Screening occult anal sphincter injuries in primigravid women after vaginal delivery with transperineal use of vaginal probe: a prospective, randomized controlled trial.

PURPOSE: Here we aimed to evaluate the incidence of obstetric anal sphincter injuries in spontaneous primigravid deliveries with mediolateral episiotomy beyond 36 gestational weeks. METHODS: We performed a prospective, randomized controlled study including 201 primigravid women that delivered vaginally. Anal sphincter anatomy and integrity was evaluated before hospital discharge in all cases with transvaginal sonography (5-9 MHz) (Siemens Sonoline G50 and Voluson 730 Expert). The vaginal ultrasound probe is placed in the fourchette of the vaginal introitus to obtain the transverse section of the anal sphincter. RESULTS: In the cases with sphincter defect, mean gestational week and second stage of labor were prolonged significantly (p = 0.039 and p < 0.0001, respectively). The mean perineal body distance in cases with sphincter injury, as detected by sonography, 2.18 ± 0.33 cm, is compared to 2.31 ± 2.43 cm in cases without injury. There was a significant difference between the two groups (p = 0.0142). Shoulder dystocia was significantly higher in cases with sphincter injury, compared to cases without injury (p = 0.011). No clinical findings were reported in 11.5 % of cases (Sonography findings 1A∓, 1B∓) and 3.5 % of cases had clinical and sonographic findings (Sonography findings 2A∓, 2B∓). "Occult tears" were considered as those cases not detected clinically, but detected by sonography (11.5 % of all cases). Two months after examination, a moderate incontinence (Wexner continence scale) was found in 71.5 % of cases with overt sphincter tear, which was significantly different to the non-overt sphincter tear group. Multiple logistic regression analyses for sphincter injuries identified prolonged second stage of labor and shoulder dystocia as two independent risk factors. CONCLUSION: Here, we found that only a portion of anal sphincter injuries can be detected after physical examination, with many of cases of "occult tears" escaping notice. These cases of occult anal sphincter injury are detectable by sonography with transperineal use of a vaginal probe. Based on these findings, we propose that this technique is convenient for obstetric, gynecologic and proctologic evaluation of sphincter anatomy.

Double notches: association of uterine artery notch forms with pregnancy outcome and severity of preeclampsia.

OBJECTIVE: To assess uterine artery Doppler waveforms and notches performed in the third trimester as a predictor of adverse outcomes. METHODS: Of 490 preeclampsia (PE) patients between 24 and 34 weeks gestation, 166 were diagnosed with mild PE and 324 were diagnosed with severe PE. Patients were divided into four groups (no notch, a unilateral notch, bilateral notches and double notches). RESULTS: Bilateral and double notches were predictive of shorter follow-up times, adverse laboratory outcomes, HELLP syndrome, prematurity, neonatal intensive care unit admission and perinatal mortality. CONCLUSION: Double notches represent progressive deterioration in the uterine artery and are predictive of adverse maternal outcomes.

Partial HELLP syndrome: maternal, perinatal, subsequent pregnancy and long-term maternal outcomes.

AIMS: Hemolysis, elevated liver enzymes and low platelet count (HELLP) syndrome, in its complete form, is associated with increased risk of maternal mortality and increased rate of serious obstetric complications, such as acute renal failure, hepatic failure, abruptio placentae, pulmonary edema, sepsis, hemorrhage and disseminated intravascular coagulopathy. To compare maternal and perinatal outcomes, we investigated the subsequent pregnancy outcomes and long-term complications of women with partial HELLP (pHELLP) and complete HELLP (cHELLP) syndromes. MATERIAL AND METHODS: In this retrospective study, patients complicated with HELLP between the years 2002 and 2007 were analyzed. cHELLP syndrome was defined by the presence of all of the three laboratory criteria according to the Tennessee Classification System. pHELLP syndrome was defined by the presence of one or two features of HELLP, but not the complete form. RESULTS: Sixty-four patients had cHELLP syndrome and 67 had pHELLP syndrome. Maternal complications and neonatal outcomes of the indexed pregnancies were similar. The rate of blood product transfusion was significantly higher in the cHELLP group (P<0.0001). Twenty-eight patients within the cHELLP group and 26 within the pHELLP group had subsequent pregnancies with a mean interpregnancy interval of 2.9 ± 1.5 years and 2.4 ± 1.1 years, respectively. Elective termination of pregnancy (dilatation and curettage) was more frequent in the cHELLP group. Pre-eclampsia recurrence was higher in the pHELLP group than in the cHELLP group (7.1% vs 34.6%). CONCLUSIONS: Partial and complete HELLP syndrome are not distinct groups based on neonatal, long-term and subsequent pregnancy outcomes. They probably represent a continuum in the natural evolution of the same disease.

