Effect of metformin alone compared with metformin plus simvastatin on polycystic ovarian syndrome in Pakistani women

Objective: To determine the efficacy of metformin alone versus metformin plus simvastatin for treatment of polycystic ovarian syndrome [PCOS]

Study Design: Randomized controlled trial

Place and Duration of Study: Maternal and Child Health Centre, Unit II, Pakistan Institute of Medical Sciences [PIMS], from November 2014 to April 2015

Methodology: One hundred and eight patients [108] were randomly divided into metformin group [n=54] and metformin plus simvastatin group [n=54], detailed clinical history, including menstrual details, was taken with thorough examination performed. Baseline ultrasound was performed to evaluate ovarian size and these were considered enlarged with volume >10cc or with >12 follicles in any one ovary. Blood samples were taken at baseline and after three months of therapy to determine the LH/FSH ratio and lipid profile. Efficacy was defined as >15% decrease in the baseline values

Results: The mean age of patients was 28.82 +/- 7.18 years. Mean BMI of the patients was 22.41 +/- 1.55 Kg/m[2]. Efficacy was achieved in 66.7% patients with metformin alone, while in 92.6% with combination medication [p=0.001]

Conclusion: The combination of metformin plus simvastatin is more efficacious as compared to metformin alone for management of females with PCOS

Responsiveness of pelvic floor distress inventory [PFDI] and pelvic floor impact questionnaire [PFIQ] in women with pelvic organ prolapse, undergoing vaginal reconstructive surgery versus women with no surgery

Objective: To determine the responsiveness of Pelvic Floor Distress Inventory [PFDI] and Pelvic Floor Impact Questionnaire [PFIQ] in women with pelvic organ prolapse, undergoing vaginal reconstructive surgery versus women with no surgery

Methodology: This study was a cross sectional comparative study carried out in the department of Obstetrics and Gynecology, Pakistan Air Force Hospital, Mianwali in a period from January 2011 to December 2015. Prolapsed women with stage II or more and with willingness for surgery were included in the surgery group. Those willing for conservative management [pelvic floor exercises] were included in the non-surgical group. All patients in both groups completed the PFDI and PFIQ at baseline and 6 month follow-up

Results: Mean [+/-SD] age, weight, and parity of the patients were 51.42 [+/-9.07] years, 58.60 [+/-6.8] kg and 4.00 [+/-2.14] respectively. More than half of the patients [61%] belonged to low socio economic status, followed by middle class 34% and upper class 5%. Majority of the patients [61%] were post-menopausal. Most of the patients [72%] had stage II prolapse, followed by stage III [27%] and stage IV [1%]. Among the associated symptoms, voiding dysfunction [81%] was most commonly observed symptom. At baseline all the scores were found to be significantly high in surgical group as compared to non-surgical group however at follow-up significantly low scores were observed in surgical group than non-surgical group. Also, significant decrease in mean scores was observed in both the groups from baseline to follow-up

Conclusion: The PFDI and PFIQ both are responsive to change in women undergoing surgical and non-surgical treatment for pelvic organ prolapse. But PFDI and PFIQ are more responsive to change in the surgical group. It was also concluded that PFDI is more responsive than the PFIQ in women with pelvic organ relapse

Impact of multidisciplinary care in gynecological cancer patients

Objective: To determine the impact of multidisciplinary care in Gynecological cancer patients through multidisciplinary meetings [MDM] at MCH centre, Pakistan Institute of Medical Sciences [PIMS], Islamabad

Study Design: A pre and post intervention comparative study

Place and Duration of Study: The study was conducted at MCH centre, PIMS and Nuclear Oncology and Radiotherapy Institute, Islamabad from 1[st] April 2009 to 31[st] Mar 2010

Material and Methods: MDM is a regularly scheduled meeting of core and limited team members for the purpose of prospective treatment and care planning of newly diagnosed cancer patients. It was started in 2009 in order to improve the management of the cancer patients according to the international recommendations. In a total of 1 year study period 24 meetings were held. The major audit tool was the documentation of the meeting and its outcomes, patient communication and record of the Nuclear Oncology and Radiotherapy Institute of Islamabad [NORI]. A postgraduate student was deputed for documentation

