TEMPORARY REMOVAL: The Effect of Preoperative Intravenous Tranexamic Acid Versus Rectal Misoprostol in Reducing Blood Loss During and After Elective Cesarean Delivery in Primigravida: A Double-Blinded, Randomized, Comparative-Placebo Trial.

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Transabdominal versus transvaginal ultrasound to assess the thickness of lower uterine segment at term in women with previous cesarean section.

OBJECTIVE: This study aims to compare transvaginal (TVS) and transabdominal (TAS) ultrasonography precision in to evaluate the lower uterine (LUS) thickness in women with a previous Cesarean section at the term pregnancy; to be an effective method for assessment of previous cesarean scar strength. MATERIAL AND METHODS: An observational cross-sectional study was conducted at kasr el-ainy Hospital in Egypt. From May to November 2020, we admitted 130 pregnant women at term with a previous cesarean section for an elective cesarean delivery. Lower uterine segment thickness was obtained using both transvaginal ultrasound and transabdominal ultrasound before the cesarean. The exact thickness of the lower uterine segment was recorded using a sterile metal ruler before the neonate had been delivered. RESULTS: The mean thickness of the lower uterine segment obtained by transabdominal ultrasound was 5.2 ± 1.6 mm and 4.8 ± 1.33 mm by transvaginal ultrasound, then compared each of them to the mean actual thickness, which was 4.5 ± 1.22 mm. The lower uterine segment thickness with transabdominal ultrasound showed a good correlation (r = 0.722) with the actual thickness, the correlation with transvaginal ultrasound was better (r = 0.944). A cut-off value transvaginal ultrasound of 3.65 mm with 90.8% sensitivity and 65.6% specificity. CONCLUSION: Transvaginal ultrasound is more accurate in assessing the thickness of the lower uterine segment than transabdominal ultrasound. A total lower uterine segment thickness of <3.65 is considered a thin scar, and <2.85 mm is associated with a higher risk of uterine dehiscence. The trial was registered in ClinicalTrials.gov registry with clinical trial. https://clinicaltrials.gov/ct2/show/NCT04687891.

Histopathological profile of women who had previously failed in-vitro fertilization and the association to the outcome in the subsequent in-vitro fertilization cycle.

OBJECTIVE: To evaluate the endometrial histopathological profile of patients undergoing curettage and the association of the histopathological profile with the pregnancy outcome during the subsequent in-vitro fertilization (IVF) cycle. METHODS: In this retrospective cohort study, a total of 248 women with at least one failed attempt of IVF and who underwent curettage and a subsequent IVF were included. Demographic data, endometrial histopathological records, stimulation information, and pregnancy outcomes were collected and analyzed. RESULTS: The histopathological analysis of endometrial tissues showed that 130 women (52.4%) had endometrial pathologies. Of these women, 103 (41.5%) had endometrial polyps, 22 (8.9%) had chronic endometritis, and five (2.0%) had both polyps and endometritis. No statistical difference was observed between the normal histopathology group and the abnormal histopathology group in the outcome of the subsequent IVF cycle. Subgroup analyses were performed to further characterize and compare women with normal histopathology and women with endometrial polyps (polyp subgroup) or chronic endometritis (endometritis subgroup). No statistical differences were found among the three groups in the rates of pregnancy (44.1% vs. 49.5% vs. 45.5%, P=0.72), biochemical pregnancy loss (13.5% vs. 15.7% vs. 20.0%, P=0.86), clinical pregnancy loss (25.0% vs. 31.4% vs. 30.0%, P=0.77), and live birth (27.1% vs. 26.2% vs. 22.7%, P=0.91) during the subsequent IVF cycle. CONCLUSION: Women with previously failed IVF and abnormal endometrial histopathology treated with curettage had the same outcome in the subsequent IVF cycle as women with normal endometrial histopathology.

Isosorbide mononitrate for cervical ripening in induction of labor for pregnant women with PROM at or post term.

