of labor at any time in both groups were excluded. The primary outcome was mode of delivery. RESULTS: Overall, 161 patients were included in the TOLAC group and 1577 in the nulliparous group. The rate of CD was similar in both groups and remained similar after adjusting for confounders (29.8 % vs. 28.9 %, p = 0.86, OR 1.1, 95 %, CI 0.76-1.58). CD due to fetal distress was more common in the TOLAC group (75 % vs. 56 %, p = 0.014). Other maternal outcomes and neonatal outcomes were similar in the two groups. CONCLUSION: Comparable vaginal delivery rates may be achieved in patients with or without a previous CD attempting their first trial of labor, with a cervical ripening balloon for labor induction, without increasing adverse maternal or neonatal outcomes.

10.
Am J Obstet Gynecol MFM ; 5(7): 100910, 2023 07.
Artigo em Inglês | MEDLINE | ID: mdl-36828283

RESUMO

BACKGROUND: The French AmbUlatory Cesarean Section is a cesarean delivery technique, which includes a vertical fascial incision to the left of the linea alba and an extraperitoneal approach to the uterus. The presumed benefits of this technique are decreased postoperative pain and accelerated recovery. However, evidence supporting these impressions is scarce. OBJECTIVE: This study aimed to compare maternal recovery after French AmbUlatory Cesarean Section vs standard cesarean delivery technique. STUDY DESIGN: In this double-blind randomized controlled trial, women undergoing elective cesarean delivery at term were allocated into French AmbUlatory Cesarean Section vs standard cesarean delivery technique. A modified French AmbUlatory Cesarean Section technique was used, adhering to all French AmbUlatory Cesarean Section operative steps except for the extraperitoneal approach. In both groups, the use of intravenous hydration, intrathecal morphine, and bladder catheter was avoided, and all women were encouraged to stand and walk 3 to 4 hours after the operation. The primary adverse composite outcome included either of the following: a visual analog scale score of >6 at 3 to 4 hours after the operation, an inability to stand up and walk to the restroom 3 to 4 hours after the operation, and a 15-Item Quality of Recovery (QoR) questionnaire score of <90 at 24 hours after the operation. The women were followed up for 6 weeks. RESULTS: Overall, 116 women were included in the trial (58 in each group). The adverse composite outcome did not differ between the 2 groups (38.9% for the French AmbUlatory Cesarean Section group vs 53.8% for the regular cesarean delivery group; P=.172). In both groups, more than 90% of the women were able to get up and walk 3 to 4 hours after the operation. Compared with the standard cesarean delivery group, the French AmbUlatory Cesarean Section group had a longer duration of the operation (43.7±11.2 vs 54.4±11.3 minutes; P<.001), a higher rate of intraoperative complications (0.0% vs 13.8%; P=.006), and a higher rate of umbilical cord pH level of <7.2 (3.4% vs 17.2%; P=.029) were noted. Evaluation via phone call 1 week after the operation showed better quality of recovery scores in the French AmbUlatory Cesarean Section group than in the standard cesarean delivery group (27.1±8.4 vs 24.6±8.0; P=.043). Other secondary outcomes did not differ between the 2 groups. CONCLUSION: As excellent maternal recovery was noted in both groups, we believe that the main factor affecting this recovery is the perioperative management (including avoidance of the use of intraoperative intravenous hydration, intrathecal morphine, and bladder catheter, with early postoperative mobilization). The maternal and neonatal safety outcomes of the French AmbUlatory Cesarean Section technique remain to be proven by larger-scale high-quality randomized controlled trials.


Assuntos
Cesárea , Dor Pós-Operatória , Feminino , Humanos , Recém-Nascido , Gravidez , Derivados da Morfina , Dor Pós-Operatória/diagnóstico , Dor Pós-Operatória/epidemiologia , Dor Pós-Operatória/etiologia , Método Duplo-Cego
11.
J Matern Fetal Neonatal Med ; 35(25): 6708-6713, 2022 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-33980117