Do we protect the pelvic floor with non-elective cesarean? A study of 3-D/4-D pelvic floor ultrasound immediately after delivery.

AIM: To compare levator defect, loss of tenting, change in biometric measurements of the levator ani and genital hiatus according to the mode of delivery, length of the labor, Bishop score, birthweight and head circumference immediately after delivery. METHODS: One hundred and seventy-one primiparous women who delivered either by vaginal delivery or cesarean were prospectively evaluated. Two 3-D volumes (one at rest, one on Valsalva maneuver) were recorded in the supine position after voiding, and levator biometry, levator defect and loss of tenting were determined on the axial plane. RESULTS: Of 171 nulliparous women, 84 had vaginal delivery and 87 had cesarean delivery. All hiatal dimensions on resting and maximal Valsalva were found to be higher in the vaginal delivery group. Levator defect rate was found to be significantly higher in the vaginal delivery group (P<0.0001). We found a positive correlation with head circumference, fetal weight and first stage labor length in women who delivered vaginally. In the cesarean delivery group, mean fetal head circumference, fetal weight, length of first stage of labor and Bishop score were higher in women with levator ani defect. Loss of tenting rate was significantly higher in vaginal delivery women (P=0.03). CONCLUSION: Labor itself, and factors such as fetal head circumference and fetal weight that cause prolongation of labor, can induce levator ani muscle defect or microtrauma which in turn can cause morphological alterations of the levator hiatus.

A 5-year follow-up study comparing Burch colposuspension and transobturator tape for the surgical treatment of stress urinary incontinence.

OBJECTIVE: To compare the effectiveness of transobturator tape (TOT) and Burch colposuspension in the treatment of stress urinary incontinence (SUI). METHODS: The present retrospective study included 770 patients who underwent SUI surgery with Burch colposuspension (n=498) or TOT (n=272). Clinical follow-up occurred at 2 weeks, 3, 6, and 12 months, and annually thereafter. Objective and subjective cure rates and intra- and postoperative complications were assessed. RESULTS: Among patients who had SUI surgery without another concomitant procedure, the Burch group had a significantly longer mean operation time (41.48 ± 10.61 minutes versus 23.77 ± 10.49 minutes; P<0.001) and a significantly longer length of hospital stay (3.11 ± 0.49 days versus 1.98 ± 0.40 days; P<0.001), compared with the TOT group. The rates of unintended functional outcomes were lower among women undergoing TOT than among those undergoing the Burch procedure (long-term voiding dysfunction 0.7% versus 4.2%, P=0.007; urinary retention 10.7% versus 26.9%, P<0.001). The 5-year cure rates were similar in the 2 groups (objective cure rate, 73.9% versus 77.5%, P=0.574; subjective cure rate, 76.8% versus 81.7%, P=0.416). CONCLUSION: In terms of efficacy, TOT appears equal to Burch colposuspension; however, TOT has fewer unintended functional outcomes than Burch colposuspension.

Does vitamin C and vitamin E supplementation prolong the latency period before delivery following the preterm premature rupture of membranes? A randomized controlled study.

OBJECTIVE: To determine whether maternal vitamin C and vitamin E supplementation after the premature rupture of membranes is associated with an increase in the latency period before delivery. METHODS: In the present prospective open randomized trial, 229 pregnant women with preterm premature rupture of membranes (PPROM) at ≥ 24.0 and < 34.0 weeks' gestation were randomly assigned to receive either 1,000 mg of vitamin C and 400 IU of vitamin E (n = 126) or a placebo (n = 123). The primary outcome was the latency period until delivery. Analysis was performed on an intention-to-treat basis. RESULTS: No significant differences in demographic or clinical characteristics were observed between the groups. Latency period until delivery was significantly higher in the group that received vitamins compared with the control group (11.2 ± 6.3 days versus 6.2 ± 4.0 days; p < 0.001). Gestational age at delivery was also significantly higher in the vitamin group compared with the control group (31.9 ± 2.6 weeks versus 31.0 ± 2.6 weeks; p = 0.01). No significant differences in adverse maternal outcome (i.e., chorioamnionitis or endometritis) or neonatal outcome (i.e., neonatal sepsis, neonatal death, necrotizing enterocolitis, or grade 3 to 4 intraventricular hemorrhage) were noted between groups. CONCLUSIONS: The findings of the present study suggest that the use of vitamins C and E in women with PPROM is associated with a longer latency period before delivery. Moreover, adverse neonatal and maternal outcomes, which are often associated with prolonged latency periods, were similar between the groups.

