Effects of speculum lubrication on cervical smears for cervical cancer screening: A double blind randomized clinical trial.

BACKGROUND: Speculum lubrication may help to reduce the pain experienced during Pap-smear collection and hence increase uptake of cervical cancer screening and repeat testing, but there are fears of its interference with cytological results. AIM: To determine and compare the adequacy of cervical cytology smears and the mean pain scores of women undergoing cervical cancer screening with or without speculum lubrication. METHODS: This was a randomised controlled study of 132 women having cervical cancer screening at a tertiary hospital in Nigeria. Sixty-six participants were randomly assigned to the 'Gel' and 'No Gel' groups, respectively. Pap smears were collected from each participant with a lubricated speculum ('Gel group') or a non-lubricated speculum ('No Gel group'). The primary outcome measures were the proportion of women with unsatisfactory cervical cytology smears and the mean numeric rating scale pain scores, while the secondary outcome measures were the proportion of women who were willing to come for repeat testing and the cytological diagnosis of Pap-smear results. RESULTS: The baseline socio-demographic variables were similar in both groups. There was no significant difference in the proportion of unsatisfactory cervical smear results between the two groups (13.6% vs. 21.2%, p = 0.359). However, the mean pain scores were significantly lower in the gel group than in the no gel group (45.04 vs. 87.96; p<0.001). An equal proportion of the participants in each group (90.9% vs. 90.9%; p > 0.999) were willing to come for repeat cervical smears in the future. CONCLUSION: Speculum lubrication did not affect the adequacy of cervical smears but significantly reduced the pain experienced during pap smear collection. Also, it did not significantly affect the willingness to come for repeat cervical smears in the future. TRIAL REGISTRATION: The trial was registered with the Pan-African Clinical Trial Registry with a unique identification and registration number: PACTR2020077533364675.

Diagnostic accuracy of transvaginal ultrasonography and hysterosalpingography in the detection of uterine cavity pathologies among infertile women.

Background: Uterine cavity pathology may affect the endometrium or myometrium, resulting in distortion of the uterine cavity, and is responsible for 2%-5% of infertility. The methods for its assessment usually involve imaging modalities like pelvic ultrasonography, often transvaginal-(TVS), and hysterosalpingography-(HSG), with hysteroscopy-(HSC) as the gold standard. However, HSC is not readily available in resource-poor-settings. Purpose: To determine and compare the diagnostic accuracy of TVS and HSG in detecting uterine cavity pathology using HSC as a gold standard. Materials and Methods: A cross-sectional analytical study of consenting infertile women for evaluation of the uterine cavity using transvaginal-ultrasonography, hysterosalpingogram, and hysteroscopy. The primary-outcome-measures were the sensitivity, specificity, and accuracy of TVS and HSG in detecting uterine cavity abnormalities using HSG as the gold standard. Results: Eighty-eight participants were analysed for this study. The lesions confirmed on HSC were intrauterine-adhesions (43.1%), endometrial polyps (14.8%), submucous fibroids (18.2%), intrauterine-septum (13.6%), and cavity distortion (14.8%). The overall sensitivity with TVS was 57.7%, with a specificity of 97.6%, a positive-predictive-value (PPV) of 88.2%, and a negative-predictive-value (NPV) of 88.2%, giving a percentage-accuracy of 88.2%. In comparison, HSG had a sensitivity of 72.1%, a specificity of 99.4%, a PPV of 97.4%, and an NPV of 92.0%, giving an overall accuracy of 92.9%. The detection rates of TVS and HSG in this category were: fibroids (97.7% vs 89.8%; p = .0004) and adhesions (73.9% vs 87.5%; p = .0002), respectively. Conclusion: HSG appears to be the superior modality for detection of obliterative uterine cavity pathologies, while TVS is better suited for myometrium and endometrial lesions.

