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Variations exist in the surgical techniques used for caesarean section and many have not been rigorously assessed in randomised controlled trials. We aimed to assess whether any surgical techniques were associated with improved outcomes for women and babies. CORONIS was a pragmatic international 2×2×2×2×2 non-regular fractional, factorial, unmasked, randomised controlled trial that examined five elements of the caesarean section technique in intervention pairs. CORONIS was undertaken at 19 sites in Argentina, Chile, Ghana, India, Kenya, Pakistan, and Sudan. Each site was assigned to three of the five intervention pairs: blunt versus sharp abdominal entry; exteriorisation of the uterus for repair versus intra-abdominal repair; single-layer versus double-layer closure of the uterus; closure versus non-closure of the peritoneum (pelvic and parietal); and chromic catgut versus polyglactin-910 for uterine repair. Pregnant women were eligible if they were to undergo their first or second caesarean section through a planned transverse abdominal incision. Women were randomly assigned by a secure web-based number allocation system to one intervention from each of the three assigned pairs. All investigators, surgeons, and participants were unmasked to treatment allocation. The primary outcome was the composite of death, maternal infectious morbidity, further operative procedures, or blood transfusion (>1 unit) up to the 6-week follow-up visit. Women were analysed in the groups into which they were allocated. The CORONIS Trial is registered with Current Controlled Trials: ISRCTN31089967. Between May 20, 2007, and Dec 31, 2010, 15 935 women were recruited. There were no statistically significant differences within any of the intervention pairs for the primary outcome: blunt versus sharp entry risk ratio 1·03 (95% CI 0·91–1·17), exterior versus intra-abdominal repair 0·96 (0·84–1·08), single-layer versus double-layer closure 0·96 (0·85–1·08), closure versus non-closure 1·06 (0·94–1·20), and chromic catgut versus polyglactin-910 0·90 (0·78–1·04). 144 serious adverse events were reported, of which 26 were possibly related to the intervention. Most of the reported serious adverse events were known complications of surgery or complications of the reasons for the caesarean section. These findings suggest that any of these surgical techniques is acceptable. However, longer-term follow-up is needed to assess whether the absence of evidence of short-term effects will translate into an absence of long-term effects. UK Medical Research Council and WHO.

Background This prospective clinical trial aimed to compare the effects of single-layer versus double-layer uterine closure techniques on cesarean scar healing in women undergoing repeat cesarean delivery. Methods Seventy women aged 18–50 years with a history of at least one prior cesarean delivery were randomized into two groups: single-layer non-locking closure ( n  = 35) and double-layer non-locking closure with surgical refreshing of the incision edges ( n  = 35). The primary outcome was residual myometrial thickness (RMT) measured by transvaginal ultrasonography at six months. Secondary outcomes included RMT at six weeks, healing ratios, presence of niche, operative time, transfusion need, infectious morbidity, and hospital stay duration. Sample size was based on preliminary data indicating a mean RMT of 5 mm (SD 0.6 mm). To detect a 0.5 mm difference with α = 0.05 and β = 0.8, 26 participants per group were required; 35 were enrolled per group. Results At six months, the double-layer group had significantly greater RMT (5.1 ± 0.4 mm vs. 4.1 ± 0.4 mm; p  < 0.001). Similar findings were seen at six weeks. Operative time was shorter in the single-layer group. However, this group required more frequent additional uterine suturing due to suboptimal tissue approximation or bleeding, which did not significantly extend operative duration. Hemoglobin levels and hospital stay were comparable. Transfusion was needed in one patient in the single-layer group and three in the double-layer group. Conclusion Double-layer closure with surgical edge refreshing was associated with improved cesarean scar healing based on RMT. Trial registration ClinicalTrials.gov NCT03644433. Registered on 06 July 2018.

This study aims to assess the efficacy of laparoscopic modified uterine incision pressure repair in treating type II-III cesarean scar pregnancy (CSP). A total of 20 patients diagnosed with type II-III CSP and admitted to the Affiliated Hospital of Guizhou Medical University between April 2021 and May 2023 were enrolled. The patients were divided into two groups: the study group (Group A), consisting of newly treated surgical patients, and the control group (Group B), including patients with type II-III CSP treated by doctors of similar grade and surgical experience (non-novel). Various parameters, including age, menopause duration, pregnancy and delivery history, cesarean section frequency, preoperative human chorionic gonadotropin (HCG) levels, pregnancy sac size, HCG turnover time, operation duration, intraoperative blood loss, blood transfusion requirements, and hospitalization costs, were compared. When comparing mean age, menopause duration, preoperative HCG levels, pregnancy and cesarean section frequencies, pregnancy sac size, and HCG turnover time, no statistically significant differences were observed (P > .05). The number of transfusions and hospitalization costs in Group A were lower than in Group B, although the differences were not statistically significant (P > .05). However, operative time, intraoperative bleeding, and hospitalization costs were significantly lower in Group A compared to Group B (P < .05). The laparoscopic modified uterine incision pressure repair method demonstrated clinical value with its advantages of short operation time, reduced bleeding, lower costs, and rapid recovery for type II-III CSP.