Is there an appropriate cutoff age for sampling the endometrium in premenopausal bleeding?

AIM: To determine a cutoff age for endometrial evaluation in premenopausal abnormal uterine bleeding (AUB). METHODS: Histopathology reports of endometrial sampling performed due to AUB in women aged 50 years or less were reviewed retrospectively. Histopathological findings were categorized into three groups as follows: group 1: hyperplasia without atypia + hyperplasia with atypia + malignancy, group 2: hyperplasia with atypia + malignancy, and group 3: malignancy. RESULTS: Data from 2,516 patients were analyzed for this study. Overall, 13.5% of patients had endometrial hyperplasia without atypia, 1% of patients had hyperplasia with atypia and 0.6% of patients had malignant disease. Logistic regression revealed a significant difference in the odds ratios of group 1 in the age ranges of 40-45 and 45-50 years compared with <40 years (p = 0.001 and p = 0.01, respectively). There were no significant differences between the age groups for the odds ratio of group 2 and group 3. CONCLUSION: There is no cutoff age for sampling the endometrium in order to detect hyperplasia with atypia and cancer in premenopausal women with AUB. Therefore, the management of AUB should be tailored to each patient regardless of age, incorporating all risk factors for malignant disease.

Experience of tubo-ovarian abscess in western Turkey.

OBJECTIVE: To investigate the clinical and laboratory parameters, treatments, and complications of patient with tubo-ovarian abscess (TOA). METHODS: Data for 296 patients diagnosed with TOA (clinically and sonographically) between January 2005 and December 2012 were retrospectively reviewed at 3 tertiary referral hospitals in Turkey. Patients were compared on the basis of TOA size, demographic characteristics, clinical and sonographic presentation, and laboratory findings. RESULTS: Seventy-six patients (25.7%) underwent surgery because antibiotic treatment was unsuccessful. The mean abscess size was larger and the mean C-reactive protein (CRP) level and the erythrocyte sedimentation rate (ESR) were higher among patients who required surgery. The ESR had a diagnostic value of 83.6%, and a specificity and sensitivity of 73.7% and 82.7%, respectively, for the need for surgical intervention, based on a cut-off value of 63.0mm/hour. The CRP level had a diagnostic value of 80.4%, a specificity of 82.3%, and a sensitivity of 65.8% based on a cut-off value of 21.0mg/L. CONCLUSION: The combined use of the sonographic TOA diameter and laboratory parameters (ESR and CRP level) can aid clinical treatment decisions and improve the prediction of the outcome of medical TOA treatment.

Unintended extension of the lower segment uterine incision at cesarean delivery: a randomized comparison of sharp versus blunt techniques.

OBJECTIVE: This study compared two methods of expanding the uterine incision at the time of cesarean delivery, which is associated with the risk of unintended extension. STUDY DESIGN: This randomized trial included 1,076 women who underwent elective cesarean delivery. The primary outcome measure was the incidence of unintended extension related to the method used for expanding the uterine incision. RESULTS: Participants in both groups (blunt vs. sharp) had similar demographic and clinical characteristics. The incidence of unintended extension (8.8% vs. 4.8%; p = 0.009), mean estimated blood loss (853.67 ± 42 mL vs. 664.80 ± 38 mL; p = 0.001), and blood loss >1000 mL (11.4% vs. 6.8%; p = 0.009) was significantly higher in the sharp group compared with the blunt group. No difference in transfusions (7.5% vs. 6.3%; p = 0.440) or the need for additional supertonic agents (16% vs. 12.9%; p = 0.144) was noted. CONCLUSION: Sharp expansion of the uterine incision was related to a higher risk of unintended extension and maternal blood loss. Because blunt expansion is associated with a lower risk for unintended extension and maternal blood loss, it should be the first option during elective cesarean delivery.

