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1.
J Gynecol Obstet Hum Reprod ; 53(8): 102810, 2024 Jun 05.
Article in English | MEDLINE | ID: mdl-38849116

ABSTRACT

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.

2.
Article in English | MEDLINE | ID: mdl-38477600

ABSTRACT

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.

3.
Am J Obstet Gynecol MFM ; 5(7): 100910, 2023 07.
Article in English | MEDLINE | ID: mdl-36828283

ABSTRACT

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.


Subject(s)
Cesarean Section , Pain, Postoperative , Female , Humans , Infant, Newborn , Pregnancy , Morphine Derivatives , Pain, Postoperative/diagnosis , Pain, Postoperative/epidemiology , Pain, Postoperative/etiology , Double-Blind Method
4.
J Obstet Gynaecol ; 42(7): 2893-2898, 2022 Oct.
Article in English | MEDLINE | ID: mdl-35993543

ABSTRACT

The objective of our survey was to evaluate the anxiety experienced by women receiving abnormal results of prenatal Down syndrome screening by an electronic anonymous survey. Anxiety level was evaluated by a six-item Spielberger State-Trait Anxiety Inventory. Of 559 respondents, high anxiety scores were reported in the majority (86.0%). Higher anxiety scores were noted in women informed of the abnormal result by the caregiver vs. written answer. 59.1% of the respondents preferred the risk reported as percentage, while only 4.4% gave precedence to the current form (e.g. 1 in 100). The participants noted several factors which could relieve their anxiety, including an explanatory booklet (72.4%) or a website (77.9%). In conclusion, women receiving abnormal results of Down syndrome screening experience significant anxiety. Efforts should be made to relieve this distress, including changing the historical ratio risk format to percentage, adding a non-directive verbal annotation, an explanatory website and improving health professionals' understanding of the exact statistical meaning of the risk.Impact statementWhat is already known on this subject? Abnormal results of prenatal screening for Down syndrome might cause the women significant anxiety. Several simple methods are able to relieve this distress; however, they are frequently not implemented in the routine practice.What the results of this study add? We show that abnormal results of the screening tests are associated with high anxiety scores in the majority of women (86.0%). The majority of the respondents preferred the risk reported as percentage (vs. historical representation as a ratio). The participants noted several factors which could relieve their anxiety, including an explanatory booklet or a website.What the implications are of these findings for clinical practice and/or further research? Based on the results, we discuss the numerous ways able to available alleviate the distress.


Subject(s)
Down Syndrome , Pregnancy , Female , Humans , Down Syndrome/diagnosis , Prenatal Diagnosis , Anxiety/diagnosis , Anxiety/etiology , Anxiety/prevention & control , Informed Consent , Health Knowledge, Attitudes, Practice
5.
J Matern Fetal Neonatal Med ; 35(25): 6708-6713, 2022 Dec.
Article in English | MEDLINE | ID: mdl-33980117

ABSTRACT

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.


Subject(s)
Cesarean Section , Labor Stage, Second , Pregnancy , Infant, Newborn , Humans , Female , Retrospective Studies , Perinatology , Delivery, Obstetric
6.
J Obstet Gynaecol Can ; 44(4): 372-377, 2022 04.
Article in English | MEDLINE | ID: mdl-34740851

ABSTRACT

OBJECTIVE: To investigate whether there is a specific maternal age cut-off at which there is an increase in maternal and neonatal adverse outcomes. METHODS: A retrospective study comparing maternal and neonatal outcomes between nulliparous women of different ages. The receiver operating characteristic model with the Youden index was used to find the best age cut-off using cesarean delivery (CD) and composite adverse outcomes. A multivariable logistic regression analysis was calculated after adjusting for smoking, induction of labour, epidural use, hypertensive disorders, gestational diabetes, and birth weight. RESULTS: The study included 11 343 nulliparous women. Age 28 years was found to be the cut-off age at which we found a significant increase in adverse outcomes. Women older than age 28 years had a higher risk of CD than women younger than 28 years (35.7% vs. 21.3%, P < 0.0001). They were also more likely to deliver prematurely (11.9% vs. 7.9%; P < 0.0001) and had higher rates hypertensive disorders (2.3% vs. 1.1%; P < 0.0001) and gestational diabetes mellitus (0.4% vs. 0.1%; P = 0.001). Furthermore, their babies were more likely to be growth restricted (1.1% vs. 0.3%; P < 0.0001). There were no differences in the rates of induction of labour or macrosomia. After adjusting for confounders, we found that women older than 28 years had higher risks of CD and adverse outcomes than younger women (aOR 1.9 [95% CI 1.744-2.1] and aOR 1.6 [95% CI 1.6-1.77], respectively). CONCLUSION: Increasing maternal age is independently associated with adverse maternal and neonatal outcomes with an age cut-off of 28 years. Women older than age 28 years are at higher risk for composite adverse outcomes than younger women.