Excessive haemorrhage at cesarean section requires donor (allogeneic) blood transfusion. Cell salvage may reduce this requirement. We conducted a pragmatic randomised controlled trial (at 26 obstetric units; participants recruited from 4 June 2013 to 17 April 2016) of routine cell salvage use (intervention) versus current standard of care without routine salvage use (control) in cesarean section among women at risk of haemorrhage. Randomisation was stratified, using random permuted blocks of variable sizes. In an intention-to-treat analysis, we used multivariable models, adjusting for stratification variables and prognostic factors identified a priori, to compare rates of donor blood transfusion (primary outcome) and fetomaternal haemorrhage ≥2 ml in RhD-negative women with RhD-positive babies (a secondary outcome) between groups. Among 3,028 women randomised (2,990 analysed), 95.6% of 1,498 assigned to intervention had cell salvage deployed (50.8% had salvaged blood returned; mean 259.9 ml) versus 3.9% of 1,492 assigned to control. Donor blood transfusion rate was 3.5% in the control group versus 2.5% in the intervention group (adjusted odds ratio [OR] 0.65, 95% confidence interval [CI] 0.42 to 1.01, p = 0.056; adjusted risk difference -1.03, 95% CI -2.13 to 0.06). In a planned subgroup analysis, the transfusion rate was 4.6% in women assigned to control versus 3.0% in the intervention group among emergency cesareans (adjusted OR 0.58, 95% CI 0.34 to 0.99), whereas it was 2.2% versus 1.8% among elective cesareans (adjusted OR 0.83, 95% CI 0.38 to 1.83) (interaction p = 0.46). No case of amniotic fluid embolism was observed. The rate of fetomaternal haemorrhage was higher with the intervention (10.5% in the control group versus 25.6% in the intervention group, adjusted OR 5.63, 95% CI 1.43 to 22.14, p = 0.013). We are unable to comment on long-term antibody sensitisation effects. The overall reduction observed in donor blood transfusion associated with the routine use of cell salvage during cesarean section was not statistically significant. This trial was prospectively registered on ISRCTN as trial number 66118656 and can be viewed on http://www.isrctn.com/ISRCTN66118656.

Objective This study aimed to evaluate the effect of maternal active pushing during cesarean section (CS) on postoperative pain, intraoperative discomfort, and the mother’s sense of control and participation. Design A prospective, randomized controlled study. Methods Patients were randomly assigned into two groups. In the Conventional group ( n  = 45), the CS was performed traditionally without maternal pushing. In the Assisted group ( n  = 55), patients were instructed to push during delivery. Outcomes measures included patients’ perceived pressure, pain, and sense of participation. Breastfeeding and postnatal depression were assessed using validated scales, along with maternal and neonatal outcomes, surgeon satisfaction, and operation duration. Results Patients in the Assisted group reported significantly lower fundal pressure intensity (VAS score 3 vs. 5, P  < 0.01) compared to the Conventional group. There was no significant difference in postoperative pain. However, women in the Assisted group reported a greater sense of participation (6 vs. 0, P  < 0.01) and control (4 vs. 0, P  < 0.05) than those in the Conventional group. No significant maternal or neonatal complications were observed. Conclusion Maternal active pushing during CS positively impacted intraoperative experience by reducing perceived pressure and enhancing the sense of control and participation, without adverse effects on maternal or neonatal outcomes. These findings support further research with larger, multi-center studies to validate the potential benefits of this approach. Trial Registration NCT05520580 ( https://clinicaltrials.gov/ct2/show/NCT05520580 ).