OBJECTIVE: To evaluate the efficacy of isosorbide mononitrate (IMN) for stimulating cervical ripening among pregnant women with premature rupture of membranes (PROM) at or post term. METHODS: A prospective randomized double-blind, placebo-controlled trial at Kasr El-Ainy Hospital, Cairo, Egypt, from October 2018 to May 2019. Pregnant women at or post term with PROM and unfavorable cervix (Bishop score ≤6) were randomly assigned to receive intra-vaginal IMN (n = 70) or placebo (n = 70) before admission for induction of labor. The main outcome was induction to the delivery interval. Data were compared between groups by t test. RESULTS: The mean ± SD duration from the initial dose of IMN/placebo to the beginning of the active phase of labor was significantly shorter in the IMN group than in the control group (9.7 ± 5.6 h vs. 12.9 ± 5.3 h). The IMN group also had a shorter time interval from induction to delivery (P < 0.01). There was no difference in adverse effects between the groups. CONCLUSION: Intra-vaginal IMN for cervical ripening in the induction of labor among pregnant with PROM at or post term was found to be effective and safe with minimal adverse effects, and good neonatal and maternal outcomes. ClinicalTrials.gov: NCT03665779.

Risk factors associated with preterm labor, with special emphasis on preterm premature rupture of membranes and severe preterm labor.

BACKGROUND: Preterm labor (PTL) can lead to preterm birth, which can cause neonatal mortality and morbidity. Preterm premature rupture of membranes (PPROM) and severe PTL (SPTL) are serious PTL subtypes. Hereby, we aimed to investigate risk factors associated with PPROM and SPTL, among Egyptian women. METHODS: In this case-control study, 117 women were enrolled without any known medical risk for PTL. The control group (n = 45) had term labor (≥37 gestational weeks), while the case group (n = 72) had PTL (<37 gestational weeks). The PTL group was subdivided into those with PPROM (n = 18) and those with intact membranes (n = 54). Fifty-two PTL women, with accurate gestational age, were subdivided into SPTL (n = 31, ≤34 gestational weeks) and mild preterm labor (MPTL; n = 21, 35-36 gestational weeks). All groups were examined for different demographic characteristics, obstetrical history, clinical signs, and vaginal and urinary tract infections. Nominal logistic regression was applied to investigate significant variables associated with PPROM and intact membranes PTL, while ordinal logistic regression was used to estimate significant variables associated with SPTL and MPTL. RESULTS: The final multivariate nominal model identified abortion history, heavy vaginal bleeding history, and elevated vaginal pH as significant predictors of PPROM. The same model identified age <20 years old, abortion history, heavy growth of vaginal organisms, and any growth of Gram-negative bacilli as the significant predictors of intact membranes PTL. The final multivariate ordinal model identified age <20 years old, abortion history, vaginal pH, and heavy growth of vaginal organisms as the significant predictors of SPTL and MPTL. CONCLUSION: Age <20 years old, abortion history, heavy vaginal bleeding, vaginal pH, and heavy growth of vaginal organisms were reported as risk factors for PPROM and SPTL. Most of these factors are related to infection; therefore, proper infection control is recommended during prenatal and antenatal care.

The prevalence of combined vascular endothelial growth factor, endothelial nitric oxide synthase and thrombin-activatable fibrinolysis inhibitor genetic polymorphisms among Egyptian patients with recurrent spontaneous abortion.