Subject(s)
Diabetes, Gestational , Hypertension, Pregnancy-Induced , Adult , Cesarean Section , Diabetes, Gestational/epidemiology , Female , Humans , Hypertension, Pregnancy-Induced/epidemiology , Infant, Newborn , Maternal Age , Pregnancy , Pregnancy Outcome/epidemiology , Retrospective Studies
7.
Vaccine ; 39(44): 6535-6538, 2021 10 22.
Article in English | MEDLINE | ID: mdl-34600749

ABSTRACT

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.


Subject(s)
COVID-19 , Premature Birth , BNT162 Vaccine , COVID-19 Vaccines , Child , Female , Humans , Infant, Newborn , Pregnancy , Premature Birth/epidemiology , Prospective Studies , SARS-CoV-2 , Vaccination
8.
Int Urogynecol J ; 32(7): 1727-1732, 2021 07.
Article in English | MEDLINE | ID: mdl-33439282

ABSTRACT

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.


Subject(s)
Lacerations , Obstetric Labor Complications , Delivery, Obstetric/adverse effects , Episiotomy/adverse effects , Female , Humans , Lacerations/etiology , Lacerations/surgery , Obstetric Labor Complications/etiology , Obstetric Labor Complications/surgery , Perineum/injuries , Perineum/surgery , Pregnancy , Sutures
9.
Explore (NY) ; 17(6): 569-573, 2021.
Article in English | MEDLINE | ID: mdl-32563673

ABSTRACT

OBJECTIVE: To summarize the available evidence exploring the influence of date fruit consumption on delivery outcomes. METHODS: A search was conducted for relevant articles in three databases for manuscripts in English, with no time restrictions. RESULTS: Four articles were eligible for inclusion. Women consuming date fruit were admitted with higher cervical dilatation (mean difference (MD) 1.1 cm [95% confidence interval (CI) 0.2-1.99 cm) and yielded a lower need for labor induction/augmentation (relative risk (RR) 0.6, 95% CI 0.43-0.83). Date fruit consumption was associated with shorter latent phase (MD -4.6 hours, 95% CI -7.77 to -1.4) and second stage duration (MD -7.7 minutes, 95% CI -12.0 to -3.4). CONCLUSIONS: Although the overall quality of the included studies was weak due to high risk of bias, the results of our meta-analysis point to beneficial effects of date fruit consumption on labor process. fruit.


Subject(s)
Labor, Obstetric , Phoeniceae , Female , Humans , Pregnancy
10.
Arch Gynecol Obstet ; 303(3): 653-658, 2021 03.
Article in English | MEDLINE | ID: mdl-32886235

ABSTRACT

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.


Subject(s)
Delivery, Obstetric , Nurses/psychology , Physicians/psychology , Shift Work Schedule/psychology , Adult , Birth Weight , Female , Humans , Infant, Newborn , Labor, Obstetric , Obstetrics , Parity , Pregnancy , Pregnancy Complications/epidemiology , Pregnancy Outcome/epidemiology , Retrospective Studies
12.
Int Urogynecol J ; 31(11): 2377-2385, 2020 Nov.
Article in English | MEDLINE | ID: mdl-32448935

ABSTRACT

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.


Subject(s)
Lacerations , Obstetric Labor Complications , Episiotomy/adverse effects , Female , Humans , Incidence , Odds Ratio , Perineum/injuries , Pregnancy
13.
Obstet Gynecol ; 135(5): 1153-1160, 2020 05.
Article in English | MEDLINE | ID: mdl-32282603

ABSTRACT

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.


