Lidocaine vs. tramadol vs. placebo wound infiltration for post-cesarean section pain relief: a randomized controlled trial.

OBJECTIVES: In low-income settings, postoperative pain relief could be challenging as a high patient/nurse ratio limits pain assessment and adequate analgesics administration. The multi-center prospective double-blinded parallel randomized controlled trial was done to compare lidocaine, tramadol, and placebo (saline) intraoperative wound infiltration to relieve post-cesarean section wound pain during the first 24 h. METHODS: Ninety-nine cases were equally randomized into three groups, each containing 33 pregnant women undergoing cesarean section under general anesthesia. During operation, the wound was infiltrated subcutaneously with 20 mL of 2% lidocaine solution in the first group, 2 mg/kg tramadol in the second group, and saline in the third group. The primary outcome was to assess the postoperative pain at 2, 4, 6, 12, and 24 h by the Yes-No-Don't Know (YNDK) Scale, while the secondary outcome was to assess the need for further postoperative analgesia. RESULTS: Wound infiltration with lidocaine or tramadol was effective in pain relief, and both were superior to placebo. Wound infiltration with tramadol was superior to lidocaine in pain relief at 2 h and up to 24 h. CONCLUSIONS: Wound infiltration with tramadol has a more prolonged pain relief effect than lidocaine in post-cesarean section pain relief in patients performing cesarean section under general anesthesia lasting up to 24 h, and both are superior to placebo in pain relief.

Effect of Intra Uterine Granulocyte Colony Stimulating Factor vs. Human Chorionic Gonadotropin at Ovum Pick Up Day on Pregnancy Rate in IVF/ICSI Cases With Recurrent Implantation Failure.

OBJECTIVE: Recurrent implantation failure is defined as failure to achieve clinical pregnancy after the transfer of four or more good-quality embryos in a minimum of three fresh or frozen cycles in a woman aged less than 40 years. The objective is to compare between the effect of intrauterine G-CSF, hCG, and saline solution injection (as placebo) at the day of ovum pick-up on clinical pregnancy, chemical pregnancy, implantation, and miscarriage rates in patients with recurrent implantation failure undergoing IVF/ICSI. METHODS: This prospective, double blind, parallel, randomized controlled trial included 150 patients equally divided into 3 groups, each containing 50 individuals. Subjects in Group 1 received intrauterine injections of G-CSF; Group 2: received intrauterine injections of 500 IU of hCG; and Group 3 received intrauterine injections of saline solution as placebo. The primary outcome measure is clinical pregnancy rate. Secondary outcomes are biochemical pregnancy, implantation, and miscarriage rates. RESULTS: Clinical pregnancy, biochemical pregnancy, and implantation rates were highest in the group given G-CSF and lowest in the group administered saline solution; miscarriage rates were not significantly different between the groups. CONCLUSIONS: Intrauterine administration of G-CSF at a dose of 100 µg/1.0 cc at the time of ovum pick-up is associated with better clinical pregnancy, chemical pregnancy, and implantation rates as compared with intrauterine saline solution administration. Further studies are needed to determine the optimum timing of intrauterine administration of G-CSF that achieves the best results, and longer follow-up is needed to determine take-home baby percentages.

Transverse versus longitudinal blunt extension of the uterine incision during cesarean section in women with a uterine scar of previous cesarean delivery: A randomized controlled trial.

OBJECTIVE: To compare two different blunt extension techniques of the lower segment transverse uterine incision at cesarean delivery in women with a uterine scar of previous cesarean delivery. METHODS: Study design: Prospective single-blinded parallel multi-center randomized controlled trial involving 392 cases equally divided into two groups. Group one had their incision extended transversely, while group two had their incision extended longitudinally. OUTCOME MEASURES: The primary outcome was the unintended extension of the uterine incision, while the secondary outcomes included the need for additional stitches to achieve hemostasis, the drop in hemoglobin level, uterine vessels injury, and the need for blood transfusion. RESULTS: No significant difference between the transverse and longitudinal extension of the uterine incision during cesarean section as regards unintended uterine extension (P = 0.860), uterine vessel injury (P = 0.501), and cases requiring blood transfusion (P = 0.814). Significantly lower drop in hemoglobin level (P ≤ 0.001) and significantly less need for additional stitches (P ≤ 0.001) in cases with the longitudinal extension of uterine incision. CONCLUSION: In women with a uterine scar of previous cesarean delivery, the blunt longitudinal extension of the uterine incision in the lower segment cesarean section didn't differ from the blunt transverse extension as regards unintended uterine extension but is associated with less hemoglobin drop and less need for additional stitches as compared to transverse extension of the incision. Further studies are needed to assess the long-term complications of both techniques.

Relationship Between Ano-vaginal Distance and Bacterial Vaginosis (Cross-sectional Study).

