A review of vaginal hysterectomies in the gynaecology department of a tertiary care hospital.

This retrospective cohort study analysed the trends and complications of vaginal hysterectomy conducted at Services Hospital, Lahore, from January 1, 2015 to December 31, 2020. Demographics, indications, surgery duration, complications (haemorrhage, urological or rectal problems, infection), and hospital stay were recorded. Out of 819 hysterectomies performed for benign gynaecological conditions, 112 (13.68%) were vaginal hysterectomies. Non-descent vaginal hysterectomy (NDVH) accounted for 33(29.46%) and uterine prolapse for 79(70.53%) of the cases. Mean age was 52.35±8.74 years, parity was 5.01±1.32, intraoperative haemorrhage was 796.87±450.1 ml, surgery duration was 48.61±12.28 minutes, and hospital stay was 2.58±0.41 days. Complications occurred in 19(16.97%) of the cases, while 93(83.03%) cases had no complications. Outcomes were comparable between NDVH and vaginal hysterectomy for prolapse (p=0.552). This indicates that vaginal hysterectomy is a safe procedure with minimal complications and quick recovery for uterine prolapse and non-descent uterus. However, a declining trend was observed over the study period.

Efficacy of Letrozole vs Clomiphene Citrate for induction of ovulation in women with polycystic ovarian syndrome.

Objective: To compare the efficacy of letrozole vs Clomiphene citrate for ovulation induction in PCOS women. Methods: This double blind randomized controlled trial was conducted at Services Hospital, Lahore, from January 2016 to December 2020. Total 220 patients, diagnosed with PCOS according to Rotterdam criteria were randomly assigned into two groups after taking informed consent. The women were followed for ovulation, pregnancy and live birth rates in the next five consecutive menstrual cycles with either clomiphene citrate or letrozole. Results: Letrozole had significantly better pregnancy rate (29.0% vs 15.4% p-value 0.015), monofollicular development (77.2% vs 52.7% p-value 0.000) and live birth rate (25.4% vs 10.9% p-value 0.005) as compared to clomiphene citrate. There was no difference between the two groups in ovulation rate (68.1% vs 63.6%, p-value 0.477), early pregnancy loss (3.6% vs 4.5% p-value 0.734), and twin pregnancy (0.0% vs 1.81% p-value 0.155). There was no ectopic pregnancy and no congenital anomalies in both groups. Hot flushes were higher in clomiphene group (31.8% vs 12.7% p-value 0.001) while fatigue (30.9% vs 8.1% p-value 0.000) and dizziness (21.8% vs 10.0% p-value 0.029) was higher with letrozole but these were well tolerated. Conclusion: Letrozole is better treatment choice than clomiphene citrate in PCOS women with infertility in terms of pregnancy and live birth rate.ClinicalTrials.gov Identifier: NCT05702957.

Ferritin screening and Iron treatment for maternal anemia and fetal growth restriction prevention - A multicenter randomized controlled trial (FAIR Study).

