Intravenous tranexamic acid vs. sublingual misoprostol in high-risk women for postpartum haemorrhage following cesarean delivery; a randomised clinical trial.

OBJECTIVE: This study compares the effectiveness of administering sublingual misoprostol combined with oxytocin to that of IV tranexamic acid combined with oxytocin to reduce intra and post-operative blood loss in high-risk women for postpartum haemorrhage (PPH) following cesarean section (CS). METHODS: About 315 high-risk pregnant women undergoing CS participated in this trial. They were randomly assigned into three groups; tranexamic group, misoprostol group, and control group, according to the medication given in the operative theatre. All patients received oxytocin intraoperatively. They were assessed regarding intraoperative blood loss, the incidence of PPH, and the reduction in haemoglobin and hematocrit values. RESULTS: Both tranexamic and misoprostol groups had similar results in reducing intra and post-operative blood loss. However, the reduction in haemoglobin and hematocrit were significantly lower in tranexamic and misoprostol groups compared to the control group (-0.78 ± 0.57 vs. -0.83 ± 0.52 vs. -1.32 ± 0.57 gm/dl, P < 0.001 and - 3.05 ± 1.28 vs. -3.06 ± 1.13 vs. -4.94 ± 1.82%, P < 0.001 respectively). In addition, the estimated blood loss was significantly lower in the tranexamic and misoprostol groups compared to the control group (641.6 ± 271.9 vs. 617.9 ± 207.4 vs. 1002.4 ± 340.7 ml, P < 0.001). CONCLUSION: Both tranexamic acid and misoprostol are equally capable of reducing blood loss, but the results were significantly better compared to using oxytocin alone in high-risk patients. CLINICAL TRIAL REGISTRATION: Registered at www. CLINICALTRIALS: govon07/10/2019 with registration number NCT04117243.

Kasr Alainy simplified uterine preserving surgery for conservative management of placenta accreta spectrum (PAS): A modified surgical approach.

OBJECTIVE: The incidence of placenta accreta spectrum (PAS) is rising rapidly due to the global surge in Caesarean delivery. It is associated with significant maternal morbidity and mortality. It is usually managed with Caesarean hysterectomy. However, uterine preserving surgeries can have advantages over Caesarean hysterectomy and intentional placental retention techniques. STUDY DESIGN: We present a modified technique of uterine preserving surgery that uses a safe approach for placental bed surgical devascularization. This is followed by resection of the invaded uterine segment and uterine wall reconstruction. RESULTS: The technique was used in the management of 20 patients with antenatally suspected PAS that were confirmed at laparotomy. It was successful in preserving the uterus in 18/20 (90 %) women. The mean intraoperative blood loss in was 1305 CC (SD: +361.6) with a mean operative time of 123 min (SD: ±38.7). There was only one urinary bladder injury and no other maternal morbidity. CONCLUSION: Our surgical technique is safe and may be useful for conservative surgical management of PAS, particularly in low- and middle-income countries, where access to complex resources, such as interventional radiology, is limited.

Laparoscopic guided minilaparotomy: a modified technique for management of benign large ovarian cysts.

BACKGROUND: The aim of the study is to evaluate the efficiency and safety of a novel technique to treat large benign ovarian cysts combining benefits of laparoscopic management along with mini-laparotomy without affection of the ovarian reserve. METHODS: The study included 112 women with large benign ovarian cyst candidate for ovarian cystectomy. The technique started with laparoscopy followed by guided cyst aspiration followed by exteriorization of the ovary through minilaprotomy and completion of cystectomy through microsurgical technique. The primary outcome was ipsilateral recurrence of the cyst. Other outcomes included ovarian reserve assessment and postoperative pain. RESULTS: The number of women with recurrence in the ipsilateral ovary after 12, 18 and 24 months were 5 (4.5%),16 (14.3%),20 (17.85%) respectively. Assessment of ovarian reserve revealed a significant decrease in the level of serum AMH (2.82 ± 0.44 vs. 2.50 ± 0.42) and a significant increase in AFC (3.5 ± 1.7 vs. 4.9 ± 1.3) after our novel technique in surgical treatment of ovarian cysts (P value < 0.001). The operative time was 50 ± 7 and 62 ± 7 min in unilateral and bilateral cysts respectively. CONCLUSIONS: Laparoscopic guided minilaparotomy is a safe and effective technique for the management of large benign ovarian cysts with minimal recurrence rate, ovarian reserve affection and adhesions. TRIAL REGISTRATION: clinical trial registry no. NCT03370952. Registered 13 December 2017, https://clinicaltrials.gov/ct2/show/NCT03370952.