RESUMO

OBJECTIVE: In 2014, the American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal Fetal Medicine (SMFM) published an Obstetric Care Consensus for safe prevention of primary cesarean delivery. We aimed to assess whether these guidelines decreased the primary CD rate during the second stage of labor, in our department. DESIGN, SETTING, AND POPULATION: A retrospective cohort study of all women reaching the second stage of labor, at term, in a single university-affiliated medical center between2010 and 2017. METHODS: We compared maternal and neonatal outcomes over three year's periods:-pre-guidelines (2010-2013) vs. 2nd period - post-guidelines (2014-2017). THE MAIN OUTCOME MEASURES: CD rate at 2ndstage of labor. RESULTS: The study included 11,464 women. The CD rate in the 2nd stage of labor has increased significantly from 4% to 5.9% in the post-guidelines period (OR 1.48, 95% CI 1.16-1.89, p = .001). After a sub-analysis of specific subgroups, and adjustment for confounders, the increase was solely observed in nulliparous women (aOR 1.418, 95% CI 1.067-1.885, p = .016). Furthermore, increased odds for vaginal operative delivery were observed in the multiparous women in the post-guidelines period (2.7% vs. 4.1%, p = .046). CONCLUSIONS: The implementation of the new ACOG and SMFM guidelines was not associated with a change in the CD rate performed at the 2nd stage of labor in the whole study population. However, there was a rise in the CD rate performed at the 2nd stage in nulliparous women. Furthermore, there was an increase in operative deliveries in the whole study population, especially in multiparous women, without an apparent increase in other immediate adverse neonatal or maternal outcomes.


Assuntos
Cesárea , Segunda Fase do Trabalho de Parto , Gravidez , Recém-Nascido , Humanos , Feminino , Estudos Retrospectivos , Perinatologia , Parto Obstétrico
12.
Vaccine ; 39(44): 6535-6538, 2021 10 22.
Artigo em Inglês | MEDLINE | ID: mdl-34600749

RESUMO

OBJECTIVE: During December 2020, a massive vaccination program was introduced in our country. The Pfizer-BioNTech, BNT162b2 vaccine was first offered exclusively to high-risk population, such as medical personnel (including pregnant women). In this study we compare short term outcomes in vaccinated vs. non-vaccinated pregnant women. METHODS: In this prospective observational cohort study, vaccinated and non-vaccinated pregnant women were recruited using an online Google forms questionnaire targeting medical groups on Facebook and WhatsApp. A second questionnaire was sent one month after the first one for interim analysis. Our primary outcome was composite complications in vaccinated and non-vaccinated groups, considered any of the following: vaginal bleeding, pregnancy loss, hypertension, gestational diabetes, and preterm birth. Secondary outcomes included: vaccine side effects, diagnosis of COVID-19 since the last questionnaire, prevalence of vaccinated participants, and reasons for refusal to be vaccinated. RESULTS: Overall, 432 women answered the first questionnaire, of which 326 responses were received to the second questionnaire. Vaccination rate increased from 25.5% to 62% within a month. Maternal age, gestational age at enrollment, nulliparity and number of children were similar in both groups. The rate of composite pregnancy complications was similar between vaccinated and non-vaccinated group (15.8% vs 20.1%, p = 0.37), respectively. The risk for COVID-19 infection was significantly lower in the vaccinated group (1.5% vs 6.5%, p = 0.024, Odds Ratio: 4.5, 95% confidence interval 1.19-17.6). CONCLUSIONS: mRNA vaccine during pregnancy does not seem to increase the rate of pregnancy complications and is effective in prevention of COVID-19 infection.


Assuntos
COVID-19 , Nascimento Prematuro , Vacina BNT162 , Vacinas contra COVID-19 , Criança , Feminino , Humanos , Recém-Nascido , Gravidez , Nascimento Prematuro/epidemiologia , Estudos Prospectivos , SARS-CoV-2 , Vacinação
13.
Obstet Gynecol ; 135(5): 1153-1160, 2020 05.
Artigo em Inglês | MEDLINE | ID: mdl-32282603

RESUMO

OBJECTIVE: To evaluate whether removal of a double-balloon device for cervical ripening for 6 compared with 12 hours in women with an unfavorable cervix will result in a shorter time to delivery, similar cervical ripening, and without affecting cesarean delivery rate. METHODS: In a prospective randomized trial, cervical ripening was performed using a double-balloon device. Women were randomized to removal of the device after 6 compared with 12 hours. Primary outcome was time to delivery. Secondary outcomes included mode of delivery, Bishop score, and maternal and neonatal adverse outcomes. A sample size of 100 nulliparous and 100 parous women was required assuming a 95% CI, power of 80%, and mean decrease of 6 hours to delivery between the groups. RESULTS: From March 2017 through February 2019, 688 women were screened, 243 were found eligible, and 197 were randomized as follows: nulliparous cohort (n=101): removal after 6 hours (n=48) compared with removal after 12 hours (n=53); parous cohort (n=96): removal after 6 hours (n=49) compared with removal after 12 hours (n=47). Insertion-to-delivery interval was significantly shorter in the 6-hour group for both nulliparous (25.6±12.8 hours vs 31.4±15.2 hours, P<.04; mean difference 5.8, 95% CI 0.2-11.3), and parous cohorts (18.0±6.8 hours vs 22.6±8.2 hours, P=.003; mean difference 4.7, 95% CI 1.6-7.7). Bishop score change and cesarean delivery rate were similar between groups regardless of parity. The 12-hour group in the combined cohort was associated with higher rates of maternal intrapartum fever (2% vs 10%, P=.02; odds ratio 5.3, 95% CI 1.1-24.8). CONCLUSION: Insertion-to-delivery interval is shorter after 6 compared with 12 hours for both nulliparous and parous women. Cervical ripening with a double-balloon device may be achieved in 6 hours. The longer time was associated with a higher rate of intrapartum fever. Six hours should be considered as standard placement time for double-balloon catheters. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT03045939.