Subject(s)
Catheterization/methods , Cervical Ripening , Labor, Induced/methods , Oxytocics/administration & dosage , Time Factors , Adult , Catheterization/adverse effects , Cervix Uteri , Cesarean Section/statistics & numerical data , Delivery, Obstetric/methods , Delivery, Obstetric/statistics & numerical data , Female , Fever/chemically induced , Fever/epidemiology , Humans , Labor, Induced/adverse effects , Parity , Pregnancy , Pregnancy Complications/chemically induced , Pregnancy Complications/epidemiology , Prospective Studies
14.
Complement Ther Clin Pract ; 38: 101085, 2020 Feb.
Article in English | MEDLINE | ID: mdl-32056811

ABSTRACT

BACKGROUND AND PURPOSE: Reflexology alleviates anxiety and may shorten the duration of labor. We evaluated the effect of reflexology on anxiety level and duration of labor in primiparas with moderate-to-severe anxiety. MATERIALS AND METHODS: In this open-label randomized-controlled trial, primiparas with moderate-to-severe anxiety were randomized into one of two groups: addition of reflexology to usual care, or usual care only. The primary outcome was a change in the level of anxiety during reflexology treatment. RESULTS: Ninety-nine women were assigned to reflexology treatment while ninety received usual care only. A larger alleviation of anxiety was observed immediately after reflexology treatment as compared to the control group during the 30 min following group assignment. Reflexology did not affect the length of delivery. CONCLUSION: Foot reflexology had a positive short-term anxiolytic effect during labor in primiparas with moderate-to-severe anxiety but did not affect the duration of labor.


Subject(s)
Anxiety/therapy , Labor, Obstetric/psychology , Massage , Musculoskeletal Manipulations/methods , Adult , Female , Foot , Humans , Parity , Pregnancy , Young Adult
16.
J Obstet Gynaecol Can ; 42(4): 481-487.e2, 2020 Apr.
Article in English | MEDLINE | ID: mdl-31285170

ABSTRACT

Data supporting a survival advantage of endometrial cancer diagnosed before the onset of postmenopausal bleeding are lacking. This study sought to compare overall survival and disease recurrence between women who were asymptomatic at diagnosis and women who were symptomatic at diagnosis. A systemic search was conducted in databases using the terms: "asymptomatic," "ultrasound," "screening," and "endometrial cancer." Only original research studies that compared characteristics of tumour advancement and survival measures were included. The six articles included in the meta-analysis comprised 2961 patients. Data were collected on study design and period, number and characteristics of participants, and outcomes in terms of tumour histology and survival measures. Higher rates of stage I tumours were shown among asymptomatic patients (relative risk 1.19). The proportion of high-grade histology did not differ between the two groups (relative risk 0.92). The crude pooled estimate for overall survival did not yield statistical significance, nor did recurrence-free survival (which was reported by three studies). In conclusion, endometrial cancer diagnosed in asymptomatic women is not associated with higher survival than in symptomatic women. Invasive procedures in asymptomatic women with incidental ultrasonographic findings should be carefully weighed because no survival advantage is expected.


Subject(s)
Asymptomatic Diseases , Endometrial Neoplasms/diagnosis , Endometrium/pathology , Polyps/pathology , Ultrasonography/methods , Uterine Hemorrhage/etiology , Disease-Free Survival , Early Detection of Cancer , Endometrial Neoplasms/diagnostic imaging , Female , Humans , Polyps/diagnostic imaging , Survival Analysis , Uterine Hemorrhage/pathology
17.
J Matern Fetal Neonatal Med ; 33(11): 1831-1839, 2020 Jun.
Article in English | MEDLINE | ID: mdl-30269627

ABSTRACT

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.