Single daily dose of moxifloxacin versus ofloxacin plus metronidazole as a new treatment approach to uncomplicated pelvic inflammatory disease: a multicentre prospective randomized trial.

OBJECTIVES: To evaluate the efficacy and safety of moxifloxacin versus ofloxacin plus metronidazole in patients with uncomplicated pelvic inflammatory disease (uPID; defined as PID symptoms and signs, but no complications such as septicemia, perihepatitis, and tubo-ovarian abscess) in Turkey. STUDY DESIGN: This was a multicenter, prospective, randomized, parallel-group study conducted between June 2010 and March 2013 in four hospitals in Turkey. Women received a 14-day course of either oral moxifloxacin at 400mg once daily (n = 560) or oral ofloxacin at 400mg twice daily plus oral metronidazole at 500 mg twice daily (n = 543). RESULTS: A total of 1156 women were randomized to the study. Total compliance was achieved in 1103 patients. For the primary measure of efficacy (clinical cure), moxifloxacin showed no difference compared with ofloxacin plus metronidazole (445/560 [79.5%] vs. 449/543 [82.7%]; p = 0.172). Bacteriological cure rates were high and comparable between treatment arms (99/119 [83.2%] vs. 93/110 [84.5%]; p = 0.781). Drug-related adverse events occurred less frequently with moxifloxacin than with ofloxacin plus metronidazole (210/560 [37.5%] vs. 252/543 [46.4%]; p = 0.003). Furthermore, moxifloxacin treatment was lower in cost and achieved higher patient compliance compared with ofloxacin plus metronidazole (31.4 Euros vs. 23.4 Euros and 7/578 (1.2%) vs. 22/578 (3.8%), respectively; p = 0.005). CONCLUSIONS: In patients with uPID, once-daily moxifloxacin monotherapy was clinically and microbiologically as efficacious as twice-daily ofloxacin plus metronidazole therapy and was associated with fewer drug-related adverse events, lower patient non-compliance, and a lower treatment cost.

Can intravenous injection of tranexamic acid be used in routine practice with active management of the third stage of labor in vaginal delivery? A randomized controlled study.

OBJECTIVE: To estimate the effects of adding intravenous tranexamic acid (TA) to the standard active management of third-stage labor to reduce vaginal blood loss during the third and fourth stages of labor. STUDY DESIGN: A prospective, double-blind, equivalence randomized, controlled study was performed. Women were randomly allocated to receive an intravenous infusion of TA (experimental group, n = 228) or 5% glucose (placebo group, n = 226) at delivery of the anterior shoulder. Active management of the third stage of labor, which includes prophylactic injection of 10 IU of oxytocin within 2 minutes of birth, early clamping of the umbilical cord, and controlled cord traction following delivery, was used in both groups. The primary outcome was mean blood loss during the third and fourth stages of labor. RESULTS: Mean estimated blood loss at the third and fourth stages of labor was significantly lower in the experimental group than that in the placebo group (261.5 ± 146.8 mL versus 349.98 ± 188.85 mL, respectively; p < 0.001). The frequency of postpartum hemorrhage > 500 mL was also lower in the experimental group (4, 1.8%) compared with that in the placebo controls (15, [6.8%]; relative risk, 3.76; 95% confidence interval, 1.27 to 11.15; p = 0.01). No episode of thrombosis occurred in the women who received TA. CONCLUSIONS: The use of TA with standard active management of the third stage of labor reduced postpartum blood loss, and no increase in the incidence of thromboembolic events was observed.

Labor induction in term premature rupture of membranes: comparison between oxytocin and dinoprostone followed 6 hours later by oxytocin.

OBJECTIVE: The aim of this randomized study was to compare 2 protocols for inducing labor in women with premature rupture of membranes (PROM) at term. STUDY DESIGN: Women with PROM and a Bishop score ≤5 were randomly assigned to receive either an intravenous oxytocin infusion (n = 223) or a dinoprostone pessary followed 6 hours later by an intravenous oxytocin infusion (n = 227). RESULTS: Vaginal delivery within 24 hours of labor induction increased significantly with sustained-released dinoprostone followed by oxytocin infusion (78.5% vs 63.3%; relative risk, 1.23; 95% confidence interval, 1.09-1.39; P = .001). Maternal and neonatal outcomes were similar between the groups. CONCLUSION: Sustained-released dinoprostone followed 6 hours later by an oxytocin infusion in term women with PROM was associated with a higher rate of vaginal delivery within 24 hours, and no difference in maternal-neonatal complications was observed compared with oxytocin infusion alone.