AIM: As angiogenesis is an essential step for chorionic villi formation. Vascular endothelial growth factor (VEGF) is essential for endothelial cell proliferation. Endothelial nitric oxide synthase (eNOS) is a powerful playmaker in hypoxia-induced angiogenesis. Thrombin-activatable fibrinolysis inhibitor (TAFI) regulates both fibrinolysis and inflammation. Genetic alterations of these factors may lead to recurrent spontaneous abortion (RSA). We aimed to investigate the combined genetic variants of VEGF G-1154A and two eNOS genetic variants: T-786C promoter region and intron 4 variable number of tandom repeats in addition to TAFI C-1040T among RSA patients. METHODS: The study included 50 patients with RSA and 50 healthy controls. Polymerase chain reaction and restriction fragment length polymorphism were used for genotyping. RESULTS: Both genetic alterations of eNOS confirmed at least a sixfold increase of RSA risk. Interestingly, they were associated with TAFI C-1040Tgenetic variant in 21 patients, eight of them had both studied eNOS genetic alterations and TAFI C-1040Tgenetic variant, while each eNOS genetic variant associated with TAFI C-1040Tconfirmed an almost one and half fold increase risk of RSA. CONCLUSION: These findings highlighted the role of eNOS and nitric oxide metabolism in RSA and opened the gate to investigate the interaction of vasoconstrictive and fibrinolytic inhibitor systems.

Thrombin-Activatable Fibrinolysis Inhibitor Gene Polymorphism (TAFI1040C/T) in Women With Recurrent Spontaneous Abortion.

Recurrent spontaneous abortion (RSA) is defined as 3 or more consecutive pregnancy failures. Thrombin-activatable fibrinolysis inhibitor (TAFI) is a plasma zymogen that regulates both fibrinolysis and inflammation. The TAFI 1040C/T polymorphism could alter the circulating levels of TAFI with a reduced capacity to remove the fibrin clots from the circulation; therefore, it could be considered a molecular risk factor for RSA. The TAFI 1040C/T polymorphism was studied in 50 patients with RSA by polymerase chain reaction-restriction fragment length polymorphism technique and compared to 50 age- and gender-matched healthy volunteers as a control group to verify its possible association with RSA. In case group, the wild genotype (C/C) and heterozygous genotype (C/T) did not reduce the risk of RSA (odds ratio: 0.368 and 0.767, respectively), even when compared to the number of RSA ( P = .71). A higher frequency of C allele in the control group and a higher frequency of T allele in the case group were observed but with no statistical significance. In conclusion, our study revealed that TAFI 1040C/T could not be considered a molecular predictive factor for RSA in Egyptians.

Administration of prednisolone and low molecular weight heparin in patients with repeated implantation failures: a cohort study.

Conflicting results exist for low molecular weight heparin (LMWH) and prednisolone when tested as separate adjuncts for the improvement of the clinical outcomes in patients with repeated implantation failures (RIF) undergoing IVF/ICSI treatment. Through a cohort study, we evaluated the combined effect of both drugs on pregnancy parameters in 115 women with RIF. Clinical pregnancy rate was the primary end point while the sample size was calculated through the results of a pilot study. Clinical and IVF cycle characteristics were also compared between the groups. Baseline and cycle characteristics were comparable between groups. Biochemical and clinical pregnancy rates were similar in both groups [23/57 (40.4%) vs. 14/58 (24.1%), and 17/57 (29.8%) vs. 11/58 (19%), p = .063, and .175, respectively]. Similarly, miscarriage rates were comparable between the groups (35.7% vs. 34.8%), as well as live birth rates [15/57 (26.3%) vs. 9/58 (15.5%), p = .154]. In conclusion, the administration of LMWH with prednizolone in subfertile women with RIF seems not to improve clinical pregnancy rates, but a full-scaled RCT would definitely be more accurate.

Association between preterm labor and genitourinary tract infections caused by Trichomonas vaginalis, Mycoplasma hominis, Gram-negative bacilli, and coryneforms.