Results: The study identified that MDM helped in achieving many of the best practices of international recommendations which include team approach to treatment planning as well as to care provision, throughout the complete patient pathway. The workload almost doubled as regards the surgery and outdoor cancer claims. There was a shorter delay to first seen in the cancer clinic and shorter duration from diagnosis to treatment. Team members were present in 90-100% of the meetings

Conclusion: MDM has swiftly improved the quality of care and follow up of patients with gynecological cancers and should be conducted at all tertiary care hospitals. Problems of access to high quality and timely care of poor patients in public sector should be addressed as poor patients are not compliant to timely follow-up

Manual vacuum aspirator: a safe and effective tool for decentralization of post miscarriage care

To compare the efficacy and safety of Manual Vacuum Aspiration [MVA] performed as outpatient versus inpatient procedure in terms of success rate, blood loss, hospital stay and procedure related complications. A quasi-experimental study. Maternal and Child Health Centre [MCHC], Unit-I, Pakistan Institute of Medical Sciences [PIMS], Islamabad, from December 2009 to December 2010. Cases with early pregnancy failure [incomplete, missed and an embryonic] at gestational age less than 12 weeks were allocated to MVA as outpatient or elective procedure performed in the operation theatre. Studied variables were noted as above. A total of 177 women were eligible for study, out of whom 78 underwent MVA as outpatient procedure and 99 as indoor procedure. The baseline characteristics were comparable in both groups except significantly high multipara in the indoor group. Complete evacuation was achieved in 96.1% in outpatient vs. 79.7% in indoor cases [p=0.001]. Outpatient group had a shorter hospital stay [median 3 hours, IQR-1 vs. 10 hours, IQR-4; p < 0.001], though the median hospital cost was less but statistically insignificant [Rs. 800, IQR-25 vs. 735, IQR-1265; p=0.728]. Blood loss was comparable in both groups [median 60 ml, IQR-20 vs. 60 ml-IQR-30; p=0.350]. There were two uterine perforations noted in the inpatient group [2.02%] vs. none in outpatient setting. Outpatient based manual vacuum aspiration is a safe and effective tool for management of early pregnancy loss. A decentralized approach proved useful in reducing hospital stay

Outpatient diagnostic hysteroscopy in premenopausal women with abnormal uterine bleeding below 35 years of age

To determine the hysteroscopy findings [by outpatient diagnostic hysteroscopy] in Premenopausal Women with Abnormal Uterine Bleeding below 35yrs of Age. Descriptive study. It was one year study conducted at Pakistan Institute of Medical Sciences [PIMS], Islamabad from 27th Feb 2010 to 28th Feb 2011. Total 51 married women were included in our study between 19 to <35yrs of age. All women with irregular pervaginal bleeding, failed medical treatment or pathology detected on ultrasound pelvis were included. Women with Pregnancy, lower genital tract infection and those with incomplete follow-up were excluded. Diagnostic hysteroscopy and curettage was done under paracervical block in the outpatient department. Endometrial curretings were sent for histopathology and data was recorded on predesigned proformas. On hysteroscopy the findings were, endometrial hyperplasia in 12 cases [23.5%], submucous fibroids in 03 [5.9%], intrauterine adhesions in 02 [3.9%] and retained products of conception [RPOC] in 02 [3.9%] cases, respectively. Total 22 [43.1%] patients had a pathology detected on histopathology; hormonal imbalance in 11[21.5%], endometrial hyperplasia in 4[7.8%], disordered proliferative endometrium in 3 [5.8%], Asherman`s and RPOCs in 2 cases each[3.9%], as already stated. Diagnostic hysteroscopy remains a gold standard in patients with failed medical treatment. Premenopausal women with irregular cycles or failed medical treatment should have an endometrial biopsy regardless of the age because they are at increased risk of having an endometrial pathology.