Prophylactic tranexamic acid for reducing intraoperative blood loss during cesarean section in women at high risk of postpartum hemorrhage: A double-blind placebo randomized controlled trial.

BACKGROUND: Postpartum hemorrhage remains a leading cause of maternal mortality especially in developing countries. The majority of previous trials on the effectiveness of tranexamic acid in reducing blood loss were performed in low-risk women for postpartum hemorrhage. A recent Cochrane Systematic Review recommended that further research was needed to determine the effects of prophylactic tranexamic acid for preventing intraoperative blood loss in women at high risk of postpartum hemorrhage. OBJECTIVE: This study aimed to evaluate the effectiveness and safety of tranexamic acid in reducing intraoperative blood loss when given prior to cesarean delivery in women at high risk of postpartum hemorrhage. STUDY DESIGN: The study is a double-blind randomized controlled trial. METHODS: The study consisted of 200 term pregnant women and high-risk preterm pregnancies scheduled for lower-segment cesarean delivery at Enugu State University of Science and Technology, Teaching Hospital, Parklane, Enugu, Nigeria. The participants were randomized into two arms (intravenous 1 g of tranexamic acid or placebo) in a ratio of 1:1. The participants received either 1 g of tranexamic acid or placebo (20 mL of normal saline) intravenously at least 10 min prior to commencement of the surgery. The primary outcome measures were the mean intraoperative blood loss and hematocrit change 48 h postoperatively. RESULTS: The baseline sociodemographic characteristics were similar in both groups. The tranexamic acid group when compared to the placebo group showed significantly lower mean blood loss (442.94 ± 200.97 versus 801.28 ± 258.68 mL; p = 0.001), higher mean postoperative hemoglobin (10.39 + 0.96 versus 9.67 ± 0.86 g/dL; p = 0.001), lower incidence of postpartum hemorrhage (1.0% versus 19.0%; p = 0.001), and lower need for use of additional uterotonic agents after routine management of the third stage of labor (39.0% versus 68.0%; p = 0.001), respectively. However, there was no significant difference in the mean preoperative hemoglobin (11.24 ± 0.88 versus 11.15 ± 0.90 g/dL; p = 0.457), need for other surgical intervention for postpartum hemorrhage (p > 0.05), and reported side effect, respectively, between the two groups. CONCLUSION: Prophylactic administration of tranexamic acid significantly decreases postpartum blood loss, improves postpartum hemoglobin, decreases the need for additional uterotonics, and prevents postpartum hemorrhage following cesarean section in pregnant women at high risk of postpartum hemorrhage. Its routine use during cesarean section in high-risk women may be encouraged.The trial was registered in the Pan-African Clinical Trial Registry with approval number PACTR202107872851363.

A randomized controlled trial of rectal versus intramuscular diclofenac for post-operative analgesia after open myomectomy.

