Association between serum vitamin D status and uterine leiomyomas: a case-control study.

OBJECTIVE: Uterine leiomyoma is a common gynecological condition that negatively affects women's quality of life. Vitamin D plays an important role in tumor development and progression. However, clinical studies comparing serum vitamin D levels between women with and without uterine leiomyomas are limited and inconclusive. This study aimed to compare serum vitamin D levels in women with and without uterine leiomyomas. METHODS: This hospital-based case-control study included 150 women who visited a gynecological clinic. The cases included 75 women with uterine leiomyoma, whereas the controls included 75 age-and parity-matched participants without uterine leiomyoma. Serum vitamin D levels were measured in each participant and volumes of the uterine leiomyomas were determined using the water displacement method following myomectomy. The statistical significance was inferred at P<0.05. RESULTS: The mean serum vitamin D level was 15.26±4.96 ng/mL and 22.45±6.93 ng/mL for the case and control groups, respectively. The difference was statistically significant (t-value -7.302 and P<0.001). Within the fibroid group, nine (12.0%), 49 (65.33%), and 17 (22.67%) participants had vitamin D deficiency, insufficiency, and sufficiency, respectively; and in the control group, two (2.67%), 24 (45.33%), and 39 (52.0%) participants had vitamin D deficiency, insufficiency, and sufficiency, respectively. There was significant negative correlation between the fibroid volume and the serum vitamin D level (r=-0.591, P<0.001). CONCLUSION: Women with uterine leiomyoma had lower vitamin D levels than women in the control group. Lower vitamin D levels were associated with larger fibroid masses. Therefore, vitamin D supplementation may reduce fibroid growth and development.

Improving Treatment Outcome for Cervical Cancer Using 2-Point Assessment of Quality of Life Among Nigerian Women: A Protocol for a Multi-Center Study.

Background: Cervical cancer is the fourth most common cancer among women globally, with quality of life (QOL) being a major concern for patients with cervical cancer, especially in low- and middle-income countries (LMICs). This is largely due to the advanced nature of the disease at presentation. Although there are a higher number of studies focusing on the QOL of high-income countries, the QOL of cervical cancer patients in LMICs is not available. The aim of this study is to evaluate QOL among women with cervical cancer in Nigeria using a 2-point assessment. Methods: A multi-center prospective cohort study will be conducted in 6 tertiary health facilities randomly selected from the 6 geopolitical zones of Nigeria and consisting of a 2-point assessment of the QOL of participants at the time of diagnosis of cervical cancer and after treatment. Women who were recently diagnosed with histologically confirmed cervical cancer (treatment naïve) will be included. QOL will be assessed using Quality of Life Questionnaire domains (EORTC QLQ30) as developed by the European Organization for Research and Treatment of Cancer (EORTC). In addition to the QOL assessment, relevant and clinicopathological variables will be obtained using a self-structured data extraction sheet designed for this study. All data will be anonymized and will be analyzed using SPSS version 25. Levels of QOL will be calculated using EORTC QLQ30. Ethical approval was obtained from National Health Research Ethics Committee (NHREC/01/01/2007-08/11/2021). Discussion: In view of the paucity of data on QOL in LMICs like Nigeria, where most women with cervical cancer present with advanced disease, this research was designed to help in formulating evidence-based interventions to improve the QOL and treatment outcomes provided to women with cervical cancer in Nigeria and other LMICs. The study is expected to fill these knowledge gaps.

Efficacy and safety of Mojeaga remedy in combination with conventional oral iron therapy for correcting anemia in obstetric population: A phase II randomized pilot clinical trial.