Background: Non-anemic iron deficiency precedes iron deficiency anaemia and has an estimated prevalence of 1-2 billion worldwide. Few studies have comprehensively researched the idea of treating non-anemic iron deficiency (NAID) with iron to improve the outcome of the mother and the offspring. Methods and Analysis: FAIR will be a multicenter randomized controlled trial that will be conducted in multiple clinical academic obstetrics units in Lahore (including Services Institute of Medical Sciences, Lahore, Allama Iqbal Medical College, Lahore and Fatima Jinnah Medical University). Pregnant women at gestational age <20 weeks with hemoglobin 11-13 g/L and ferritin below the threshold (<30 ng/ml) will be invited to take part in the study. Randomization will be done by computer based generated random numbers. One group (usual care or oral group) will be offered routine care prophylactic dose of oral iron (30-45 mg/day) and the other group (intervention arm or IV group) will be offered therapeutic dose of IV iron (dose calculated by Ganzoni formula) in addition to usual care. All patients will be followed up till delivery. Primary maternal outcome will be hemoglobin at 36 weeks' gestation. Secondary outcomes are fetal birthweight or small for gestational age, preterm birth, preeclampsia, multidimensional fatigue inventory, breast feeding initiation, blood transfusion, and fetal cord ferritin and hemoglobin. Discussion: The study will generate evidence as to whether screening serum ferritin in non-anemic pregnant women and replenishing their iron stores will likely reduce the rate of predelivery anemia in pregnant women, improve birthweight and preventing perinatal complications. Roles and responsibilities: Tayyiba Wasim is principal Investigator and other members of data management team are Natasha Bushra, Shamsa Humayoun, Khalid Saeed Khan, Fatima Shehbaz, Saba Rasool, Anam Riaz and Sonia Irshad. Principal investigator will assume the full responsibility of Fair trial including training of research assistants, administration of informed consent and protecting participants confidentiality. Data management team will help in the management, development and execution of trial. Khadija Irfan Khawaja is the operational lead for fair trial´s technology team comprising of Aziz Fatima and Zubia Zafar, responsible for gathering requirements from study teams and supporting the operational implementation of technology to drive the collection of high-quality study data. Protocol contributors are Gynae unit I of Services Institute of Medical Sciences/ Services hospital, Lahore, Gynae Unit II of Allama Iqbal Medical College/ Jinnah hospital, Lahore and Gynae unit 1 of Fatima Jinnah Medical College/ Sir Ganga Ram hospital, Lahore. These coordinating centres will recruit patients (sample size=600) and will discuss their progress in trial management meetings quarterly. Steering committee: has an independent chair Prof Samia Malik, one expert member Prof Faiza Bashir and Ms Neelam to represent patients, public and consumers. Trial steering committee with independent chair and member with a patient representative will oversee the study. Chair of steering committee has the authority to stop the trial whenever needed in case of positive or negative results. Steering committee meetings will be held on annual basis. Independent Data monitoring committee: comprises of Dr. Shehnoor Azhar as chair and Prof Ejaz Hussain and Dr. Shehla Javed Akram as members. Data monitoring committee will assess the progress, data safety and if needed critical efficacy points of the clinical study and will show their results quarterly in data interim meetings. The committee will focus on integrity of the whole process and compliance of all sites with all aspects of the protocol. It will perform confidential interim analyses quarterly, which may be used to determine if an effect is observed and if the study should continue to its planned sample size. Data monitoring committee will report to the Chair of the steering committee.

Maternal condition as an underlying cause of perinatal mortality: Prospective cohort study.

AIM: To compare the distribution of various causes of perinatal mortality in a public hospital in low-middle-income country setting. METHODS: A prospective cohort study was conducted from January 2016 to December 2018 at a large public hospital, Services Institute of Medical Sciences, Services Hospital, in Lahore, Pakistan. We applied the World Health Organization's perinatal mortality coding in the International Classification of Diseases. All stillbirths after 28 weeks' gestation weighing more than 1 kg were identified and followed up till delivery. All live births were followed up till discharge or early neonatal death. A multidisciplinary group of obstetricians, pediatricians, midwife and related healthcare professionals was established to assess each case of fatality. The associated maternal conditions were identified for each of the antepartum, intrapartum and neonatal deaths. RESULTS: Of 11 850 births, there were 690 perinatal deaths, with 240 stillbirths (antepartum 167, intrapartum 73) and 450 early neonatal deaths (perinatal mortality rate 58.2/1000 births). Among antepartum deaths, hypoxia accounted for 70 (42%) cases. Among intrapartum deaths, an acute event was responsible for 50 (68%) cases. Among neonatal deaths (450, 65% of total), low birthweight and prematurity contributed to 152 (34%) cases. A maternal condition was found in 183 (76%) of stillbirths and 355 (79%) patients with neonatal death. CONCLUSION: In our study, the most important causes of perinatal deaths were maternal in origin. There was an excess in the distribution of neonatal causes of perinatal deaths. These data should inform policy and practice.

Maternal near-miss, mortality and their correlates at a tertiary care hospital.

