The Journal of Obstetrics and Gynaecology of India
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ORIGINAL ARTICLES

ORIGINAL ARTICLES
GYNECOLOGY

IOTA Simple Ultrasound Rules for Triage of Adnexal Mass: Experience from South India

Jyothi Shetty1 ● Aruna Saradha1 ● Deeksha Pandey1 ● Rajeshwari Bhat1 ● Pratap Kumar1 ● Sunanda Bharatnur1

Abstract

Objectives: To assess the diagnostic performance of International Ovarian Tumor Analysis (IOTA) simple ultrasound rules to discriminate adnexal masses as benign or malignant.

Materials and Methods: It was a prospective observational study, which included 156 primigravidas with uncomplicated term singleton pregnancy with spontaneous onset and progression of labor, who had normal vaginal delivery with good maternal and neonatal outcome.

Methods: A cross-sectional prospective study was conducted on women scheduled for elective surgery due to adnexal masses. Ultrasound examiner systematically assessed the tumors according to the IOTA simple rules to determine the risk of the tumor being malignant. If the simple rules yielded inconclusive result, pattern recognition was used to categorize the mass. Results were then compared with histologic findings after surgery. Diagnostic performance was assessed by calculating sensitivity and specificity.

Results: Two hundred and five women undergoing surgery were included. The rules were applicable in 183 (89.3%) of the tumors; and for these tumors, sensitivity was 92.8% (95% CI 77–99%) and specificity was 92.9% (95% CI 88–96.4%). Of the tumors, 144 were benign and 39 were malignant. The simple rules yielded inconclusive results in 22 masses which were analyzed by pattern recognition.

Conclusion: IOTA simple rules provide excellent discrimination between benign and malignant adnexal masses.

IOTA simple rules, Adnexal mass, Ultrasound, Benign ovarian tumor
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GYNECOLOGY

Role of Chromohysteroscopy in Evaluation of Endometrial Pathology Using Methylene Blue Dye

Taru Gupta1 ● Sonam Singh1 ● Anand Kumar Verma2

Abstract

Background: Chromohysteroscopy is expected to help in diagnosing subtle endometrial pathologies which could be missed on conventional hysteroscopy and also help in targeting biopsy from endometrium.

Objective: To study staining pattern of endometrium in patients undergoing chromohysteroscopy and to evaluate and compare the histopathology of chromohysteroscopy-guided endometrial biopsy with conventional endometrial sampling.

Method: This was a cross-sectional study conducted during the period of 18 months in Department of Obstetrics and Gynaecology, ESI PGIMSR, New Delhi, India, from September 2016 to February 2018. Totally, 60 women with complaints of infertility, failed intrauterine insemination (IUI), recurrent spontaneous abortions (RSA), heavy menstrual bleeding (HMB), intermenstrual bleeding (IMB) and postmenopausal bleeding (PMB) meeting inclusion criteria were evaluated and enrolled in the study. In patients with normal looking endometrium on hysteroscopy, methylene blue dye was administered through the hysteroscopic inlet. Tissue samples were obtained from stained areas followed by blind endometrial sampling immediately. The results of chromohysteroscopy-guided biopsy from light- and dark-blue-stained areas and blind biopsy were compared.

Results: Mean age of the study group was 37 years, with mean BMI of 24 kg/m2. There were 24 cases of HMB, 9 of IMB, 7 of PMB, 15 of infertility, 2 of failed IUI and 3 with RSA. On chromohysteroscopy, 39(65%) cases showed light-stained endometrium (group I) and 21(35%) showed dark-stained endometrium (group II). Comparison was done between histopathology obtained through chromohysteroscopy and blind endometrial sampling. The diagnostic accuracy of chromohysteroscopyguided endometrial biopsy in evaluation of endometrial pathology was 86.67% with sensitivity of 91.67%, specificity of 85.41%, PPV of 61.12% and NPV of 97.61% (P <0.001).

Conclusion: Chromohysteroscopy was able to detect endometrial pathology which was missed on conventional hysteroscopy and detected more cases of endometrial pathology than blind endometrial sampling.

Chromohysteroscopy, Chromohysteroscopy-guided endometrial biopsy, Blind, Endometrial sampling, Dark staining, Light staining
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GYNECOLOGY

A Comparative Study of Non‑descent Vaginal Hysterectomy and Laparoscopic Hysterectomy

M. Sarada Murali1 ● Afreen Khan2

Abstract

Objective:To compare intra- and post-op complications between non-descent vaginal hysterectomy and laparoscopic hysterectomy and establish the better method for hysterectomy in non-descent uterus.