BACKGROUND: To our knowledge, there is no prior randomized trial on the efficacy of Mojeaga remedy (a special blend of Alchornea cordifolia, Pennisetum glaucum and Sorghum bicolor extracts) when co-administered with standard-of-care for correction of anemia in obstetrics practice. This study determined the efficacy, safety and tolerability of Mojeaga as adjunct to conventional oral iron therapy for correction of anemia in obstetric population. METHODS: A pilot open-label randomized clinical trial. Participants with confirmed diagnosis of anemia in three tertiary hospitals in Nigeria were studied. Eligible participants were randomized 1:1 to either Mojeaga syrups 50 mls (200mg/50mls) administered three times daily in conjunction with conventional iron therapy (Mojeaga group) for 2 weeks or conventional iron therapy alone without Mojeaga (standard-of-care group) for 2 weeks. Repeat hematocrit level were done 2 weeks post-initial therapy. Primary outcome measures were changes in hematocrit level and median hematocrit level at two weeks post therapy. Maternal adverse events and neonatal outcomes (birth anomalies, low birthweight, preterm rupture of membranes and preterm labor) were considered the safety outcome measures. Analysis was by intention-to-treat. RESULTS: Ninety five participants were enrolled and randomly assigned to the Mojeaga group (n = 48) or standard-of-care group (n = 47). The baseline socio-demographic and clinical characteristics of the study participants were similar. At two weeks follow-up the median rise in hematocrit values from baseline (10.00±7.00% vs 6.00±4.00%;p<0.001) and median hematocrit values (31.00±2.00% vs 27.00±3.00%;p<0.001) were significantly higher in the Mojeaga group. There were no treatment-related serious adverse events, congenital anomalies or deaths in the Mojeaga group and incidence of other neonatal outcomes were similar (p>0.05). CONCLUSION: Mojeaga represents a new adjuvants for standard-of-care option for patients with anemia. Mojeaga remedy is safe for treating anemia during pregnancy and puerperium without increasing the incidence of congenital anomalies, or adverse neonatal outcomes. CLINICAL TRIAL REGISTRATION: www.pactr.samrc.ac.za: PACTR201901852059636 (https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=5822).

Intra-operative Diagnosis of Lower Segment Scar Dehiscence in a Second Gravida After One Previous Lower Segment Cesarean Section: Should We Advocate for Routine Antenatal Uterine Scar Thickness Testing?

Background: Uterine dehiscence is a separation of uterine musculature with intact uterine serosa. It can be encountered at the time of cesarean delivery, suspected on obstetric ultrasound or diagnosed in-between pregnancies. The antenatal diagnosis may occasionally elude the Obstetricians. This particular case demonstrates an intra-operative diagnosis of uterine dehiscence with missed antenatal ultrasound diagnosis in an asymptomatic woman. Case presentation: She was a 32-year-old Nigerian second gravida who booked for antenatal care at 32 weeks of gestation following a referral from her attending Obstetrician from a neighboring state due to relocation. She had 3 antenatal visits and 2 antenatal ultrasound investigations without uterine scar thickness report. She subsequently had elective Cesarean section (CS) at a gestational age of 38 weeks plus 2 days due to persistent breech presentation on a background of a previous lower segment CS scar. There was no previous uterine curettage prior to or after the previous lower segment CS scar and there was no labor pains prior to the elective CS. The surgery was successful with intra-operative findings of moderate intra parietal peritoneal adhesions with rectus sheath and obvious uterine dehiscence along the line of the previous CS scar. The fetal outcomes were normal. Immediate post-operative condition was satisfactory and the woman was discharged on a third-day post operation. Conclusion: Obstetricians are charged to maintain a high index of suspicion when managing pregnant women with history of emergency CS in order to avert the adverse consequences of uterine rupture from asymptomatic uterine dehiscence. Based on this report, it may be useful to routinely assess the lower uterine segment scar of women with previous emergency CS using the available ultrasound facilities. However, more studies are needed before advocating for routine antenatal uterine scar thickness testing following emergency lower segment CS in low and middle-income settings.

A randomised control trial on oral dydrogesterone versus micronized vaginal progesterone pessary for luteal phase support in in vitro fertilization cycles.

This study aimed to evaluate the pregnancy rates, adverse reactions, and medication costs of two luteal phase support regimens: oral dydrogesterone and micronized vaginal progesterone (MVP) pessary in in vitro fertilization cycles. A randomized open-label trial with participants randomly assigned to either 400 mg MVP twice daily or 10 mg dydrogesterone three times daily. The primary endpoints were pregnancy rates, and the secondary endpoints included tolerance, miscarriage rates, and medication cost. Per-protocol principle analysis was performed. The baseline characteristics of the 162 participants were similar. Dydrogesterone had statistically similar (p>0.05) positive pregnancy test rates fifteen days post embryo transfer (35.8% vs. 32.7%), clinical pregnancy rates at the gestational age of 6 weeks (32.1% vs. 28.8%), ongoing pregnancy rates (26.4% vs. 23.1%) and miscarriage rates at 14 weeks of gestation (9.2% vs. 9.4%) and safety profile to MVP. Dydrogesterone was better tolerated as vaginal itching was significantly more prevalent in the MVP arm (p=0.008). Dydrogesterone is significantly less expensive than MVP pessary. Oral dydrogesterone and MVP pessary had similar pregnancy rates and adverse effects. Dydrogesterone appears more user-friendly and less expensive in cases of luteal-phase support in in vitro fertilization cycles.

