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The publisher regrets that this article has been temporarily removed. A replacement will appear as soon as possible in which the reason for the removal of the article will be specified, or the article will be reinstated. The full Elsevier Policy on Article Withdrawal can be found at: https://www.elsevier.com/about/policies/article-withdrawal.
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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.
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Aborto Habitual/genética , Carboxipeptidase B2/genética , Óxido Nítrico Sintase Tipo III/genética , Fator A de Crescimento do Endotélio Vascular/genética , Adolescente , Adulto , Estudos de Casos e Controles , Egito , Feminino , Humanos , Gravidez , Adulto JovemRESUMO
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.
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Anticoagulantes/uso terapêutico , Fármacos para a Fertilidade Feminina/uso terapêutico , Glucocorticoides/uso terapêutico , Heparina de Baixo Peso Molecular/uso terapêutico , Infertilidade Feminina/tratamento farmacológico , Indução da Ovulação , Prednisolona/uso terapêutico , Adulto , Anticoagulantes/efeitos adversos , Estudos de Coortes , Terapia Combinada/efeitos adversos , Quimioterapia Combinada/efeitos adversos , Egito/epidemiologia , Características da Família , Feminino , Fármacos para a Fertilidade Feminina/efeitos adversos , Fertilização in vitro , Glucocorticoides/efeitos adversos , Heparina de Baixo Peso Molecular/efeitos adversos , Hospitais Universitários , Humanos , Infertilidade Feminina/terapia , Infertilidade Masculina , Análise de Intenção de Tratamento , Masculino , Ambulatório Hospitalar , Indução da Ovulação/efeitos adversos , Prednisolona/efeitos adversos , Gravidez , Taxa de Gravidez , Estudos RetrospectivosRESUMO
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.
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Cesárea , Útero , Cesárea/efeitos adversos , Cesárea/métodos , Cicatriz/diagnóstico por imagem , Cicatriz/patologia , Estudos Transversais , Feminino , Humanos , Recém-Nascido , Gravidez , Ultrassonografia , Ultrassonografia Pré-Natal/métodos , Útero/diagnóstico por imagem , Útero/patologiaRESUMO
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.
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OBJECTIVE: To evaluate the use of a thin catheter for hysterosalpingography (HSG) for reducing the pain experienced during the procedure. METHODS: Infertile women undergoing tubal patency tests were randomised into two groups. In the study group (n=66) a thin catheter originally designed for intrauterine insemination was used to inject the dye. Leakage of the dye was prevented using a vaginal speculum to press on the portiovaginalis of the cervix. The control group (n=23) underwent HSG using the standard metal cannula. Visual analogue scale (VAS) was used to evaluate the level of pain immediately after the procedure. The main outcome measures were the level of pain experienced by the patient during the procedure and the efficacy of the new technique. RESULTS: The mean (±SD) VAS was 11.2±3.1 in the study group and 54.7±10.1 in the metal cannula group (p<0.0001). During the dye injection, the VAS was 10.3±5.2 in the study group compared to 64.1±17.3 in the metal cannula group (p<0.0001). The new technique was successful in filling the uterine cavity with the dye and studying the fallopian tubes. CONCLUSIONS: Using a thin catheter for HSG and pressing on the cervix with the vaginal speculum to prevent leakage of the dye is a successful method to study the uterine cavity and fallopian tubes, and it significantly reduces the pain as compared to a metal cannula.
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Catéteres/estatística & dados numéricos , Histerossalpingografia/métodos , Infertilidade Feminina/diagnóstico por imagem , Medição da Dor/métodos , Adolescente , Adulto , Catéteres/economia , Colo do Útero/diagnóstico por imagem , Feminino , Humanos , Dor/prevenção & controle , Projetos Piloto , Vagina/diagnóstico por imagem , Adulto JovemRESUMO
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.
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Maturidade Cervical , Ocitócicos , Administração Intravaginal , Feminino , Humanos , Recém-Nascido , Dinitrato de Isossorbida/análogos & derivados , Trabalho de Parto Induzido , Doadores de Óxido Nítrico/uso terapêutico , Gravidez , Gestantes , Estudos ProspectivosRESUMO
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.