Methods: A prospective comparative study of 80 hysterectomies was done over a period of January 2017–Dec 2017, with 40 cases each in one group of non-descent vaginal hysterectomy (NDVH) and other group of total laparoscopic hysterectomy (TLH). Demographic characteristics, co-morbid conditions, indications for surgery, operative time, intra-operative blood loss, post-operative analgesia requirements, post-operative hospital stay and post-operative complications were compared between both groups.

Results: The most common age in both groups was 41–50 years. Fibroid uterus was the most common indication for surgery in both groups. The mean operative time in NDVH group was 40 min while it was 120 min in TLH group, and the mean blood loss in NDVH group was 50 ml, while it was 120 ml in TLH group. P < 0.001 when intraoperative blood loss and operative time were compared between both groups. There were no conversions to laparotomy in NDVH group, while there were three conversions to laparotomy in TLH group. Both groups were similar in post-operative analgesia requirement and post-operative hospital stay. Post-operative complications were similar in both groups.

Conclusions: Non-descent vaginal hysterectomy has advantage over laparoscopic hysterectomy as scarless surgery with fewer complications.

NDVH, Laparoscopic hysterectomy, Scar less surgery
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OBSTETRICS

A Randomized, Open-labelled, Interventional Study to Evaluate the Incidence of Infection with or Without Use of Prophylactic Antibiotics in Patients of Episiotomy in a Normal Vaginal Delivery

Amrita N. Tandon1 • Asha R. Dalal1,2

Abstract

Aim: The aim of this study was to compare the incidence of infection in patients of episiotomy with or without the use of prophylactic antibiotics and to compare other morbidities associated with episiotomy and the role of antibiotics in their prevention and treatment.

Design: This open-labelled, randomized, interventional study was conducted in the Department of Obstetrics and Gynaecology at BYL Nair Charitable Hospital, Mumbai, Maharashtra, from October 2014 to October 2015. Three hundred women subjected to episiotomy during normal vaginal delivery in the labour ward from BYL Nair Charitable Hospital fulfilling specific criteria were enrolled in this study and randomly divided into two study groups A and B. In group A, 5-day course of prophylactic antibiotics including tablet cefixime 200 mg BD and tablet metronidazole 400 mg TDS was given, and in group B, prophylactic antibiotics were not given. The two groups were followed up for a period of 5-days postpartum and observed for signs and symptoms of infection.

Main Outcome: Presence of infection, i.e. presence of any positive finding including redness/pain/swelling/wound discharge or wound gape in group A (with antibiotics), was 0.7%, and in group B (without antibiotics) was 2%. The p value by Fischer’s exact test was 0.622 which is not significant. Hence, there was no increased incidence of infection in either group, whether antibiotics were given or not.

Conclusion: To summarise, in our study, it was seen that prophylactic antibiotics did not decrease the incidence of infection in episiotomy following normal vaginal delivery in uncomplicated cases, but further studies are required to evaluate this topic and come to a more definitive conclusion.

Episiotomy, Prophylactic antibiotics, Vaginal delivery, Antibiotic resistance, Episiotomy infection
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OBSTETRICS

Frequency of Red Cell Alloantibodies in Pregnant Females of Navsari District: An Experience that Favours Inclusion of Screening for Irregular Erythrocyte Antibody in Routine Antenatal Testing Profile

Manoj Kahar1

Abstract

Background: Alloimmunisation due to irregular erythrocyte antibodies is a recognised cause of hemolytic disease of the fetus and newborn (HDFN). Prior knowledge of red cell alloimmunisation in pregnant females guides the obstetrician to monitor the foetus for HDFN and if required for appropriated intervention. As limited data are available on prevalence of red cell alloimmunisation in pregnant females in India, the current study was carried out to know the prevalence of red cell alloimmunisation in pregnant females coming at our laboratory.

Methods: Screening for irregular erythrocyte antibodies was performed in 1960 pregnant females after obtaining informed consent between June 2015 and June 2016. MatrixTM screening and identification reagent red cells from Tulip Diagnostics (P) Ltd were used, and column agglutination technique was employed as a method for the test.

Results: Twenty antibodies (all of single specificity) were detected in 1960 samples giving a prevalence rate of alloimmunisation of 1.02%. Out of the 20 antibodies, 18 were identified to be anti-D, 1 was anti-c and 1 antibody was anti-H. The results obtained were then compared with those reported in the literature.

