Randomized controlled trial of elevation of the fetal head with a fetal pillow during cesarean delivery at full cervical dilatation.

OBJECTIVE: To evaluate whether use of the Fetal Pillow (Safe Obstetric Systems, Shenfield, UK) affects maternal and fetal morbidity in cesarean delivery at full cervical dilatation. METHODS: A randomized controlled trial was conducted at two teaching hospitals in West Bengal, India, between April 1, 2013, and March 31, 2014. Women undergoing cesarean delivery at full dilatation were enrolled and randomly assigned with computer-generated random numbers (block size 10) to undergo delivery with or without the Fetal Pillow. Group assignment was not masked. The primary outcome was the incidence of major uterine wound extensions (grade 2-3). RESULTS: Overall, 120 women were assigned to each group. Major uterine wound extensions occurred in 6 (5.0%) women in the Fetal Pillow group and 39 (32.5%) in the control group (relative risk 0.23, 95% confidence interval 0.11-0.48). CONCLUSION: Use of the Fetal Pillow in second-stage cesarean delivery significantly reduces the risk of a major extension of the uterine incision. CTRI registration number: CTRI/2015/03/005651.

Does route of delivery affect maternal and perinatal outcome in women with eclampsia? A randomized controlled pilot study.

OBJECTIVE: The route of delivery in eclampsia is controversial. We hypothesized that adverse maternal and perinatal outcomes may not be improved by early cesarean delivery. STUDY DESIGN: This was a randomized controlled exploratory trial carried out in a rural teaching institution. In all, 200 eclampsia cases, carrying ≥34 weeks, were allocated to either cesarean or vaginal delivery. Composite maternal and perinatal event rates (death and severe morbidity) were compared by intention-to-treat principle. RESULTS: Groups were comparable at baseline with respect to age and key clinical parameters. Maternal event rate was similar: 10.89% in the cesarean arm vs 7.07% for vaginal delivery (relative risk, 1.54; 95% confidence interval, 0.62-3.81). Although the neonatal event rate was less in cesarean delivery-9.90% vs 19.19% (relative risk, 0.52; 95% confidence interval, 0.25-1.05)-the difference was not significant statistically. CONCLUSION: A policy of early cesarean delivery in eclampsia, carrying ≥34 weeks, is not associated with better outcomes.

Randomized controlled study comparing effect of magnesium sulfate with placebo on fetal umbilical artery and middle cerebral artery blood flow in mild preeclampsia at ≥ 34 weeks gestational age.

AIMS: The aim of this study was to evaluate whether prophylactic magnesium sulfate given in women with mild preeclampsia or gestational hypertension brings any significant change in umbilical artery and fetal middle cerebral artery pulsatility index. MATERIAL AND METHODS: Forty-eight women with gestational age greater than 34 weeks with mild preeclampsia or gestational hypertension were randomly assigned to receive either magnesium sulfate or placebo. Pre- and post-magnesium sulfate pulsatility index of umbilical and fetal middle cerebral artery were compared by Mann-Whitney U-test between the groups. Within-group comparison was conducted using Wilcoxon's signed rank test. RESULTS: There was a significant reduction in the post-magnesium sulfate umbilical artery pulsatility index in the intervention group (median 0.88 [0.82-1.03]) when compared to the placebo group (median 1.00 [0.89-1.10]). Post-magnesium sulfate fetal middle cerebral artery pulsatility index in the intervention group (median 1.78 [1.63-1.98]) did not show a significant change compared to the placebo group (median 1.65 [1.42-1.91]). Within-group comparison showed change in both variables after treatment in the intervention group. CONCLUSION: Magnesium sulfate produces a significant decrease in fetal umbilical artery and middle cerebral artery pulsatility index.

A randomized controlled trial comparing two different antibiotic regimens for prophylaxis at cesarean section.

OBJECTIVES: To compare the efficacy of intravenous single dose, less costly cefotaxime and more expensive amoxycillin-clavulanic acid combination for prophylaxis at cesarean section. METHOD: A double blind randomized controlled trial was undertaken on 760 subjects with two parallel treatment groups. Data were analyzed using Graphpad Instat 3 McIntosh software by Student's t test, Mann-Whitney U test, the Chi-squared test or fisher's exact test. RESULTS: Comparatively narrow spectrum low cost cefotaxime is as effective as more expensive commonly used amoxicillin-clavulanic acid with no significant difference of infectious morbidity and hospital stay (p = 0.27 and 0.11 in elective and emergency cases respectively). CONCLUSION: Less costly cefotaxime should be preferred compared to more costly amoxicillin-clavulanic acid combination for prophylaxis at cesarean section.

Aromatase inhibitors in recurrent ovarian endometriomas: report of five cases with literature review.

