fort, psychosocial discomfort, worries/concerns, and satisfaction). For the overall scale and each subscale of PAC-SYM and PAC-QOL, scores can range from 0 through 4, higher scores indicate worse situation. RESULTS: Both placebo and prucalopride groups were well-matched at baseline in terms of demographic data and disease characteristics such as age, gender distribution, body weight, BMI, overall scales and subscales of PAC-SYM and PAC-QOL. At week 12 last observation carried for- ward (LOCF), the mean score reduction was significantly greater in the prucalo- pride group than that in the placebo group for the overall PAC-SYM score (0.3 point), the stool symptom (0.4 point), the abdominal symptom (0.2 point) and the rectal symptom (0.2 point) (P0.008). Mean overall PAC-QOL scores showed significant improvement (0.3 point) with prucalopride than with placebo (at week 12 LOCF), as well as physical discomfort (0.3 point), psychosocial discomfort (0.2 point), worries/ concerns (0.2 point), and satisfaction (0.6 point) (P0.017). CONCLUSIONS: During a treatment period of 12 weeks, prucalopride significantly reduced the severity of symptoms, and improved satisfaction and the disease-related quality of life in Chinese patients with chronic constipation. INDIVIDUAL’S HEALTH - Clinical Outcomes Studies PIH1 PREGNANCY OUTCOMES AFTER MATERNAL EXPOSURE TO TOPICAL CORTICOSTEROIDS: A POPULATION-BASED COHORT STUDY Chi CC 1 , Wang SH 2 , Mayon-white R 3 , Wojnarowska F 3 1 Chang Gung Memorial Hospital-Chiayi, Chang Gung University College of Medicine, Puzih, Chiayi, Taiwan, 2 Far Eastern Memorial Hospital, Oriental Institute of Technology, New Taipei, Taiwan, 3 University of Oxford, Oxford, UK OBJECTIVES: To investigate whether maternal exposure to topical corticosteroids results in adverse pregnancy outcomes. METHODS: We used the UK Health Infor- matics Centre (HIC) Datasets to conduct a population-based retrospective cohort study. We identified 2645 women who were given a topical corticosteroid during the period from last menstrual period (LMP) to delivery and 7212 unexposed women matched for maternal age and the calendar year of pregnancy. We exam- ined if there was an increased risk of adverse pregnancy outcomes (including oro- facial cleft, low birth weight, preterm delivery, and stillbirth) in the exposed group. RESULTS: No significant increase in adverse pregnancy outcomes (including oro- facial cleft, low birth weight, preterm delivery, and stillbirth) was found in relation to maternal exposure to topical corticosteroid [adjusted risk ratio (RR) 1.85 [95% confidence interval (CI) 0.22-15.20], 0.97 (95% CI 0.78-1.19), 1.14 (95% CI 0.70-1.86), and 1.04 (95% CI 0.55-1.98), respectively]. Stratified analyses based on the potency of topical corticosteroids did not substantially change the results. Neither did sen- sitivity analyses that included topical corticosteroids given up to 85 days before last menstrual period. CONCLUSIONS: Congruent with previous studies, the present study found no associations of maternal exposure to topical corticosteroids with orofacial cleft, preterm delivery and stillbirth. In contrast to two previous cohort studies, the present study did not find an association of low birth weight with maternal exposure to either potent or very potent topical corticosteroid. This, how- ever, may be due to the limited sample size and the risk being small. PIH2 TOPICAL ESTROGEN THERAPY IN POSTMENOPAUSAL WOMEN - INDIAN EXPERIENCE Donde S 1 , Uchit G 2 , Valanju N 3 1 Pfizer India, Mumbai, India, 2 Pfizer, Mumbai, India, 3 M M Hospital, Mumbai, Maharashtra, India Twenty-five to 30 % of menopausal Indian women suffer from local vaginal symp- toms. Dearth of Indian data on hormone therapy to relieve local vaginal symptoms prompted this research. OBJECTIVES: The overall objective of the research was to assess the effects of treatment with local estrogen therapy on atrophic vaginitis and gynecological health in Indian post menopausal women. METHODS: Data of 50 menopausal Indian women having moderate to severe vaginal atrophy was col- lected. It was ensured that the women had intact uterus and were not suffering from any significant uterine pathology. Vaginal maturation index (VMI), vaginal pH, and severity of participant-reported most bothersome symptom (vaginal dry- ness, itching, burning, or dyspareunia) at week 12 were the primary outcome. Physiological changes were assessed by Genital Health Clinical Evaluation (GCHE) tool. Local estrogen therapy in the form of Conjugated Equine Estrogen and Estra- diol was used in the dose of 0.5 g twice a week and 1 mg daily respectively for 12 weeks RESULTS: At week 12, there was significant improvements in VMI with the two low-dose preparations compared to baseline values (p0.05). Local estrogen therapy re- duced the most bothersome symptoms in 80 % of the patients. There was a significant improvement in GCHE score after 12 weeks. The local estrogen therapy was well tolerated in the patients and the adverse events were noted in only 5% of the patients. CONCLUSIONS: Local estrogen therapy was effective in relieving the symptoms of mod- erate-to-severe atrophic vaginitis when used twice weekly. Twelve weeks local estrogen therapy was well tolerated and resulted in beneficial changes in the vaginal tissue and induced an overall genital health pattern more characteristic of the premenopausal state. PIH3 PREGNANCY OUTCOMES FOLOWING EXPOSURE TO SEROTONIN REUPTAKE INHIBITORS: A META-ANALYSIS Nikfar S 1 , Abdollahi M 2 , Hendoiee N 3 , Rahimi R 4 1 Tehran University of Medical Sciences, Tehran, Tehran, Iran, 2 Tehran University of Medical Sciences, Tehran, Iran, 3 Mazandaran University of Medical Sciences, Sari, Mazandaran, Iran, 4 Faculty of Traditional Medicine, and Pharmaceutical Sciences Research Center, Tehran University of Medical Sciences, Tehran, Iran OBJECTIVES: Serotonin reuptake inhibitors (SRIs) are extensively used in manage- ment of clinical depression. Reports vary about the risk of these drugs during pregnancy. To determine the risk of exposure to SRIs, we pooled data from multiple clinical studies that investigated obstetrical outcomes in women exposed to this group of drugs during pregnancy. METHODS: Studies were identified by search of PUBMED, OVID, Web of Sciences and SCOPUS databases and the data were derived from 1966 to 2011(September). Types of outcome investigated were spontaneous abortion, major malformations, cardiovascular malformations, and minor malfor- mations. The criteria for inclusion of studies in this meta-analysis were exposure of women to any therapeutic dosage of SRI (citalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, escitalopram, venlafaxine) during pregnancy. RESULTS: A total of 22 studies and 616 522 patients were included in the meta-analysis. Overall, we did not find significant risks of cardiovascular and minor malformations for exposure to SIRs during all trimesters of pregnancy but OR for spontaneous abor- tion was 1.87 with 95% CI = 1.5 to 2.33 and for major malformations 1.37 with 95% CI = 1.11 to 1.68 respectively. CONCLUSIONS: Our results find that SRIs do not increase the risk of cardiovascular and minor malformations but increasing the risks of spontaneous abortion and major malformations significantly should be consider during pregnancy cautiously. PIH4 IMMUNIZATION STATUS AND FAMILIES’ FACTORS IN IRAQ Al-lela OQB 1 , Bahari MB 2 , Alabbassi MG 3 , Salih M 3 , Basher AY 4 1 Discipline of Clinical Pharmacy, School of Pharmaceutical Sciences, Universiti Sains Malaysia, Minden, Penang, Malaysia, 2 Discipline of Clinical Pharmacy, School of Pharmaceutical Sciences, Universiti Sains Malaysia, Pinang, Malaysia, 3 Department of Clinical Pharmacy, College of Pharmacy, The University of Mustansiriyah, Baghdad, Al-Baya, Iraq, 4 Universiti Sains Malaysia, Advance Medical and Dental Institute, Pinang, Malaysia OBJECTIVES: To evaluate immunization status and to identify the family factors associated