Conclusion: Red cell alloimmunisation is not uncommonly observed in pregnant females; the information gained can help the obstetrician to identify high-risk cases to timely start antenatal and post-natal treatment. Obstetricians should request screening for irregular red cell antibody desirably in all pregnant females; however, if limiting factors are there, it should be done at least in select group of pregnant females having bad obstetric history.

Alloimmunisation, Antenatal, RBC antibody, HDFN, Antibody screening
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GYNECOLOGY

Dienogest Versus Leuprolide Acetate for Recurrent Pelvic Pain Following Laparoscopic Treatment of Endometriosis

Ahmed Mahmoud Abdou1 • Islam Mohamed Magdi Ammar1 • Amr Abd Almohsen Alnemr1 • Amr Ahmed Abdelrhman1

Abstract

Objective: To compare the efficacy and safety of dienogest (DNG) with depot leuprolide acetate (LA) in patients with recurrent pelvic pain following laparoscopic surgery for endometriosis.

Design: Prospective randomized trial.

Setting: Zagazig University hospitals, Egypt.

Patients: Two hundred and forty-two patients with recurrent pelvic pain following laparoscopic surgery for endometriosis.

Intervention: Dienogest (2 mg/day, orally) or depot LA (3.75 mg/4 weeks, intramuscularly) for 12 weeks. Main Outcome Measures A visual analogue scale was used to test the intensity of pain before and after the end of treatment.

Results: There was highly significant reduction in pelvic pain, back pain and dyspareunia in both groups with mean of difference in dienogest group (28.7 ± 5.3, 19.0 ± 4.3 and 20.0 ± 3.08 mm, respectively) and in LA group (26.2 ± 3.01, 19.5 ± 3.01 and 17.9 ± 2.9 mm, respectively). The most frequent drug-related adverse effects indienogest group were vaginal bleeding and weight gain (64.5 and 10.8%, respectively) which were significantly higher than LA group (21.5 and 3.3%, respectively). While the most frequent drug-related adverse effects in LA group were hot flushes and vaginal dryness (46.3 and 15.7%, respectively) which were significantly higher than dienogest group (15.7 and 3.3%, respectively).

Conclusion: Daily dienogest is as effective as depot LA for relieving endometriosis-associated pelvic pain, low back pain and dyspareunia. In addition, dienogest has acceptable safety, tolerability and lower incidence of hot flushes. Thus, it may offer an effective and well-tolerated treatment in endometriosis.

Endometriosis, Pelvic pain, Leuprolide acetate, Dienogest
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GYNECOLOGY

Thirteen Years of Experience with Opportunistic Bilateral Salpingectomy During TLH in Low-Risk Premenopausal Women

P. G. Paul1 • Sumina Mannur1 • Hemant Shintre1 • George Paul1 • Gunjan Gulati1 • Santwan Mehta1

Abstract

Background: Opportunistic bilateral salpingectomy (OBS), also called as prophylactic salpingectomy or risk-reducing salpingectomy is the concurrent removal of the fallopian tubes in premenopausal women. Though there are some studies comparing the intraoperative complications and effect of salpingectomy on ovarian reserve, limited data are available on long-term follow-up after OBS.

Purpose of the Study: To evaluate the surgical outcome of routine bilateral salpingectomy during total laparoscopic hysterectomy (TLH) in terms of intraoperative and postoperative complications. We also evaluated the incidence and reoperation rate for adnexal pathology after TLH.

Methods: A retrospective study of 1470 patients undergoing total laparoscopic hysterectomy (TLH) with opportunistic bilateral salpingectomy (OBS) over 13 years was carried out at Paul’s Hospital.

Results: The mean age of the subjects was 43.6 ± 4.2 years, mean body mass index was 27 ± 5.4 kg/ m2 , and median parity was 2 (range 0–7). 43% of women had at least one previous surgery. The most common indication for surgery was fibroid uterus (67%, n = 985). The total complication rate was 4.4% (n = 65). One specimen showed paratubal borderline serous malignancy. The follow-up period ranged from 6 months to 13 years during which 17 (1.1%) women had adnexal pathology, and eight women (1.1%) needed resurgery for it. No ovarian malignancies were reported on follow-up.

Conclusions: OBS is a simple and short surgical step during TLH without increasing morbidity. OBS eliminates the risk of future diseases of tubal origin, and there might be a possible reduction in incidence and reoperation rate for future ovarian pathologies.