OBJECTIVE: To determine the role of the aromatase inhibitor letrozole in the treatment of recurrent ovarian endometrioma cases. DESIGN: Nonrandomized proof of concept study. SETTINGS: Outpatient tertiary-care center. PATIENT(S): Five premenopausal patients with documented ovarian endometriomas and chronic pelvic pain, all of whom were previously treated with surgery and medicine with unsatisfactory results. INTERVENTION(S): Ovarian endometriomas were diagnosed by biopsy after laparoscopic ovarian cystectomy and subsequently treated with hormones. After a 6-month washout of endometriosis hormone therapies, women took letrozole (2.5 mg), one tablet of 0.15 mg of desogestrel, and 0.03 mg of ethinyl estradiol, calcium (1,200 mg), and vitamin D3 (800 IU) daily for 6 months. MAIN OUTCOME MEASURE(S): Size of endometriomas (monitored by ultrasound), assessment of pelvic pain (by visual analog scale), and bone density (DEXA scan). RESULT(S): Disappearance of ovarian endometrioma and reduction in pelvic pain in all cases at the end of 6 months. The size of ovarian endometriomas was reduced after 3 months. Pain scores decreased only after 1 month of treatment and continued decreasing in each treatment month. Overall, no significant change in bone density was detected. CONCLUSION(S): Letrozole given with combined pills achieved complete regression of recurrent endometriotic cysts and pain relief in all cases.

Maternal mortality and cesarean delivery: an analytical observational study.

AIM: Pregnant women and their doctors need to know the maternal risks associated with different methods of delivery. There are few publications with ideal study design and adequate power to establish the relationship between maternal mortality and mode of delivery. The present retrospective cohort study was undertaken to evaluate the intrinsic risk of maternal death, directly attributed to cesarean delivery (CD) compared to vaginal delivery (VD), and to evaluate further the differential risk associated with antepartum and intrapartum CD. METHODS: After exclusion of medical or obstetric comorbidities, all deliveries, either vaginal or cesarean, were critically analyzed. The surviving mothers who had either method of delivery represented the two comparative groups. In the same period, relevant clinical information of every maternal death was noted. RESULTS: Twenty seven mothers died among the 13 627 CD mothers and 19 died among 30 215 VD mothers. CD was associated with a 3.01-fold increase in the risk of maternal mortality, compared with VD. The risk of antepartum CD differed from intrapartum CD (OR 1.73 vs OR 4.86). There was a significantly increased risk of maternal death from complications of anesthesia, puerperal infection and venous thromboembolism. The risk of death from postpartum hemorrhage did not differ significantly (95% CI 0.7-3.95). CONCLUSION: CD is increasingly perceived as a low-risk procedure. However, the present study clearly demonstrates that the risk of maternal death due to CD is significantly high, particularly when performed in labor. Therefore, CD should only be practiced when conditions clearly demand it.

Outcome in second- versus first-stage cesarean delivery in a teaching institution in eastern India.

We evaluated the maternal and perinatal complications of cesarean delivery performed in the second stage compared with the first stage of labor in nulliparous women. We performed a hospital-based cohort study in a teaching institution in Kolkata, West Bengal, India. The primary maternal outcomes measured included intraoperative surgical complications, duration of surgery, need for blood transfusion, wound infection, transfer to intensive care unit, and length of hospital stay. The neonatal outcomes included 5-minute Apgar score 3 or less, need for endotracheal intubation, admission to neonatal intensive care unit, fetal injury, septicemia, neonatal seizures, and neonatal death. There were 1702 cesarean deliveries performed in the first stage and 124 cases in the second stage. Cesarean deliveries performed in the second stage were associated with longer operation time and increased need for blood transfusion, rates of wound infection, intraoperative complications, and need for transfer to intensive care unit. Neonatal complications included significantly low Apgar score at 5 minutes, increased neonatal death, admission to neonatal intensive care unit, increased need for intubation, septicemia, neonatal seizures, and fetal injury (all having P < 0.05). Cesarean deliveries performed in the second stage of labor were associated with higher rates of maternal and neonatal complications.

A randomized controlled trial comparing short versus long-term catheterization after uncomplicated vaginal prolapse surgery.

AIMS: Routine catheterization following vaginal prolapse surgery has advantages like prevention of postoperative retention of urine and prevention of any adverse effect on surgical outcome. However, it increases the risk of urinary tract infection (UTI), prevent early ambulation and prolong hospital stay. This randomized controlled trial was done on how best to minimize catheter related complication after prolapse surgery. METHODS: 200 patients planned for vaginal prolapse surgery were recruited and randomized into two groups. In group I and group II catheter was removed on 1(st) and 4(th) post operative day, respectively. After removal, if patient could not void or when residual urine volume exceeds 150 mL, recatheterisation was done for another three days. Sample of urine was sent for culture during catheter removal. RESULTS: Age, parity, type of surgery and mean operation time did not differ significantly between the two groups. Mean duration of catheterization was significantly shorter (1.64 vs 4.09) and mean duration of hospital stay was shorter by 1.2 days, in first group. However a significantly higher number of retention of urine or residual urine more than 150 mL was found in the early removal group (OR 3.10) but lesser chance of development of urinary tract infection (OR 0.10). CONCLUSIONS: The early removal of catheter seems more advantageous, with lower incidence of urinary tract infection and a shorter hospital stay although associated with an increased risk of recatheterisation.