AIM: To determine the efficacy and safety of rectal versus intramuscularly administered Diclofenac in reducing post-operative pain in the first 24 h after open-myomectomy. METHODS: A single blind, placebo controlled randomized trial consisting of 90 consenting women that had open-abdominal-myomectomy. They were randomized into two-groups (rectal-group and intramuscular-group) of 45 women (1:1 ratio). Rectal-group received 75 mg of Diclofenac suppository 12 hourly for 24 h and placebo (3 ml of intramuscular injection-water) 12hourly for 24 h while intramuscular-group received intramuscular Diclofenac 75 mg 12 hourly for 24 h and placebo (Anusol suppository) 12 hourly for 24 h. Both groups received intramuscular Pentazocine 30 mg 6 hourly for 24 h as primary analgesic after myomectomy. Pain was assessed using a Ten-Point Visual-Analogue-Scale. Participants' satisfaction of the mode of the pain relief was assessed using the Likert-scale after 24 h. The primary outcome was the pain score using the visual-analogue-scale. The secondary outcome-measures were participants' satisfaction after 24 h of administration of the drugs, the need and frequency of rescue-analgesia and maternal-side-effects. RESULT: The baseline socio-demographic characteristics were similar in both groups. There was no statistically significant difference between both groups in pain assessment at 1 h post-myomectomy (p-value > 0.05). However, the pain assessments at 6, 12, 18 and 24 h post-myomectomy were statistically significant with more pain in intramuscular-group when compared to rectal-group. Majority of participants in rectal-group were both very satisfied (35.6 %) and satisfied (55.6 %) when compared to intramuscular-group (11.1 %) and (31,1%) respectively (p-value < 0.05). Also majority of the participants in intramuscular-group were dissatisfied (17.8 %) with none of the participant showing any form of dissatisfaction (p-value < 0.05). Majority of the participant in rectal-group had no drug side effects when compared with intramuscular-group. Epigastric discomfort was commoner in rectal-group while drowsiness was commoner in intramuscular-group. CONCLUSION: Rectal Diclofenac with intramuscular Pentazocine is significantly associated with better effectiveness in pain reduction and maternal satisfaction when compared with intramuscular Diclofenac and intramuscular Pentazocine following open-myomectomy. While epigastric discomfort was the commonest side-effect in rectal-group, drowsiness was commoner in intramuscular-group. TRIAL REGISTRATION: Pan-African-clinical-trial-registry (PACTR); PACTR202206556144219.

Active versus expectant management for premature rupture of membranes at term: A randomized, controlled study.

OBJECTIVE: To compare the effects on feto-maternal outcomes of expectant versus active management for premature rupture of membranes (PROM) at term. METHODS: This was a prospective randomized (1:1) controlled study involving 86 pregnant-women who received either expectant management (n = 43) or active management with misoprostol (n = 43) for PROM at term. Primary outcome was route of delivery. Secondary outcomes were: PROM to presentation interval; latency period; PROM to delivery interval; recruitment to delivery interval; labour and delivery complications. RESULTS: Baseline-characteristics were similar between groups. There was no significant difference between active and expectant groups in mean PROM to presentation/admission, or PROM to delivery. However, mean latency period (11.1 ± 7.3 hours vs 8.8 ± 5.5 hours) and mean recruitment to delivery intervals after PROM (14.7 ± 5.2 hours vs 11.8 ± 5.0 hours) were significantly shorter for the active group compared with the expectant group. Although the rate of caesarean section was less in expectant management group (21%) compared with the active management group (30%), the difference was not statistically significant. There were no significant differences between groups in delivery or perinatal complications. CONCLUSION: Active and expectant management for PROM at term gave comparable outcomes in terms of methods of delivery and complications. However, active management significantly shortened the latency period and induction to delivery intervals compared with expectant management.Trial-Registration: Pan-African-trial-registry-(PACTR)-approval-number PACTR202206797734088.

Efficacy of zinc supplementation for the treatment of dysmenorrhoea: a double-blind randomised controlled trial.

OBJECTIVES: To determine the efficacy of zinc sulfate supplementation in managing dysmenorrhoea. METHODS: In total, 103 high school students were randomised into an experimental arm (52 students) and a control arm (51 students) and received 40-mg zinc sulfate or placebo, respectively, over three cycles. Primary outcome measures were the mean Visual Analogue Scale score, which measured pain over three cycles, and the frequency of nausea and vomiting. Secondary outcomes were the use of additional analgesics and the frequency of allergic reactions. RESULTS: Fifty participants were analysed in each group. Mean pain scores were not significantly different between the groups before administering zinc sulfate therapy. Following the intervention, the mean pain scores for the treatment (2.80 ± 2.28) and placebo (3.48 ± 2.85) groups were not significantly different in the first cycle; however, scores in the treatment group were significantly better in the second (2.56 ± 1.97 vs 3.80 ± 2.77) and third (1.95 ± 1.72 vs 3.95 ± 2.82) cycles. No significant differences were observed between the groups in the nausea and vomiting incidence and the requirement for additional analgesics. CONCLUSIONS: Zinc sulfate reduces dysmenorrhoea severity with minimal or no adverse effects, especially with more than one cycle of usage.Trial Registration Number: PACTR202105843292338. The trial is publicly available and was registered at www.pactr.org on 25 May 2021.