Prediction of metabolic syndrome in women with polycystic ovary syndrome.

OBJECTIVE: To identify biochemical factors that serve as predictors for the metabolic syndrome (MetS) in patients with polycystic ovary syndrome (PCOS) and to investigate the value of adipocytokines in the prediction of metabolic syndrome. MATERIAL AND METHODS: A total of 91 pre-menopausal women with PCOS diagnosed according to the Rotterdam consensus criteria were recruited as study subjects. Waist circumference, blood pressure, body mass index (BMI), fasting glucose, serum lipids, insulin, FSH, LH, E2, total testosteron, homeostatic model assessment-insulin resistance (HOMA-IR), serum leptin and adiponectin levels were evaluated for all patients. RESULTS: Of the 91 women with PCOS, 15 patients met the criteria for MetS. Body weight, BMI, waist circumference, systolic blood pressure, diastolic blood pressure, fasting glucose, total cholesterol, triglyceride, and VLDL concentrations were significantly higher and HDL was significantly lower in women with PCOS+MetS compared with those with PCOS only. However, the level of LDL, FSH, LH, E2 and total testesterone was not significantly different between these two groups. Women with PCOS+MetS had significantly higher levels of leptin and HOMA-IR, and significantly lower levels of adiponectin compared to the women with PCOS only. In the multiple logistic regression model, the association between HOMA-IR and leptin, and MetS remained statistically significant (p=0.001 and 0.018), while the association between adiponectin and MetS was no longer statistically significant. CONCLUSION: Aside from the biochemical markers such as glucose, cholesterol and triglyceride, adipose tissue factors and insulin resistance are valuable parameters in the prediction of MetS in patients with PCOS.

Is post-partum oxygen inhalation useful for reducing vaginal blood loss during the third and fourth stages of labour? A randomised controlled study.

OBJECTIVE: To determine the effectiveness of oxygen inhalation after delivery in reducing vaginal blood loss during the third and fourth stages of labour. METHODS: In this prospective randomised trial, 450 women undergoing vaginal delivery who did not have risk factors for post-partum haemorrhage were randomly assigned to receive either 8 L/min O(2) via a face mask for 2 h (n = 214) or normally breathe room air after the delivery (n = 216). The oxygen was given to the women after delivering their babies. Active management of the third stage of labour was used in both groups. The primary outcome was mean blood loss during the third and fourth stages of labour. RESULTS: No differences in demographic or clinical characteristics were observed between groups. The mean estimated blood loss at the third and fourth stages of labour did not significantly differ between the control and oxygen-inhalation groups (294.5 ± 179.7 vs 273.4 ± 146.6 mL, respectively; P = 0.18). In addition, there was no significant difference in the proportion of women who experienced an estimated blood loss >500 mL or the percentage of women who needed additional uterotonic agents (11 [5.1%] vs 9 [4.2%], respectively; RR 1.2 95% CI 0.5-2.8; P = 0.82 and 12 [5.6%] vs 8 [3.7%], respectively; RR 1.4 95% CI 0.6-3.5; P = 0.49). CONCLUSION: Post-partum oxygen inhalation is not beneficial for reducing vaginal blood loss during the third and fourth stages of labour.

Efficacy of intravenous tranexamic acid in reducing blood loss after elective cesarean section: a prospective, randomized, double-blind, placebo-controlled study.

