Abstract

Objective: The objective of this study were to (1) quantify the concentrations of inhibin A, activin A, and follistatin in maternal serum and umbilical vein (inhibin A, activin A) in IUGR due to placental dysfunction pregnancies and control group, (2) determine the concentration differences of these factors in maternal and umbilical vein serum in control and subject group, and (3) examine the relationship between fetal growth and placental function.

Method: Sandwich ELISA was used to measure the concentrations in  control  (n := 40)  and  subject  groups  (n := 30).

Results: Umbilical vein serum inhibin A, activin A con- centrations were increased in subject group compared with controls  (inhibin  A   regression   coefficient,   0.7647, P :\ 0.001, activin A P :\ 0.0005). Maternal serum inhibin A, activin A were significantly increased in subject group compared with controls (inhibin A regression coefficient, 0.7614, P :\ 0.001, activin A P :\ 0.0005). Maternal serum activin: follistatin ratio was significantly increased in sub- ject group compared with controls (P :\ 0.0005). Maternal serum inhibin A, activin A concentrations were more when compared to the umbilical vein inhibin A, activin A con- centrations in subject group.

Conclusion: The present study strengthens the evidence of using inhibin A, activin A, and follistatin as serum markers in routine screening for early detection of IUGR. But large prospective studies are needed to further define their role in clinical practice.

Abstract

Objective: To determine the clinical value of uterine artery Doppler Pulsatility index (PI) at 22–24 ? 6 weeks scan and importance of maternal history and mean arterial pressure (MAP) in the prediction of pre-eclampsia.

Materials and Methods: This was a prospective screening study of 200 women with singleton pregnancy. Maternal history and blood pressure were recorded, and MAP was calculated. Transabdominal Doppler ultrasound of uterine artery was performed. Mean PI was calculated, and the presence or the absence of bilateral early diastolic notch was noted. Women were then followed up through pregnancy and delivery for the development of pre-eclampsia, gestational hypertension, and SGA.

Result: The mean ± SD PI value for subjects who had an adverse pregnancy outcome was significantly higher (0.84 ± 0.28) than mean ± SD PI value for subjects who had normal pregnancy outcome (0.71 ± 0.16) with P value <0.000.

Conclusion: Second trimester uterine artery Doppler is a useful screening method for identification of high risk pregnancy in women who can be kept under close surveillance for better maternal and neonatal outcome. This test works better when combined with previous history of pre-eclampsia and MAP.

Abstract

Purpose: Intra uterine growth retardation (IUGR) due to fetoplacental vascular insufficiency is rampant in developing countries like India. Owing to the lack of awareness, antenatal patients often present in their third trimester for their first ultrasound examination. Alterations in the waveforms and Doppler indices of fetal middle cerebral artery (MCA), umbilical artery and bilateral uterine arteries have been extensively described in various studies in the literature. However, the role of each doppler parameter in actually predicting reduced birth weight (for gestational age) in the third trimester is often debatable and frustrating.

Method: A prospective study was done on 100 patients of clinically suspected IUGR/high-risk pregnancies of 31–41 weeks. The cases were followed till delivery; the doppler and grey scale findings were correlated with the birth weight of the baby.

Result: The highest sensitivity was found to be of HC/AC ratio, (84.4 %), the highest specificity of oligohydramnios and Cerebral/Umbilical Pulsatility ratio[C/U ratio] (100 %). The sensitivity of C/U ratio was found to be 68.8 %. Fetal MCA had the lowest sensitivity (7.7 %).

Conclusion: HC/AC ratio is quite sensitive, and oligohydramnios is a highly specific parameter to diagnose IUGR. However, the former has lower specificity, and the latter has very poor sensitivity. The MCA PI alone is not sensitive at all, and should not be used for screening purposes in IUGR patients. Also, C/U ratio is more sensitive than oligohydramnios and more specific than HC/AC ratio and stands out as the best parameter of all to diagnose IUGR in the third trimester.

Abstract

Objective: To compare effectiveness of intravenous iron– sucrose versus oral ferrous fumarate in postpartum anemia.

Methods: In this study, 40 women with postpartum anemia with hemoglobin (Hb) less than 8 g/dl within 48 h postpartum were randomised into two groups. Group I consisted of 20 women who received 300–600 mg of intravenous iron–sucrose every alternate day for 3 days. Group II consisted of 20 women who were given 300 mg ferrous fumarate orally daily for 14 days.