Delayed versus early umbilical cord clamping for near-term infants born to preeclamptic mothers; a randomized controlled trial.

OBJECTIVE: This study aims to assess delayed versus early umbilical cord clamping in preeclamptic mothers undergoing scheduled caesarean delivery regarding the maternal intra-operative blood loss and neonatal outcomes. METHODS: A clinical trial was conducted on 62 near-term preeclamptic mothers (36-38+6 weeks) who were planned for caesarean delivery. They were randomly assigned into two groups. The first group was the early cord clamping (ECC) group (n= 31), in which clamping the umbilical cord was within 15 seconds, while the second group was the delayed cord clamping (DCC) group (n= 31), in which clamping the umbilical cord was at 60 seconds. All patients were assessed for intra-operative blood loss and incidence of primary postpartum haemorrhage (PPH). Otherwise, all neonates were assessed for APGAR scores, the need for the neonatal intensive care unit (NICU) admission due to jaundice, and blood tests (haemoglobin, haematocrit. and serum bilirubin). RESULTS: There was not any significant difference between the two groups regarding the maternal estimated blood loss (P=0.673), the rates of PPH (P=0.1), post-delivery haemoglobin (P=0.154), and haematocrit values (P=0.092). Neonatal outcomes also were showing no significant difference regarding APGAR scores at the first minute (P=1) and after 5 minutes (P=0.114), day 1 serum bilirubin (P=0.561), day 3 serum bilirubin (P=0.676), and the rate of NICU admission (P=0.671). However, haemoglobin and haematocrit values were significantly higher in the DCC group than in the ECC group (P<0.001). CONCLUSION: There is no significant difference between DCC and ECC regarding maternal blood loss. However, DCC has the advantage of significantly higher neonatal haemoglobin. TRIAL REGISTRATION: It was first registered at ClinicalTrials.gov on 10/12/2019 with registration number NCT04193345.

Medical therapy options for endometriosis related pain, which is better? A systematic review and network meta-analysis of randomized controlled trials.

Our objective was to assess and rank different pharmacological interventions for relieving endometriosis-related pain. We conducted an online bibliographic search in different databases from their inception until March 2019. We included randomized controlled trials (RCTs) that assessed different medical therapies in the management of endometriosis-related pain. We applied this network meta-analysis (NMA) based on the frequentist approach using statistical package "netmeta" (version 1.0-1) in R software. Our main outcomes were the change in severity of pelvic pain, dysmenorrhea score, non-menstrual pelvic pain score, and dyspareunia score. Overall, 36 RCTs were included in this study (patients no. = 7942). Dienogest (0.94), combined hormonal contraceptives (CHCs) (0.782), and elagolix (0.38) were the highest-ranked interventions for reducing the severity of pelvic pain at three months, while at six months, gonadotropin-releasing hormone (GnRH) analogues (0.75), levonorgestrel-releasing intrauterine system (LNG-IUS) (0.73), and dienogest (0.65) were linked to more reduction in pelvic pain. The ranking p-score showed that GnRH analogues was the highest-ranked treatment for reducing dysmenorrhea at 3 months (1.00), while CHCs were the highest-ranked treatment at 6 months (0.97), followed by GnRH analogues (0.89). GnRH analogues (0.63) and elagolix (0.54) at three months while desogestrel (0.94) and CHCs (0.91) at six months were the highest-ranked treatment to reduce non-menstrual pelvic pain. GnRH analogues and elagolix were the highest-ranked pharmacologic therapies for reducing dyspareunia. In conclusion, CHCs, GnRH analogues, progesterone, and elagolix were the best approaches in reducing the pain of endometriosis.

