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 ovariansyndrome (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/m2. 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.

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

OBJECTIVE: 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. STUDY DESIGN: A quasi-experimental study. PLACE AND DURATION OF STUDY: Maternal and Child Health Centre (MCHC), Unit-I, Pakistan Institute of Medical Sciences (PIMS), Islamabad, from December 2009 to December 2010. METHODOLOGY: 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. RESULTS: 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. CONCLUSION: 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.

Where does ergometrine stand in prevention of postpartum haemorrhage in caesarean section?

OBJECTIVE: To compare the safety and efficacy of 10 units of intravenous syntocinon alone with 10 units intravenous syntocinon and 0.25 mg intramuscular ergometrine in the prevention of atonic uterine haemorrhage during caesarean section. METHOD: The quasi-experimental study was conducted at the Maternal and Child Health Centre, Unit I, Pakistan Institute of Medical Sciences, Islamabad, from November 1, 2010 to February 28, 2011. All women undergoing caesarean section were included in the study. Patients were given intravenous 10 units syntocinon alone intraoperatively from November 1 to December 31,2010, while 0.25 mg ergometrine intramuscular was added to 10 units intravenous syntocinon from January 1 to February 28, 2011. Frequency of postpartum haemorrhage, adverse effects of drugs and maternal morbidity and mortality were assessed by using chi square test. P < 0.05 was taken as statistically significant. RESULTS: Of the total number of 701 subjects, 378 (54%) women were given 10 units syntocinon and 323 (46%) were given 0.25 mg ergometrine in addition to 10 units syntocinon. The mean age in the syntocinon group was 28 +/- 3.5 yrs with gestational age of 37.5 +/- 2 wks, while that in syntocinon-ergometrine group was 29 +/- 3.4 years and 38 +/- 2 weeks respectively. Postpartum haemorrhage in the syntocinon group was found in 38 (10%) women versus 05 (1.5%) women) in the other group (p < 0.001). Adverse effects like nausea, vomiting and raised blood pressure were slightly more with syntocinon-ergometrine than syntocinon alone (n = 56; 15.3% vs n = 35; 9.2%), but it was not statistically significant. Post partum haemorrhage was responsible for 40% of maternal mortality during the study period and that was in the syntocinon group. CONCLUSION: Prophylactic ergometrine in addition to syntocinon is superior to syntocinon alone in decreasing frequency of postpartum haemorrhage in caesarean section and associated maternal morbidity and mortality. Regarding safety profile, the two groups showed no statistically significant change.

VBAC scoring: successful vaginal delivery in previous one caesarean section in induced labour.

OBJECTIVE: To develop a scoring system for the prediction of successful vaginal birth after caesarean section, following induction of labour with intra-vaginal E2 gel (Glandin). METHODS: The cross-sectional study was conducted from January 2010 to August 2011, at the Pakistan Institute of Medical Sciences in Islamabad. Trial of labour in previous one caesarean section, undergoing induction with intra-vaginal E2 gel, was attempted in 100 women. They were scored according to six variables; maternal age; gestation; indications of previous caesarean; history of vaginal birth either before or after the previous caesarean; Bishop score and body mass index. Multivariate and univariate logistic regression analysis was used to develop the scoring system. RESULTS: Of the total, 67 (67%) women delivered vaginally, while 33 (33%) ended in repeat caesarean delivery. Among the subjects, 55 (55%) women had no history of vaginal delivery either before or after previous caesarean section; 15 (15%) had history of vaginal births both before and after the previous caesarean; while 30 (30%) had vaginal delivery only after the previous caesarean section. Rates of successful vaginal birth after caesarean increased from 38% in women having a score of 0-3 to 58% in patients scoring 4-6. Among those having a score of 7-9 and 10-12, the success rates were 71% and 86% respectively. CONCLUSION: Increasing scores correlated with the increasing probability of vaginal birth after caesarean undergoing induction of labour.The admission VBAC scoring system is useful in counselling women with previous caesarean for the option of induction of labour or repeat caesarean delivery.

Manual vacuum aspiration: a safe and cost-effective substitute of electric vacuum aspiration for the surgical management of early pregnancy loss.

OBJECTIVE: To compare the efficacy, safety and cost-effectiveness of Manual vacuum aspiration (MVA) with Electrical vacuum aspiration (EVA) in the management of first trimester pregnancy loss. METHODS: A single-centre randomized controlled trial (RCT) was conducted at Maternal and Child Health Centre (MCHC), Unit-I, Pakistan Institute of Medical Sciences (PIMS), Islamabad from April 2007-Dec 2008. A total of 176 cases with early pregnancy loss at < 12 weeks gestation, with a diagnosis of anembryonic pregnancy, incomplete, missed or septic induced abortion and molar pregnancy were randomly allocated to either MVA or EVA in the operation theatre. RESULTS: A total of 176 women were included out of which 70 underwent EVA and 106 had MVA. Baseline characteristics were similar in the two groups except significantly higher gestational age and gestational sac diameter in MVA group. Majority of EVA were performed under general anaesthesia (95.7%) while majority of MVA were performed under paracervical block (60.3%). Complete evacuation was achieved in 89.6% with MVA vs 91.4% with EVA (p=0.691). MVA was superior in terms of significantly less blood loss (62.08 +/- 32.19 vs 75.71 +/- 35.53; p=0.008), shorter hospital stay (12.26 hours +/- 6.97 vs 19.54 hours +/- 7.95; p=0.000) and less hospital cost (Rs 1419.5 +/- 1337.620 vs Rs. 3222.5 +/- 1816.02; p=0.000). Post-operative pain assessment by visual analogue score (VAS) at 0 and 6 hours showed no significant difference (p=0.845 and p=0.157 respectively). The only complication was uterine perforation in 2 (2.4%) cases both belonging to EVA. CONCLUSION: MVA is a safe and effective alternative of conventional EVA. It is superior to EVA in terms of reduced cost and need for general anaesthesia and is thus useful at low resource setting with scarcity of electricity and general anaesthesia.