Maternal mortality in India: a 20-year study from a large referral medical college hospital, West Bengal.

AIM: The present study was carried out to analyze the maternal death rate and its changing trends over a 20-year period in a large referral/teaching institution in Eastern India. METHODS: A retrospective analysis of maternal deaths was carried out from January 1986 to December 2005 at the Department of Obstetrics and Gynaecology, R. G. Kar Medical College and Hospital, Kolkata, India. Records were divided into four 5-yearly periods: 1986-1990; 1991-1995; 1996-2000; and 2001-2005, for comparison of the trends. The initial interval from 1986 to 1990 was chosen as the reference period. RESULTS: The cumulative maternal mortality ratio (MMR) was 599.3 per 100 000 live births. Comparison between the first 5-year period (1986-1991) and the last (2001-2005) showed a statistical significant downward trend in MMR (683.6 vs 474.3; P < 0.001). Deaths due to direct causes are still the leading cause, accounting for 82.09% of total deaths. Hypertensive disorders (36.14%), hemorrhage (21.91%) and sepsis (19.54%) were still the major causes of direct obstetric deaths throughout the study period. Hypertensive disorders alone showed a substantial decline after the introduction of magnesium sulphate. CONCLUSION: The fall in maternal mortality has been very slow.

Relaparotomy after cesarean delivery: experience from an Indian teaching hospital.

AIM: Analysis of cases requiring relaparotomy following cesarean delivery (within 6 weeks of surgery). METHODS: This was a retrospective observational study set in a teaching institution in Kolkata, India, of 66 cases requiring relaparotomy following cesarean delivery. RESULTS: Over a period of 3 years from 1 January 2002 to 31 December 2004, 12 967 cesarean deliveries were done. During the same period, 66 cases had repeat laparotomy. Of these, 43 cases followed cesarean delivery at the institution itself, while 23 had had a cesarean delivery at a peripheral hospital. Post-partum hemorrhage in 28 cases (42.4%) and rectus sheath hematoma in 18 cases (27.3%) were the leading indications for relaparotomy. Of these 66 cases, 63 (95.5%) had intrapartum cesarean delivery, while three (4.5%) had an elective operation. Procedures undertaken at relaparotomy were resuturing of uterine incision in 22 cases (33.3%), uterine artery ligation in 19 cases (28.8%), and drainage of hematoma in 18 cases (27.3%). A third laparotomy was needed in 13 cases (19.6%), of which 11 were due to secondary post-partum hemorrhage. There were eight maternal deaths following relaparotomy. CONCLUSION: Repeat laparotomy within 6 weeks of cesarean delivery was required following 1 in 300 cases done in an Indian teaching hospital. The majority of these were preventable and could have been avoided if adequate attention had been paid at the time of the primary surgery.

Caesarean section for the dead baby--an unhappy reality.

Caesarean section for the dead baby is sometimes still needed to prevent maternal complications. The objective of the study is to critically analyse the characteristics of the mother and indications for the operation in women who delivered stillbirths following caesarean section. The study period covered a 2 years span from January, 2003 to December, 2004. During this time 121 mothers (study group) underwent caesarean section for the dead baby representing 1.41% of all caesarean section operations done in the hospital. The study group was compared to the overall caesaren section done during the two years in relation to parity (parous 77.7% versus 45.7%), type of caesarean section (emergency 83.5% versus 69.8%) and timing of caesarean section within 12 hours of admission (74.4% versus 50.2%). Common indications in the study group included antepartum haemorrhage (31.4%), malpresentation (19.0%), postcaesarean pregnancies (16.5%), obstructed labour (15.7%), foetal distress (9.9%), second twin (4.1%) and eclampsia (3.3%). In some indications like obstructed labour and malpresentation, abdominal deliveries could be reduced by more destructive operations. The maternal reasons for resorting to caesarean section to save maternal lives are understandable. But caesaren section done for foetal distress was a disturbing revealation.

Changing trends in the management of eclampsia from a teaching hospital.

Eclampsia is a major source of both maternal and perinatal mortality. In the management of eclampsia, the role of magnesium sulphate as anticonvulsant and early delivery are well established. The present study is an analysis of maternal and perinatal outcomes after the introduction of magnesium sulphate and liberalisation of caesarean section over a period from August 2002 to September 2004. The observations were compared with statistics from the same hospital from 1995-1997. The incidenceof eclampsia has remained relatively constant but postpartum cases of eclampsia have increased. The case fatality rate of eclampsia has fallen from 11.3% to 5.3%. The perinatal mortality has also fallen from 54.8% to 24.3%. The caesarean section rate for eclampsia has increased from near 10% to 49.7%. Both maternal mortality and perinatal mortality are lowest in the caesaean section group. But the improved perinatal salvage in caesarean section babies may partially reflect the tendency to avoid caesarean section in gross prematurity. The ideal anaesthesia for eclampsia remains unknown but the results with use of general anaesthesia in all cases with precautions produced favourable results.