Bacterial vaginosis is a vaginal condition caused by the overgrowth of anaerobic bacteria, owing to a shift in the vaginal microbial ecosystem. The aim of the study is to investigate the relationship between the ano-vaginal distance and the risk of developing bacterial vaginosis. In this cross-sectional study, the ano-vaginal distance was measured in 100 women participants complaining of vaginal discharge, divided into two groups. Group (1) consisted of 74 women who were negative for bacterial vaginosis, and group (2) consisted of 26 women who had bacterial vaginosis based on Amsel criteria. The negative cases for bacterial vaginosis had significantly longer ano-vaginal distance as compared with those who had bacterial vaginosis (3.85 ± 0.54 versus 3.38 ± 1.02). A positive correlation was detected between ano-vaginal distance and the risk of developing bacterial vaginosis. Further extensive studies are required to investigate this finding in different population groups.

Comparing sequential vs day 3 vs day 5 embryo transfers in cases with recurrent implantation failure: randomized controlled trial.

OBJECTIVE: The recent improvement in sequential media has refocused its attention on the role of human blastocysts in ART, not only because of its advantages but also because of the possible cancellation of embryo transfer when relying on blastocyst transfer only. Hence, the idea of sequential transfer on day 3 and day 5 was proposed. Objective: To compare the pregnancy outcomes of sequential embryo transfer on day 3 and day 5, versus cleavage transfer on day 3 and blastocyst transfer on day 5 in cases of recurrent implantation failure. METHODS: This was a prospective and randomized trial, in which 210 qualified patients with recurrent implantation failures undergoing IVF/ICSI were randomized into three groups, each group included 70 patients. Embryo transfer was performed in day 3 in the first group, day 5 (blastocyst transfer) in the second group and sequential embryo transfer in days 3 and 5 in the third group. We assessed pregnancy outcomes from all the three groups. Results: Clinical pregnancy and live birth rates were significantly higher in the sequential group than either group day-3 or day-5 of embryo transfer in cases with recurrent implantation failures. CONCLUSIONS: Sequential embryo transfer in cases with recurrent implantation failures and adequate number of retrieved oocytes is associated with higher implantation and clinical pregnancy rates, and it is advocated for patients having an adequate number of good quality embryos.

Pre-operative tranexemic acid vs. etamsylate in reducing blood loss during elective cesarean section: randomized controlled trial.

OBJECTIVES: To investigate whether etamsylate may be an alternative to tranexamic acid in reduction of blood loss during elective cesarean section. METHODS: Prospective double-blinded multi-center randomized controlled trial involving 180 qualified women equally divided into three groups each containing 60 women received either tranexamic acid, etamsylate or placebo 20 min before elective cesarean section and blood loss was estimated. RESULTS: Mean blood loss, cases needing blood transfusion and cases needing further interventions were significantly lower in tranexamic acid and etamsylate group than placebo group, while mean postoperative hemoglobin and hematocrite were significantly higher in both tranexamic acid and etamsylate as compared to placebo. CONCLUSIONS: Etamsylate is an effective second-line therapy (after tranexamic acid) in reducing blood loss during elective cesarean section with low risk of side effects, therefore, it can be an effective alternative to tranexamic acid in cases with contraindications or anticipated to be at high-risk of developing side effects from tranexamic acid.

RETRACTION NOTE TO: Comparing sequential vs. day 3 vs. day 5 embryo transfers in cases with recurrent implantation failure: randomized controlled trial

This corrects the article DOI: 10.5935/1518-0557.20200083.

Cesarean scar ectopic pregnancy: A cause of failed first trimester surgical termination of pregnancy (case report).

Cesarean scar (ectopic) pregnancy is due to blastocyst implantation on a Caesarean scar. The current case presented by vaginal bleeding after a failed surgical termination of pregnancy. The ultrasound scan revealed a cesarean scar ectopic pregnancy managed by surgical removal. The possibility of cesarean scar ectopic pregnancy should be considered in any case presenting with a low-lying gestational sac.

Effect of amlodipine on blood flow of preovulatory follicle in women with clomiphene resistant polycystic ovaries: a randomized controlled trial.

OBJECTIVE: To detect whether amlodipine could increase pre-ovulatory follicular blood flow, thus enhancing ovulation and creating a better chance of conception in women with PCOS. METHODS: 165 women were screened of which 124 were qualified and women were equally randomized to 62 receiving clomiphene citrate and amlodipine and 62 receiving clomiphene citrate and placebo. The primary outcome was to detect if amlodipine can improve pre-ovulatory follicle blood flow studied by colour and power Doppler Pulsatility index of ovarian arteries, with drug administration. The secondary outcomes were endometrial thickness and clinical pregnancy. RESULTS: The mean value of the ovarian arteries Pulsatility Index was significantly lower in the amlodipine group when compared to those of the placebo group (1.36 and 1.82, respectively, with P value 0.002). Mean endometrial thickness, for all women in both groups, on the day of detecting a mature follicle was significantly higher in the amlodipine group compared to the placebo group (8.99 and 7.0, respectively, with P value 0.003), and clinical pregnancy increased from 11% to 37% in the amlodipine group compared to the placebo group. CONCLUSION: Amlodipine improves ovarian blood flow and increases the chances of conception. TRIAL REGISTRATION: Pan African Clinical Trial Registry (http://www.pactr.org). Trial No: PAC TR201708002485292.

