A multi-centre, randomized, double-blind, placebo-controlled clinical trial of the efficacy and safety of chloroquine phosphate, hydroxychloroquine sulphate and lopinavir/ritonavir for the treatment of COVID-19 in Lagos State: study protocol for a randomized controlled trial.

BACKGROUND: The coronavirus disease 2019 (COVID-19) is caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that was first identified in Wuhan, Hubei, China, in December 2019. It was recognized as a pandemic by the World Health Organization on 11 March 2020. Outbreak forecasting and mathematical modelling suggest that these numbers will continue to rise. Early identification of effective remedies that can shorten the duration and severity of illness is critical for Lagos State, which is the epi-centre of the disease in Nigeria. METHODS: This is a multi-centre, randomized, double-blind placebo-controlled superiority trial. The study investigates the efficacy of chloroquine phosphate, hydroxychloroquine sulphate and lopinavir/ritonavir added on to standard of care compared to standard of care only in patients with COVID-19 disease. The primary outcome is the clinical status of patients measured using a 7-point ordinal scale at day 15. Research participants and clinicians will be blinded to the allocated intervention. Outcome measures will be directly assessed by clinicians. Statistical analysis will be done by a team blinded to the identity and allocation of research participants. Data analysis will follow intention-to-treat methods, using R software. DISCUSSION: The current study is of strategic importance for Lagos State in potentially curbing the health, social and economic burden of COVID-19 disease. Should the current study demonstrate that either of the three intervention drugs is more efficacious than standard therapy alone, the State Ministry of Health will develop an evidence-based guideline for the management of COVID-19 in Lagos State. The findings will also be shared nationally and with other states which may lead to a standardized national guideline for the treatment of COVID-19 in Nigeria. TRIAL REGISTRATION: Pan African Clinical Trials Register PACTR202004801273802 . Registered prospectively on April 2, 2020.

Epidural anesthesia: views and outcomes of women in labor in a Nigerian hospital.

BACKGROUND: Pain during childbirth is a well known cause of dissatisfaction amongst women in labor. The use of epidural analgesia in labor is becoming widespread due to its benefit in terms of pain relief. METHOD: After approval of the local Ethics Committee on Research and obtaining informed written consent, 50 American Society of Anesthesiologists (ASA) class I-II consecutive multiparous women in labor requesting pain relief were enrolled in this prospective study. After providing description of the two options of pain relief available to them, they were allocated into two groups according to their request-to receive either parenteral opioid/sedative or epidural labor analgesia. Both groups received analgesia of choice at 4-cm cervical os dilatation. The epidural group received 0.125% plain bupivacaine, while the other group received pentazocine/promethazine intravenously. The time taken to locate the epidural space, catheter-related complications encountered and the amount of intravenous fluid used were documented. RESULT: The two groups were comparable in terms of socio-demographic data. The mean duration of the first and second stages of labor, respectively, were significantly shorter in the epidural group when compared with those in the non-epidural group ([P < 0.01] and [P < 0.02]). There was no difference in the rate of cesarean delivery between them - epidural analgesia (32% [8/25]) versus parenteral opioid/sedative (44% [11/25]), (OR, 0.60; 95% CI, 0.19-1.90). The maternal blood loss from delivery was minimal, with no statistical difference between the two groups (P = 0.27). The neonatal outcome was the same in both groups. Closed questionnaire showed that the overall experience of labor was much better (it was also better than expected) in the epidural group when compared with that in the non-epidural group (80% versus 4%). Eighteen (72%) women had inadequate pain relief in the non-epidural group as compared to 2 (8%) women in the epidural group. CONCLUSION: The study shows that epidural labor analgesia is acceptable to women in our setting. More women in the epidural analgesia group were satisfied with the experience of labor than those who did not receive this form of analgesia than among those who received parenteral opioid/sedative.

Episiotomy and perineal trauma prevalence and obstetric risk factors in Port Harcourt, Nigeria.

BACKGROUND: Perineal trauma sustained during vaginal delivery may predispose to short and long-term complications such as postpartum haemorrhage and sexual dysfunction. Most published literature on perineal trauma and episiotomy come from developed countries and there is limited information from developing countries. The objective of this study was to determine the rate and risk factors for episiotomies and perineal trauma at the University of Port Harcourt Teaching Hospital (UPTH), Nigeria. METHODS: A retrospective review of vaginal deliveries at the UPTH between 1st January 1996 and 31st December 2000. RESULTS: The episiotomy rate in 4720 vaginal deliveries during the period of study was 39.1% in all parturients, while in primigravidae, it was 77.1%. Rates for first and second degree perineal tears in all women were 10.6 and 25% respectively. The incidence of episiotomy decreased with increasing parity while the incidence of perineal tears slightly increased with parity. Nulliparity, vaginal breech deliveries and instrumental vaginal deliveries were identified as risk factors for episiotomy. CONCLUSION: Episiotomy rate at the UPTH is high but the procedure appears to have prevented the occurrence of third degree and complete perineal tears.