A Five-Year Review of Feto-Maternal Outcome of Antepartum Haemorrhage in a Tertiary Center.

Background: Pregnancies complicated with antepartum-haemorrhage is high risk pregnancies associated with adverse maternal, fetal-and-perinatal-outcomes. It contributes significantly to fetal and maternal mortality especially in the developing countries. Proper antenatal care and prompt intervention is necessary to forestall adverse and improve outcome. Objective: To determine the prevalence, sociodemographic characteristics, risk factors, fetomaternal outcome of pregnancies with antepartum haemorrhage. Methods: The case files of the patients were retrieved from the medical records department. The total number of deliveries within the study period was obtained from the labour ward records. The feto-maternal-outcome-measures were; prevalence of caesarean-section, postpartum-haemorrhage, hysterectomy, need for blood-transfusion, maternal-death, prematurity, need for admission in intensive-care-unit and still births. The data was analysed using SPSS version 21. Chi-square was used to test for significance. Results: Within the 5-year period under review, out of a total of 6974 deliveries, 234 had antepartum-haemorrhage (3.4% prevalence rate). Abruptio-placentae was the commonest cause and accounted for 69.5% of the cases (prevalence of 2.1%) while placenta praevia accounted for 28.2% of the cases (prevalence rate of 0.9%). The mean age of the women was 31.8±5.3 years. The mean parity was 3.4±1.7 and majority (63.8%) of the women were unbooked. The commonest identifiable risk factors were multiparity and advanced maternal age. One-hundred-and sixty-six (77.9%) women were delivered through the abdominal route. Postpartum-haemorrhage occurred in 22.1% (47) of the cases while prematurity was the commonest fetal complications. Maternal mortality was 0.47% (1) while still birth was 44.1% (94). Conclusion: There is high prevalence of antepartum-haemorrhage in our environment. Abruptio-placentae was the commonest cause and associated with significant adverse fetomaternal-outcome when compared with placenta-praevia. Thus, good and quality antenatal care as well as high index of suspicion, prompt diagnosis and treatment remain the key to forestall these complications and improve fetomaternal-outcome.

A randomized clinical trial of Premaquick biomarkers versus transvaginal cervical length for pre-induction cervical assessment at term among pregnant women.

Objectives: To compare Premaquick biomarkers (combined insulin-like growth-factor binding protein 1 and interleukin-6) and cervical length measurement via transvaginal ultrasound for pre-induction cervical evaluation at term among pregnant women. Methods: A randomized clinical trial of consenting pregnant women at the Nnamdi Azikiwe University Teaching Hospital, Nnewi, Nigeria. The women were randomized equally into Premaquick group (n = 36) and transvaginal ultrasound group (n = 36). The cervix was adjudged 'ripe' if the Premaquick test was positive or if the trans-vaginal measured cervical length was less than 28 mm. The primary outcome measures were the proportions of women who needed prostaglandin analogue for cervical ripening and the proportion that achieved vaginal delivery after induction of labour. The trial was registered in Pan African clinical trial registry (PACTR) registry with approval number PACTR202001579275333. Results: The baseline characteristics were similar between the two groups (p > 0.05). There was no statistically significant difference between the two groups in terms of proportion of women that required prostaglandins for pre-induction cervical ripening (41.7 versus 47.2%, p = 0.427), vaginal delivery (77.8 versus 80.6%, p = 0.783), mean induction to delivery interval (22.9 ± 2.81 h versus 24.04 ± 3.20 h, p = 0.211), caesarean delivery (22.2 versus 19.4%, p = 0.783), proportion of neonate with birth asphyxia (8.30 versus 8.30%, p = 1.00) and proportion of neonate admitted into special care baby unit (16.7 versus 13.9%, p = 0.872). Subgroup analysis of participants with 'ripe' cervix at initial pre-induction assessment showed that the mean induction to active phase of labour interval and mean induction to delivery interval were significantly shorter in Premaquick than transvaginal ultrasound group. Conclusion: Pre-induction cervical assessment at term with either Premaquick biomarkers or transvaginal ultrasound for cervical length is effective, objective and safe with similar and comparable outcome. However, when compared with women with positive transvaginal ultrasound at initial assessment, women with positive Premaquick test at initial assessment showed a significantly shorter duration of onset of active phase of labour and delivery of baby following induction of labour.