Efficacy and safety of 12 hours versus 24 hours maintenance therapy of magnesium sulphate in patients with severe pre eclampsia

To determine the efficacy and safety of 12 hour magnesium sulphate maintenance therapy in management of severe pre eclampsia by comparing it with 24 hours standard magnesium sulphate maintenance therapy. Randomized control trial. MCH Centre PIMS from November 2011 to April 2012. All patients with severe preeclampsia [blood pressure of 160/110 mm of Hg or more, proteinuria 2+ on dipstick] or signs and symptoms of impending eclampsia were included in the study. After receiving the loading dose, patients were randomly assigned to 12 hours maintenance therapy of magnesium sulphate in group A versus 24 hours therapy in group B.The main Outcomes measures included: frequency of occurrence of fits, side effects of magnesium sulphate [major and minor], degree of rise in serum uric acid, SGOT and proteinuria, maternal complications and neonatal outcomes. Of 104 patients 52 patients were assigned to each group. Both groups were comparable with regards to maternal age, parity and gestational age. In group A [12 hours regimen] had higher baseline levels of S.uricacid, SGOT, proteinuria versus 24 hours of administration of magnesium sulphate [p=0.15]. Regarding outcome, none of patients in either group had eclamptic fit, conveying that 12 hour magnesium sulphate therapy was equally effective in term of prevention of eclampsia as 24 hours magnesium sulphate therapy. On the other hand group B had significantly higher frequency of minor side effects of magnesium sulphate [nausea, flushing] [p=0.09], compared with 12hours regime. No difference was found among 2 groups in terms of major side effects of magnesium sulphate [respiratory depression, renal failure],occurrence of eclamptic fits, maternal complications and neonatal outcomes. 12 hours maintenance therapy is equally effective in prophylaxis of eclamptic fits and maternal complications, as 24 hours maintenance therapy in patients with severe pre eclampsia and is associated with lesser side effects than 24 hours regime. Large scale studies are however required for generalization of results.

Validity of hysteroscopy and histopathology in patients with menstrual irregularity

Abnormalities in menstrual cycle is the most common presenting symptom in Gynaecology out-patient. Dilatation and curettage has been the diagnostic investigation of choice for decades in such cases. With the advent of new more valid and safe methods, it has been replaced by hysteroscopy as gold standard. The objective of this study was to know the sensitivity and specificity of hysteroscopy in patients presenting with menstrual irregularity. Validity study was conducted over 269 cases for a period of two years at Maternal and child health centre, Pakistan Institute of Medical Sciences, Islamabad. Inclusion criteria were age >/= 35 years and abnormal uterine bleeding. Patient with positive pregnancy test, recent cervicitis, vaginitis, endometritis, pelvic infection were excluded. Hysteroscopy and curettage was performed after taking informed consent, mostly on outpatient basis. A predesigned Performa was used for a detailed record of hysteroscopic findings, which were later compared with histopathology report. Data was analysed using MS Excel, and Cross Tabulation was done using Epi-info. Sensitivity, specificity, positive predictive value and negative predictive value of hysteroscopy was calculated against histopathology, the gold standard. Sensitivity, specificity, positive predictive value and negative predictive value of hysteroscopy was calculated against histopathology after excluding 46 [17.1%] cases of uterine fibroid that were diagnosed only at hysteroscopy. Hysteroscopy has shown highest sensitivity for retained products of conception and adenocarcinoma [100%] while a specificity of 90% and above for all hysteroscopic findings. Seventy eight percent of the procedures were performed on outpatient basis, 95% under intravenous sedation and 95% with no operative complication. Hysteroscopy should be used as an adjunct procedure to curettage as it is a better tool for diagnosis of intracavity lesions, with a high sensitivity and specificity for endometrial carcinoma