Interventions to increase mammography screening uptake among women living in low-income and middle-income countries: a systematic review.

OBJECTIVE: To systematically identify interventions that increase the use of mammography screening in women living in low-income and middle-income countries (LMICs). DESIGN: Systematic review. DATA SOURCES: MEDLINE, Embase, Global Health, CINAHL, PsycINFO, Web of Science, Cochrane Central Register of Controlled Trials, Google Scholar and African regional databases. ELIGIBILITY CRITERIA: Studies conducted in LMICs, published between 1 January 1990 and 30 June 2021, in the English language. Studies whose population included asymptomatic women eligible for mammography screening. Studies with a reported outcome of using mammography by either self-report or medical records. No restrictions were set on the study design. DATA EXTRACTION AND SYNTHESIS: Screening, data extraction and risk-of-bias assessment were conducted by two independent reviewers. A narrative synthesis of the included studies was conducted. RESULTS: Five studies met the inclusion criteria consisting of two randomised controlled trials, one quasi-experiment and two cross-sectional studies. All included studies employed client-oriented intervention strategies including one-on-one education, group education, mass and small media, reducing client out-of-pocket costs, reducing structural barriers, client reminders and engagement of community health workers (CHWs). Most studies used multicomponent interventions, resulting in increases in the rate of use of mammography than those that employed a single strategy. CONCLUSION: Mass and small media, group education, reduction of economic and structural barriers, client reminders and engagement of CHWs can increase use of mammography among women in LMICs. Promoting the adoption of these interventions should be considered, especially the multicomponent interventions, which were significantly effective relative to a single strategy in increasing use of mammography. PROSPERO REGISTRATION NUMBER: CRD42021269556.

Challenges of Management of Ruptured Second Trimester Ovarian Pregnancy in Low-and Middle-Income Settings: A Case Report.

Background: Ovarian ectopic pregnancy is a rare form of non-tubal ectopic pregnancy. It can rupture before the end of the first trimester, causing hemoperitoneum, and present with signs and symptoms similar to other commoner abdominal emergencies or the pregnancy can continue intraperitoneally. Therefore, they are not often diagnosed preoperatively. Ultrasound can assist in diagnosis of ovarian ectopic pregnancy but the findings could be ambiguous or inconclusive. We present a case of ruptured ovarian ectopic pregnancy at the second trimester causing massive hemoperitoneum that was suspected as an intrabdominal malignancy co-existing with intrabdominal pregnancy. Case presentation: She was a 34 year-old Nigerian unbooked G4P3+0, (3 alive), who presented to the labor ward on 21st January, 2021 with a complaint of a 6-week history of abdominal pain and swelling. Pain was insidious in onset, generalized, non-colicky, non-radiating, constant, no known aggravating or relieving factor, but it was of moderate intensity. She had amenorrhea with a positive serum pregnancy test without prior early ultrasound. At presentation, initial abdominopelvic ultrasound revealed intra-uterine viable pregnancy but repeat ultrasound done showed a left adnexal ectopic gestation and an echo-rich intraperitoneal fluid collection. Laparotomy was done and ovarian pregnancy was accurately diagnosed intra-operatively. Tissue samples from the ovary confirmed normal products of conception, namely chorionic villi, trophoblastic cells and ovarian stroma at histology. Conclusion: Despite advances in imaging techniques, the diagnosis of ovarian ectopic gestation is still very difficult. When premenopausal women present with amenorrhea, generalized non-colicky abdominal pain and swelling in combination with ambiguous findings of pregnancy on ultrasound in the absence of trauma, differential diagnoses should include ruptured ovarian pregnancy. Obstetricians should maintain a high index of suspicion to forestall delayed diagnosis and the potential maternal morbidity and mortality. However, the need for high-index of suspicion should be for any ectopic, not just ovarian pregnancy.