Gynaecologic mortality in Enugu, Nigeria.

A retrospective review of 79 deaths in 2033 gynaecologic admissions at a referral centre showed that the leading causes of mortality were cervical cancer, choriocarcinoma, septic abortion and ovarian cancer, in that order. The results suggest a need for an organized cancer programme to limit morbidity and mortality from malignant disease of the female genital tract.

Obstetric mortality in a Nigerian general hospital.

BACKGROUND: The aim of the study was to evaluate the progress towards achieving a 50% reduction in maternal mortality by the year 2000 at a referral hospital. METHODS: A retrospective review of births and maternal deaths over an 18-year period from 1981 to 1998. RESULTS: There was a 30% reduction among booked women in the period 1990-1998 compared to 1981-1989 while only 8% reduction was achieved among referred women. Infection and hypertensive disorders remained the leading causes of death but the contribution of haemorrhage declined due to improved blood transfusion services. CONCLUSION: Further improvement in maternal survival can be achieved by training health personnel involved in maternity care to recognise or anticipate complications early and refer.

Knowledge, attitude, and practice of female health professionals regarding cervical cancer and Pap smear.

BACKGROUND: The objectives of this paper was to determine what female health professionals knew and felt about cervical cancer and Pap smear and their uptake of Pap smear. METHODS: A questionnaire survey of 144 female health professionals at two referral hospitals with facilities for Pap smear. RESULTS: Nurses constituted 52.8% of respondents followed by laboratory scientists (18.8%), doctors (14.6%) and pharmacists (13.9%). One hundred and thirty two (91.7%) respondents had heard of cervical cancer and 80.6% knew it was associated with vaginal bleeding. Twenty two percent could not list any risk factor A significantly greater proportion of doctors (100%) knew the purpose of a Pap smear compared to 59.2% of nurses, 50% of pharmacisits and 48.1% of laboratory scientists (p = 0.003). Only 13 respondents (9%) had everhad a Pap smear with doctors (p = 0.003) and divorced/separated women (p = 0.005) significantly more likely to have done so. Perceived non-availability of Pap smearservice was the main reason (51.3%) for not having had a Pap smear. However, 30.3% had not thought of it or did not consider themselves at risk of cervical cancer. CONCLUSION: Health professionals themselves need to be properly informed about cervical cancer and Pap smears because of their own needs as women and also to improve their effectiveness in educating and encouraging other women to have Pap smears. Available Pap smear services should be publicized and made more affordable.

Five-year experience with depot medroxy progesterone acetate injectable contraception.

BACKGROUND: The objective of this article is to describe the characteristics and experiences of clients who used depot medroxy progesterone acetate for contraception. METHODS: A retrospective review of family planning records of clients who used depo-provera between 1992 and 1996 at the family planning clinic of University of Nigerian Teaching Hospital, Enugu. RESULTS: The mean age of clients was 32.7 +/- 5.2 years. Over 71% of clients had five or more children. Clients with no education (78.7%) or primary education (75.1%) were more likely to be grand-multiparous compared to women with at least secondary education (49.6%). Among clients with 1-4 living children, 81.3% used depo-provera for child spacing. Among those with 5-8 living children, 48.8% used it for child spacing. Menstrual abnormalities were the main complications but the commonest reason given for discontinuation was "husband's wish". The continuation rate at 36 months was 82.7%. CONCLUSION: Depot medroxy progesterone acetate is an acceptable and effective method of contraception. The involvement of men in family planning programmes cannot be over-emphasised as they significantly influence the decision of women regarding contraceptive use.

Perinatal outcome among elderly nulliparae at the University of Port Harcourt Teaching Hospital.

