SummaryBackgroundPost-partum haemorrhage is the leading cause of maternal death worldwide. Early administration of tranexamic acid reduces deaths due to bleeding in trauma patients. We aimed to assess the effects of early administration of tranexamic acid on death, hysterectomy, and other relevant outcomes in women with post-partum haemorrhage.MethodsIn this randomised, double-blind, placebo-controlled trial, we recruited women aged 16 years and older with a clinical diagnosis of post-partum haemorrhage after a vaginal birth or caesarean section from 193 hospitals in 21 countries. We randomly assigned women to receive either 1 g intravenous tranexamic acid or matching placebo in addition to usual care. If bleeding continued after 30 min, or stopped and restarted within 24 h of the first dose, a second dose of 1 g of tranexamic acid or placebo could be given. Patients were assigned by selection of a numbered treatment pack from a box containing eight numbered packs that were identical apart from the pack number. Participants, care givers, and those assessing outcomes were masked to allocation. We originally planned to enrol 15 000 women with a composite primary endpoint of death from all-causes or hysterectomy within 42 days of giving birth. However, during the trial it became apparent that the decision to conduct a hysterectomy was often made at the same time as randomisation. Although tranexamic acid could influence the risk of death in these cases, it could not affect the risk of hysterectomy. We therefore increased the sample size from 15 000 to 20 000 women in order to estimate the effect of tranexamic acid on the risk of death from post-partum haemorrhage. All analyses were done on an intention-to-treat basis. This trial is registered with ISRCTN76912190 (Dec 8, 2008); ClinicalTrials.gov, number NCT00872469; and PACTR201007000192283.FindingsBetween March, 2010, and April, 2016, 20 060 women were enrolled and randomly assigned to receive tranexamic acid (n=10 051) or placebo (n=10 009), of whom 10 036 and 9985, respectively, were included in the analysis. Death due to bleeding was significantly reduced in women given tranexamic acid (155 [1·5%] of 10 036 patients vs 191 [1·9%] of 9985 in the placebo group, risk ratio [RR] 0·81, 95% CI 0·65–1·00; p=0·045), especially in women given treatment within 3 h of giving birth (89 [1·2%] in the tranexamic acid group vs 127 [1·7%] in the placebo group, RR 0·69, 95% CI 0·52–0·91; p=0·008). All other causes of death did not differ significantly by group. Hysterectomy was not reduced with tranexamic acid (358 [3·6%] patients in the tranexamic acid group vs 351 [3·5%] in the placebo group, RR 1·02, 95% CI 0·88–1·07; p=0·84). The composite primary endpoint of death from all causes or hysterectomy was not reduced with tranexamic acid (534 [5·3%] deaths or hysterectomies in the tranexamic acid group vs 546 [5·5%] in the placebo group, RR 0·97, 95% CI 0·87-1·09; p=0·65). Adverse events (including thromboembolic events) did not differ significantly in the tranexamic acid versus ...

Background There are few published data on the role of vitamin D concentrations during pregnancy in sub-Saharan Africa. Thus, the aim of the current study was to investigate the association between 25-hydroxyvitamin D (25[OH)]D) levels and pre-eclampsia. Method A case-control study, with 60 women in each arm, was conducted in Medani Hospital in Sudan. The cases were women with pre-eclampsia and healthy pregnant women as controls. The medical and obstetric history was obtained using a questionnaire. The serum 25(OH)D concentrations were measured using ELISA. Results The median (IQR) of 25(OH)D concentration was significantly lower in women with pre-eclampsia than in the controls (10.0 [6.5] vs 18.3 [22.1] ng/mL). Fifty-three cases with pre-eclampsia (88%) and 36 cases in the control group (60%) had vitamin D deficiency (25(OH)D level≤20 ng/mL). Multivariate logistic regression showed that the 25(OH)D levels were negatively associated with pre-eclampsia (adjusted OR [AOR]=0.87, 95% CI 0.81 to 0.92). Vitamin D-deficient women were at a higher risk of pre-eclampsia (AOR=4.51, 95% CI 1.70 to 11.94). Conclusion Low 25(OH)D levels were reported in women with pre-eclampsia and were an independent risk factor for pre-eclampsia.