Conception following successful repair of two previous failed attempts at repair of partial transverse vaginal septum diagnosed after marital union: A case report.

Transverse vaginal septum is a congenital anomaly in which a membrane obstructs the vagina. This can be partial or complete in type. Although rare, it presents peculiar challenges in symptomatology, diagnosis, and ultimate management. To our knowledge, we are the first to report a shortest vaginoplasty-conception interval following successful repair of previously failed repair of partial transverse vaginal septum. A 28-year-old Nigerian married nulliparous lady who presented to us with history of inability of penile-vaginal penetration with the presence of normal menstrual flow after two previous failed attempts at repair. She had a vaginoplasty with placement of a vaginal mold to prevent stenosis. She was subsequently able to have successful sexual intercourse and achieved pregnancy after 2 months, without recurrence of vaginal stenosis. When transverse vaginal septum is encountered in a married nullipara, a thorough clinical evaluation of the viability and feasibility of a vaginoplasty should be made during the first surgery. If repeated failed repair occurs, as in our case, we recommend meticulous and experienced surgical attention from the outset. The originality in this report lies in the very short period between repair and successful conception. Thus, we obtained satisfactory short-term clinical outcome of successful conception at the 2 months follow-up.

Comparison of Placenta Previa and Placenta Accreta Spectrum Disorder Following Previous Cesarean Section between Women with a Short and Normal Interpregnancy Interval.

Objectives: The aim of this study is to determine the effect of interpregnancy interval (IPI) on the incidence of placenta previa and placenta accreta spectrum disorders in women with a previous cesarean section. Methods: A prospective cohort three-center study involving parturients who had previous cesarean section was conducted. Participants were included if pregnancy has lasted up to 34 weeks. Parturients with co-existing uterine fibroids, multiple gestations, premature rupture of membranes, and those with prior postcesarean delivery wound infection were excluded. The eligible women recruited were distributed into two groups, namely, short (<18 months) and normal (18-36 months) IPI. The outcome measures were incidences of placenta previa and placenta accreta spectrum disorder and factors associated with the occurrence of placenta previa. A univariate analysis was performed using the chi-square test or Mann-Whitney U test, wherever appropriate, to examine the significance of the differences in clinical variables. Results: A total of 248 women met the inclusion criteria. The incidence of placenta previa by ultrasound was 8.9% and 4.0% for short and normal IPI (odds ratios = 2.32; 95% confidence intervals = 0.78-6.88; p = 0.13), respectively. The incidence of placenta accreta spectrum disorder was 1.6% and 0.8% for short and normal IPI (odds ratios = 2.02; 95% confidence intervals = 0.18-22.13; p = 0.57), respectively. The only observed significant difference between the clinical variables and placenta previa is the number of cesarean sections (p = 0.02) in women with short IPI. Conclusion: A short interpregnancy interval does not significantly affect the incidence of placenta previa and placenta accreta spectrum disorder following a cesarean section. There is a need for further study with large numbers to corroborate these findings in low- and middle-income settings.

Correlation between hysterosalpingography diagnosis and final hysterolaparoscopy with dye-test diagnosis in women with utero-tubal infertility: A cross-sectional study of the implication for which test should be the first-line investigation.

Objective: To assess the accuracy of hysterosalpingography in diagnosis of uterine and/or tubal factor infertility, using hysterolaparoscopy with dye test as the gold standard with an implication for which test should be the first-line investigation. Methods: A prospective cross-sectional study of 96 women who underwent hysterosalpingography and hysterolaparoscopy with dye test. All women within reproductive age group with utero-tubal infertility who underwent both hysterosalpingography and hysterolaparoscopy with dye-test procedure were included. The outcome measures were proportions of tubal blockage and intrauterine pathology. Individual and overall mean accuracy were calculated for hysterosalpingography, using hysterolaparoscopy with dye test as the gold standard. Patient had procedure of hysterosalpingography first and both laparoscopic surgeons and patients were blinded to the outcome of hysterolaparoscopy with dye test until analysis. Statistical significance was set at p < 0.05. Results: Overall, 128 women were assessed for eligibility while 96 women finally completed the study. Hysterosalpingography demonstrated diagnostic accuracy of 77.8% (p < 0.001), 76.3% (p < 0.001) and 78.3% (p < 0.001) for right, left and bilateral tubal blockage, respectively. Overall accuracy of hysterosalpingography tubal factor assessment was 77.4 ± 0.8% (95% confidence interval = 76.5% to 78.4%). Hysterosalpingography showed an accuracy of 85.7%, 86.6% and 76.7% for right, left and bilateral hydrosalpinx, respectively, given overall diagnostic accuracy of 83.0 ± 5.1% (95% confidence interval = 77.9% to 88.1%). Overall accuracy of hysterosalpingography in diagnosing intrauterine pathology was 68.5 ± 9.8% (95% confidence interval = 53.9% to 83.1%). Conclusion: Hysterosalpingography detects tubal blockade and intrauterine pathology poorly compared to hysterolaparoscopy with dye test. Hysterosalpingography may face unpredictable clinical situations biased by technological error, leading to unsuccessful evaluation and uncertain diagnosis. Although the cost-effectiveness, risk of surgery or anaesthesia flaws hysterolaparoscopy with dye test. Hysterosalpingography should not be the first-line utero-tubal assessment tool rather hysterolaparoscopy with dye test.