Diagnostic value of Chorioquick for detecting chorioamnionitis in women with premature rupture of membranes.

OBJECTIVE: To determine the accuracy of a semi-quantitative interleukin-6 (IL-6) vaginal secretion rapid test (Chorioquick) for detecting chorioamnionitis in women with premature rupture of membranes (PROM). METHODS: A prospective cohort study in five tertiary hospitals in Nigeria involved women with confirmed PROM at term and preterm PROM with or without suspected chorioamnionitis from August 1, 2017, to October 31, 2018. Cervicovaginal fluid samples were tested for chorioamnionitis using the Chorioquick test. Samples were repeated at decision to deliver. The test was considered positive if at least the indicator 'IL-6 low' of the three Chorioquick biomarkers (low, medium, high) was positive, or negative if none of the biomarkers were positive. Chorioamnionitis was histologically confirmed post-delivery using three tissue samples. Primary outcome measures were sensitivity, specificity, and accuracy. RESULTS: Of 73 women, on histological confirmation, 39 were true positive and 29 were true negative (for chorioamnionitis) to the Chorioquick test at repeat assessment. Overall, the Chorioquick test had a sensitivity of 97.5% (95% confidence interval [CI] 85.3-99.9), specificity 87.9% (70.9-96.0), and accuracy 93.2% (79.5-99.1). Sub-group analysis of women <37 weeks of pregnancy showed a sensitivity of 100.0% (95% CI 83.4-100.0), specificity of 91.3% (70.5-98.5), and accuracy of 95.8% (82.5-99.5). Triple positive samples were 100.0% specific in all gestations. CONCLUSION: Chorioquick showed favorable utility for detecting chorioamnionitis in PROM and could be a reliable, non-invasive rapid tool in a real-world clinical setting.

Anaesthetic agent usage and wastage during caesarean deliveries done with spinal anaesthesia in a labour ward theatre: a concern for the financial implication

Background: Local anaesthesia usage and wastage are common in the operation rooms. The wastage is often not given due considerations. Budgetary allocation for drugs is an identifiable area for cost-cutting and savings. Hence, the need to minimize wastage Objectives: To assess and estimate the amount of local anaesthesia usage and wastage in the labour ward theatre. Also, to analyze the financial implications of the wastages and suggest appropriate steps to reduce the wastages. Methodology: A prospective observational study conducted in the labour ward theatre of a tertiary care hospital. The amount of local anaesthesia administered to the patient during spinal anaesthesia prior to caesarean section was considered the dose used. The wastage was considered as the amount of local anaesthetic agents left unutilized in the syringes, ampules or vials after completion of each caesarean delivery. An estimation of the cost of wasted local anaesthetic agents was made. Result: The local anaesthetic agents being used in significant quantities were hyperbaric bupivacaine, plain lidocaine and lidocaine with adrenaline. The wastage was found more during the use of hyperbaric bupivacaine as the cost of its wastage formed the bulk (N75,000.00/ $210.10) of the estimated total cost of wasted local anaesthetic agents during the study period which was N88, 100.00 ($246.77). Conclusion: There were appropriate uses of the local anaesthesia with respect to the choice and doses for caesarean deliveries but there were wastages often ignored as infinitesimal. In the long run, the wastages become significant and the financial implication scale up the burden of health bills. Effective waste reduction strategies have input in the overall reduction of financial burden associated with health care. Emphasis should be t ailored towards awareness of these wastages among resident doctors and their prudent use of local anaesthesia

Performance indices of AmnioQuick Duo+ versus placental α-microglobulin-1 tests for women with prolonged premature rupture of membranes.