BACKGROUND: Preterm labor (PTL) is responsible for most cases of neonatal death. In most of these cases, the causes of PTL have not been established although several risk factors have been described. Therefore, the aim of this study was to investigate risk factors for PTL before 37 gestational weeks among Egyptian women. METHODS: In this case-control study, 117 pregnant women without risk factors for PTL were chosen. The control group (n=45) had term labor (gestational weeks≥37 weeks), and the case group (n=72) had PTL (gestational weeks < 37 weeks). The two groups were screened for urinary and vaginal infections. The role of different demographic characteristics, patient history, and clinical signs were also investigated. RESULTS: Several risk factors were identified in this study, including age<20 years, nulliparity, previous abortion and previous preterm birth, menses vaginal bleeding, a vaginal pH>5, a positive whiff test, Trichomonas vaginalis infection, Mycoplasma hominis infection, coryneforms heavy vaginal growth, and any vaginal growth of Gram-negative bacilli. Urinary tract infection with any colony count was not associated with PTL. CONCLUSION: Our study demonstrated that the main risk factors for PTL were vaginal infection with T. vaginalis, M. hominis, coryneforms, and Gram-negative bacilli, and their determinants (vaginal pH>5, positive whiff test, heavy vaginal bleeding). Both young age (< 20 years) and poor obstetric history were also the risk factors. Therefore, screening for genitourinary tract infections is strongly recommended to be included in prenatal care.

Intralipid supplementation in women with recurrent spontaneous abortion and elevated levels of natural killer cells.

OBJECTIVE: To investigate the efficacy of intralipid supplementation in women with recurrent spontaneous abortion (RSA) and elevated natural killer cell activity undergoing in vitro fertilization/intracytoplasmic sperm injection. METHODS: Between February 10, 2013, and April 30, 2015, a double-blind randomized controlled study was conducted at a center in Egypt. Women with unexplained secondary infertility, RSA, and elevated levels of natural killer cells (>12%) were enrolled and randomly assigned to receive intralipid (2mL diluted at 20% in 250mL saline) or saline (250mL) infusion on the day of oocyte retrieval using random numbers and sealed envelopes. Patients and attending physicians were masked to group assignment. The infusions were repeated within 1week of a positive pregnancy test and then every 2weeks until the end of the first trimester. The primary outcome was chemical pregnancy 14days after embryo transfer. Analyses were by intention-to-treat. RESULTS: Overall, 296 women were enrolled. Chemical pregnancy was recorded for 84 (58.3%) of 144 women in the intralipid group and 76 (50.0%) of 152 in the control group (P=0.129). CONCLUSION: Intralipid supplementation did not increase frequency of chemical pregnancy. However, findings related to ongoing pregnancy and live birth should be investigated further. ClinicalTrials.gov:NCT01788540.

A randomized controlled trial of clomifene citrate, metformin, and pioglitazone versus letrozole, metformin, and pioglitazone for clomifene-citrate-resistant polycystic ovary syndrome.

OBJECTIVE: To examine the efficacy of clomifene citrate, metformin, and pioglitazone versus letrozole, metformin, and pioglitazone among women with polycystic ovary syndrome (PCOS) resistant to clomifene citrate. METHODS: A prospective double-blind randomized controlled trial of women younger than 40 years who had primary/secondary infertility associated with PCOS and had not ovulated in response to clomifene citrate regimens previously was conducted at a center in Cairo, Egypt, between August 1, 2013, and December 31, 2014. Computer-generated random number tables and opaque envelopes were used to assign participants to group A or group B. Participants allocated to group A received 100mg clomifene citrate daily for 5 days from the third day of the menstrual cycle, whereas those in group B received 5mg letrozole daily in the same regimen. All patients received 850 mg metformin and 15 mg pioglitazone for 10 days from the first day of the menstrual cycle. The primary outcome was cumulative ovulation rate. Analyses were by intention to treat. RESULTS: Fifty women were assigned to each group. Ovulation occurred in 108 (92.3%) of 117 cycles in group A and 93 (86.9%) of 107 cycles in Group B (P=0.184). CONCLUSION: Combined treatment with letrozole, metformin, and pioglitazone was efficacious among women with PCOS resistant to clomifene citrate. ClinicalTrials.gov: NCT01909141.

A novel protocol for postpartum magnesium sulphate in severe pre-eclampsia: a randomized controlled pilot trial.