External cephalic version with salbutamol-Success rate and predictors of success

To determine the success rate of External Cephalic Version [ECV] with 0.25 mg Salbutamol in singleton term breech and to identify the predictors of success. Quasi experimental study. Mother and Child Health Centre, Pakistan Institute of Medical Sciences, Islamabad, from January 2000 to March 2005. Women, presenting with uncomplicated breech, between 37-40 completed weeks gestation, underwent ECV in day care ward. Fifteen minutes before the procedure, injection salbutamol 0.25 mg was administered subcutaneously. Cases with contraindication to ECV or Salbutamol injection were excluded from the study. The outcome measures included success rate of ECV [in terms of conversion from breech to cephalic presentation at the completion of procedure confirmed through ultrasound], association of maternal and fetal demographic characteristics with successful version and adverse effects related to the procedure in terms of fetal bradycardia, ante-partum still birth, antepartum hemorrhage and preterm labour. Rate of reversion to breech and drug-related side effects were also recorded as secondary outcome measures. Chi-square test was used for categorical variables and independent sample t-test for continuous variables. Of the 101 ECV procedures, 41 [40.5%] were successful. Success rate was significantly lower in nullipara [p=0.01] and with AFI 7 cm or less [p=0.04]. No significant association was found between success rate and gestational age [p=0.35] or fetal birth weight [p=0.57]. None of the patient suffered from serious maternal complications. Salbutamol related minor effects [tremors, anxiety and palpitations] were observed in 36 [35.6%] patients. Fetal tachycardia was seen in 17 [16.8%], reversible fetal bradycardia in 3 [2.9%] and intractable fetal bradycardia in one patient. External cephalic version with 0.25 mg Salbutamol was safe and a feasible option in term breech presentation in this series. Administration of tocolytic agent improved the success rate and reduced complication rate of the procedure. Major determinants of success were amniotic fluid index and parity

Predictive accuracy of intrapartum cardiotocography in terms of fetal acid base status at birth

To find out the predictive value of intrapartum Cardiotocograph [CTG] in terms of fetal acid base status at birth in women undergoing emergency caesarean section for a suboptimal CTG trace. Observational study. At the MCH Centre, Pakistan Institute of Medical Sciences, Islamabad, from June 2004 to July 2005. All women undergoing emergency caesarean section for a suboptimal intrapartum CTG were recruited in the study. Immediately after the delivery of the baby a segment of umbilical cord was doubly clamped at a distance of 10 cm, and 2 ml of arterial cord blood was taken in a heparinized syringe for arterial blood gas indices analysis. All CTG tracings were reviewed using FIGO guidelines and compared for fetal arterial blood gas indices. Of the 57 patients who underwent cesarean section due to suboptimal CTG, 51 [89%] had suspicious trace while 6 [11%] had pathological trace. Positive predictive value of CTG was 18% for fetal hypoxia, 21% for fetal hypercarbia., 26% for fetal acidosis and 37% for base excess. Predictive value of suspicious trace for similar blood indices was 13%, 13%, 17% and 35% respectively. For pathological trace, predictive value was 50%, 83%, 100% and 66% and respectively. Based on the results, it is concluded, that the suspicious CTG trace has low predictive value in terms of fetal acid base status at birth and needs to be complemented with other diagnostic modalities before undertaking any operative intervention. Pathological CTG on the other hand is highly predictive of fetal acidosis at birth warranting immediate intervention

Impact of reduced prenatal visit frequency on obstetric outcome in low risk mothers

To determine an association between reduced prenatal visit frequencies and pregnancy outcome in women, found to be at low-risk of obstetric complications at initial prenatal visit. Prospective cohort study. Mother and Child Health Center, Pakistan Institute of Medical Sciences, Islamabad. from January to December 2002. The hospital case records of 1290 women, who were found to be at low risk of obstetric complications at their first prenatal visit. Prenatal visits were categorized into '<3', '3-6' and ' >/= 7 visits groups'. ' >/= 7' visits were taken as controls. The main outcome measures were peripartum maternal complications, obstetric interventions and perinatal outcome. The median number of prenatal visits was four, [range 1-14; lower quartile 2, upper quartile 6]. Women with less than 3 prenatal visits had significantly higher risk of antepartum complications, low birth weight neonates [<2500 grams], pre-term deliveries, neonatal morbidity, and peri-natal mortality. [OR: 2.58, 2.66, 6.3, 1.57 and 2.2 respectively]. However, they were at equal risk of obstetric interventions and postpartum maternal morbidity. No significant difference was found between 3-6 visits and >/= 7 visits group, except significantly higher risk of preterm deliveries in the former group [OR: 2.84]. Less than 3 prenatal visits were associated with significantly higher incidence of prenatal feto-maternal complications and low birth weight babies compared to 7 or more visits but were at equal risk of obstetric interventions and postpartum maternal morbidity. The obstetric outcome of 3-6 visits group was similar to 7 or more visits group except considerably higher incidence of preterm deliveries in the former group