Pentazocine with rectal diclofenac versus pentazocine alone for pain relief following caesarean delivery in Enugu, Nigeria: A randomized controlled trial.

OBJECTIVE: To measure postoperative pain relief following the use of rectal diclofenac combined with intramuscular pentazocine compared with intramuscular pentazocine alone in patients undergoing a caesarean delivery. METHODS: This single-blind randomized controlled trial enrolled pregnant women that had a caesarean section at the Enugu State University of Science and Technology Teaching Hospital, Enugu, Nigeria. Study participants were randomized to receive either 100 mg of rectal diclofenac given every 12 h plus 30 mg of intramuscular pentazocine given every 6 h (group A) or 60 mg of intramuscular pentazocine given every 6 h (group B). The primary outcome was the level of pain as measured using a visual analogue scale. The secondary outcomes were the level of satisfaction with pain relief and need for rescue analgesia. RESULTS: A total of 200 participants were randomized equally into the two groups. Participants in group A had significantly better pain control and satisfaction over the 48 h after surgery compared with group B. Significantly more of group B required rescue analgesia for breakthrough pain compared with group A. CONCLUSION: Rectal diclofenac combined with intramuscular pentazocine was significantly better at controlling pain compared with pentazocine alone in the first 48 h following caesarean section.Trial registration number: PACTR202107706925314 at www.pactr.org on 28 July 2021.

Interventions to increase mammography screening uptake among women living in low-income and middle-income countries: a protocol for a systematic review.

INTRODUCTION: Breast cancer is the most prevalent cancer and the second leading cause of cancer-related deaths among women in low and middle-income countries (LMICs), including sub-Saharan Africa. Mammography screening is the most effective screening method for the early detection of breast cancers in asymptomatic individuals and the only screening test that decreases the risk of breast cancer mortality. Despite the perceived benefits, it has a low utilisation rate in comparison with breast self-examination and clinical breast examination. Several interventions to increase the uptake of mammography have been assessed as well as systematic reviews on mammography uptake. Nonetheless, none of the published systematic reviews focused on women living in LMICs. The review aims to identify interventions that increase mammography screening uptake among women living in LMICs. METHODS AND ANALYSIS: Relevant electronic databases will be systematically searched from 1 January 1990 to 30 June 2021 for published and grey literature, including citation and reference list tracking, on studies focusing on interventions to increase mammography screening uptake carried out in LMICs and written in the English language. The search will incorporate the key terms: mammography, interventions, low- and middle-income countries and their associated synonyms. Randomised controlled trials, observational studies and qualitative and mixed methods studies of interventions (carried out with and without comparison groups) reporting interventions to increase mammography screening uptake in LMICs will be identified, data extracted and assessed for methodological quality by two independent reviewers with disagreements to be resolved by consensus or by a third author. We will use narrative synthesis and/or meta-analysis depending on the characteristics of the data. ETHICS AND DISSEMINATION: Ethical approval is not required as it is a protocol for a systematic review. Findings will be disseminated through peer-reviewed publications and conference presentations. PROSPERO REGISTRATION NUMBER: CRD42021269556.

An Assessment of Ovarian Cancer Histotypes Across the African Diaspora.

OBJECTIVE: Ovarian 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. METHODS: Patients 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 p<0.05. RESULTS: Nigerians 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). CONCLUSION: There 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.