To compare induction of labour at 41 weeks with expectant management until 42 weeks in low risk women. Open label, randomised controlled non-inferiority trial. 123 primary care midwifery practices and 45 hospitals (secondary care) in the Netherlands, 2012-16. 1801 low risk women with an uncomplicated singleton pregnancy: randomised to induction (n=900) or to expectant management until 42 weeks (n=901). Induction at 41 weeks or expectant management until 42 weeks with induction if necessary. Primary outcome was a composite of perinatal mortality and neonatal morbidity (Apgar score <7 at five minutes, arterial pH <7.05, meconium aspiration syndrome, plexus brachialis injury, intracranial haemorrhage, and admission to a neonatal intensive care unit (NICU). Secondary outcomes included maternal outcomes and mode of delivery. The null hypothesis that expectant management is inferior to induction was tested with a non-inferiority margin of 2%. Median gestational age at delivery was 41 weeks+0 days (interquartile range 41 weeks+0 days-41 weeks+1 day) for the induction group and 41 weeks+2 days (41 weeks+0 days-41 weeks+5 days) for the expectant management group. The primary outcome was analysed for both the intention-to-treat population and the per protocol population. In the induction group, 15/900 (1.7%) women had an adverse perinatal outcome versus 28/901 (3.1%) in the expectant management group (absolute risk difference -1.4%, 95% confidence interval -2.9% to 0.0%, P=0.22 for non-inferiority). 11 (1.2%) infants in the induction group and 23 (2.6%) in the expectant management group had an Apgar score <7 at five minutes (relative risk (RR) 0.48, 95% CI 0.23 to 0.98). No infants in the induction group and three (0.3%) in the expectant management group had an Apgar score <4 at five minutes. One fetal death (0.1%) occurred in the induction group and two (0.2%) in the expectant management group. No neonatal deaths occurred. 3 (0.3%) neonates in the induction group versus 8 (0.9%) in the expectant management group were admitted to an NICU (RR 0.38, 95% CI 0.10 to 1.41). No significant difference was found in composite adverse maternal outcomes (induction n=122 (13.6%) expectant management n=102 (11.3%)) or in caesarean section rate (both groups n=97 (10.8%)). This study could not show non-inferiority of expectant management compared with induction of labour in women with uncomplicated pregnancies at 41 weeks; instead a significant difference of 1.4% was found for risk of adverse perinatal outcomes in favour of induction, although the chances of a good perinatal outcome were high with both strategies and the incidence of perinatal mortality, Apgar score <4 at five minutes, and NICU admission low. Netherlands Trial Register NTR3431.

Placenta accreta spectrum (PAS), or morbidly adherent placenta, is a life-threatening condition requiring caesarean section (C-section) and often hysterectomy due to massive postpartum haemorrhage. The widely adopted conservative management—the Triple-P procedure—carries a risk of substantial blood loss. Modifications like blunt bladder dissection and haemostatic suturing can help control bleeding however, bladder injury remains a concern, as identifying vesicouterine planes can be difficult among placental and prior C-sections adhesions. While some studies have used Cystoinflation (retrograde bladder filling) to delineate bladder edges in complex C-sections, its efficacy in preventing bladder injury during PAS surgeries is inconclusive, and no trial has evaluated its integration with the Modified Triple-P technique. To address this gap, we conducted a single-centre, single-blinded controlled trial with 150 women with PAS confirmed during C-section. Participants were randomised to either Modified Triple-P alone or the combined approach with Cystoinflation. Bladder injury, the primary outcome, occurred in 2 (2.7%) of the Cystoinflation group versus 14 (18.7%) of the controls ( P  < .0001). Secondary outcomes, including blood loss, hysterectomy rates, urologic complications, neonatal outcomes, and fertility, also favoured the combined approach. These results suggest adding Cystoinflation to Modified Triple-P enhances bladder safety and optimises maternal and foetal outcomes in PAS management. Trial registration This trial is a part of project “Cystoinflation to Prevent Bladder Injury in Obstetrics and Gynaecology Surgery” with ethical approval from King Edward Medical University. Trial Registration NCT04302545.

•Remimazolam significantly reduces nausea and vomiting in cesarean sections, enhancing patient satisfaction (P < 0.05).•Intravenous remimazolam administration effectively mitigates adverse reactions to carboprost tromethamine without affecting postpartum bleeding.•Study demonstrates remimazolam's potential for improving sedative outcomes in cesarean sections with CSEA anesthesia. To evaluate the effectiveness of remimazolam in preventing adverse reactions triggered by carboprost tromethamine during cesarean section procedures. A total of 200 parturients scheduled for cesarean sections at risk of postpartum hemorrhage in our hospital from October 2022 to July 2023 were included. The participants were assigned via random number table method to either a study group or a control group, resulting in 100 cases in each. All parturients received combined spinal and epidural anesthesia (CSEA) during cesarean section, followed by administration of carboprost tromethamine (250 µg) for preventing postpartum hemorrhage after childbirth. CSEA was performed with 1.8 to 2 mL of 0.5% bupivacaine and 7 to 10 mL of 2% lidocaine. The study group was given remimazolam via intravenous infusion at a rate of 0.3 mg/kg/h commencing at 1 minute prior to CSEA and concluding with a final dosage adjustment 20 minutes preceding the end of surgery, while the control group was given the same volume of saline within this time frame. Primary outcome measures were adverse reactions and sedative effects of the parturients. Nausea and vomiting were the only adverse reactions that exhibited significant differences between groups. The study group reported significantly fewer cases (32 cases) of nausea and vomiting when compared to the 48 cases observed in the control group. Moreover, the use of remimazolam appeared to alleviate the severity of nausea and vomiting, as evidenced by the significantly lower incidence of Grade III event and the higher risk of Grade I event in comparison with the control group (P < 0.05). The Apgar scores of newborns at birth and 5 minutes after birth were compared, and no statistically significant difference was found (P > 0.05). Parturients receiving remimazolam exhibited better effective sedation outcomes and were more satisfied with the treatment when compared with controls (P < 0.05). There were no significant differences in postpartum bleeding volume at 2 and 12 hours postpartum, as well as in the duration of postpartum bleeding between the two groups (P > 0.05). Intravenous administration of remimazolam effectively prevents adverse reactions induced by carboprost tromethamine during cesarean section performed under CSEA, thereby improving sedative effects.