Total laparoscopic hysterectomy, Opportunistic bilateral salpingectomy, Prophylactic salpingectomy, Adnexal pathology, Ovarian cancer
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OBSTETRICS

Importance of Adopting BMI Classifications Using Public Health Action Points to Delineate Obstetric Risk Factors Resulting in Worsening Obstetric Outcomes Among Asian Population

Muniswaran Ganeshan1 • Mohamad Adam Bujang2 • Shahrul Aiman Soelar3 • Shamala Devi Karalasingam4 • Harris Suharjono1 • Ravichandran Jeganathan5

Abstract

Aims: The aim of this study is to compare obstetric outcomes between overweight and class 1 obesity among pregnant women in their first pregnancy based on WHO’s BMI cut-offs and the potential public health action points identified by WHO expert consultations specific for highrisk population such as Asians.

Methods: This is a retrospective cohort review of data obtained from the Malaysian National Obstetrics and Gynaecology Registry between the year 2010 and year 2012. All women in their first pregnancy with a booking BMI in their first trimester were included in this study. The association between BMI classifications as defined by the WHO cut-offs and the potential public health action points identified by WHO expert consultations towards adverse obstetric outcomes was compared.

Results: A total of 88,837 pregnant women were included in this study. We noted that the risk of adverse obstetric outcomes was significantly higher using the public health action points identified by WHO expert consultations even among the overweight group as the risk of stillbirths was (OR 1.2; 95% CI 1.0,1.4), shoulder dystocia (OR 1.9; 95% CI 1.2,2.9), foetal macrosomia (OR 1.8; 95% CI 1.6,2.0), caesarean section (OR 1.9; 95% CI 1.8,2.0) and assisted conception (OR 1.9; 95% CI 1.6,2.1).

Conclusion: A specifically lower BMI references based on the potential public health action points for BMI classifications were a more sensitive predictor of adverse obstetric outcomes, and we recommend the use of these references in pregnancy especially among Asian population.

Asians, Clinical outcomes, Body mass index (BMI), Screening, WHO
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OBSTETRICS

Maternal and Early Perinatal Outcomes of Triplet Pregnancy: Study of 82 Triplets from a Single Perinatal Centre in South India

Priya Rajan1 • Srinivas Murki2 • Suseela Vavilala2 • Nirupama Surubhotla2

Abstract

Objectives: To study the recenttrends in maternal and perinatal outcomes of triplet pregnancy from a perinatal centre in South India.

Methods: All triplet pregnancies booked at Fernandez hospital, Hyderabad (a tertiary care perinatal centre in South India), or those referred between 2000 and 2014 were included in the study. The maternal, fetal and neonatal outcome and any interventions like cerclage, steroid administration were studied.

Results: There were 82 triplet deliveries over the study period of 15 years (82 per 69,584 live births). Most of them (78%) conceived with assistance and 83% of the triplets were trichorionic triamniotic. Anaemia and pregnancy induced hypertension were the commonest medical disorders (40.2 and 22%, respectively). Mean gestational age at delivery was 32 ± 2.8 weeks and 91% were delivered by caesarean section. Preterm labour and preterm pre-labour rupture of membranes were present in 29 and 15%, respectively. Antenatal steroids were administered in 87.8 and 53.7% had a cerclage. There were 20.7% growth restricted fetuses and 5.6% still births among the triplets. The mean birthweight among the live born neonates was 1.5 kg, and birthweight discordancy of [25% was seen in 14%. Among the live born neonates, 80% required admission to the neonatal intensive care unit, 11% had culture positive sepsis, 3% had bronchopulmonary dysplasia, and 4% died during the hospital stay. None of them had periventricular leukomalacia or retinopathy requiring LASER. Mothers in the spontaneous conception group were younger and had more monochorionic triamniotic pregnancies than in the assisted conception groups (11.8 vs. 2.9%, p = 0.001). The incidence of PPROM was significantly more in the spontaneous conception group than in the ovulation induction, intrauterine insemination groups (29.4 vs. 2.9%, p = 0.03), we do not have an explanation for this. There was no difference in the other maternal, fetal or neonatal parameters based on the mode of conception.

Conclusion: Though triplet pregnancies are encountered infrequently, obstetricians should be familiar with their management. Appropriate antenatal, perinatal care with neonatal support can result in optimal outcome.

Triplets, Maternal outcome, Fetal and neonatal outcome, Gestational age, Birthweight
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OBSTETRICS

Intrauterine Inflated Foley’s Catheter Balloon in the Management of Abnormally Invasive Placenta Previa: A Case–Control Study

Mahmoud Thabet1 • Mohamed Sayed Abdelhafez1 • Emad Ahmed Fyala1

Abstract

Objective: To describe the use of intrauterine inflated Foley’s catheter balloon for control of postpartum hemorrhage (PPH) during cesarean section (CS) in cases of abnormally invasive placenta previa aiming to preserve the uterus.