Assuntos
Cateterismo/métodos , Maturidade Cervical , Trabalho de Parto Induzido/métodos , Ocitócicos/administração & dosagem , Fatores de Tempo , Adulto , Cateterismo/efeitos adversos , Colo do Útero , Cesárea/estatística & dados numéricos , Parto Obstétrico/métodos , Parto Obstétrico/estatística & dados numéricos , Feminino , Febre/induzido quimicamente , Febre/epidemiologia , Humanos , Trabalho de Parto Induzido/efeitos adversos , Paridade , Gravidez , Complicações na Gravidez/induzido quimicamente , Complicações na Gravidez/epidemiologia , Estudos Prospectivos
14.
J Matern Fetal Neonatal Med ; 33(11): 1831-1839, 2020 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-30269627

RESUMO

Background: The macrosomic fetus predisposes a variety of adverse maternal and perinatal outcomes. Although older studies have shown no benefit in inducing women of suspected macrosomic fetuses, more updated studies show different information.Objectives: The aim of our study was to compare induction of labor versus expectant management among women with macrosomic neonates weighing more than 4000 g at term (between 37°/7 and 416/7 weeks' gestation).Study design: This was a retrospective cohort study of all live-born singleton pregnancies with macrosomic newborns who were delivered at our institution between 1 January 2000 and 1 June 2015. We compared the outcomes of induction of labor, at each gestational age (GA), between 37 and 41 weeks (study group) with ongoing pregnancy. The primary outcome was cesarean section (CS) rate. Secondary outcomes were composite maternal and neonatal outcome and birth injuries.Results: Overall, out of 3095 patients with macrosomic newborns who were included in the study, 795 women (25.7%) underwent induction of labor. The cesarean section rate was not found to be significantly different between the groups at all gestational ages, nor was the vaginal delivery rate. After adjusting for confounders, induction of labor at 40 and 41 weeks' gestation was associated with composite maternal outcome (adjusted odds ratio (aOR) 1.6, 95% confidence interval (CI): 1.3-2.1; aOR 1.7, 95% CI: 1.3-2.2, respectively) and composite neonatal outcome (aOR 1.6, 95% CI: 1.1-2.4; aOR 1.8, 95% CI: 1.1-2.9). Induction of labor at 40 weeks' gestation was also associated with increased risk of birth injuries (aOR 2.9, 95% CI: 1.4-6).Conclusions: Compared with ongoing pregnancy, induction of labor of women with macrosomic neonates between 37 and 41 weeks of gestation does not reduce the CS rate, nor does it increase the vaginal delivery rate. Moreover, induction of labor of those women beyond 39 weeks' gestation is associated with composite adverse maternal/neonatal outcome, specifically birth injuries.


Assuntos
Macrossomia Fetal/terapia , Trabalho de Parto Induzido , Conduta Expectante , Adulto , Cesárea/estatística & dados numéricos , Feminino , Humanos , Recém-Nascido , Masculino , Gravidez , Estudos Retrospectivos , Resultado do Tratamento
15.
J Matern Fetal Neonatal Med ; 32(15): 2539-2542, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-29471705