BACKGROUND: Maternal and perinatal health is influenced by sociodemographic factors including maternal age, parity, social class and ethnicity. Elderly nulliparity is considered traditionally, to be high risk and has not been evaluated in our centre. The objective of our study was to determine the perinatal outcome in the elderly nullipara at the University of Port Harcourt Teaching Hospital. METHODS: This was a two-year retrospective case controlled study. The study population consisted of all nulliparae aged 35 years and above who delivered in the hospital during the period and the control group consisted of all nulliparae less than 35 years of age. The chi2-test was used for comparison of both groups and statistical significance set at p values of P < or = 0.05. RESULTS: Fifty-nine (2%) of 2967 women who delivered during the period were elderly nulliparae. They accounted for 4.8% of all nulliparae. Compared to other nulliparae, there was no significant difference in the rate of preterm delivery (21.8% vs. 25.8%; p = 0.6), postterm delivery (9.1% vs. 17.3%; p = 0.2), caesarean section rate (41% vs. 32.8%; p = 0.3), low birth weight (5.2% vs. 11.6%; p = 0.2), macrosomia (10.3% vs. 5.7%; p = 0.2), still birth rate (0% vs. 3.2%), birth asphyxia (31% vs. 25.4%; p = 0.4), and sex ratios of babies. There were no congenital malformations in both groups. CONCLUSION: Elderly nulliparae are not at increased risk of adverse perinatal outcome compared to younger nulliparae in our hospital.

Accidental incision of the fetus at caesarian section.

BACKGROUND: Caesarian section is the most common major surgical procedure among women of reproductive age. It is thought to be safer for the baby than the mother. However, the baby is at risk of laceration injury. METHODS: Retrospective review of clinical records of women who were delivered by caesarian section during a seven-year period from January 1, 1991 to December 31, 1997. RESULTS: Fetal laceration injury was documented in 0.55% of live caesarian section births. Accidental incision of the fetus was associated with emergency caesarian section, ruptured membranes and relative inexperience of the operating surgeon. Documentation of injury was poor and there was no evidence that parents were counselled. CONCLUSION: Laceration of the fetus is an occasional complication of caesarian section. Proper documentation and counselling of parents are required especially as there are potential medicolegal implications. Careful attention to the technique of uterine entry at caesarian section should reduce the risk of injury to the fetus.

Genital prolapse in Port Harcourt, Nigeria.

BACKGROUND: Damage to the genitourinary supports from repeated pregnancies and labour is the most important predisposing aetiological factor in genital prolapse, a chronic gynaecological disorder that causes distressing morbidity (stress urinary incontinence, micturitional difficulties and problems of defecation). OBJECTIVE: To determine the pattern of presentation and management of genital prolapse at the University of Port Harcourt Teaching Hospital, and compare with experience elsewhere. METHODS: Retrospective review of all cases of genital prolapse admitted and operated upon during the period January 1990 to December 1999. Data collected and analyzed by simple percentages included sociodemographic characteristics, aspects of clinical presentation, management modality and outcome. RESULTS: Genital prolapse (118 cases) accounted for 37.5 per 1,000 gynaecological admissions during the study period. Seventy percent of the study subjects were above age 45 years, while seventy-three percent were grandmultiparous. Thirty percent were of reproductive age. The commonest symptom was "something coming down the vagina" (95% of the study subjects). Only 4% had stress incontinence. Second degree prolapse was the commonest finding on presentation (68.6%) while vaginal hysterectomy with pelvic floor repair was the main operative procedure (undertaken in 73.7% of the subjects). Postoperative deaths occurred in two patients, both diabetics (case fatality ratio 1:59) from septicaemia and intestinal obstruction respectively following vaginal hysterectomy. Postoperative morbidity following vaginal hysterectomy was also higher than that following Manchester Repair. CONCLUSION: This study's results are similar to previous findings in Nigeria and other developing countries. Measures to reduce grandmultiparity, difficult deliveries and postoperative morbidity and mortality are advocated.

Malignancies of the female genital tract at the University of Port Harcourt Teaching Hospital: a ten year review -- 1990-1999.

OBJECTIVES: To determine the relative frequencies of malignant disease of the female genital tract. DESIGN: A retrospective review of histopathology report. SETTING: University of Port Harcourt Teaching Hospital, Port Harcourt, Nigeria. SUBJECTS: Women who had gynaecologic cancers. RESULTS: The cervix was the commonest site of malignant disease (63.1% ) followed by the endometrium, ovary, vulva and vagina. The age of the patients varied with the type of cancer as follows - endometrium (54.8 years), cervix (51.9 years), ovary (40.4 years), choriocarcinoma (30.6 years). CONCLUSION: There is an urgent need to establish a national community - based cervical cytology service to reduce the incidence of cervical cancer and its attendant morbidity and mortality.

Maternal deaths associated with cesarean section in Enugu, Nigeria.

Maternal deaths from cesarean sections in Nigeria are exceptionally high and result from avoidable causes such as hemorrhagic shock, sepsis and hypertensive disorders in pregnancy. Increased involvement of specialists in the care and improved intra and post-operative management of cases are advocated to reduce the high maternal mortality rate.