Result: On day 14, the increase in mean Hb level in group I was 2.4 g/dl in comparison to 1.2 g/dl in group II. Women in group I had significantly higher mean Hb values on days 7 and 14 (p\0.001) than women in group II.

Conclusion: These results suggest that intravenous iron– sucrose increases the Hb level more rapidly than oral ferrous fumarate in postpartum anemia without any serious side effects.

Abstract

Objective(s): To determine the risk factors for pregnancy among unmarried adolescents and young adults.

Method(s): Case–control study was done over a period of 2 years. Data collected from 181 unmarried abortion seekers and 181 unmarried non-pregnant controls (B24 years) attending three Medical Colleges of Kerala.

Results: Logistic regression analysis showed a strong association between unmarried adolescent pregnancy and lack of parental supervision and control (OR 8.74, P = 0.000), poor intra-family relationship (OR 7.01, P = 0.000), family problem (OR 4.41, P = 0.000), lack of knowledge on sexual and reproductive health (OR 4.95, P = 0.0003), and nonengagement of adolescent in any productive activity (OR 4.41, P = 0.0373).

Conclusion(s): Lack of parental control, family problem, poor intra-family relationship, lack of knowledge on sexual and reproductive health, and lack of engaging in any productive activity were found to be significant predictors for unmarried adolescent pregnancy.

Abstract

Objectives: To assess the prevalence of Pap smear abnormalities and to characterize the associated risk factors in HIV seropositive women.

Material and methods: We conducted a cross-sectional study on 252 HIV seropositive women in and around Krishna district, Andhra Pradesh, India by screening them for cervical cytological abnormalities by means of con- ventional Pap smear screening and the abnormalities reported as per modified Bethesda system.

Results: The prevalence of Pap smear  abnormalities  in HIV seropositive women was found to be 7.17 % which was a twofold increased risk as compared to the general population. On analysis of the risk factors like younger age for abnormal pap smears, mean CD4 count, duration of disease, and ART/HAART therapy the difference between the two groups of HIV seropositive women with normal pap smears and seropositive women with abnormal pap smears was found to be not statistically significant.

Conclusion: HIV/AIDS is associated with a twofold increased risk for cervical cytological abnormalities, and hence the need for periodic pap smear screening in this high risk group to reduce the global burden of cervical cancer.

Abstract

Objectives: The study was undertaken to evaluate maternal, perinatal outcomes following transcervical intrapartum amnioinfusion in women with meconium-stained amniotic fluid.

Methods: A prospective comparative study was conducted on 100women with meconium-stainedamniotic fluid in labor. Group A: study group (50 cases) received amnioin fusion. Group B: control group (50 cases) did not receive amnioin fusion. FHR monitoring was done using cardiotocography.

Results: Significant relief from variable decelerations was seen in 68.18 % cases in the amnioinfusion group as compared to 7.1 % cases in the control group. 78 % cases who were given amnioin fusion had vaginal delivery as compared to 18 % cases in the control group. Fourteen percent cases in the study group had cesarean delivery as compared to 68 % cases in the control group. Meconium aspiration syndrome was seen in six percent neonates in the study group as compared to 20 % in the control group. Two neonates died in the control group due to meconium aspiration syndrome. There was no maternal mortality or major maternal complication.

Conclusions: Intrapartum transcervical amnioinfusion is valuable in patients with meconiumstained amniotic fluid.

Abstract

Objective: To perform analyses of maternal and fetal complications in overweight and obese women.

Methods: Eighty-seven women with singleton pregnancies with BMI[25–29.9 kg/m2 and 83 women with singleton pregnancies with BMI[30 kg/m2 were studied for maternal and fetal complications at Nehru Hospital, B.R.D. Medical College, Gorakhpur during June 2007–October 2008. Forty-five women with BMI 20–24.9 kg/m2 were selected to serve as control.

Results: Compared with women with normal BMI, the outcomes which were more common in overweight and obese women were gestation hypertension (p\0.05); preeclampsia (p\0.001); preterm delivery (p\0.05); induction of labor (p\0.05); instrumental vaginal delivery (p[0.05); cesarean section (p\0.01); increased operative time (p\0.01); still births (p\0.05); early neonatal deaths (p\0.05); Apgar score\7 at 5 min (p\0.05); and admission to NICU (p\0.001). No significant differences were noted among groups regarding hypoglycemia hyperbilirubinemia and respiratory distress.

