Randomized controlled trial comparing efficacy of a combination regime containing two cervical sensitizers (mifepristone + Foley's catheter) versus single agent mifepristone or Foley's catheter for labor induction in women attempting TOLAC at late third trimester with a dead fetus in utero.

Randomized controlled trial comparing efficacy of a combination regime containing two cervical sensitizers (mifepristone + Foley's catheter) versus single agent mifepristone or Foley's catheter for labor induction in women attempting TOLAC at late third trimester with a dead fetus in utero. AIM: To compare efficacy and safety of a new combination regime comprising of two cervical sensitizers used simultaneously with single agents, for labor induction in women attempting TOLAC at ≥34 weeks' gestation with a dead fetus. METHOD: This was a multiarm randomized controlled trial (RCT) where participants received one of the three regimes-single agent oral Mifepristone 200 mg, intracervical Foley's catheter (16 Fr size, filled with 40 mL normal saline after intracervical instillation), and combination regime consisting of both used simultaneously. Number of women undergoing vaginal birth within 48 h of induction (VB48 ) was the primary outcome compared between groups. RESULTS: VB48 was higher in participants on combination regime in comparison to participants on Foley's catheter (54 vs. 42). Total vaginal births were higher in participants on combination regime compared to both single agents (58 vs. 48 and 44). Duration and dose of oxytocin augmentation was lower in participants on combination regime compared to both single agents. Induction birth interval was short in participants on combination regime compared to those on Foley's catheter. Maternal complications between groups were similar. CONCLUSION: Combination of cervical sensitizers for labor induction in late third trimester among women with dead fetus attempting TOLAC resulted in higher proportion of vaginal births and might reduce risk of scar dehiscence due to requirement of a lower dose of oxytocin for augmentation.

Development of a multivariate predictive nomogram among women with antepartum fetal death diagnosed at ≥ 34 weeks of gestation for outcome of TOLAC.

OBJECTIVE: The present study was planned to develop a nomogram that will give a priori estimate on the probability of vaginal birth from maternal features in women with antepartum fetal death diagnosed at ≥ 34 week's gestation and previous one low transverse cesarean section (LTCS). This will help to reduce maternal complications and increase confidence when planning a trial of labor after cesarean section (TOLAC). METHODS: A prospective observational study was planned where participants underwent induction of labor with Foley's catheter (unless already in spontaneous labor) within 24 h of enrolment. Participants with absent or inadequate contractions, oxytocin infusion as an additional agent was used. Data was collected on maternal predelivery features. Outcome of participants was categorized into two classes-vaginal and cesarean delivery. Classifiers were trained with data on maternal features and the accuracy of predicting outcome class determined. The classifier with maximum accuracy was used to develop a nomogram. RESULT: Three hundred and one women underwent treatment as per protocol. Two hundred and twenty women attained successful vaginal delivery and eighty-one women underwent caesarean section. Factors having a significant impact on outcome were maternal body mass index (BMI), bishop score, duration of augmentation, estimated foetal weight, interval from previous LTCS, admission to active labor interval, vaginal delivery after LTCS and gestational age. The Naïve -Bayes model gave the highest prediction accuracy (0.88). CONCLUSION: Non-linear classifiers by using selective features could predict the outcome of TOLAC among women with intra-uterine fetal death attempting vaginal birth at or beyond 34 weeks gestation with high accuracy.

Randomized control trial to compare effects of ultra-low dose (Ethinylestradiol 20 µg or 15 µg) with low dose (Ethinylestradiol 30 µg) hormonal pills on lipid discordance in non-obese PCOS women.