Delayed presentation of giant uterine fibroids in a Nigerian private specialist health facility.

Giant uterine fibroids (leiomyoma or myomas) which are fibroid masses greater than 11.4 kg are very rare. Although benign in nature, it may present with symptoms that impact negatively on the quality of life and health of the patient and impose greater management challenges. We present two cases of giant uterine fibroids that were successfully managed in a private specialist hospital without complications. Case 1 was a 38-year-old nulliparous Nigerian woman who presented with giant uterine fibroids (11.6 kg) who initially had delay of surgery due to fear that after surgery she may lose her "womb" or not be able to conceive after the operation. Later, she had successful open abdominal myomectomy, with the use of Foley catheters as improvise equipment for tourniquet and abdominal drain. Anti-adhesion agent was not used. Case 2 was a 47-year-old nulliparous Nigerian teacher with giant fibroids (13.2 kg) who also initially had delayed surgery due to fear that fibroid surgery is a major operation that it may get complicated and she may die. Also, she was afraid that she may not have her womb in her next world if she gets reincarnated. She had total abdominal hysterectomy and bilateral salpingo-oophorectomy without complications. For both cases, pre-surgery leiomyosarcoma assessment with computed tomography scan or magnetic resonance imaging and anti-adhesion agent were not used due to very unaffordable high costs. These reports of giant uterine fibroids (leiomyoma or myomas) are very rare gynecological entity, and management can be successful despite overwhelming challenges in low-income countries. Cheaper, affordable and available alternatives (improvises) can be resorted to for tackling its challenges in low-income settings.

Comparative study on the adequacy of cervical smears using wooden Ayre's spatula, VS Papcone® sampling device.

This is a comparative study on the adequacy of cervical smears obtained using the Papcone® sampling device or wooden Ayre's spatula conducted from two tertiary health facilities -- Nnamdi Azikiwe University Teaching Hospital Nnewi and Chukwuemeka Odumegwu Ojukwu University Teaching Hospital Awka, in Anambra State, Nigeria. Slides from smears obtained using both devices were read by a cytopathologist blinded for the study. The primary outcome was the proportion of smears with an adequate endocervical component. Significantly higher adequate cervical smears were obtained in 177/192 (92.2%) women using the Papcone® sampling device, compared to 152/192 (79.2%) using wooden Ayre's spatula (p < 0.001). Kappa analysis showed moderate inter-rater agreement between the two devices. We recommend the use of the Papcone device when it is available, as the adequacy of cervical smears obtained with the Papcone® was better than that obtained using wooden Ayre's spatula.

Efficacy and safety of Syferol-IHP for the treatment of peptic ulcer disease: a pilot, double-blind randomized trial.

BACKGROUND: To our knowledge, there is no prior randomized study on the utility of Syferol-IHP (blend of virgin coconut oil and Ocimum sanctum oil) when coadministered with a triple therapy schedule. AIM: This study determined the efficacy and safety of Syferol-IHP as adjunct to conventional triple therapy for the treatment of peptic ulcer disease (PUD). METHODS: A pilot double-blind randomized trial was conducted in patients with confirmed diagnosis (endoscopy-guided biopsy) of PUD. Eligible patients were randomized to Pylorest (a three-in-one tablet containing rabeprazole 20 mg, amoxicillin 1 g, and clarithromycin 500 mg) and Syferol-IHP for 2 weeks, followed by rabeprazole and Syferol-IHP for 2 weeks or Pylorest and placebo for 2 weeks, followed by rabeprazole and placebo for 2 weeks. Repeat endoscopy-guided biopsy and histology were done 4 weeks posttherapy. Primary outcome measures were the healing of ulcer and eradication of Helicobacter pylori. Secondary outcome measures were the disappearance of epigastric pain, gastritis, and duodenitis. Analysis was by intention-to-treat. RESULTS: Of the 63 patients enrolled, 60 patients had complete evaluation, with 37 patients receiving Pylorest and Syferol-IHP and 23 patients receiving Pylorest and Placebo. Healing of the PUD in favor of Pylorest and Syferol-IHP was significantly higher for gastric ulcer (RR=0.000, 95% CI=undefined, P=0.048) but not for duodenal ulcer (RR=0.400, 95% CI=0.07-2.37, P=0.241). H. pylori eradication was 100% with Syferol-IHP vs 50% with placebo (P=0.066). Epigastric pain (reduction to 16.2% vs 43.5%; P=0.021), gastritis (reduction to 13.5% vs 39.1%; P = 0.024), and duodenitis (reduction to 0% vs 8.7%; P=0.327) were observed in the Syferol-IHP and Pylorest vs placebo and Pylorest groups, respectively. Adverse events (RR=0.971, 95% CI=0.46-2.04, P=0.937) and laboratory parameters were not significantly different pre- and posttherapies (P>0.05, for both groups). CONCLUSION: Although both treatment arms were equally safe, co-administration of Syferol-IHP and triple therapy is more efficacious than triple therapy alone for treating PUD. Pan African Clinical trial registry identifier number is PACTR201606001665364.