Conclusion: Overweight and obesity are definite risk factors for adverse pregnancy outcomes. This may be due to altered metabolic state in obesity.

Abstract

Objective: The present study was undertaken to assess the impact of intravenous iron sucrose (Feronia IV) in the treatment of iron deficiency anemia observed in gynecological and obstetrical practice.

Methods: Seventy-seven practicing gynecologists and obstetricians throughout India collaborated in the recruitment of 145 women over a period of 1 year, of which 143 were analyzable cases.

Results: The overall mean rise in hemoglobin level was observed to be 2.43 gm % at the end of 4 weeks. The dose of iron sucrose administered ranged from 100 to 1,050 mg. In women who received 200 mg of the drug, and the mean Hb rise was found to be 2.21 ± 1.06 gm %. The highest observable rise in hemoglobin level was 5.5 gm % with 800 mg of iron sucrose. No serious adverse reactions were reported during the observation period.

Conclusion: Intravenous Iron sucrose is a safe and effective treatment for the rapid reversal of iron deficiency anemia, in obstetric and gynecological settings.

Abstract

Objective: To determine if community-based, low-cost interventions during third trimester of pregnancy can reduce the incidence of low birth weight babies.

Methods: In a case control study, 290 pregnant women from a slum area were registered in the beginning of third trimester of pregnancy and provided full antenatal care comprising fortnightly check up, one IFA tablet daily, counseling for minimum one-and-a-half hour post-lunch rest in left lateral position, additional diet to ensure minimum 2,200 kcal per day, and management of clinical conditions, if any. An equal number of pregnant women belonging to the same slum area were registered as control who received routine antenatal services from the existing health care facilities. The birth weight of the babies in the two groups were recorded and compared. Test of significance and correlation coefficient were applied to the data.

Results: Mean birth weight of the babies of the Subjects was 2.76 kg (SD 0.39) compared to mean birth weight of 2.57 kg (SD 0.36) of the babies in the Control group. Incidence of low birth weight babies among subjects who consumed minimum 2,400 kcal per day, had one-and-ahalf hour post-lunch rest in left lateral position and who consumed one tablet of IFA (100 mg iron and 5 mg folic acid) per day during the last trimester of pregnancy was lower (17.6 %) as compared with women in the Control group (36.2 %). The difference in the mean birth weight of newborns of the two groups was statistically significant (t = 2.52, p\0.01).

Conclusions: Incidence of low birth weight babies can be significantly reduced by providing simple, low-cost care to pregnant women during the last trimester of pregnancy in the community setting.

Abstract

Aim: The aim of this study was to assess the role of total serum estradiol on the day of injection HCG, estradiol per mature follicle, and estradiol per oocytes retrieved (OR) on clinical pregnancy rate (CPR) and oocyte/embryo quality in assisted reproduction.

Materials and Methods: A retrospective review of 342 in vitro fertilization cycles with normal ovarian reserve in women who underwent long GnRH agonist protocol was included. The outcomes assessed are number of OR, number of mature oocytes (MO), number of oocytes fertilized (FO), fertilization rate, number of embryos cleaved (EC), cleavage rate (CR), number of Grade I embryos (E), number of cryopreserved embryos (CPE), and CPR. The Estradiol/follicle ratio (E2/fol) was defined as estradiol level per mature follicle[14 mm in diameter. Estradiol/ oocyte (E2/O) ratio was defined as estradiol level per OR. These two ratios were categorized by the 25th percentile into four groups.

Results: A positive correlation was seen between E2/fol and OR (r = .334, p value = .0001), MO (r = .335, p value = .0001), FO (r = .222, p value = .002), and CPE (r = .289, p value = .0001). Increased CPR was seen in Group C (E2/ fol = 200–299.99) compared to Group A, B, and D (p value = .033). With E2/O ratio, negative correlation was seen between E2/O and OR (r = -.281, p value = .002),MO (r = -.296, p value = .008), FO (r = -.220, p value = .003), EC (r = -.211, p value = .004), Grade 1 embryo (r = -.216, p value = .001), and CPE (r = -.206, p value = .005).No difference in FR, CR, orCPRwas seen.No difference was seen in CPR with total serum estradiol.