We sought to determine the efficacy and safety of tranexamic acid (TA) in reducing blood loss during elective cesarean section (CS). We performed a randomized, double-blind, placebo-controlled study of 660 women who underwent elective CS. The patients were randomly selected to receive an intravenous infusion of either TA (1 g/10 mL in 20 mL of 5% glucose; N = 330) or 30 mL 5% glucose prior to surgery. The primary outcome was the estimated blood loss following CS. No demographic difference was observed between groups. The mean estimated blood loss was significantly lower in women treated with TA compared with women in the placebo group (499.9 ± 206.4 mL versus 600.7 ± 215.7 mL, respectively; P < 0.001), and the proportion of women in the TA group who had an estimated blood loss >1000 mL was significantly lower than in the placebo group (7 [2.1%] versus 19 [5.8%], respectively; relative risk [RR] 2.7; 95% confidence interval [CI] 1.1 to 6.3; P < 0.03). Furthermore, more women in the placebo group than in the TA group required additional uterotonic agents (48 [14.5%] versus 28 [8.5%], respectively; RR 1.7; 95% CI 1.1 to 2.6; P = 0.02). Maternal and neonatal outcomes did not differ significantly. TA significantly reduced bleeding during CS, the percentage of patients with blood loss >1000 mL, and the need for additional uterotonic agents. Furthermore, the incidence of thromboembolic events did not increase. Our results suggest that TA can be used safely and effectively to reduce CS bleeding.

Sustained-release dinoprostone vaginal pessary with concurrent high-dose oxytocin infusion compared to sustained-release dinoprostone vaginal pessary followed 6 h later by high-dose oxytocin infusion for labor induction in women at term with unfavorable cervix: a randomized controlled trial.

OBJECTIVE: To compare the efficacy and safety of sustained-release dinoprostone vaginal pessary and concurrent high-dose oxytocin infusion with sustained-release dinoprostone vaginal pessary followed 6 h later by high-dose oxytocin infusion for cervical ripening and labor induction. METHODS: A total of 500 nulliparous or multiparous women with a singleton pregnancy, Bishop score ≤4 and admitted for labor induction. Women were randomly assigned to induction of labor using intravaginal dinoprostone with concurrent high-dose oxytocin (n = 250) or intravaginal dinoprostone pessary followed 6 h later by high-dose oxytocin (n = 250). The primary outcome was the number of vaginal deliveries achieved within 24 h of labor induction. RESULTS: Baseline characteristics of both groups were comparable. Vaginal delivery within 24 h of labor induction was significantly increased with sustained-release dinoprostone followed 6 h later by high-dose oxytocin infusion (92.8 vs. 82.0%, RR 2.82, 95% CI 1.58-5.04). There were more cesarean section deliveries in the dinoprostone with concurrent high-dose oxytocin group (16.8 vs. 6.8%, RR 0.36, 95% CI 0.20-0.65). Maternal outcomes did not differ significantly. An Apgar score of <7 at 5 min was found more often in the dinoprostone with concurrent high-dose oxytocin group (3.6%) in comparison to dinoprostone pessary followed 6 h later by high-dose oxytocin (0.8%), although this was not statistically different (RR 0.21, 95% CI 0.04-1.01). CONCLUSION: Sustained-release dinoprostone followed 6 h later by high-dose oxytocin infusion appears to be safer and more effective than sustained-release dinoprostone with concurrent high-dose oxytocin infusion in achieving cervical ripening and successful vaginal delivery.

Results of TOT operations alone and combined with other vaginal surgical procedures.

OBJECTIVE: To evaluate the safety and efficacy of transobturator vaginal tape (TOT) procedure in women with stress urinary incontinence (SUI). METHODS: The study population consisted of 210 patients who were diagnosed as having stress urinary incontinence, and they underwent a TOT operation alone (99) or concomitant vaginal surgery (101) between January 2005 and February 2009 and were followed up for at least one year. Patients with detrusor overactivity and intrinsic sphincter deficiency were excluded. The cure and complication rates were investigated. RESULTS: The mean follow-up was 46.4 ± 8.7 months (range 13-48). No vascular, nervous system, or digestive perioperative complications were observed; however, 3.9% of the patients had voiding difficulty. The overall 12-month objective cure and subjective cure rates were 89.0% and 89.0% respectively. The overall four-year objective and subjective cure rates were 83.3% and 86.2% respectively. There was no difference between the four-year objective and subjective cure rates when TOT alone was performed (83.8 and 86.9%) or when performed as part of another surgical procedure (82.9 and 85.6%). CONCLUSION: The TOT procedure is a safe, effective and minimally invasive procedure for treating SUI with a low rate of complications. Moreover, it can be carried out safely and effectively in association with vaginal surgery.

Using intraumbilical vein injection of oxytocin in routine practice with active management of the third stage of labor: a randomized controlled trial.