There are few published studies on the association between vitamin D concentrations and preterm birth (PB) in sub-Saharan Africa. The current study aimed to assess the association between 25-hydroxyvitamin D (25[OH)] D) levels and PB. A matched case–control study (60 women in each arm) was conducted in Medani maternity hospital in central Sudan. The cases were women with spontaneous PB, and healthy women with term deliveries were the controls. The clinical/medical and obstetric history was gathered using a questionnaire. The enzyme-linked immunosorbent assay was used to measure the serum 25(OH)D levels. Women with PB had significantly lower median (interquartile range) 25(OH)D concentrations compared with the controls (18.4 (7.3) ng/mL vs. 20.2 (16.5) ng/mL, p = 0.001). Forty-two (70.0%) women with PB and 29 (48.3%) women in the control group had vitamin D deficiency (25(OH)D level ≤ 20 ng/mL). The results of the multivariable logistic regression showed that the 25(OH)D concentrations were negatively associated with PB (adjusted odds ratio (aOR) = 0.92, 95% confidence interval (CI) = 0.87–0.97). Vitamin D-deficient pregnant women were at a higher risk of PB (aOR = 2.69, 95% CI = 1.17–6.23). Low 25(OH)D concentrations were found at the time the variable was determined in women with spontaneous PB and were an independent risk factor for PB.

Objective To determine the cut‐off values for low birth weight (LBW) and high birth weight (HBW) of Sudanese newborns. Methods Data (maternal age, parity, birth weight, and gender of the newborn) from women (n = 2818) who delivered at Saad Abualila Hospital in Khartoum were retrieved from the medical files. Results The cut‐off for LBW (the 10th centile) was 2400 g and the 90th centile (HBW) was 3700 g. Out of 2818 newborns, 317 (11.2%) had birth weights below 2400 g. Using the WHO (traditional) cut‐off of 2500 g, the prevalence of LBW was 14.3%. The difference between the two prevalences of LBW was statistically significant (P < 0.001). However, the agreement rate between the two was high (κ = 0.86). The cut‐off to define HBW was 3700 g. In the study, 292 (10.4%) newborns had birth weights of at least 3700 g. Using the cut‐off of 4000 g, the prevalence of HBW was 9.5%. The difference between the two prevalences of HBW was statistically significant (P < 0.001). However, the agreement rate between the two was low (κ = 0.06). Conclusion The cut‐off values for low and high birth weight were 2400 and 3700 g, respectively.

Background Preterm birth is the most common cause of neonatal morbidity and mortality. Tocolytics are considered a standard treatment for women with threatened preterm delivery to allow time for maternal steroid administration and transfer to referral centers with neonatal intensive care units. However, there is controversy about the best tocolytic therapy to be considered as the first choice. The aim of this study is to compare the tocolytic effectiveness and tolerability of combination therapy with nifedipine and indomethacin versus nifedipine monotherapy among Sudanese women with preterm labor (PTL) as well as to compare the possible neonatal outcomes associated with each drug. Methods/design This is a randomized controlled clinical trial to be conducted in the Medani Maternity Hospital, Sudan. Women aged 18–40 years that are diagnosed with preterm labor and have a gestational age between 25 and 34 weeks will be eligible to participate in this trial. The diagnosis of threatened PTL is defined as persistent uterine contractions “(four contractions every 20 min or eight contractions every 60 min)” with cervical changes “(cervical effacement ≤80% or cervical dilatation >two cm)”. Patients will be eligible regardless of the presentation of the fetus. It will be randomly decided whether participants receive nifedipine/indomethacin combination therapy or nifedipine monotherapy. The primary outcome is the number of women who do not deliver and do not need alternative tocolytic drug (terbutaline). The secondary outcome is an estimated association with neonatal morbidity and mortality. The sample size will be 117 subjects in each arm of the study, according to a type I error of 0.05 and a study power of 80%. Discussion We expect higher effectiveness of the combination indomethacin/nifedipine tocolytic therapy compared with nifedipine monotherapy. We plan to suggest this combination therapy as the best option for postponing PTL. Trial registration Clinical trial registration: PACTR202004681537890, date of registration: March 8, 2020.