OBJECTIVE: To determine the frequency and causes of maternal near-miss and mortality among pregnant women. METHODS: The cross-sectional prospective study was conducted from January 2016 to December 2018 at the Services Hospital, Lahore, Pakistan, and comprised all near-miss cases admitted in the gynaecology department. The World Health Organisation criterion was used to identify the near-miss cases. Primary outcome measures were frequency and causes of near-miss and the ratio between maternal mortality and near-miss cases. Secondary outcome measures were delays, need for massive blood transfusion, intensive care unit admission, obstetric hysterectomy and hospital stay >7 days. Data was analysed using SPSS 23. RESULTS: Of the 10,739 live births, there were 344(3.2%) complications resulting in 305(2.8%) near-miss cases and 29(0.3%) maternal deaths. Frequency of near miss was 28.4 per 1000 live births and the ratio between maternal mortality and near-miss cases was 1:10.5. There were 215(62.5%) unbooked patients and 23(6.7%) of them died (p<0.001). Among the near-miss cases, haemorrhage accounted for 150(49.18%), hypertensive disorders 102(33.44%), cardiac disease 25(8.28%) and infection 12(3.97%). Maternal mortality was significantly low for haemorrhage, hypertension, sepsis and cardiac disease (p<0.001). Massive blood transfusion was given to 64(20.98%) patients, 48(15.74%) underwent hysterectomy, and 98(32.13%) required admission to intensive care unit. First and second delays were seen in 240(78.6%) near-miss and 25(86.2%) mortality cases (p<0.001). CONCLUSIONS: Haemorrhage and hypertension were found to be major reasons for near-miss cases, but timely intervention could prevent mortality.

Gynecological malignancies at tertiary care hospital, Pakistan: A five-year review.

BACKGROUND & OBJECTIVE: Gynecological malignancies are important cause of female morbidity and mortality. They pose significant burden on health resources in low middle-income countries. Data on presentation and risk factors can help in early identification and reduce this burden. Our objective was to evaluate frequency, stage of presentation and risk factors of gynecological malignancies in a tertiary care setting. METHODS: It was cross sectional study done in Gynecology Department, Services Institute of Medical Sciences, Services Hospital, Lahore from January 2015- December 2019. The records of the patients were retrospectively reviewed to include all cases of gynecologic malignancies. Demographic information, frequency, risk factors, symptoms, grade and stage of tumor was collected. RESULTS: There were 122 patients diagnosed with gynecological malignancy during the study period. Ovarian cancer was seen in 60 (49.18%) patients followed by cervical cancer in 29(23.7%), endometrial cancer 27(22.1%) and vulva 06(4.9%). Mean age for all cancers was 51±12.7 to 55±9.3 except cervical cancer which was seen in 43±8.9 years. Patients with ovarian cancer had significantly more hypertension and diabetes (p<0.05). Heavy menstrual bleeding and postmenopausal bleeding was significantly seen in patients of endometrial and cervical cancer (p<0.05). Abdominal symptoms of pain, mass and distension were seen in patients with ovarian cancer (p<0.05). Majority patients presented in advanced stage. Among ovarian cancer, 52/60(86.6%) were epithelial in origin while 25(86.2%) cervical cancer and all vulva cancers were squamous cell carcinoma. CONCLUSION: Ovarian cancer was commonest gynecological malignancy followed by cervical cancer. Late presentation with advanced stage was seen in majority of all cancers.

Oral Nifidepine versus IV labetalol in severe preeclampsia: A randomized control trial.

OBJECTIVE: To compare oral Nifidepine and IV labetalol in terms of rapidity of BP control in severe preeclampsia. METHODS: All patients coming to Services Hospital from March 2017 to February 2019 with diagnosis of severe preeclampsia ≥ 24 weeks gestation were randomized to either receive Nifidepine or Labetalol. Primary outcome measure was time taken to control BP and number of doses required. Secondary outcome measures were side effects of drugs, APGAR score, NICU admission and perinatal mortality. RESULTS: Two hundred four patients were included in trial with 102 patients in each group. Labetalol took 22.6± 13.5minutes and Nifidepine took 22.09± 11.7 minutes to achieve target BP (p>0.05). Labetalol required 2.3± 1.58 doses and Nifidepine 2.2± 1.58 doses to control BP ( p>0.05). No maternal side effects were seen in 86 (84.31%) and 92(90.19%) patients in both groups (p>0.05). Mean gestational age at birth was 34.8 ±2.73weeks in Labetalol and 35.2±2.48 weeks in Nifidepine group (p>0.05). In labetalol group, 43 (42.15%) babies had APGAR Score < 7/10 and 23(22.54%) babies required admission to NICU while in Nifidepine group 42 (41.17%) babies had Apgar score < 7/10 & 30(29.4%) babies were admitted to NICU(p>0.05). There were 21(20.5%) perinatal deaths in labetalol Group-And 19(18.6%) in Nifidepine group (p>0.05). CONCLUSION: Oral Nifidepine and IV labetalol are equally efficacious in controlling BP in patients with severe pre eclampsia without any significant side effects.