Subject(s)
Fetal Macrosomia/therapy , Labor, Induced , Watchful Waiting , Adult , Cesarean Section/statistics & numerical data , Female , Humans , Infant, Newborn , Male , Pregnancy , Retrospective Studies , Treatment Outcome
18.
Harefuah ; 158(11): 728-731, 2019 Nov.
Article in Hebrew | MEDLINE | ID: mdl-31721516

ABSTRACT

INTRODUCTION: There are two methods to diagnose oligohydramnios: maximal vertical pocket (MVP) and amniotic fluid index (AFI). Following a recent large Cochrane review and other studies, MVP is being recommended as the method of choice by professional societies, after it was shown to result in fewer inductions of labor and C-sections (CS), without compromising neonatal outcome. There is controversy regarding the management of isolated oligohydramnios (IO). It is unclear whether this finding reflects an underlying pathological process, and therefore management protocols differ between different institutions. Studies have shown a higher rate of CS (RR of >2) in IO. Whether this is a true complication of IO or is a result of different confounders like labor inductions and primigravidity is unclear. The effects on neonatal outcomes are also unclear; whereas some authors did not show any adverse effects, others have shown higher rates of neonatal intensive care unit (NICU) admissions, lower Apgar scores and higher rate of Meconium aspiration syndrome. Some studies have shown a higher rate of undiagnosed small for gestational age (SGA) in IO pregnancies. There is no consensus regarding the optimal management and time of delivery. Until now, common practice was to induce labor at term, and some advocate induction in late preterm. Recently, the growing awareness to early term morbidity has led practitioners to question the benefit of early induction. There are several studies that have shown maternal hydration to improve AFI, but there is insufficient data to show the effect on outcomes. In conclusion, many questions regarding IO are still unanswered, and further research, specifically RCT studies, is needed.


Subject(s)
Meconium Aspiration Syndrome , Oligohydramnios , Amniotic Fluid , Female , Humans , Infant, Newborn , Labor, Induced , Meconium Aspiration Syndrome/diagnosis , Oligohydramnios/diagnosis , Oligohydramnios/therapy , Pregnancy , Pregnancy Outcome
19.
Gynecol Obstet Invest ; 84(6): 606-615, 2019.
Article in English | MEDLINE | ID: mdl-31344705

ABSTRACT

BACKGROUND: The yield of adjuvant radiotherapy in cervical cancer patients with intermediate risk factors is controversial. The objective of our meta-analysis was to shed light on this important issue. MATERIAL AND METHODS: Search was conducted in several databases. By independent screening of titles and abstracts, 2 investigators selected original researches examining the effect of adjuvant radiation treatment on overall survival and progression-free survival in cervical cancer patients with intermediate risk factors. RESULTS: Of the 5 articles included, a total of 591 patients with intermediate risk factors were encompassed. Statistical significance was noted in favor of radiation therapy in a subgroup of patients with 2 or more intermediate factors in terms of recurrence (OR 0.46 [95% CI 0.28-0.74, p = 0.001]) and overall survival (OR 1.86 [95% CI 1.03-3.36, p = 0.04]). After adding patients with one risk factor, radiation exerted a non-significant effect on recurrence rate, overall survival, disease-free survival, and 5-year cancer-specific survival, while increasing the rate of gastrointestinal side effects (2.4 vs. 0%, p = 0.0156). CONCLUSIONS: Adjuvant radiation therapy decreases the risk for recurrence and increases the overall survival in patients with 2 intermediate risk factors. These benefits were not shown after adding patients with one risk factor.


Subject(s)
Radiotherapy, Adjuvant , Uterine Cervical Neoplasms/radiotherapy , Disease-Free Survival , Female , Gastrointestinal Diseases/etiology , Humans , Hysterectomy , Neoplasm Recurrence, Local/epidemiology , Neoplasm Recurrence, Local/prevention & control , Neoplasm Staging , Odds Ratio , Radiotherapy, Adjuvant/adverse effects , Risk Factors , Uterine Cervical Neoplasms/pathology , Uterine Cervical Neoplasms/surgery
20.
Arch Gynecol Obstet ; 300(2): 293-297, 2019 08.
Article in English | MEDLINE | ID: mdl-31069489

ABSTRACT

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.


Subject(s)
Cesarean Section/methods , Delivery Rooms/standards , Delivery, Obstetric/methods , Labor, Obstetric/physiology , Adult , Female , Humans , Infant, Newborn , Pregnancy , Retrospective Studies
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