Methods: Retrospective case–control study of the data of women who underwent elective CS on abnormally adherent placenta previa was carried out. Women in whom inflated Foley’s catheter balloon was used for control of PPH during CS (n = 40) were compared with a control group of women who underwent elective CS by the same technique but without use of intrauterine catheter balloon (n = 38).

Results: Use of intrauterine inflated Foley’s catheter balloon significantly reduced the estimated amount of blood loss (P = 0.008), amounts of crystalloids, colloids and packed red blood cells transfusion (P = 0.025, 0.017 and 0.022, respectively), and the need for bilateral internal iliac artery (IIA) ligation (P = 0.016). No significant difference was observed between both groups regarding the use of massive transfusion protocol, performing cesarean hysterectomy, relaparotomy, and admission to the intensive care unit.

Conclusion: Application of an intrauterine inflated Foley’s catheter balloon during CS in cases of morbidly adherent placenta previa helps to control PPH with preservation of the uterus and decreases the need for the invasive IIA ligation.

Placenta previa, Placenta accreta, Foley’s catheter, Cesarean hysterectomy
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OBSTETRICS

First-Trimester Uterine Artery Pulsatility Index and Maternal Serum PAPP-A and PlGF in Prediction of Preeclampsia in Primigravida

Mostafa Abdo Ahmed Salem1 • Islam Mohamed Magdi Ammar1

Abstract

Background: Preeclampsia is a heterogeneous disorder affecting different body systems and frequently associated with morbidity and mortality. Early preeclampsia prediction will reduce this associated morbidity and mortality as it will give the chance for frequent maternal and fetal surveillance and application of prophylactic procedures.

Objective: The aim of this work is to evaluate the role of mean pulsatility index (PI) of the uterine arteries and maternal serum concentrations of pregnancy-associated plasma protein A (PAPP-A) and placental growth factor (PlGF) in early preeclampsia prediction in primigravida. Patients and Methods Three hundred primigravida attending the antenatal care clinic in Zagazig University Hospitals were included in the study. The mean PI of the uterine arteries was calculated. Maternal serum levels of PAPP-A and PIGF were analyzed by specific immunoassay.

Results: Three hundred women were included in the final analysis, of them 30 patients (10%) suffered from preeclampsia. There was a significant difference between preeclamptic and normal women as regards the mean PI of the uterine arteries and levels of PAPP-A and PIGF at 11–13 weeks. When combining the cutoff levels of the three methods, mean PI of the uterine arteries C1.69, PAPP-A assay\0.96 multiple of median (MoM) and PlGF assay \0.91 MoM, the sensitivity, specificity, positive predictive value, negative predictive value and overall accuracy were 56.7, 99.3, 89.5, 95.4 and 67%, respectively.

Conclusion: The combined measurement of maternal serum PAPP-A and PlGF concentrations and mean PI of the uterine arteries at 11–13 weeks of pregnancy may help to predict preeclampsia in primigravida when other parameters of preeclampsia prediction are normal. However, we need more studies on larger and variable populations to evaluate the use of those combined methods in preeclampsia prediction.

Preeclampsia, PAPP-A, PIGF, Pulsatility index
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OBSTETRICS

Nonimmune Hydrops Fetalis: Factors Which Predict Outcome

Manisha Kumar1 • Vandana Jha1 • Anuradha Singh1

Abstract

Aims and Objective: To evaluate the cause of NIHF cases referred to a tertiary referral center and to analyze the outcome.

Materials and Methods: A total of 130 cases of fetal hydrops registered during eight-year study period were reviewed. Antenatal ultrasound, blood investigations and postnatal fetal examination were done, and outcome was noted.

Results: Out of 130 cases of NIHF, antenatal ultrasound showed the presence of structural malformations in 94/130 (72.3%), cardiac abnormality was the most common (34/ 130, 26.1%) and cystic hygroma was seen in 15/130 (11.5%). Chromosomal abnormality was observed in 15(11.5%) cases, and Doppler US showed anemia in 4/130 (3.1%) cases only. Live born were 25 (12.9%), and rest all were stillborn or abortion. Later mean gestational age of presentation (p = 0.0001), presence of gastrointestinal malformation (p = 0.0001) and absence of structural malformations (p = 0.0441) were factors significantly associated with live birth; the presence of cystic hygroma (p = 0.0431) or structural heart defect (p = 0.007) was significantly associated with poor outcome.