RESUMO

OBJECTIVE: We aimed to compare maternal morbidity and mortality of cesarean sections (CS) in the second versus first stage of labor. STUDY DESIGN: Retrospective study of all CS at a single, university-affiliated medical center, between January 2010 and December 2014. Eligibility was limited to term, singleton pregnancies with cephalic presentation. Maternal outcomes of second-stage CS were compared to those of first-stage CS. The primary outcome was defined as estimated blood loss >1000 ml. RESULTS: Overall, 1004 women met the inclusion criteria, of which 290 (29%) had a second-stage CS and 714 (71%) had a first-stage CS. Women in the second-stage CS group had a higher nulliparity and hypertensive disorders rates and a lower rate of previous CS. Second-stage CS was associated with more than double the rate of estimated blood loss >1000 ml (9.7% versus 3.8%, p<.001), and more prone to unintentional uterine incision extension, uterine atony, hemoglobin decrease >2 g/l and antibiotic treatment for suspected endometritis. In a multivariable logistic regression model, second-stage CS was found to be independently associated with unintentional uterine incision extension (OR 6.8, 95% CI 4.1-11.2), uterine atony (OR 3.3, 95% CI 1.4-8.0) and antibiotic treatment for suspected endometritis (OR 2.6, 95% CI 1.4-5.1), but not with excessive blood loss (OR 1.5, 95% CI 0.8-2.8). Additionally, failed assisted vaginal delivery prior to second-stage CS was not associated with a higher rate of complications. CONCLUSION: Second-stage CS is associated with higher rates of adverse maternal outcomes, mainly unintentional uterine incision extension, uterine atony, and suspected endometritis.


Assuntos
Cesárea/mortalidade , Complicações Intraoperatórias/epidemiologia , Primeira Fase do Trabalho de Parto , Segunda Fase do Trabalho de Parto , Complicações Pós-Operatórias/epidemiologia , Adulto , Cesárea/efeitos adversos , Feminino , Humanos , Complicações Intraoperatórias/etiologia , Complicações Pós-Operatórias/etiologia , Gravidez , Estudos Retrospectivos , Adulto Jovem
16.
J Matern Fetal Neonatal Med ; 31(4): 474-480, 2018 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-28147892

RESUMO

BACKGROUND: The optimal gestational age for a planned high-order cesarean delivery (CD) reflects the balance between the risk of neonatal morbidity and the risk of unscheduled cesarean delivery prior to the scheduled date. METHODS: A retrospective cohort study of 656 women with ≥2 previous CDs were divided in two groups of women based on the gestational age at which the CD was scheduled: "38 group" and "39 group". Medical records were reviewed for demographic, medical and obstetrical history, and for adverse maternal and neonatal outcomes. RESULTS: The rate of unscheduled CDs was significantly higher among the 39 group (23.2% vs. 12.7%). There were no significant differences in the rate of maternal or neonatal composite adverse outcome between the two groups. The rate of neonatal respiratory morbidity, however, was higher among the 38 group (5.8% vs. 2.1%).Compared with planned CD, unscheduled CD was associated with a similar rate of maternal composite adverse outcome, but with increased rate of neonatal composite adverse outcome (23.3% vs. 8%, respectively). In a multivariable logistic regression analysis we found that this latter association was due to the earlier actual gestational age at delivery in cases of unscheduled versus planned CD. CONCLUSIONS: Planned CD at 39 weeks, rather than at 38 weeks, is associated with more unscheduled CDs, a similar rate of maternal and neonatal composite morbidity, but a decreased rate of neonatal respiratory morbidity.


Assuntos
Recesariana/efeitos adversos , Recesariana/estatística & dados numéricos , Idade Gestacional , Adulto , Peso ao Nascer , Feminino , Fidelidade a Diretrizes , Humanos , Recém-Nascido , Modelos Logísticos , Gravidez , Resultado da Gravidez , Estudos Retrospectivos , Fatores de Risco
17.
J Matern Fetal Neonatal Med ; 30(2): 219-223, 2017 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-27002548

RESUMO

OBJECTIVE: To compare maternal and neonatal outcomes associated with a policy for induction of labor at ≥ 41 versus at ≥42 weeks'. STUDY DESIGN: Retrospective cohort study of a 2 years' period before and after policy change from induction of labor at ≥ 42 gestational weeks' versus ≥41 gestational weeks. RESULTS: During the 41-policy period (N = 968), the induction rate was higher, 60% versus 40% (p < 0.0001) while the cesarean delivery (CD) rate was lower, 15% versus 19.4% (p = 0.0135). Moreover, among women that were induced, the rate of CD was lower during the 41-policy period, 19% versus 27% (p = 0.0067). No significant differences in maternal or neonatal outcomes were noted. There was one case of intrauterine fetal death at 41 + 4 weeks during the 42-policy period. CONCLUSION: As a policy for induction of labor at ≥ 41 reduces the rate of CD without any adverse maternal or neonatal outcomes, such a policy seems to be superior to a policy for induction at ≥ 42 weeks.


Assuntos
Idade Gestacional , Trabalho de Parto Induzido/normas , Guias de Prática Clínica como Assunto , Gravidez Prolongada , Adulto , Feminino , Humanos , Recém-Nascido , Gravidez , Resultado da Gravidez , Estudos Retrospectivos , Estatísticas não Paramétricas
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