The value of fetal Doppler indices as predictors of perinatal outcome in women with preeclampsia with severe features.

Objective: To evaluate the diagnostic performance of Doppler sonography of umbilical artery (UA), fetal middle cerebral artery (MCA), ductus venosus (DV) & umbilical vein (UV) for prediction of adverse perinatal outcome.Material and Methods: A prospective cohort study conducted on 60 women diagnosed  with preeclampsia with severe features divided into two groups based on adverse perinatal outcome.Results: Statistically Significant differences were demonstrated UA PI (1.28 ± 0.23 vs. 0.96 ± 0.21, P <0.001), UA RI (0.78 ± 0.09 vs. 0.62 ± 0.09, P <0.001), MCA PI (1.27 ± 0.28 vs. 1.45±0.20, P 0.005), MCA RI (0.67 ± 0.10 vs. 0.76 ± 0.08, P<0.001), Cerebroplacental ratio (1.01 ± 0.36 vs. 1.57 ± 0.35, P <0.001), DV PVIV (0.67 ± 0.20 vs. 0.51 ± 0.14, P= 0.004), DV PSV (54.74 ± 17.11 vs. 42.15 ± 9.42, P= 0.004)  and abnormal DV a wave (23.8 vs. 0%, P = 0.004) in women with adverse and normal perinatal outcome respectively. UA PI and CPR had the highest specificity while UA RI had the highest sensitivity for detection of adverse perinatal outcome.Conclusion: CPR < 1 can be used to identify fetuses at risk of morbidity and mortality among such cases.

A randomized controlled trial of a new technique for laparoscopic management of ovarian endometriosis preventing recurrence and keeping ovarian reserve.

INTRODUCTION: Laparoscopic cystectomy provides more favourable outcomes as regards the recurrence and subsequent clinical pregnancy rates. It is associated with significant reduction in the ovarian reserve due to the inevitable removal of unaffected ovarian tissue. The aim of our study was to evaluate the efficiency of Surgicel in preventing recurrence of endometriomas after their laparoscopic conservative management (cystectomy or drainage). MATERIAL AND METHODS: A randomized controlled trial included two hundred women (candidate for conservative laparoscopic management of ovarian endometriomas). They were randomized into four groups; group D in which patients underwent laparoscopic drainage of the endometrioma, group C in which patients underwent laparoscopic cystectomy of the endometrioma, group DS in which patients underwent laparoscopic drainage followed by insertion of Surgicel inside the cyst cavity & group CS in which patients underwent laparoscopic cystectomy of the endometrioma followed by insertion of Surgicel inside the remaining ovarian tissues. All patients were followed up for 2 years & the primary outcome was the recurrence of endometriomas in the ipsilateral ovary & the postoperative ovarian reserve was reassessed as a secondary outcome. RESULTS: The Surgicel-treated groups had significantly lower hazard of recurrence compared to untreated groups (p = 0.004). Group CS had significantly lower hazard of recurrence compared to Group D & C (p = 0.014, 0.046 respectively). Group DS had significantly lower hazard of recurrence compared to Group D (p = 0.039) but it not significantly different from Group C (p = 0.112). Group DS had the lowest drop of AMH and was significantly lower than the other three groups. CONCLUSION: Surgicel reduces effectively the recurrence risk of endometriomas and its use during laparoscopic drainage is an effective alternative for traditional laparoscopic cystectomy with minimal affection of the patient ovarian reserve. TRIAL REGISTRATION: Name of the registry: clinicaltrials.gov. Trial registration number NCT02947724 . Date of registration October 28, 2016.