OptiBreech collaborative care is a multi-disciplinary care pathway for breech presentation at term, with continuity from a breech specialist midwife, including where chosen, for vaginal breech birth (VBB). Pilot randomised trial using unblinded 1:1 parallel group allocation to OptiBreech versus standard care, within a cohort. Participants were women with a breech-presenting fetus > 33 weeks, at four sites in England, January–June 2022. A two-stage consent process was used. Participants consented to undergo random selection to be offered a ‘new care process’, with a choice to accept it, or not. Primary objectives were to identify recruitment, acceptance, and attrition rates. Randomisation procedures and potential primary outcomes for a substantive study were also feasibility-tested. 68 women were randomised between January–June 2022. The consent process was acceptable to participants, but randomisation was unacceptable to women who specifically sought OptiBreech care. Two women withdrew due to concerns about sharing personal information. More women planned a VBB when randomised to OptiBreech Care (23.5% vs 0, p = .002, 95% CI = 9.3%,37.8%). Women randomised to OptiBreech care had: lower rates of cephalic presentation at birth (38.2% vs 54.5%), higher rates of vaginal birth (32.4% vs 24.2%), lower rates of in-labour caesarean birth (20.6% vs 36.4%), lower rates of neonatal intensive care (5.9% vs 9.1%), and lower rates of severe neonatal morbidity (2.9% vs 9.1%). Randomisation was stopped on the advice of the steering committee before the planned sample of 104, as lack of access to VBB within standard care prohibited comparison of outcomes. Demand for VBB is sufficient for a cohort study, but comparison of outcomes by 1:1 randomisation is not feasible. OptiBreech care would be best evaluated using stepped wedge cluster randomisation. Funded by the United Kingdom National Institute for Health and Care Research (NIHR300582). Clinical trial registration: ISRCTN 14521381.

Background Cesarean scar defects can lead to long-term complications, such as cesarean scar disorders, cesarean scar pregnancy, and the risk of uterine scar dehiscence and rupture in subsequent pregnancy. However, the optimal closure technique to prevent the development of cesarean scar defects (CSD) remains unclear. Therefore, this study aimed to explore whether two-layer interrupted versus two-layer continuous sutures could prevent the formation of CSD. Methods A randomized controlled trial was conducted in a single university hospital in Japan. We recruited pregnant women with ≥ 20 primary or previous cesarean sections. Participants were randomly assigned to either a two-layer interrupted or a two-layer continuous suture group. Residual myometrial thickness (RMT) and the depth of CSD were measured using sonohysterography, 6–8 months post-cesarean section. In addition, the rate of severe CSD, defined as a loss of over 50% of the myometrium, was examined. Results Of the 220 study participants, 43 dropped out; 89 in the interrupted group and 88 in the continuous group underwent sonohysterography. No significant difference in RMT was observed in the interrupted and continuous groups (median 8.1 [interquartile range, 6.2–9.9] mm and 7.9 [4.6–10.3] mm, respectively). However, the incidence of severe CSD in the interrupted group was significantly lower than that in the continuous group (2% versus 22%, p  < 0.0001). Multivariate logistic regression analysis revealed that the factors contributing to developing severe CSD were interrupted suture (odds ratio [OR]: 0.04, 95% confidence interval [95%CI]: 0.006–0.281, p  = 0.0011), the difference in myometrial thickness between the fundal and cervical sides at the center of the uterine wound before suturing (OR: 1.65, 95%CI: 1.144–2.367, p  = 0.0072), and retroversion of the uterus at 6–8 months after cesarean section (OR: 3.42, 95%CI: 1.074–10.946, p  = 0.0374). Conclusion This study suggested that two-layer interrupted sutures are superior to two-layer continuous sutures in preventing the development of severe CSD. Trial registration Clinical trial identification number: University Hospital Medical Information Network registration code, UMIN000040601. URL of the registration site: https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046334 .