A Randomized Controlled Trial on Efficacy and Safety of Trocar-Site Infiltration with Lidocaine for Postoperative Pain Relief after Diagnostic Laparoscopy.

BACKGROUND/AIMS: To compare the efficacy and safety of trocar-site infiltration with lidocaine and no intervention for postoperative pain relief after diagnostic laparoscopy. METHODS: A randomized clinical trial of women with infertility scheduled for diagnostic laparoscopy without additional procedures in Life Institute for Endoscopy at Life Specialist Hospital, Nnewi, Nigeria. One hundred and ninety nine women were assigned at random to either trocar-site infiltration with lidocaine (n = 100) or no intervention (n = 99). Pain was assessed using visual analogue scale (VAS) scores at 2 and 4 h post surgery. The primary endpoints were postoperative pain control and time to first request of analgesia, while the secondary endpoints were total analgesic consumption, shoulder pain, and side effects. Evaluations between the groups were done according to the principle of intention-to-treat. RESULTS: Baseline characteristics were similar. A nonsignificant reduction was observed in the VAS in the intervention group at base line, 2 and 4 hours into the postoperative period in comparison with no intervention (p > 0.05), and the time to first analgesic requirement was not significantly prolonged (p > 0.05). The mean total consumption of rescue analgesia was not significantly reduced (p > 0.05). CONCLUSIONS: Postoperative injection of lidocaine in laparoscopy port sites did not significantly improve pain scores after diagnostic laparoscopy. CLINICAL TRIAL REGISTRATION: PACTR201611001263105.

Accuracy of a combined insulin-like growth factor-binding protein-1/interleukin-6 test (Premaquick) in predicting delivery in women with threatened preterm labor.

PURPOSE: To determine values of combinations of interleukin-6 (IL-6)/cervical native insulin-like growth factor-binding protein-1 (IGFBP-1)/total IGFBP-1 (Premaquick©) in predicting spontaneous deliveries and spontaneous exclusive preterm deliveries in women with threatened preterm labor. METHODS: Women with singleton pregnancies between gestation age (GA) of 24 weeks and 36 weeks and 6 days with preterm labor were recruited during a prospective multicenter study. Premaquick© was positive when at least two of three biomarkers were positive. Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy were estimated for both prediction of spontaneous deliveries and spontaneous exclusive preterm deliveries. RESULTS: Ninety-seven (99.0%) out of 98 women enrolled were analyzed. Based on delivery status 7/14 days post-enrollment of general study population, Premaquick© had a sensitivity of 87.1/85.7%, a specificity of 92.4/96.8%, a PPV of 84.4/93.8% and a NPV of 93.9/92.3% for prediction of spontaneous delivery. Predictive accuracy of Premaquick© test in relation to days of enrollment were: 90.7% (≤7 days) and 92.8% (≤14 days). For women enrolled at GA <35 weeks, Premaquick© had a sensitivity of 100.0/87.5%, a specificity of 94.1/96.9%, a PPV of 70.5/87.5%, a NPV of 100.0/96.9% and an accuracy of 95.0/95.0% for prediction of preterm delivery within 7/14 days of enrollment, respectively. PPV was most significantly different in both groups when outcomes were compared between 2 days and 14 days post-enrollment (P<0.001). CONCLUSION: This novel triple biomarker model of native and total IGFBP-1 and IL-6 appears to be an accurate test in predicting spontaneous deliveries and spontaneous exclusive preterm deliveries in threatened preterm labor in singleton pregnancies.