The role of three-dimensional ultrasonography fetal lung volume measurement in the prediction of neonatal respiratory function outcome.

BACKGROUND: Respiratory distress is commonly encountered among premature babies immediately after birth resulting in significant neonatal morbidity or mortality. OBJECTIVES: To evaluate the possible correlation between three dimensional fetal lung volumes (FLVs) and neonatal respiratory outcomes. STUDY DESIGN: A cohort study included 100 pregnant women who participated in the study and were divided into two groups; group A (n: 50 - women pregnant ±34-37 weeks) and group B (n: 50 - women pregnant ±37+1 to 40 weeks). A three dimensional measurement of the right fetal lung was made using virtual organ computer-aided analysis (VOCAL) software then correlated to neonatal respiratory functions namely Apgar score at birth and the occurrence of respiratory distress syndrome (RDS). RESULTS: In group A, FLV was negatively correlated with Apgar score and the occurrence of RDS. In group B, FLV showed no statistical correlation with Apgar score and the occurrence of RDS. CONCLUSIONS: Three dimensional fetal lung volumes might be an accurate noninvasive predictor for the development of RDS among preterm fetuses.

Multicenter randomized controlled trial assessing the impact of a cervical traction maneuver (Amr's maneuver) on the incidence of postpartum hemorrhage.

OBJECTIVE: To assess the impact of a cervical traction maneuver (Amr's maneuver) used in conjunction with active management of the third stage of labor (AMTSL) on the incidence of postpartum hemorrhage (PPH). METHOD: The present multicenter randomized controlled trial was conducted in Cairo between March 1, 2016, and June 30, 2017. Women aged at least 18 years who had singleton pregnancies and were candidates for vaginal delivery were enrolled. After block randomization, AMTSL was performed for all participants. Following placental delivery, Amr's maneuver using cervical traction for 90 seconds was carried out in the study group. The primary outcome, incidence of PPH (>500 mL blood loss) within 6 hours of delivery, was compared between the study and control groups in an intention-to-treat analysis. RESULTS: There were 852 patients randomized to the study (n=426) and control (n=426) groups. The incidence of PPH was significantly lower in the study group compared with the control group (6 [1.4%] vs 19 [4.5%]; P=0.015). Absolute risk reduction of 3.1% (95% CI 0.8-5.6), relative risk reduction of 0.32 (95% CI 0.13-0.78), and number needed to treat of 33 (95% CI 129-18) were observed in the study group. CONCLUSION: Amr's maneuver was effective in decreasing the incidence of PPH. ClinicalTrials.gov Identifier: NCT02660567.

Can AMH levels predict the need for increased medication during IVF/ICSI in PCOS women?

PURPOSE: To investigate the ability of anti-Mullerian hormone (AMH) to predict the step up of human menopausal gonadotropins (HMG) dose in women with polycystic ovarian syndrome (PCOS) undergoing IVF/ICSI cycles. METHODS: AMH was drawn before ovulation induction in 976 PCOS women scheduled for IVF/ICSI. After all cycles ended, a receiver operating characteristic (ROC) curve analysis was done to investigate the ability of AMH to predict step up of the HMG. RESULTS: The area under the curve (AUC) was 0.820 95%CI (0.792-0.848), and a cutoff value of 4.6 ng/ml (sensitivity 74%, specificity 82%) for AMH was taken (p < 0.01). Cases were divided into two groups retrospectively; group (A) (AMH ≤4.6 ng/ml), and group (B) (AMH >4.6 ng/ml). No difference in the mean age (p = 0.147); BMI (p = 0.411), basal FSH (p = 0.221), and starting dose (p = 0.195); however, the dose at which the first response occurred was higher in group (B) (p < 0.01). The total dose and number of days were higher in group (B) (both p < 0.01) irrespective of the PCOS subtype or androgen levels. Severe OHSS was also higher in group (B) (p = 0.026). CONCLUSIONS: PCOS with AMH >4.6 ng/ml are resistant to HMG stimulation, require dose step up during ART cycles, and are at higher risk for severe OHSS.

