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.

Diclofenac Potassium Alone Versus Diclofenac Potassium with Hyoscine-N-butyl Bromide (HBB) in Reduction of Pain in Women Undergoing Office Hysteroscopy: A Double Blind Randomized, Placebo-Controlled Trial.

Study Objective: To compare between oral diclofenac potassium alone versus a combination of it with hyoscine-N-butyl bromide (HBB) in reduction of pain in women undergoing office hysteroscopy. Design: Randomized, double-blind controlled trial. Setting: Kasralainy  hospital (a tertiary hospital). Intervention: Sixty-Four patients undergoing office hysteroscopy were randomly divided into 2 groups (study group and placebo group) in the ratio of 1:1. Group 1 (study group = 32 participants) received two oral HBB tablets and one tablet of diclofenac potassium and group 2 (placebo group = 32 participants) received two oral placebo tablet similar in size, structure and color to buscopan in addition to the diclofenac tablet. The patient was given the drugs 30-60 min before the procedure. Results: There was statistically significant difference between the two groups in the pain score immediately during entry (p value = 0.001) and after 30 min of the procedure (p value = < 0.001). And there was a statistically significant difference as regards the side effects (gastric irritation) of the medications (p value = 0.04) between the women participating in the two groups. Conclusion: The combination of diclofenac potassium and HBB helps a lot in decreasing the pain and discomfort during and after performing office hysteroscopy but with more gastric side effects.

A Randomized Controlled Trial of a 30- versus a 120-Second Delay in Cord Clamping after Term Birth.

OBJECTIVE: Delayed cord clamping (DCC) has been recently adopted in neonatal resuscitation. The immediate cardiac hemodynamic effects related to DCC more than 30 seconds was not studied. We aimed to study the effect of DCC at 120 seconds compared with 30 seconds on multiple hemodynamic variables in full-term infants using an electrical cardiometry (EC) device. STUDY DESIGN: Present study is a randomized clinical trial. The study was conducted with full-term infants who were delivered at the Obstetrics and Gynecology Department in Cairo University Hospital. Sixty-eight full term infants were successfully enrolled in this trial. Cardiac output (CO) and other hemodynamic parameters were evaluated in this study by EC device. Hemoglobin, glucose, and bilirubin concentrations were measured at 24 hours. Newborn infants were assigned randomly into group 1: DCC at 30 seconds, and group 2: DCC at 120 seconds, based on the time of cord clamping. RESULTS: Stroke volume (SV) (mL) and CO (L/min) were significantly higher in group 2 compared with group 1 at 5 minutes (6.71 vs. 5.35 and 1.09 vs. 0.75), 10 minutes (6.43 vs. 5.59 and 0.88 vs. 0.77), 15 minutes (6.45 vs. 5.60 and 0.89 vs. 0.76), and 24 hours (6.67 vs. 5.75 and 0.91vs. 0.81), respectively. Index of contractility (ICON; units) was significantly increased in group 2 at 5 minutes compared with group1 (114.2 vs. 83.8). Hematocrit (%) and total bilirubin concentrations (mg/dL) at 24 hours were significantly increased in group 2 compared with group 1 (51.5 vs. 40.5 and 3.8 vs. 2.9, respectively). CONCLUSION: Stroke volume and cardiac output are significantly higher in neonates with DCC at 120 seconds compared with 30 seconds that continues for the first 24 hours. KEY POINTS: · CO is significantly increased with DCC at 120 seconds.. · SV is significantly increased with DCC at 120 seconds.. · Such effects continued during the entire 24 hours of life in full-term infants..

A comparative study between preoperative rectal misoprostol and intraoperative intrauterine administration in the reduction of blood loss during and after cesarean delivery: A randomized controlled trial.

OBJECTIVE: To compare the efficacy and safety of rectal misoprostol with intrauterine misoprostol in the reduction of blood loss during and after cesarean delivery. METHODS: Ninety-eight pregnant women, all candidates for elective cesarean delivery, were equally randomized into two groups: the rectal group (received preoperative misoprostol rectally) and the intrauterine group (received intrauterine misoprostol after the delivery of the placenta). The primary outcome was the estimated blood loss (EBL) during cesarean delivery. Secondary outcomes included the occurrence of excessive blood loss (>1000 mL) within the first 24 hours postoperatively and the occurrence of any maternal or fetal side effects. RESULTS: There were no statistically significant differences between the two groups regarding either the EBL (693.12 ± 139.09 vs 692.39 ± 132.83; P=0.979) or the occurrence of postpartum hemorrhage (>1000 mL) (6.1% vs 4.1%; P=0.99. Apgar scores at 1 and 5 minutes were significantly higher in the intrauterine group compared to the rectal group. CONCLUSION: Insertion of intrauterine misoprostol is as effective as rectal insertion in reducing blood loss during and after cesarean delivery; however, it has a safer neonatal outcome and is more convenient when administered during cesarean delivery. ClinicalTrials.gov: NCT03723031.

Role of maternal serum ferritin in prediction of preterm labour.

The aim of this study was to evaluate the value of measurement of serum ferritin level in pregnant women to predict preterm labour. The study included 236 women whose haemoglobin (Hb) levels were ≥10.5 gm/dl and gestational age (GA) was less than 30 weeks. Serum ferritin levels were measured at 30 weeks of gestational age. At the end of the study, 23 women delivered with preterm premature rupture of membrane (PPROM) and 17 women delivered before 37 weeks but without PROM (study group). The rest of the pregnant women (196 women) delivered between 37 and 40 weeks (control group). We found a significant difference between the two groups with respect to serum ferritin level. The cut off value of serum ferritin between the two groups was 31 ng/ml with sensitivity 92.8%, specificity 99.4%, positive predictive value 97.5%, negative predictive value 98.4% and accuracy 98.3%. Impact statement What is already known on this subject: maternal serum ferritin has been found to be elevated in women who delivered preterm. What the results of this study add: In this study, we have shown that serum ferritin 31 ng/ml is the optimal cut-point between preterm and full-term women. What the implications are of these findings for clinical practice and/or further research: Serum ferritin 31 ng/ml could be proposed as a potential helpful marker to predict preterm labour.

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.