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Ruptura Prematura de Membranas Fetais , Trabalho de Parto Prematuro/etiologia , Adulto , Estudos de Casos e Controles , Feminino , Humanos , Idade Materna , Razão de Chances , Gravidez , Fatores de Risco , Infecções Urinárias/complicações , Vagina/microbiologia , Adulto JovemRESUMO
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.
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Aborto Habitual/genética , Carboxipeptidase B2/genética , Polimorfismo de Nucleotídeo Único , Adulto , Estudos de Casos e Controles , Egito , Feminino , Humanos , Gravidez , Adulto JovemRESUMO
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.
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Bactérias Gram-Negativas/isolamento & purificação , Mycoplasma hominis/isolamento & purificação , Trabalho de Parto Prematuro/etiologia , Trichomonas vaginalis/isolamento & purificação , Infecções Urinárias/complicações , Vagina/microbiologia , Adulto , Estudos de Casos e Controles , Feminino , Humanos , Idade Materna , Gravidez , Fatores de RiscoRESUMO
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.
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Anticonvulsivantes/administração & dosagem , Eclampsia/prevenção & controle , Sulfato de Magnésio/administração & dosagem , Pré-Eclâmpsia/tratamento farmacológico , Adulto , Protocolos Clínicos , Feminino , Humanos , Projetos Piloto , Período Pós-Parto , Gravidez , Adulto JovemRESUMO
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.
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Clomifeno/administração & dosagem , Fármacos para a Fertilidade Feminina/administração & dosagem , Infertilidade Feminina/tratamento farmacológico , Metformina/administração & dosagem , Nitrilas/administração & dosagem , Síndrome do Ovário Policístico/complicações , Tiazolidinedionas/administração & dosagem , Triazóis/administração & dosagem , Adulto , Método Duplo-Cego , Resistência a Medicamentos , Quimioterapia Combinada , Egito , Feminino , Humanos , Infertilidade Feminina/etiologia , Análise de Intenção de Tratamento , Letrozol , Ovulação/efeitos dos fármacos , Indução da Ovulação/métodos , Pioglitazona , Estudos ProspectivosRESUMO
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.
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Maturidade Cervical/efeitos dos fármacos , Dinitrato de Isossorbida/análogos & derivados , Trabalho de Parto Induzido/métodos , Misoprostol/administração & dosagem , Doadores de Óxido Nítrico/administração & dosagem , Ocitócicos , Administração Intravaginal , Adulto , Feminino , Humanos , Dinitrato de Isossorbida/administração & dosagem , Gravidez , Estudos Prospectivos , Adulto JovemRESUMO
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.
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Aborto Habitual/terapia , Fosfolipídeos/administração & dosagem , Óleo de Soja/administração & dosagem , Injeções de Esperma Intracitoplásmicas , Adulto , Método Duplo-Cego , Egito , Emulsões/administração & dosagem , Feminino , Humanos , Células Matadoras Naturais/citologia , Nascido Vivo , Recuperação de Oócitos/estatística & dados numéricos , Gravidez , Resultado da Gravidez , Taxa de Gravidez , Primeiro Trimestre da GravidezRESUMO
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.
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Cálcio/administração & dosagem , Infertilidade Feminina/epidemiologia , Infertilidade Feminina/terapia , Síndrome de Hiperestimulação Ovariana/epidemiologia , Síndrome de Hiperestimulação Ovariana/prevenção & controle , Indução da Ovulação/estatística & dados numéricos , Resultado da Gravidez/epidemiologia , Adulto , Comorbidade , Método Duplo-Cego , Egito/epidemiologia , Feminino , Humanos , Incidência , Injeções Intravenosas , Gravidez , Taxa de Gravidez , Fatores de RiscoRESUMO
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.
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Endométrio/lesões , Histeroscopia , Inseminação , Adulto , Feminino , Humanos , Gravidez , Taxa de Gravidez , Estudos ProspectivosRESUMO
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.