Laparoscopic transabdominal cerclage: new approach.

OBJECTIVE: To evaluate efficiency and safety of the new approach of laparoscopic cerclage. STUDY DESIGN: Fifteen women were operated with our new technique. Their age ranged from 22 years to 35 years. Inclusion criteria included those with history of two or more second trimesteric abortions or early preterm labor. These women had at least two previous unsuccessful vaginal cerclage or vaginal insertion of cerclage is not possible because of congenitally short cervix, cervical conization or excessive cervical scarring. RESULTS: Twelve of the participants delivered vaginally with the removal of cerclage, two had CS due to breech presentation and the cerclage was left in place and the last one has surgical evacuation. No intraoperative or postoperative complications were encountered namely; excessive bleeding, injury of uterine vessels or postoperative peritonitis. No technical difficulties upon doing the procedure or cerclage removal were met apart from one case where removal of the vaginal stitch was not possible [incision was done in the cervix over the tape and the Mersilene tape was cut followed by repair of the cervical tissue using (00) Vicryl stitches]. CONCLUSION: The new approach for laparoscopic cerclage is a safe, effective and reasonable treatment after failure of vaginal cerclage.

Periconceptional risk factors of spina bifida among Egyptian population: a case-control study.

OBJECTIVE: To study the preconceptual & early conceptional risk factors predisposing to the development of spina bifida (SB) among Egyptian population. STUDY DESIGN: The study involved 197 pregnant women undergoing fetal anatomy scan; 97 women proved to have fetal SB and 100 women with normal fetuses as a control group. The control group was recruited randomly in the same period from patients undergoing anatomical scan. Risk factors that might lead to SB were investigated including maternal age, gravidity, parity, residence, history of diabetes mellitus or drug intake, smoking, infections, exposure to X-ray, history of congenital anomalies in other offspring, parental consanguinity, positive family history, and folate supplementations. RESULTS: SB affected the lumbo-sacral region in the majority of cases (89.7%). It was associated with hydrocephalus in 66 cases (68%), polyhydramnios in 12 cases (12.4%). The SB group showed significantly higher parity (p = 0.005), more frequent history of drug intake (p < 0.001), higher frequency of infection with CMV (p = 0.004), and HSV (p = 0.013) and less proportion of folate supplementation (p < 0.001). CONCLUSION: The rate of SB in the tested group was five per 1000. Risk factors were lack of folate supplementation and history of antiepileptic drugs intake.

A randomized placebo-controlled trial of preoperative tranexamic acid among women undergoing elective cesarean delivery.

OBJECTIVE: To study the efficacy and safety of preoperative intravenous tranexamic acid to reduce blood loss during and after elective lower-segment cesarean delivery. METHODS: A single-blind, randomized placebo-controlled study was undertaken of women undergoing elective lower-segment cesarean delivery of a full-term singleton pregnancy at a center in Cairo, Egypt, between November 2013 and November 2014. Patients were randomly assigned (1:1) using computer-generated random numbers to receive either 1g tranexamic acid or 5% glucose 15 minutes before surgery. Preoperative and postoperative complete blood count, hematocrit values, and maternal weight were used to calculate the estimated blood loss (EBL) during cesarean, which was the primary outcome. Analyses included women who received their assigned treatment, whose surgery was 90 minutes or less, and who completed follow-up. RESULTS: Analyses included 100 women in each group. Mean EBL was significantly higher in the placebo group (700.3 ± 143.9 mL) than in the tranexamic acid group (459.4 ±7 5.4 mL; P<0.001). Only six women, all in the placebo group, experienced an EBL of more than 1000 mL. There were no reports of thromboembolic events up to 4 weeks postoperatively. CONCLUSION: Preoperative administration of tranexamic acid safely reduces blood loss during elective lower-segment cesarean delivery. Australian New Zealand Clinical Trials Registry:ACTRN12615000312549.