Effect of early tranexamic acid administration on mortality, hysterectomy, and other morbidities in women with post-partum haemorrhage (WOMAN): an international, randomised, double-blind, placebo-controlled trial

Background Post-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. Methods In 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. Findings Between 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 placebo group. Interpretation Tranexamic acid reduces death due to bleeding in women with post-partum haemorrhage with no adverse effects. When used as a treatment for postpartum haemorrhage, tranexamic acid should be given as soon as possible after bleeding onset. Funding London School of Hygiene & Tropical Medicine, Pfizer, UK Department of Health, Wellcome Trust, and Bill & Melinda Gates Foundation

Total laparoscopic hysterectomy: A case report from ILE‑IFE, Nigeria

Total laparoscopic hysterectomy (TLH) is an advanced gynecological laparoscopic procedure that is widely performed in the developed world. However, its feasibility in resource‑poor settings is hampered by obvious lack of equipments and/or skilled personnel. Indeed, TLH has never been reported from any Nigerian hospital. We present a 50‑year‑old multipara scheduled for hysterectomy on account of pre‑malignant disease of the cervix, who had TLH with bilateral salpingo‑oophorectomy in the Obafemi Awolowo University Teaching Hospitals Complex, Ile‑Ife, southwestern Nigeria and was discharged home on the first post‑operative day. She was seen in the gynecology clinic a week later in stable condition and she was highly pleased with the outcome of her surgery. This case is presented to highlight the attainability of operative gynecological laparoscopy, including advanced procedures like TLH in a resource‑constrained setting, through the employment of adequate local adaptation and clever improvisation.Keywords: Laparoscopy, endoscopy, hysterectomy, NigeriaNigerian Medical Journal | Vol. 53 | Issue 4 | October-December | 201

Age and pattern of Pap smear abnormalities: Implications for cervical cancer control in a developing country

Aim: To characterize the age and pattern of Pap smear abnormalities in a major teaching hospital in Southwestern Nigeria. Design: This is a review of medical records of patients that came for cervical cancer screening. Materials and Methods: The Pap smear results of women between May 2013 and April 2015 were retrieved. A total of 2048 Pap smear results were retrieved during the study period and analyzed with Statistical Package for Social Sciences (SPSS) version 20. A total of 252 (12.3%) samples were excluded from the analysis. Results: The mean age of the women was 45.77 ± 9.9 years and the mode was 50 years. Normal Pap smear result was reported in 728 (40.6%) women. Only 20 women has had more than one more than one Pap smear done. The most common abnormality was inflammatory smear result as this was reported in 613 (29.9%) women. Atypical squamous cell of undetermined significance, low-grade squamous intraepithelial lesion (LGSIL), and high-grade squamous intraepithelial lesion (HGSIL) were reported in 117 (5.7%), 209 (10.2%), and 111 (5.4%) women, respectively. Atypical glandular cell and squamous cell carcinoma were reported in 12 (6.0%) and 3 (1.0%), respectively. Conclusion: There is a high incidence of abnormal Pap smear in this environment and women start cervical cancer screening late in their reproductive life, past the age at which cervical premalignant lesions peak. This may be a contributing factor to the high burden of cervical cancer in developing countries

Lidocaine 10% sprays versus oral diclofenac sodium for pain relief in women undergoing hysterosalpingography for infertility workup: A randomized clinical trial

ABSTRACTBackground Tubal disease is the leading cause of female infertility in the West African sub-region and hysterosalpingography (HSG) is the first-line imaging technique in its assessment. HSG is an acutely painful procedure. Various studies on analgesia for HSG were inconclusive. We compared the efficacy of 10 mg lidocaine 10% spray and 50 mg oral diclofenac sodium for pain relief during HSG.Methods This randomized clinical trial was carried out at the Department of Obstetrics and Gynecology, Obafemi Awolowo University Teaching Hospitals Complex (OAUTHC) Ile-Ife, Nigeria between December 2019 and December 2021, among one hundred and eight eligible women undergoing HSG as part of their infertility workup. Ethical clearance was obtained from the ethics committee of the hospital with Protocol number ERC/2019/01/14. They were randomized into two groups. One group of 54 patients received 10 mg of 10% lidocaine spray and an oral placebo, while the second group of 54 women had 50 mg of oral diclofenac sodium and normal saline spray. Pain scores were assessed using a 10 cm visual analog scale at cervical traction, instillation of contrast media, and thirty minutes after HSG. The mean pain scores, the need for additional analgesia, and the occurrence of adverse drug reactions were compared between the two groups.Result Those in the oral diclofenac group had significantly lower pain scores than the 10% Lidocaine group 30 minutes after HSG; 1.13 ± 1.06 Vs. 2.04 ± 1.26 (p < 0.001). The additional analgesic requirement also showed no statistically significant difference between the two groups.Conclusion This study showed that oral diclofenac sodium is comparable to lidocaine spray for pain relief during HSG. It also has the additional benefit of improved quality of life 30 mins after HSG as evidenced by effective pain relief. Consideration should be given to the use of oral diclofenac sodium for pain relief during and after HSG in well-selected patients

An Assessment of Ovarian Cancer Histotypes Across the African Diaspora

ObjectiveOvarian cancer in Black women is common in many West African countries but is relatively rare in North America. Black women have worse survival outcomes when compared to White women. Ovarian cancer histotype, diagnosis, and age at presentation are known prognostic factors for outcome. We sought to conduct a preliminary comparative assessment of these factors across the African diaspora. MethodsPatients diagnosed with ovarian cancer (all histologies) between June 2016-December 2019 in Departments of Pathology at 25 participating sites in Nigeria were identified. Comparative population-based data, inclusive of Caribbean-born Blacks (CBB) and US-born Blacks (USB), were additionally captured from the International Agency for Research on Cancer and Florida Cancer Data Systems. Histology, country of birth, and age at diagnosis data were collected and evaluated across the three subgroups: USB, CBB and Nigerians. Statistical analyses were done using chi-square and student's t-test with significance set at pResultsNigerians had the highest proportion of germ cell tumor (GCT, 11.5%) and sex-cord stromal (SCST, 16.2%) ovarian cancers relative to CBB and USB (p=0.001). CBB (79.4%) and USB (77.3%) women were diagnosed with a larger proportion of serous ovarian cancer than Nigerians (60.4%) (p<0.0001). Nigerians were diagnosed with epithelial ovarian cancers at the youngest age (51.7 +/- 12.8 years) relative to USB (58.9 +/- 15.0) and CBB (59.0 +/- 13.0,p<0.001). Black women [CBB (25.2 +/- 15.0), Nigerians (29.5 +/- 15.1), and USB (33.9 +/- 17.9)] were diagnosed with GCT younger than White women (35.4 +/- 20.5, p=0.011). Black women [Nigerians (47.5 +/- 15.9), USB (50.9 +/- 18.3) and CBB (50.9 +/- 18.3)] were also diagnosed with SCST younger than White women (55.6 +/- 16.5, p<0.01). ConclusionThere is significant variation in age of diagnosis and distribution of ovarian cancer histotype/diagnosis across the African diaspora. The etiology of these findings requires further investigation