OBJECTIVE: To compare AmnioQuick Duo+ versus the placental α-microglobulin-1 (PAMG-1) test for diagnosis of prolonged premature rupture of membranes (PROM). METHODS: A multicenter prospective cohort study included women with suspected PROM at six tertiary institutions in southern Nigeria between January 1 and December 31, 2015. The inclusion criteria were features of PROM lasting at least 24 hours and a pregnancy duration of more than 24 weeks. AmnioQuick Duo+ (Biosynex, Strasbourg, France) and PAMG-1 (AmniSure International, Boston, USA) tests were used to diagnose PROM, which was confirmed after delivery by any two of the following criteria: delivery within 48 hours to 7 days, chorioamnionitis, membranes perceptibly ruptured at delivery, and adverse perinatal outcomes considerably associated with prolonged PROM. RESULTS: Of 100 women assessed for eligibility, 99 were included. Sensitivity, specificity, and accuracy were, respectively, 97.3%, 100%, and 95.9% for AmnioQuick Duo+, and 93.2%, 100%, and 90.4% for PAMG-1. The differences were not significant and the diagnostic discordant rate between the two tests was 3.1%. In equivocal cases (i.e., negative pooling test result), AmnioQuick Duo+ and PAMG-1 performed equally (diagnostic accuracy, 100% vs 97.7%; P>0.99). CONCLUSION: For diagnosis of PROM, AmnioQuick Duo+ was found to be non-inferior and comparable in accuracy to the PAMG-1 test, with a diagnostic discordance rate of 3.1%.

Premaquick© versus modified Bishop score for preinduction cervical assessment at term: A double-blind randomized trial.

AIM: To test whether Premaquick biomarkers were superior to modified Bishop score for preinduction cervical assessment at term. METHODS: A multicenter, double-blind randomized clinical trial in 151 nulliparous, cephalic presenting and singleton pregnancies was conducted. The cervix was considered 'ripe' when at least two out of three Premaquick biomarkers are positive or a Bishop score of ≥6. Main outcome measures were proportion of women who were administered or had additional prostaglandin E1 analogue (PGE1) as a preinduction agent and incidence of uterine rupture. The trial was registered in PACTR registry with approval number PACTR201604001592143. Analysis was performed by intention-to-treat principle. RESULTS: The need for initial PGE1 analogue (77.6% vs 98.7%, risk ratio [RR] =0.47, 95% confidence intervals [95% CI] =0.38-0.59, P < 0.001) and additional PGE1 analogue for cervical ripening after one insertion (44.7% vs 68.0%, RR = 0.63, 95% CI = 0.46-0.86, P = 0.004) was significantly lower in Premaquick group. There was no significant difference in incidence of uterine rupture (0% vs 1.4%, RR = 0.000, P = 0.324); however, the frequency of transition to labor was statistically higher in Premaquick group (44.7% vs 22.7%, RR = 1.59, 95% CI = 1.17-2.15, P = 0.004). Interval from start of induction to any type of delivery, need for oxytocin augmentation, vaginal delivery, number of women with cesarean section for failed induction and number of infants admitted to neonatal intensive care unit were similar between the two groups (P > 0.05). CONCLUSION: Preinduction cervical assessment with Premaquick was significantly associated with higher frequency of transition to labor and reduced need for PGE1 analogue when compared to modified Bishop score. Further similar trials in other settings are necessary to strengthen or refute this observation.