Conclusion: Fetal anemia was not a common cause of NIHF in the study population. The early onset of hydrops and presence of structural malformation carry a graver prognosis; type of structural defect also has bearing on outcome. Keywords Nonimmune hydrops Prenatal diagnosis Ultrasound

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OBSTETRICS

Validation of the Risk Score for Maternal Cardiac Complications in Women with Cardiac Disease in Pregnancy: A Retrospective Study

C. N. Sheela1 ● Nekkilady Veni2 ● Ponnusamy Vinotha3 ● Selvam Sumithra4

Abstract

Aim of the Study: To validate the new cardiac risk scoring system, Sheela’s Cardiac Disease in Pregnancy (SHE-CDIP), in predicting the cardiac complications in women with cardiac disease in pregnancy.

Materials and Methods: The study was conducted at a tertiary care hospital in South India, over a period of 5 years from January 2010 to January 2015. Pregnant women with heart disease included in this study were 102, and data was collected from medical records. Risk Score was calculated at booking according to both the new scoring system (SHE-CDIP) and the standard CARPREG scoring system. The validation was done by assessing the ability of the new scoring system to predict maternal cardiac complications by comparing with the CARPREG scoring system.

Statistical Methods: The validation of the SHE-CDIP score was done against CARPREG score using cross tabulation between current cardiac risk score with CARPREG score. McNemar square test was done to compare the proportion between two scoring methods. Agreement between CARPREG and SHE-CDIP risk score was analyzed using Kappa statistics, and accuracy was reported.

Results: Comparing the two risk scores using Kappa statistics, accuracy and good agreement were noted (kappa = 0.70). Sensitivity of 83%, specificity of 88%, positive predictive value of 86% and negative predictive value of 84% for the SHECDIP scoring system were noted.

Conclusion: The new risk score (SHE-CDIP) would be useful to stratify the risk in Indian cohort of women with cardiac disease in pregnancy as it is population specific.

Cardiac diseases, Pregnancy, Risk score, Pulmonary hypertension, CARPREG score
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OBSTETRICS

Using Near Miss Model to Evaluate the Quality of Maternal Care at a Tertiary Health‑Care Center: A Prospective Observational Study

Rubina Pandit1,2 ● Vanita Jain1 ● Rashmi Bagga1 ● Pooja Sikka1

Abstract

Background: Near miss (NM) concept has led to a more comprehensive and better assessment of effect of care on maternal health. It indicates the degree of organ function failure in the wide spectrum of severity.

Methods: This was a prospective observational study conducted from July 2015 to Feb 2016. Among women with potentially life-threatening conditions (PLTCs), those fulfilling one or more WHO NM criteria were included and followed up till the final outcome (NM or death). Various critical interventions done in them were associated with the final outcome. Standardized mortality ratio (SMR) was calculated for assessment of overall quality of health care provided.

Results: One thousand seven hundred and thirty-nine patients had PLTCs of which 174 (10%) patients were identified as NM. Of 174 patients, 116 patients (66.66%) were discharged in stable condition (group A) and 58 patients (33.34%) died (group B). Hemorrhage (31.8%) was the most frequent complication in group A followed by hypertensive disorders (18.1%) and severe anemia (11.2%). The two most common causes of maternal mortality were hypertensive disorders (27.6%) and hemorrhage (24.1%). Only two critical interventions (assisted ventilation and massive blood transfusion) had significant association with the final outcome. SMR of our center was 1.187 indicating adequate quality of provision of care to the patients.

Conclusions: Hemorrhage and hypertensive disorders were the two most common causes of NM and deaths highlighting the importance of their prompt diagnosis and vigorous management. Periodic SMR calculation can be used as an audit to guide us in improving the overall status of maternal health.

miss, Standardized mortality ratio, Critical interventions
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OBSTETRICS

The Relationship of Pregnancy‑Associated Plasma Protein A and Human Chorionic Gonadotropin with Adverse Pregnancy Outcomes: A Prospective Study

Hamideh Pakniat1 ● Atieh Bahman2 ● Iman Ansari3

Abstract

Purpose: This prospective study investigated the relationship between pregnancy-associated plasma protein A (PAPP-A) and human chorionic gonadotropin (hCG) and adverse pregnancy outcomes in the Iranian population.