Expert recommendations for the diagnosis and treatment of iron-deficiency anemia during pregnancy and the postpartum period in the Asia-Pacific region.

Anemia during pregnancy and the postpartum period is commonly caused by iron deficiency and is a significant worldwide issue with severe consequences for both mother and developing fetus. From a worldwide perspective, iron-deficiency anemia (IDA) during pregnancy is highest in the Asia-Pacific region; however, there has been little guidance in this region for safe and effective treatment. An expert panel was convened to develop a concise and informative set of recommendations for the treatment of IDA in pregnant and postpartum women in the Asia-Pacific region. This manuscript provides these recommendations and aims to reduce the morbidity and mortality associated with IDA in pregnant and postpartum women in the Asia-Pacific region. The consensus recommendations define anemia as a hemoglobin (Hb) level <10.5 g/dL during pregnancy and <10 g/dL during the postpartum period, and provide cut-off Hb levels to initiate therapy with oral iron, intravenous iron or red blood cell transfusion.

Validity of hysteroscopy and histopathology in patients with menstrual irregularity.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

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

OBJECTIVE: 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. STUDY DESIGN: Observational study. PLACE AND DURATION OF STUDY: At the MCH Centre, Pakistan Institute of Medical Sciences, Islamabad, from June 2004 to July 2005. METHODOLOGY: 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. RESULTS: 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. CONCLUSION: 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.

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

OBJECTIVE: 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. STUDY DESIGN: Quasi experimental study. PLACE AND DURATION OF STUDY: Mother and Child Health Centre, Pakistan Institute of Medical Sciences, Islamabad, from January 2000 to March 2005. METHODOLOGY: 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. RESULTS: 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. CONCLUSION: 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.

Prevalence of HIV in pregnant women identified with a risk factor at a tertiary care hospital.

BACKGROUND: HIV is an epidemic quite unlike any other, combining the problems of a lifelong medical disease with immense social, psychological, economic and public health consequences. Since we are living in a global village where human interactions has become fast and frequent, diseases like HIV are no more alien to us. HIV/AIDS in Pakistan is slowly gaining recognition as a public health issue of great importance. Objectives of this study were to determine the prevalence of HIV in pregnant women identified with a high risk factor/behaviour at a tertiary care hospital. It is a Descriptive study. METHOD: All pregnant women attending antenatal booking clinic were assessed via a pre-designed 'Risk assessment questionnaire'. Women identified with a risk factor were offered HIV Rapid screening test (Capillus HIV1/2). Positive (reactive) results on screening test were confirmed with ELISA. RESULTS: During the study period (March 2007-May 2008), out of 5263 antenatal bookings 785 (14%) women were identified with a risk factor. HIV screening test was done in 779 (99%), and 6 women refused testing. Three women (0.3%) were found positive (reactive) on screening. Two out of 3 women were confirmed positive (0.2%) on ELISA. Husbands of both women were tested and one found positive (migrant from Dubai). Second women had history of blood transfusion. Her husband was HIV negative. During the study period, in addition to 2 pregnant women diagnosed as HIV positive through ANC risk screening, 6 confirmed HIV positive women, found pregnant were referred from 'HIV Treatment Centre', Pakistan Institute of Medical Sciences (PIMS) to Prevention of Parent to Child Transmission (PPTCT) centre for obstetric care. Spouses of 5 out of 6 had history of working abroad and extramarital sexual relationships. All positive (8) women were referred to PPTCT centre for further management. CONCLUSION: A simple 'Risk Assessment Questionnaire' can help us in identifying women who need HIV screening. Sexual transmission still remains the commonest cause of HIV transmission.

Advanced abdominal pregnancy--a diagnostic and management dilemma.

Advanced abdominal pregnancy is a complex condition demanding challenging management. High index of suspicion may reduce the diagnostic error. Management varies from patient to patient. Expectant management is a feasible option in a well-equipped tertiary care hospital in case of alive viable fetuses. This evidence-based report describes the author's experience of managing a series of advanced abdominal pregnancies at 24 weeks or more of gestation.

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

OBJECTIVE: 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. DESIGN: Prospective cohort study. PLACE AND DURATION OF STUDY: Mother and Child Health Center, Pakistan Institute of Medical Sciences, Islamabad. from January to December 2002. PATIENTS AND METHODS: 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 'z 7 visits groups'. 'z7 visits were taken as controls. The main outcome measures were peripartum maternal complications, obstetric interventions and perinatal outcome. RESULTS: 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 z7 visits group, except significantly higher risk of preterm deliveries in the former group (OR: 2.84). CONCLUSION: 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.