Fetomaternal outcome in patients with placenta previa.

OBJECTIVES: To assess maternal and fetal morbidity associated with placenta previa and morbidly adherent placenta (MAP). METHODS: All patients with placenta previa who delivered in services hospital from April 1, 2017 to March 31, 2019 were included. Maternal and fetal outcomes were compared amongst patients with placenta previa and MAP. RESULTS: Total of 8002 patients delivered with 152 (1.9%) diagnosed as placenta previa and 56 (36.8%) amongst them had MAP. One hundred thirty-one out of One hundred fifty-two (86.1%) of our patients were booked. Increased number of caesarean section, multi parity and anterior placenta had significant association with MAP (p<0.0001). Maternal morbidity in terms of postpartum hemorrhage >2000ml, caesarean hysterectomy, number of blood transfusions, bladder injury, need for ICU admission was significantly more in patients with MAP (p<0.0001). Case fatality was 3% with two maternal deaths in MAP and none in placenta previa. Fetal outcome was good in both groups as gestational age at delivery was 36 weeks or more, birth weight was ≥ 2.5 kg and >6 APGAR score (p<0.05). Two neonatal deaths occurred in MAP and one in placenta previa owing to prematurity. CONCLUSION: MAP is a dreadful complication of placenta previa with increased maternal morbidity. Regular antenatal care with adequate arrangement of blood transfusion and multidisciplinary approach can reduce maternal mortality.

Outcome of immediate postpartum insertion of intrauterine contraceptive device: Experience at tertiary care hospital.

OBJECTIVE: To determine the outcome of immediate post-placental intrauterine contraceptive device insertion in women. METHODS: This quasi-experimental study was conducted at Services Hospital Lahore, Pakistan, from August 2015 to January 2017.Postpartum intrauterine contraceptive device was inserted within 10 minutes of the delivery of the placenta in patients who gave informed consent. They were followed up at 6 weeks and 6 months and those who completed the follow-up were enrolled as study subjects. Data regarding safety, efficacy and continuation was collected at 6 months. Primary outcome measures were safety in terms of associated complications and secondary outcome measure was continuation rates. Efficacy was measured in terms of prevention of pregnancy. SPSS 23 was used for data analysis. RESULTS: A total of 8,000 eligible patients were counselled, out of whom 3,012(37.6%) exhibited a positive response and had postpartum intrauterine contraceptive device inserted. Of them, 1,250(41.5%) were followed up at 6 months and 833(66.6%) had no complications. Mean age was 30.2±11.4 years. Menstrual disturbances, vaginal discharge, lost string, misplaced device and expulsion were seen in 238(19%), 193(15.4%), 268(21.4%), 14(1.8%) and 75(6%) of the patients respectively. These complications except lost strings were comparable in vaginal and caesarean section insertions (p<0.05). Lost strings were more frequently observed in caesarean section group (p=0.001). Besides, 1,058(84.3%) patients wanted to continue this method of contraception. CONCLUSIONS: Postpartum intrauterine contraceptive device was found to be an effective, acceptable contraception with fewer complications for the patients.

Daily versus stat vitamin D supplementation during pregnancy; A prospective cohort study.