Materials: Overall, 994 singleton pregnant mothers of 18–35-year old were referred for first-trimester screening tests, including PAPP-A and β-hCG, at the age of 6 days and 11–13 weeks, and were followed until the end of their pregnancy. The adverse pregnancy outcomes, PAPP-A, and β-hCG serum levels were recorded and analyzed. The sensitivity and specificity of the test were measured by calculating the area under the curve of receiver operating characteristic curve (ROC).

Results: The mean serum level of PAPP-A and β-hCG was 1.10 ± 0.69 and 1.09 ± 0.8 MoM, respectively. Pregnancy-associated plasma protein A, regardless of its percentile, showed a significant relationship with the incidence of preeclampsia, preterm birth, and fetal low birth weight (p < 0.001 for each). However, the relationship between PAPP-A and abortion was not significant (p > 0.05). According to ROC, the results indicated that PAPP-A had a significant relationship with the incidence of preeclampsia, preterm birth, and fetal low birth weight (p < 0.001). However, β-hCG levels showed no significant relationship with adverse pregnancy outcomes.

Conclusion: The result of this study revealed that lower level of PAPP-A and β-hCG could be a predictive factor in preterm labor. Also, this study indicated that PAPP-A measurements could be a screening test for adverse pregnancy outcomes, such as preeclampsia, low birth weight and preterm labor.

PAPP-A, β-hCG, Preeclampsia, Preterm labor, Low birth weight, Abortion
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OBSTETRICS

A Multicenter, Randomized, Open‑Label Trial Comparing the Efficacy and Safety of Monoclonal Anti‑Rh (D) Immunoglobulin with Polyclonal Anti‑Rh (D) Immunoglobulin for the Prevention of Maternal Rh‑Isoimmunization

Anahita R. Chauhan1 ● Yogeshwar S. Nandanwar2 ● Aruna Ramaiah3 ● Kanan A. Yelikar4 ● M. D. Rashmi5 ● Rekha Sachan6 ● Rahul V. Mayekar2 ● Yamini N. Trivedi7 ● Gopalkrishna V. Paradkar8 ● Kiran P. Patole9

Abstract

Objectives: To compare the efficacy and safety of monoclonal anti-Rhesus (anti-D) immunoglobulin (IgG) with polyclonal anti-D IgG in the prevention of maternal Rh-isoimmunization.

Methods: This was a randomized, multicenter, open-label, comparative clinical trial conducted in the obstetric in-patient departments of nine tertiary care hospitals in India. 206 Rhesus (D)-negative women, not sensitized to Rh antigen, and delivering Rh positive babies, received postpartum intramuscular administration of monoclonal or polyclonal anti-D IgG. The main outcome measures were the proportion of subjects protected from Rh-isoimmunization, identified by a negative indirect Coombs test (ICT) result, at day 180 after anti-D IgG administration, and incidence of adverse events.

Results: 105 subjects were randomized to the monoclonal group and 101 to the polyclonal group. 94 from the monoclonal group had a negative ICT result and none had a positive ICT result at day 180, whereas 87 from the polyclonal group had a negative ICT result and one had a positive ICT result; the rest (11 and 13 subjects respectively) were lost to follow-up. A total of 5 adverse events were reported (3 in the monoclonal group and 2 in the polyclonal group); only one of these was serious. All the adverse events were judged to be unrelated to the interventional drug. None of the subjects in the monoclonal group developed immunogenic reaction to the monoclonal anti-D.

Conclusion: The efficacy and safety of the monoclonal preparation of anti-D was comparable to the polyclonal preparation of anti-D when used in the prevention of maternal Rh-isoimmunization. Trial registration Clinical Trial Registration Number: CTRI/2015/09/006172.

Transversus abdominis plane block, Cesarean section, Bupivacaine, Rescue analgesia
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OBSTETRICS

Cesarean Myomectomy: An Experience from a Tertiary Care Teaching Hospital

T. Ramya1 ● Shraddha S. Sabnis1 ● T. V. Chitra1 ● Seetha Panicker1

Abstract

Background: Recent literature supports the removal of myomas during cesarean section, which traditionally was considered a relative contraindication, given a higher complication rate. This study is to share our experience of cesarean myomectomy in the last decade.

Methods: This study is a retrospective review of our prospectively maintained database, from January 2008 to December 2017, at a tertiary care level teaching institution. All patients who underwent myomectomy during cesarean section were included. There were no exclusions.

Results: A total of twenty patients underwent myoma removal along with the cesarean operation during this period with a mean age of 30 years. Majority of patients were nulliparous (70%). Common comorbidities were diabetes mellitus (40%) and hypothyroidism (20%). Mean size of myomas were 5.33 cm (± 2.08), and the number varied from one to three. The most common location was the posterior surface of the uterus with the commonest variety being subserous. Most patients were discharged on the fifth postoperative day.