OBJECTIVE: To estimate the efficacy of the routine use of intraumbilical vein injection of oxytocin with active management of the third stage of labor in reducing blood loss and length of the third stage. METHODS: In this prospective, randomized, double-blind trial, 412 women undergoing vaginal delivery who did not have risk factors for postpartum hemorrhage were randomly allocated to receive either 20 international units oxytocin diluted with 26 mL saline (n=207) or 30 mL saline (n=205) by intraumbilical vein injection. Active management of the third stage of labor (prophylactic injection of 10 international units oxytocin within 2 minutes of birth, early clamping of the umbilical cord, and controlled cord traction) was used in both groups. The primary outcome was mean blood loss during the third and fourth stages of labor. RESULTS: The mean estimated blood loss was significantly lower in women treated with oxytocin compared with women in the placebo group (195.3+/-81.0 mL compared with 288.3+/-134.1 mL, respectively; P<.001). The third stage of labor was significantly shorter in the oxytocin group than in the placebo group (4.5+/-1.6 minutes compared with 7.9+/-3.4 minutes, respectively; P<.001). The percentages of placentas remaining undelivered beyond 15 minutes were 0% in the oxytocin group and 4.4% in the placebo group (P=.002). CONCLUSION: The use of intraumbilical injection of oxytocin with the active management of the third stage of labor significantly reduced postpartum blood loss and the duration of the third stage. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT01094028. LEVEL OF EVIDENCE: I.

Use of additional oxytocin to reduce blood loss at elective caesarean section: A randomised control trial.

OBJECTIVE: The purpose of this prospective, randomised, double-blind, placebo-controlled study was to assess the effects of a 5-IU oxytocin bolus and placebo infusion versus a 5-IU oxytocin bolus and 30 IU infusion on the control of blood loss at elective lower segment caesarean section (C/S). METHODS: Participants with indication for elective C/S were randomly allocated to two groups. Group A, 360 women, received oxytocin 5 IU bolus and placebo; group B, 360 women received oxytocin 5 IU bolus and 30 IU infusion. Blood loss was estimated based on the haematocrit values before and 48 h after delivery. The primary outcome was the incidence of excessive bleeding (estimated blood loss of >1000 mL), while secondary outcomes included use of additional uterotonics, estimated blood loss, need for blood transfusion, duration of hospital stay and the incidence of adverse effects. RESULTS: No demographic difference was observed between groups. Mean estimated blood loss (P < 0.001) and the proportion of women with blood loss estimated to be greater than 1000 mL were significantly less for group B than for group A (relative risk (RR) 0.35, 95% confidence interval (CI) 0.20-0.63). In addition, more women in the group A required additional uterotonic agents (RR 0.35, 95% CI 0.22-0.56) and blood transfusion (RR 0.12, 95% CI 0.01-0.98). CONCLUSION: An additional oxytocin infusion after 5 IU oxytocin bolus infusion at elective C/S may reduce blood loss and required blood transfusion.

Is routine cervical dilatation necessary during elective caesarean section? A randomised controlled trial.

OBJECTIVE: The purpose of this prospective randomised study was to determine the effect of routine cervical dilatation during elective caesarean section on maternal morbidity. METHODS: Participants with indication for elective caesarean section were randomly allocated to two groups. Group A (n = 200) women with intraoperative cervical dilatation; group B (n = 200) women with no intraoperative cervical dilatation. RESULTS: No demographic differences were observed between groups. There was no significant difference between groups in infectious morbidity (P = 0.87) (relative risk (RR) 1.11, 95% confidence interval (CI) 0.58-2.11), endometritis (P = 0.72) (RR 1.68, 95% CI 0.39-7.14), febrile morbidity (P = 0.66) (RR 1.21, 95% CI 0.51-2.87), wound infection (P = 0.82) (RR 1.11, 95% CI 0.44-2.81), endometritis (P = 0.72) (RR 1.68, 95% CI 0.39-7.14) or urinary tract infection (P = 1.00) (RR 1.00, 95% CI 0.28-3.50), and estimated blood loss (P = 0.2). However, group A had longer operative times compared with the group B (P = 0.01). CONCLUSION: Intraoperative digital cervical dilatation during elective caesarean section did not reduce blood loss and postoperative infectious morbidity. The routine digital cervical dilatation during elective caesarean section is not recommended.