Conclusions: In conclusion, serum estradiol is an important determinant of IVF success. While total serum estradiol does not exert any positive or negative influence on IVF outcome, estradiol per mature follicle and retrieved oocytes do have an impact. Pregnancy rate is better when E2/fol is between 200 and 299.99 pg/ml. Also, increasing serum E2/fol positively correlates with better oocytes and embryo quality. In contrast, E2/O negatively correlates with oocytes and embryo quality parameters.

Abstract

Objective: To study the efficacy and safety of combining mifepristone before misoprostol use in second trimester to considerably reduce the induction–abortion interval with the lowest possible dose and adverse reaction.

Material and methods: A prospective study was conducted which included 60 patients visiting the antenatal OPD for elective abortions between 13 and 20 weeks of gestation as per the MTP act. They were randomly divided into two groups of 30 each—the study group received mifepristone 200 mg orally before misoprostol, whereas the control group was induced with misoprostol alone. The results were analyzed.

Observation: Statistical analysis of the study was done using v2 test. The induction–abortion interval was significantly shorter in the study group, thereby decreasing the side-effects of the drug as well as duration of hospital stay. Conclusion This study, like many others, offers a reliable, safe, and cost-effective option by combining mifepristone before misoprostol to decrease the induction– abortion interval.

Abstract

Objective: To evaluate factors contributing to obstetric emergencies, analyze the fetomaternal outcome and role of obstetric drill in facing these emergencies effectively.

Material and Method: Out of 10,892 deliveries, a total of 520 women were included in this prospective study. Analysis of emergency obstetric conditions was done by evaluating incidence, various contributing factors, and fetomaternal outcome. Obstetric drill was conducted among residents repetitively. Pre drill and post drill assessment of confidence in clinical, knowledge, and team work skills were compared by v2 test. Impact of drill on severe obstetric morbidities was noted.

Observations: Incidence of obstetric emergencies was found to be 4.88 %. Maternal and perinatal mortality was seen in 4.23 and 37.11 %, respectively, of these emergency obstetric women. Impact of drill showed an increase in score in knowledge (p\0.019), confidence (p, 0.001), and team work (p\0.001).

Conclusion: Active implementation of emergency obstetric care and incorporation of obstetric drill lays a strong foundation for safe fetomaternal outcome.

Abstract

Objective: The aim of this study of maternal deaths through FOGSI members is to see its current STATUS. Method A three-year retrospective observational study from January 2005 to December 2007 formed the basis for collection of the data for analysis.

Results: A wide variation of maternal mortality ratio (MMR) in the five zones (West—342; South—229; East— 709; North East—709 and North—814) was observed. Leading causes of maternal deaths also varied among the zones [hemorrhage in West (31 %), South (26 %), and North East (21.5 %); hypertension in East (34 %) and North (22 %)]. When the data were analyzed as a whole, the leading causes of deaths were determined as hypertension (29.4 %), hemorrhage (21.56 %), sepsis (15.05 %), and medical disorders (12 %). Analysis of data in India (including Kerala State) for the year 2005 revealed significant drop in MMR to 147.

Conclusion: MMR in India varied widely in zones. There is significant difference in MMR for the whole country as well as for the south zone with or without inclusion of Kerala. Areas of discrepancy in data had been observed in different sources. Prioritization of causes of death and appropriate allocation of resources are needed. A prospective study for evaluation of exact MMR in India is an immediate necessity.

Abstract

Background: Thrombocytopenia is defined as a platelet count of less than 150 9 103 ll. It is commonly diagnosed and has attracted more interest from the researchers in pregnant women during the last 20 years, especially in hypertensive pregnant women.

Aim: To assess the incidence of thrombocytopenia in hypertensive pregnant women during the third trimester of pregnancy.

Methods: Five hundred forty-four pregnant women were included in this study from a total of 10,272 admitted at the Obstetrics and Gynecology Department at Tripoli Medical Center during January–August 2007. Frequent blood pressure monitorings and full blood counts were performed in several medical follow ups. They were not known to be HBV, HCV, or HIV positive women before pregnancy, and none was reported to have evidence of HBV, HCV, or HIV upon performing HBs-Ag, anti-HCV antibody, or HIV-antigen positive tests. Data were arranged in Excel Microsoft program version 2010, and statistically analyzed by SPSS windows program version 17.