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.

Letrozole vs. Placebo Pretreatment in the Medical Management of First Trimester Missed Miscarriage: a Randomized Controlled Trial.

INTRODUCTION: Misoprostol is used for the medical management of miscarriage as it is more effective in the early stages of pregnancy. Letrozole has an anti-estrogen effect and is used for the pretreatment of miscarriage with misoprostol. AIM: The aim of this study was compare the efficacy and safety of letrozole with placebo pretreatment in the medical management of first trimester missed miscarriage. DESIGN: This was a prospective randomized case-control study. PATIENTS AND METHODS: Four hundred and thirty-eight women were randomly divided into two groups of 219; the placebo group received placebo tablets twice daily for 3 days, followed by 800 micrograms of misoprostol vaginally on the fourth day of enrolment, while the letrozole group received letrozole 10 mg twice daily for three days followed by 800 micrograms misoprostol administered vaginally. Symptoms and side effects were recorded, and the women advised to return to hospital if they experienced severe pain or bleeding or intolerable side effects and to report to hospital for a check-up one week after misoprostol administration. Ultrasound was done seven days after misoprostol administration to monitor outcomes. Surgical evacuation was carried out if medical management failed. RESULTS: There were significant differences between the two groups, with better outcomes found for the letrozole group in terms of rates of complete miscarriage, onset of vaginal bleeding, and interval between induction and onset of expulsion (p < 0.001). A higher rate of nausea and vomiting was reported for the letrozole group (p = 0.002). Differences between groups with regard to pre- and post-termination hemoglobin levels, fever, severe pain and severe bleeding needing evacuation were not statistically significant. CONCLUSION: Adding letrozole to misoprostol improves the success rate and decreases the interval between induction and expulsion in cases of first trimester miscarriage; however, nausea and vomiting is higher with letrozole.

Effect of female genital cutting performed by health care professionals on labor complications in Egyptian women: a prospective cohort study.

AIM: To examine the effect of the degree of female genital cutting (FGC) performed by health-care professionals on perineal scarring; delivery mode; duration of second stage of labor; incidence of perineal tears and episiotomy in a cohort of uncircumcised versus circumcised (types I and II) women. METHODS: A prospective cohort study included 450 primigravida women in active labor attending the Faculty of Medicine Cairo University Hospital between January 2013 and August 2014. Women were divided into three groups based on medical examination upon admission. Group I (Control) included 150 uncut women, Group II included 150 women with type I FGC and Group III included 150 women with type II FGC. A structured questionnaire elicited the information on women's socio-demographic characteristics including age, residence, occupation, educational level, age of marriage and FGC circumstances. Association between FGC and labor complications was examined. MAIN OUTCOMES: risk of perineal scarring; delivery mode; duration of second stage of labor; incidence of perineal tears and episiotomy. RESULTS: Family history of genitally cut mother/sister was the most significant socio-demographic factor associated with FGC. FGC especially type II was associated with significantly higher incidence of vulvar scar (P<0.0002), perineal tears (P<0.0001) and increased likelihood of additional vaginal and perineal trauma [odds ratio (OR): 1.85, 95% CI: 0.60-5.65. P≤0.001]. There was insignificant difference in risks of cesarean section (CS), instrumental delivery, episiotomy and short-term neonatal outcomes. CONCLUSION: The study strengthens the evidence that FGC increases the risk of tears in spite of medicalization of the practice.

Evaluation of Serum Nidogen-2 as a Screening and Diagnostic Tool for Ovarian Cancer.

INTRODUCTION: Ovarian cancer is a relatively common occurrence with the formation of a tumour in the ovaries and is the leading cause of death in the gynecological field. Despite enormous efforts, there are no successful screening methods developed until now to decrease mortality in this regard. AIM: To evaluate nidogen-2 as a new tumour marker combined with higher sensitivity, specificity and accuracy than carbohydrate antigen (CA-125) and Doppler ultrasound to improve early diagnosis of ovarian cancer. PATIENTS AND METHODS: One hundred and forty-four qualified women with a preliminary diagnosis of adnexal mass were subjected to history, examination, transvaginal Doppler ultrasound and Quantitative assessment of serum level of CA-125 and nidogen-2 followed by the resection of the masses, which were sent for histopathological examination. RESULTS: One-hundred and sixteen cases were benign and 28 cases were malignant. The surgical procedures ranged from limited resection to radical hysterectomy. There was a highly significant correlation between both serum nidogen-2 and CA-125 and the results of histopathological examination (p = 0.0001). Serum nidogen-2 had 91.6% sensitivity, 62% specificity, 37.1% positive predictive value, 97.9% negative predictive value and 68% accuracy (p < 0.05). CONCLUSION: Nidogen-2 is a new promising ovarian malignancy biomarker that correlates closely with ultrasound and CA125. It did improve the accuracy of diagnosis, but further studies are needed.