OBJECTIVE: Magnesium sulphate is the preferred anticonvulsant used to prevent the development of fits in severe pre-eclampsia; we aim to compare between three different protocols of postpartum magnesium sulphate in the effectiveness of preventing the development of fits in severe pre-eclampsia. METHODS: Double-blind randomized controlled pilot trial, done in Cairo university hospital, Cairo, Egypt during 2013-2014, on 240 women with severe pre-eclampsia. Magnesium sulphate intravenous infusion was given in the postpartum period to all the patients, women were randomly allocated to group I (Single loading dose only), group II (12 h abbreviated protocol) or group III (24 h standard protocol) (n = 80 in each group). RESULTS: There were no significant difference between the three groups as regards the incidence of eclampsia, elevated liver enzymes and low platelets syndrome, maternal ICU admission and; however The incidence of flushing was significantly higher in group III than group II and I (24 [30%] versus 12 [15%] versus 4 [5%]; p < 0.001) respectively. CONCLUSION: The pilot study demonstrates that the single-loading dose of postpartum magnesium sulphate is a promising alternative to the standard and the abbreviated protocol in preventing eclampsia; however, a large clinical trial is necessary to prove this.

Comparing vaginal misoprostol versus Foley catheter plus vaginal isosorbide mononitrate for labor induction.

OBJECTIVE(S): To compare the effectiveness and safety of intra-cervical Foley catheter combined with intra-vaginal isosorbide mononitrate (IMN) versus intra-vaginal misoprostol for cervical ripening and labor induction in pregnant women with unripe cervices. METHODS: Open-labeled randomized controlled trial in Cairo university hospital, Cairo, Egypt during 2012-2014. Three hundred and ninety-five pregnant women at term or post-term with an indication for labor induction and unripe cervix were included in the study. The subjects were randomly divided into two groups. Vaginal misoprostol was used in group 1 (n = 197) and intra-cervical Foley catheter plus vaginal IMN in group 2 (n = 198). Our main outcome measure was cesarean section rate. RESULTS: Among the 395 included patients there were significantly lower duration of induction of labor (p < 0.001) in group 1with lower cesarean section rates [22.8% in group 1versus 33.3% in group 2; RR 0.7 (0.6-0.9), (p = 0.020)]. Whereas the uterine hyperstimulation (p < 0.001) was significantly higher in group 1. There were no significant differences between both groups as regard patients' demographic characteristics. CONCLUSIONS(S): Vaginal misoprostol is more effective but less safe than Foley catheter combined with vaginal IMN for induction of labor in term and post-term pregnancy.

RETRACTED: Comparing the effect of office hysteroscopy with endometrial scratch versus office hysteroscopy on intrauterine insemination outcome: a randomized controlled trial.

This article has been retracted: please see Elsevier Policy on Article Withdrawal (https://www.elsevier.com/about/our-business/policies/article-withdrawal). This article has been retracted at the request of the Editor-in-Chief. The editors were alerted to the possibility of data fabrication in this study by a systematic reviewer who had noticed discrepancies between the trial registry and the published version, and an implausible interval between the date of last recruit and paper submission, given the duration of follow-up. The editors wrote to Dr El-Khayat, who did not give a clear explanation, but kindly supplied a copy of the trial dataset. An independent statistical review of that dataset suggested a high probability that at least some of the data had been fabricated. We shared the comments of our statistical reviewer's analysis with Dr El-Kayat who again failed to give a satisfactory explanation. As suggested by the Committee on Publication Ethics (COPE), the editor-in-chief wrote to the authorities at Cairo University requesting that they investigate. We have not heard back from them. We have therefore decided to retract.

Calcium infusion for the prevention of ovarian hyperstimulation syndrome: a double-blind randomized controlled trial.