Results: Five hundred and forty-four women were hypertensive according to WHO hypertension definition criteria. Sixty-seven women had only one reading of high blood pressure, while 39 women fulfilled HELP syndrome criteria (hemolysis elevated liver enzymes low platelet). These 39 women were excluded from the study. Therefore, only 438 pregnant women remained eligible for the study. The mean age was (32.56 ± 1.5), with their ages ranging between 18 and 49 years. Most of the included women were primigravida 179 (39 %), gravid 2, para one were 72 (16.4 %), and the rest were gravid 3 or more (42.6 %). The blood pressure was 140-160/90-110 mmHg in 365 women (83.4 %), and 73 women (16.7 %) had blood pressure readings more than 160/110 mmHg. Mean platelets count was (206.49 9 103/ll ± 3.35), and ranged between (41.0 - 449.0 9 103/ll). Thrombocytopenia (less than 150 9 103/ll) was recorded in 103 women (23.5 %). All pregnancy cases were delivered safely with no fetal complications.

Conclusion: Gestational thrombocytopenia (GT) is recognized as a major cause of thrombocytopenia particularly in hypertensive pregnant women during the third trimester. Careful follow up during and after pregnancy for those women is recommended.

Abstract

Objective: To observe the role of uterine arteryDoppler flow velocimetry at midtrimester in prediction of preeclampsia.

Method: 179 women carrying \16 weeks of pregnancy, with singleton fetus and without any fetal anomaly were recruited and were divided in high-risk and low-risk group. Doppler velocimetry of uterine artery was done at 24–26 weeks. Any notch in uterine artery, unilateral or bilateral, or RI[0.6, was considered abnormal. Women were followed up and development of preeclampsia noted.

Result: Sensitivity and specificity of abnormal uterine artery Doppler study for prediction of preeclampsia were 73.33 and 86.48 % in high-risk and 57.14 and 95.83 % in low-risk group, respectively. Relative risk with 95 % confidence interval was 5.427 (2.272–12.958) in high-risk and 13.65 (5.669–32.865) in low-risk women.

Conclusion: Doppler velocimetry of uterine artery at 24 weeks can be used as a reliable screening test for prediction of preeclampsia in both high-risk and low-risk women.

Abstract

Purpose: Profile of maternal deaths in selected districts of four Indian states was studied to examine the regional differences in non-biological causal factors (socioeconomic and sociocultural) in maternal mortality and to examine the method and completeness of implementation of Maternal and Perinatal Death Inquiry and Response (MAPEDIR) process.

Methods: An integrated qualitative and  quantitative  method was used to study the MAPEDIR process in selected districts of four states in India, through the use of standard- ized questionnaire for key informant interviews, participant observation checklist, analysis of verbal autopsy questionnaire, and maternal death reports.

Results: A comparison of Profile’s maternal deaths investigated showed that women  died  between  25  and  27 years of age. Half of the women died at home because of inability to afford transport (Delay II) and treatment costs. One third of the deaths had occurred in a health facility (Delay III) because of lack of specialists, equipments or blood. Two thirds of the delays (Delay I) were in seeking medical care. Review of the implementation process of MAPEDIR highlighted that the social audit review model is a unique field based collaborative initiative comprising of stakeholders from various sector in order to improve maternal health programming by reducing maternal mortality.

Conclusions: MAPEDIR has been able to identify socio-cultural, economic and health care systems related determinants of maternal deaths. Standardization the mechanism for information data sharing at district, sub-district and village level can maximize the use of available evidence for advocacy and policy shifts by developing policies and interventions suited to local needs.

Abstract

Introduction: Abnormalities in maternal serum marker levels and fetal measurements obtained during the first trimester screening can be a marker not only for certain chromosomal disorders and anomalies in the fetus but also for specific pregnancy complications. In particular, low maternal serum pregnancy-associated plasma protein-A (PAPP-A), at 11–13 weeks of gestation, is associated with stillbirth, infant death, intrauterine growth restriction, preterm birth, and pre-eclampsia in chromosomally normal fetuses, while a raised nuchal translucency is associated with specific structural abnormalities and genetic syndromes. We have studied the serum Papp-A level in 560 pregnant patients (11–13 weeks gestation) registered at Bharati Hospital and Research Centre, Pune. All patients undergoing testing were followed till the delivery and their neonatal outcome was also taken into consideration.