BACKGROUND: Despite favorable climatic conditions, vitamin D deficiency (VDD) is widespread in Pakistan. Current study was aimed to evaluate the prevalence of VDD in Pakistani pregnant women and effectiveness of various regimen of Vitamin D supplementation. METHODOLOGY: This hospital-based prospective cohort study included pregnant women at 12th to 24th weeks of gestation attending Gynae clinic from October 2018 to April 2019. Patients were classified into control and treatment groups (Groups: G1, G2 and G3) according to the dose of vitamin D supplementation. Patients received various regimens of vitamin D including 2000 IU/day (G1), 5000 IU/day (G2) and stat 200000 IU (G3). The levels of vitamin D were measured before and after supplementation. The effectiveness of dosages were compared between and within the groups. Moreover, factors associated with vitamin D sufficiency and insufficiency were ascertained using appropriate statistical methods. RESULTS: Among 281 pregnant women (mean age: 28.22 ± 4.61 years), VDD was prevalent in 47.3% cases. Vitamin D supplementation caused significant rise in the levels 25(OH)D in treatment groups, while there was no significant difference in control group. The highest mean increment in vitamin D (23.14 ± 11.18 ng/ml) was observed with dose 5000 IU/day followed by doses 200000 IU stat (21.06 ± 13.73 ng/ml) and 2000 IU/day (10.24 ± 5.65 ng/ml). Vitamin D toxicity was observed in one patient who received 200000 IU stat of vitamin D. The frequency of VDD following the supplementation was 5.7%. Education status, duration of sun exposure and use of sunblock was substantially associated with vitamin D sufficiency in the current study. CONCLUSION: Our findings underscore the high proportion of VDD among pregnant women in Pakistan. Maternal vitamin D supplementation substantially improved the levels of 25(OH)D. Of three used regimens, the dose of 5000 IU/day is considered safe and equally effective as of 200000 IU stat. Since pregnancy is a time of tremendous growth and physiological changes for mother and her developing fetus with lifelong implications for the child, gestational vitamin D supplementation should be considered to ensure the optimal vitamin D accrual in pregnant women. This study generates the hypothesis that vitamin D supplementation at a dose of 5000 IU/day during pregnancy is superior to the other regimens. However, well-controlled randomized trials are needed to confirm these findings.

Comparison of clinical presentation of benign and malignant ovarian tumours.

OBJECTIVE: To compare clinical presentation of benign and malignant ovarian tumours and to enlist and identify symptoms that could lead to early diagnosis of ovarian carcinoma METHODS: It was a consecutive case series study. All patients who on abdominal or bimanual examination and abdominal U/S were found to have ovarian cyst or tumour, and later underwent laparotomy were included. RESULTS: The study included 110 patients, of whom 80 (72%) had benign and the rest malignant disease. Mean age of patients with malignancy was 49.07+/-18.5 years and for benign 36.95+/-8.2 years (p= 0.0001). Eleven patients with benign tumours were asymptomatic, while 66% had abdominal pain. On the other hand 70% patients with ovarian malignancy had abdominal symptoms with abdominal pain in (76%). Abdominal enlargement and abdominal mass were significantly more in malignant tumours (p=0.003, p= 0.005). Gastrointestinal symptoms were present in both groups but more significant in malignant group (p=0.004). Constitutional symptoms like loss of appetite and weight loss were only present in malignant group (p=0.001). Seventy percent of the malignant tumours presented at late stage (III & IV). Histopathology of benign tumours revealed follicular/luteal cyst in 32% cases while serous cyst adenoma in 23%. Histopathology of malignant tumours showed serous cyst carcinoma in 46.7% and mucinous cyst carcinoma in 26% cases. CONCLUSIONS: Ovarian malignancy is a silent killer, especially affecting women above 50 years. Although presentation is often vague and non specific, symptoms are definitely present. Therefore a proper bimanual examination and appropriate investigations should be done at the outset in post menopausal women.

Foetomaternal outcome of pregnancy with cardiac disease.

INTRODUCTION: To study the prevalence of cardiac disease in pregnancy and to assess the foetomaternal outcomes. METHODS: It was a 5 year descriptive study. All pregnant females with a known or newly diagnosed congenital or acquired cardiac lesion on echo cardiography were included in the study. RESULTS: There were 17,056 births during the study period, of whom 160 were cardiac patients giving a prevalence of 1%. Out of these 36% patients were diagnosed to have cardiac disease during current pregnancy. Acquired valvular heart lesions were found in 132 (82%) patients with mitral stenosis being the commonest (55%), others were congenital. Of the group, 43% patients were in class III & IV according to NYHA. Majority delivered vaginally and only 29% had c/section, 9% had therapeutic termination of pregnancy and 45% babies were low birth weight. Ten babies expired. Maternal mortality was low (3.8%), while 55(35%) had obstetric complications. Poor functional class (III & IV) was the key determinant of adverse footomaternal outcome (p<0.0001). CONCLUSION: The good results of this study can be attrihuted to the team efforts of between obstetricians, cardiologists and patients. Adverse foetomaternal outcome was related to poor functional class III and IV of NYHA.