Oxytocin versus a combination of tranexamic acid and ethamsylate in reducing intraoperative bleeding during abdominal myomectomy: a randomized clinical trial.

OBJECTIVE: Myomectomy is the preferred surgical approach to manage uterine fibroids. However, uterine fibroids are highly vascular tumors and, consequently, extremely susceptible to problems from myomectomy-related hemorrhage. Hence, we aim to compare oxytocin efficacy and safety profile versus tranexamic acid (TA) with ethamsylate for reducing bleeding during myomectomy. METHODS: This randomized, double-blinded multicenter study was performed between 20th August 2020 and 20th October 2020 at El-Galaa Teaching Hospital, El Hussein University Hospital, Al-Azhar University Hospitals of Assiut, and Al-Azhar University Hospitals of Damietta. One hundred and eighty patients were enrolled and divided into three groups: group (1) received an injection of 30 IU of oxytocin in 500 ml of normal saline; group (2) received injections of 1 g of TA, 250 mg of Ethamsylate, and 110 ml of normal saline IV; and group (3) received an injection of 110 ml of normal saline IV just before surgical incision. RESULTS: In 180 premenopausal women, oxytocin and TA with ethamsylate had no significant value in lowering intraoperative blood loss compared with the placebo for abdominal myomectomy (666.25 ± 183.03, 630.72 ± 145.83, and 646.67 ± 168.92, respectively (P = 0.506)). Non-significant trends were observed for a reduction in operation time (P = 0.760), intra/postoperative blood transfusion (P = 0.624), hospital stay (P = 0.986), postoperative fever (P = 0.659), and wound infection (P = 1). CONCLUSION: Oxytocin and TA with ethamsylate had no significant value in lowering intraoperative blood loss compared with the placebo for abdominal myomectomy which opens a new question about the role of the use of the hemostatic drug during myomectomy especially in centers with limited resources and had higher rates. TRIAL REGISTRATION: The study was registered on Pan African Clinical Trials Registry with the following number: PACTR202008739887429 and was approved on 24/08/2020.

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.

Effect of maternal obesity on labor induction in postdate pregnancy.

OBJECTIVE: To test the hypothesis that there is a higher rate of unsuccessful induction of labor (IOL) in post-term obese pregnant women compared to non-obese ones. METHODS: In this prospective cohort study, 144 obese (BMI > 30) and 144 non-obese (BMI < 29.9) post-term (> 41 weeks) pregnant women were recruited. IOL was done by misoprostol or amniotomy and oxytocin infusion according to the Bishop score. Comparison of percentage of failed IOL in both groups (primary outcome) was performed by the Chi-test. Logistic regression and multivariable regression were performed to assess the odds ratio (OR) of cesarean section (CS) and coefficient of delay in labor till vaginal delivery (VD) in obese versus (vs) non-obese groups. Adjustment for gestational age, parity, Bishop Score, membrane rupture and amniotic fluid index was done in both regression analyses. RESULTS: CS rate was significantly higher in obese group [26.4 vs 15.9%; difference in proportion (95% CI) 0.1 (0.01, 0.19); P value 0.02]. 106 (73.6%) obese women and 121 (84.1%) non-obese women delivered vaginally. In addition, the duration till VD was significantly higher in obese group (22 vs 19 h, P value 0.01). After adjustment for possible confounding factors, the CS was still higher in the obese group in comparison to non-obese group (OR 2.02; 95% CI 1.1, 3.7; P value 0.02). This finding suggested that obesity was an independent factor for failure of IOL. In addition, after adjustment for these confounders, obesity had the risk of increasing labor duration by 2.3 h (95% CI 0.1, 4.5) in cases that ended in VD. CONCLUSION: Based on our results, we conclude that there is a higher risk of CS in obese postdate pregnant women undergoing IOL in comparison to non-obese counterparts. Therefore, obstetricians should pay more attention to advising pregnant women about optimal weight gain during pregnancy and counseling about the chances of VD in cases of IOL. CLINCALTRIAL. GOV ID: NCT02788305.

Effect of Prolonged GnRH Agonist Downregulation on ICSI Outcome in Patients With Endometriomas of Less Than 5 cm: A Randomized Controlled Trial.