OBJECTIVE: To evaluate the role of calcium infusion as a preventive strategy of ovarian hyperstimulation syndrome (OHSS) in women at high risk in in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI) treatment cycles. DESIGN: Double-blinded randomized controlled trial. SETTING: University hospital department of obstetrics and gynecology and private IVF center. PATIENT(S): Two hundred women at risk to develop OHSS undergoing IVF/ICSI treatment cycle. INTERVENTION(S): The intervention group (group 1; n = 100) received intravenous infusion of 10 mL 10% calcium gluconate in 100 mL 0.9% saline solution on the day of ovum pick-up (OPU) and days 1, 2, and 3 after, and the placebo group (group 2; n = 100) received 100 mL 0.9% saline solution on the day of OPU and days 1, 2, and 3 after. MAIN OUTCOME MEASURE(S): Incidence of OHSS. RESULT(S): OHSS incidence was significantly higher in the placebo group (group 2) than in the calcium infusion group (group 1): 23 (23%) vs. 7 (7%); moderate OHSS was significantly higher in group 2 than in group 1: 8 (8%) vs. 1 (1%); and severe OHSS was significantly higher in group 2 than in group 1: 4 (4%) vs. 0. CONCLUSION(S): Intravenous calcium infusion effectively reduced the incidence of OHSS development without reduction in the pregnancy rate. CLINICAL TRIAL REGISTRATION NUMBER: NCT01427335.

A randomized controlled trial of uterine exteriorization versus in situ repair of the uterine incision during cesarean delivery.

OBJECTIVE: To compare extra-abdominal repair of the uterine incision at cesarean delivery with in situ repair. METHODS: The present study was a double-blind randomized controlled trial conducted at a university hospital in Egypt during 2012-2013, and included women with an indication for cesarean delivery. Extra-abdominal repair was used in group 1 (n=500) and in situ repair in group 2 (n=500). The primary outcome measure was the surgery duration. RESULTS: Surgery duration was significantly longer in group 1 than group 2 (49.9±2.3 minutes vs 39.9±1.8 minutes; P<0.001). More patients in group 1 than in group 2 had postoperative moderate-to-severe pain (165 [33.0%] vs 115 [23.0%]; P=0.001) and needed additional postoperative analgesia (100 [20.0%] vs 50 [10.0%]; P<0.001). Moreover, mean time to bowel movement was longer in group 1 than in group 2 (17.0±2.7 hours vs 14.0±1.9 hours; P<0.001). CONCLUSION: In situ uterine closure is more advantageous than extra-abdominal repair in terms of surgery duration, postoperative pain and need for additional analgesia, and return of bowel movement. ClinicalTrials.gov:NCT01723605.

Comfort, ease of use and practicality of the pen injector for follitropin α for assisted reproduction: an observational post-marketing study in Egypt.

OBJECTIVE: We evaluated the ease of use of a pen injector for follitropin α (recombinant human follicle-stimulating hormone [r-hFSH]) during assisted reproduction technologies (ARTs) in Egypt. METHODS: One hundred women undergoing ART completed a questionnaire in a non-interventional, observational study. The primary endpoint was patients' rating of the comfort associated with the injector. The main limitations of the study were the design and lack of knowledge regarding any impact of failure of ART on perceptions of treatment for a minority of patients. RESULTS: Patients rated the follitropin α pen injector as 'very comfortable' (61%), 'comfortable' (29%), or 'somewhat comfortable' (10%). Understanding instructions and using it were 'very easy' or 'easy' for 97-99%; 94% reported 'no' or 'minimal' difficulty with injections, 83% were 'very confident' about altering doses, 77% reported no interference with normal daily activities and 94% reported 'no' or 'minimal' stress using the device. Women with previous experience of ART rated the device as more practical than their previous injection system. Overall, 96% were 'very satisfied' or 'satisfied' with the device and 99% would recommend its use to others. Pregnancy rates were consistent with previous clinical experience. Injection site reactions occurred in 10% (all of mild severity except one moderate event). CONCLUSIONS: Positive perceptions of the follitropin α pen injector identify this device as suitable for use for Middle Eastern women undergoing ART.