OBJECTIVE: Regular users of hormonal contraceptive pills show marked heterogeneity in metabolic effects with variations in compositions. This might be due to choice of outcome variables for comparison. Total cholesterol-high-density lipoprotein ratio (TC/HDL) discordance with low-density lipoprotein (LDL-C) has now become an established marker of future risk for atherosclerotic cardiovascular disease and stable to variations in user. METHODS: The present study was a randomized controlled trial to compare prevalence of TC/HDL and LDL discordance among non-obese women with polycystic ovarian syndrome (PCOS) treated with hormonal pills. Women were randomized into three arms, two arms received ultra-low dose pills (Ethinylestradiol [EE] 20 µg with drosperinone 3 mg or EE 15 µg with gestodene 60 µg) and one arm received low dose pill (EE 30 µg with desogestrel 150 µg). The role of baseline participant features and pill composition on discordance was determined. RESULTS: Discordance was observed in more than a quarter of the participants before intervention. After 1 year of treatment, less than a fifth of the participants were discordant. Ultralow-dose pill users had lower discordance, LDL, and TC than low-dose pill users after 1 year of treatment. The random forest, a non-linear classifier, showed the highest accuracy in predicting discordance. The baseline Parameters with the maximal impact on the occurrence of discordance were triglyceride, homeostatic model assessment for insulin resistance, body mass index, and high density lipoprotein. CONCLUSION: Non-obese PCOS women on ultra-low dose pill have a lower risk of acquiring future atherosclerotic cardiovascular disease.

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.

Is visual inspection with acetic acid better than cervical cytology to screen women ≥ 40 years of age for carcinoma cervix? A cross-sectional study on proportion of screen-positive women (by VIA and cervical cytology) having CIN II/III lesion on cervical biopsy: difference between two age groups and among screening methods.

OBJECTIVE: Proportion of CIN II/III lesion on cervical biopsy among screen-positive women of age group < 40 years and ≥ 40 years undergoing screening for carcinoma cervix by Pap smear and visual inspection of cervix with acetic acid (VIA) was determined (both the tests were performed on same population). Difference in proportion of CIN II/III lesion among screen-positive women, between two age groups (for both methods) and between methods (for both age groups) was determined. RESULT: In < 40 years age group, proportion of screen-positive women with CIN II/III lesion was similar for both cytology or VIA (12.95 vs. 9.8%). For ≥ 40 year age group, compared to cytology, VIA detected higher proportions of CIN II or III lesion (4.1 vs. 13.3%). Proportion of screen-positive women having CIN II/III lesion was higher in < 40 years compared to ≥ 40 year age group (12.95 vs. 4.1%) with cytology, while for VIA no difference was detected in between age groups (9.8 vs. 13.3%). CONCLUSION: Cytological screening is less sensitive in women ≥ 40 years while VIA has a uniform sensitivity for both groups.

Ultrasound assessment of endometrial cavity in perimenopausal women on oral progesterone for abnormal uterine bleeding: comparison of diagnostic accuracy of imaging with hysteroscopy-guided biopsy.

AIM: To investigate the effect of oral progesterone on the accuracy of imaging studies performed to detect endometrial pathology in comparison to hysteroscopy-guided biopsy in perimenopausal women on progesterone treatment for abnormal uterine bleeding. METHODS: The study population comprised of women aged 40-55 years with complaints of abnormal uterine bleeding who were also undergoing oral progesterone therapy. Women with a uterus ≥ 12 weeks' gestation size, previous abnormal endometrial biopsy, cervical lesion on speculum examination, abnormal Pap smear, active pelvic infection, adnexal mass on clinical examination or during ultrasound scan and a positive pregnancy test were excluded. A transvaginal ultrasound followed by saline infusion sonography were done. On the following day, a hysteroscopy followed by a guided biopsy of the endometrium or any endometrial lesion was performed. Comparison between the results of the imaging study with the hysteroscopy and guided biopsy was done. RESULTS: The final analysis included 83 patients. For detection of overall pathology, polyp and fibroid transvaginal ultrasound had a positive likelihood ratio of 1.65, 5.45 and 5.4, respectively, and a negative likelihood ratio of 0.47, 0.6 and 0.43, respectively. For detection of overall pathology, polyp and fibroid saline infusion sonography had a positive likelihood ratio of 4.4, 5.35 and 11.8, respectively, and a negative likelihood ratio of 0.3, 0.2 and 0.15, respectively. CONCLUSION: In perimenopausal women on oral progesterone therapy for abnormal uterine bleeding, imaging studies cannot be considered as an accurate method for diagnosing endometrial pathology when compared to hysteroscopy and guided biopsy.

Adenoma malignum of the uterine cervix--an enigma.

Adenoma malignum is a rare variant of cervical adenocarcinoma which presents a great diagnostic and therapeutic challenge to an oncologist. A 31-year-old woman presented with a mass filling up whole of the vagina which showed no evidence of malignancy by scraping cytology or punch biopsy. But histological examination of the resected mass turned up to be adenoma malignum of the cervix. The patient was subsequently treated by Wertheim's hysterectomy and radiotherapy.