with immunization rate in children younger than two years. METHODS: A cross-sectional and a cluster sampling design were implemented; five hundred twenty eight representative Iraqi families with children between 18 and 70 months of age were interviewed in five public health clinics in Mosul-Iraq. Demographic characteristics of the child and family, and the child’s immunization history were obtained. Immunization rate or completeness for the following six vaccines were assessed: one dose of Bacille Calmette-Guérin (BCG) vaccine; five doses of polio (OPV); three doses of hepatitis B (HBV) vaccine; four doses of diphtheria, tetanus, and pertussis (DTP) vaccine; one dose of measles, mumps, and rubella (MMR) vac- cine; one dose of the measles vaccine. Risk factors for partial immunization for the 1-5-3-4-1-1 vaccine series were explored using both bivariate analyses and multi- level logistic regression models. RESULTS: More than half of the children were immunized with all vaccination doses therefore considered as complete immuni- zation cases. In addition, less than half of the children had one or more than one missed dose, considered as partial immunization cases. The study found signifi- cant associations of immunization completeness with father’s education level, mother’s education level, mother’s race and family income. Six factors were found that strongly impacted on immunization completeness in the presence of other factors; birthplace, number of preschool children, family income, father’s educa- tion, mother’s education and marital status. CONCLUSIONS: There is a need to in- crease awareness and knowledge about the benefits and importance of vaccination, as well as the harmful consequences of non-complete or partial immunization. INDIVIDUAL’S HEALTH - Cost Studies PIH5 PROVIDER PAYMENT AND COST OF TREATMENT FOR COMPLICATED DELIVERY CARE: EVIDENCE FROM CASE STUDIES IN INDONESIA Rifai MN University of Indonesia, DEPOK, West Java, Indonesia OBJECTIVES: To obtain information on provider payment scheme for complicated delivery care (nearmiss cases) and compared with cost of treatment. METHODS: Crosssectional study was conducted and interview with 372 discharged patients with nearmiss (life threatening) cases in Banten province was done. Information was also captured from hospital records, including charges for consultation fees and other fees, drugs and supplies, and other expenses. Other variables were also collected from hospital documents and a statistical model was developed to learn factors affecting the cost. We combined information with additional data from other districts to obtain information on hospital’s perspective, how they accept the scheme for provider payment. RESULTS: Subsidy for the poor has been started since 2004 and provider payment scheme has been improving to respond the need of quality services with adequate funding. Hospital type C (4 specialists only), how- ever, is not happy with payment under DRG system and it was found that claims for nearmiss cases were below its costs. Medical staffs were unhappy with incentive systems and proposing ‘free delivery’ for all type of nearmiss cases would add burden for the hospitals. Cost of treatment was ranging from USD 172 to USD 272. Costs of drugs and supply constituted the major proportion (20% - 48%) varies with severity. Private hospital suggested that payment is too low and they are not inter- ested in joining the scheme for the poor. Statistical analysis showed that severe cases increased cost of treatment. Hospital claimed that the expected cost recovery was still not achieved. CONCLUSIONS: Provider payment scheme was not well accepted for severe cases since it was found below the cost. Realistic cost estimates is expected to be assessed and more fair scheme to any type of hospital is expected to undertake. PIH6 COST-EFFECTIVENESS OF ROTAVIRUS IMMUNIZATION IN VIETNAM: EXPLORING IMPACTS OF HERD IMMUNITY AND PATTERNS OF BREASTFEEDINGOF A638 VALUE IN HEALTH 15 (2012) A602–A681