Aims and Objectives: Our aim is to study the pregnancy outcome in relation to the variations of Papp-A level in the first trimester of pregnancy.

Materials and Methods: Every patient visiting the antenatal OPD was counseled for testing of First Trimester Screening to assess fetal well-being. Patients who were registered for delivery at our hospital were taken into the trial. Blood samples were taken at 11–13 weeks of pregnancy and sent to the PerkinElmer lab for analysis. Results were expressed in Multiple of Median and patients having MOM value less than 0.5 were carefully observed till the delivery, and a thorough neonatal examination was done by a pediatrician. Observations 524 patients were included in the trial out of which 452 patients were found to have a normal Papp-A level of [0.5 MOM. All these patients were followed further during the antenatal period where 18 patients developed preterm labor and few patients developed pregnancy-induced hypertension. The obstetric outcome of patients with a normal Papp-A level was fairly uneventful as compared to others with a low Papp-A level.

Conclusions: Though Papp-A level in the first trimester of pregnancy (11–13 weeks) is an important predictor of future obstetric outcome, it has poor positive predictive value. Patients having a Papp-A level less than 0.5 MOM have a high risk for preterm delivery, fetal growth restriction, and stillbirths along with increased incidence of hypertensive disorders of pregnancy. A low Papp-A level is a useful indicator of risk of preterm delivery and future chance of development of pregnancy-induced hypertension.

Abstract

Objectives: The aim of this study was to determine day 3 Serum AMH, FSH, LH, Estradiol (E2), Inhibin B levels, ovarian volume, and antral follicular count to assess
ovarian function.

Methods: This study was conducted on 130 infertile women between age 18 and 43 years. Day 3 Serum AMH level was estimated by sandwich enzyme immunoassay; Serum FSH, S. LH, S. E2, by solid-phase two-site chemiluminescent immunometric assay; Inhibin B by ELISA; and Ovarian volume and AFC, by transvaginal ultrasonography.

Results: With advancing age, Serum AMH level (p\0.0001), AFC (p\0.05), ovarian volume ([0.05), and Inhibin B ([0.05) were decreased, and Serum FSH (p\0.05), LH (p[0.05), and E2 (p\0.05) were increased. Serum AMH level was 4–6.8 ng/ml with optimal fertility in 26.15 % cases and 2.2–4.0 ng/ml with satisfactory fertility in 53.85 % cases. Serum AMH levels were more strongly correlated with AFC (p\0.0001) and ovarian volume (p\0.0001).

Conclusion: Serum AMH levels were more robustly correlated with AFC than FSH, LH, E2, and Inhibin B on day 3 of the cycle. This suggested that serum AMH might be
taken as single test to reflect ovarian reserve.

Abstract

Objectives: To study maternal heart disease in an Indian setting for: (1) different etiological factors, (2) different types of lesions, and (3) maternal and perinatal outcome.

Methods: 281 women with heart disease who delivered C28 weeks of gestation at different teaching institutions (tertiary care centres) in India were studied.

Results: Rheumatic heart disease (n = 195; 69.4 %) with isolated mitral stenosis (n = 75; 26.7 %) were the commonest. Septal defect (n = 27; 9.6 %) was the predominant lesion among the congenital heart disease (n = 60; 21.3 %) patients, whereas in the miscellaneous group (n = 26; 9.2 %), ischemic heart disease (n = 10; 3.6 %) was the leading cause. Multiple cardiac lesions were also diagnosed in 100 (35.58 %) women. In 87 (31 %) women, diagnosis was made first time in labor. Majority n = 131, (46.6 %) had spontaneous vaginal delivery and few (n = 9; 3.3 %) required induction of labor. Cardiac complications were noted in 72 women (25.6 %). There were three (1.06 %) maternal deaths and perinatal mortality was 4 % (n = 11).

Conclusion: In this study, rheumatic heart disease in pregnancy is still predominant though acquired cardiac lesions are rising. In rheumatic heart disease, mitral valve involvement was the commonest and multiple valve lesions were a major observation. Most common obstetric complication was small for gestation baby. Maternal morbidities in the unbooked women are high and congestive cardiac failure was the major cardiac complication.