Prediction of pre-eclampsia: comparative analysis of two screening tests.

Pre-eclampsia is a major cause of maternal and perinatal morbidity and mortality. Unfortunately, in spite of extensive research worldwide, still we lack an effective screening test for pre-eclampsia. The aim of the current study is to assess the importance of micro-albuminuria and uterine artery Doppler resistance index as a screening test for pre-eclampsia during antenatal period. The study is a prospective audit. The study population consisted of 160 antenatal mothers attending the outpatient department. Test for micro-albuminuria was done at 14 weeks, 18 weeks, 28 weeks and 34 weeks of gestation. Uterine artery Doppler resistance index (0.58 taken as cut-off) was recorded at 18 weeks of gestation. The subjects were followed up till delivery for development of pre-eclampsia. Sensitivity, specificity, positive and negative predictive value (along with confidence interval and diagnostic odd's ratio) of the tests were calculated. Sensitivity, specificity, positive and negative predictive value of micro-albuminuria was recorded as 66.67%, 93.24%, 44.44% and 97.18% respectively. Those of uterine artery Doppler resistance index were 33.33%, 95.96%, 40% and 94.67% respectively. Diagnostic odd's ratio of micro-albuminuria and uterine artery Doppler resistance index were 27.600 and 11.833 respectively. Confidence interval and diagnostic odd's ratios show that uterine artery Doppler study is a better screening test amongst the two. Both the tests being non-invasive in nature and having high specificity and high negative predictive value can be utilised in community-based antenatal care for identifying women who need intensive vigilance.

Primary fallopian tube carcinoma with metastasis in the contralateral ovary.

Primary malignant neoplasm of the fallopian tube is one of the rarest gynaecological malignancies and a pre-operative diagnosis is often missed due to its diagnostic confusion with the tubo-ovarian mass, hydrosalpinx, ectopic pregnancy and ovarian malignancy. Transcoelomic, lymphatic, transluminal and haematogenous spread may occur to the other abdominal and pelvic organs as well as to the distant sites. Though the body of the uterus, ovaries and the contralateral fallopian tube are frequently involved, in the present case the contralateral ovary was the only site of involvement which is very unusual.

Comparison of neonatal outcome in women with severe pre-eclampsia undergoing caesarean section under spinal or general anaesthesia.

Ideal method of anaesthesia during caesarean section in women with severe pre-eclampsia is difficult to decide. The aim and objective of the study were to compare neonatal outcome in women with severe pre-eclampsia, undergoing caesarean section in intrapartum period, either under general or spinal anaesthesia. Women with severe pre-eclampsia, undergoing caesarean section in intrapartum period, were included in the study. Diastolic blood pressure was kept below 100mm Hg by giving parenteral labetalol pre-operatively. All women received prophylactic magnesium sulphate (5g IV and 10g IM). Maternal blood- gas parameters were measured. Scalp blood pH estimation was done in all cases. Women undergoing caesarean section were randomised into two groups and received either spinal or general anaesthesia. Umbilical arterial catheterisation was done for collecting blood for estimating neonatal blood- gas parameters. Complete data was available in 82 women. Both the groups were comparable in terms of general demographic data, except that percentage of women having an induced labour was significantly more in the general anaesthesia group. Induction of anaesthesia and delivery interval was prolonged for the spinal group. Mean dose of phenylephrine was significantly higher for the spinal anaesthesia group. Preoperative maternal blood-gas parameters and foetal scalp blood pH were comparable in between groups. Difference in neonatal umbilical artery base deficit in between groups was not statistically significant (p = 0.99). Correlation coefficient between maternal base deficit and foetal base deficit was 0.414 (p = 0.01) and 0.06 (p > 0.1) respectively for general and spinal anaesthesia. Subgroup analysis in the population with pre-operative scalp blood pH < 7.2, neonatal umbilical artery base deficit was significantly higher in general anaesthesia group. Five minutes APGAR score was comparable but resuscitation at birth was more common in the general anaesthesia group. Correlation coefficient between maternal base deficit and foetal base deficit in this subgroup was 0.42 (p = 0.05) and -0.57 (p < 0.05) respectively for general and spinal anaesthesia.