OBJECTIVE: To evaluate the effect of prolonged Gonadotropin releasing hormone (GnRH) agonist downregulation in patients with endometriomas of less than 5 cm on the outcome of the proceeding Intracytoplasmic sperm injection (ICSI) trial. METHODS: In a randomized controlled trial at a university teaching hospital, 90 patients indicated for ICSI and having unilateral single endometrioma of less than 5 cm in diameter were randomized into 2 groups. Group A (45 patients) received the standard long protocol; whereas group B (45 patients) received 3 consecutive Intramuscular (IM) injections of triptorelin 3.75 mg 28 days apart followed by the standard long protocol 28 days after the last injection. RESULTS: There were no significant differences in the clinical and hormonal characteristics between the 2 groups. All ICSI cycle characteristics including number of retrieved oocytes, fertilized oocytes, and transferred embryos were also not significantly different. However, patients who received prolonged GnRH agonist therapy showed significantly higher chemical ( P = .011), clinical ( P = .018), and ongoing ( P = .028) pregnancy rates. CONCLUSION: Prolonged GnRH agonist downregulation improves the pregnancy rates in patients with small endometriomas undergoing ICSI.

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.

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

[This corrects the article DOI: 10.1055/s-0043-122499.].

Prospective study of the effect of maternal body mass index on labor progress in nulliparous women in Egypt.

OBJECTIVE: To evaluate the impact of maternal body mass index (BMI, calculated as weight in kilograms divided by the square of height in meters) on labor progress in nulliparous women. METHODS: The present prospective cohort study enrolled primigravidae admitted to Kasr Al Ainy hospital, Cairo University, Egypt, during active labor between February 1, 2016, and February 28, 2017. Patients were classified into three equal groups using their BMI at admission: underweight (<18.5), normal weight (18.5-29.9), and obese (≥30). The primary outcome was the rate of cervical dilatation; secondary outcomes included the duration of the second stage of labor, neonatal delivery weight, and the mode of delivery. RESULTS: Among the 600 primigravidae enrolled (200 in each group), significant differences were recorded in the rates of cervical dilatation (P<0.001), and the duration of the active labor phase (P<0.001) and the whole of labor (P<0.001); in the obese group, the cervical dilatation rate was lowest and the durations of the active phase of labor and the whole of labor were longer. The incidence of intrapartum cesarean delivery (P<0.001) and neonatal delivery weight (P<0.001) also differed between the groups; both were highest in the obese group. CONCLUSIONS: Patterns in labor progress, including cervical dilatation rate and labor duration, differed among patients with different BMI. ClinicalTrials.gov: NCT02686073.

GnRH agonist plus vaginal progesterone for luteal phase support in ICSI cycles: a randomized study.

In this prospective randomized study, the effect of daily gonadotrophin-releasing hormone agonist (GnRHa) in the luteal phase on IVF and intracytoplasmic sperm injection (ICSI) outcomes was assessed. Women (n = 446) were counselled for IVF-ICSI, and randomized on the day of embryo transfer to group 1 (daily 0.1 mg subcutaneous GnRHa until day of beta-HCG) (n = 224) and group 2 (stopped GnRHa on day of HCG injection) (n = 222). Both groups received daily vaginal progesterone suppositories. Primary outcome was clinical pregnancy rate. Secondary outcome was ongoing pregnancy rate beyond 20 weeks. Mean age, oestradiol on day of HCG, number of oocytes retrieved, number of embryos transferred, and clinical and ongoing pregnancy rates were 28.9 ± 4.5 years, 2401 ± 746 pg/mL; 13.5 ± 6.0 oocytes; 2.6 ± 0.6 embryos, and 36.2% and 30.4% consecutively in group 1 compared with 29.7 ± 4.7 years, 2483 ± 867 pg/mL, 13.7 ± 5.5 oocytes, 2.7 ± 0.6 embryos, 30.6% pregnancy rate, and 25.7% ongoing pregnancy rate in group 2. No significant difference was found between the groups. Subcutaneous GnRHa during the luteal phase of long GnRHa protocol cycles does not increase clinical or ongoing pregnancy rates after IVF-ICSI.