Conclusions: This study demonstrates that cesarean myomectomy to be a safe and feasible procedure in experienced hands. It offers the advantage of avoiding a second surgery in selected patients.

Cesarean myomectomy, Myoma uterus, Cesarean delivery, Myomectomy
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OBSTETRICS

Predictive Value of Single Serum Progesterone Level for Viability in Threatened Miscarriage

Vijay K. Kadam1 ● Shivani Agrawal1 ● Pinkee Saxena1 ● Poonam Laul1

Abstract

Background: Bleeding is commonly seen during early pregnancy, and predicting the outcome of pregnancy in such cases is a difficult task. The aim of our study was to evaluate the predictive value of single serum progesterone level for finding the viability in threatened miscarriage and to determine the cut-off value for a viable ongoing pregnancy.

Method: This was a prospective study in which patients attending the OPD with early pregnancy and bleeding were recruited. Inclusion criteria were period of amenorrhoea less than 12 weeks, complaints of bleeding per vaginum with or without lower abdominal pain and positive urine pregnancy test or serum beta HCG. Multiple pregnancies, inevitable miscarriage, ectopic pregnancy, molar pregnancy and pregnancy achieved by artificial reproductive techniques were excluded from this study. A detailed clinical examination was done, and routine investigations along with serum progesterone were done. Patients were followed up by serial ultrasound for viability, and their outcome was recorded.

Results: A total of 150 patients with early pregnancy threatened miscarriage were enrolled for this study. Of the patients studied, 105 (70%) had a viable pregnancy and 45 (30%) had non-viable pregnancies. The mean serum progesterone was higher in the viable pregnancy, 17.97 ± 7.75 ng/ml, compared to non-viable group, 6.21 ± 2.86 ng/ml. The area under curve was calculated, and a cut-off value of 10.08 ng/ml was obtained. 83.8% of viable pregnancies had serum progesterone more than or equal to 10.08 ng/ml which was statistically significant.

Conclusion: A single value of progesterone is useful in predicting the viability of the ongoing threatened pregnancy. Serum progesterone with a cut-off value of 10.8 ng/ml was found to have a positive predictive value of 95.7% and negative predictive value of 70.7% with an accuracy of 86%.

Progesterone, Viability
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OBSTETRICS

Effect of Melatonin on Blood Loss After Cesarean Section: A Prospective Randomized Double‑Blind Trial

Marzieh Beigom Khezri1 ● Morteza Delkhosh Reihany1 ● Talaat Dabbaghi Ghaleh2 ● Navid Mohammadi3,4

Abstract

Background and Objectives: The similarities between the melatonin and oxytocin signaling could lead to increased contractility of myometrium. We designed this randomized double-blind, placebo-controlled trial to evaluate the efficacy of melatonin in reduction of blood loss during and after the lower segment cesarean section.

Methods: One hundred and twenty patients who had been scheduled for cesarean section under spinal anesthesia were enrolled in the study. We randomly allocated them to one of the three following groups to receive either melatonin 3 mg ( M3), melatonin 6 mg ( M6), or placebo (P) sublingually 20 min before the surgery. The hemoglobin levels before and 12 h after surgery, the mean weight of the materials used in the operation time, the need for additional oxytocic therapy, and the incidence of adverse effects were probed and recorded.

Result:There was a significant difference between the group M6 and both M3 and P in the mean weight of the materials (p = .024 and .041, respectively) and between M6 and P groups in terms of mean decrease in hemoglobin during 12 h after cesarean section (p = .029).

Conclusion: Using 6 mg melatonin, sublingually, as a premedication in patients undergoing cesarean section with spinal anesthesia could statistically reduce the amount of blood loss after the lower segment cesarean section, although it may not be clinically meaningful.

Registration number: ACTRN12612000117819 and ClinicalTrials.gov Identifier: NCT01572805

Melatonin, Blood loss, Cesarean, Spinal anesthesia
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GYNECOLOGY

Assessment of a Combination of Clinical Maneuvers in Evaluation of Post‑Laparoscopic Pain: A Randomized Clinical Trial

Anju Kumari1 ● Shalini Rajaram2 ● Bindiya Gupta2 ● Meghraj Kundan3

Abstract

Background: To assess the efficacy of the combined maneuvers in evaluation of post-laparoscopic pain.

Material and Methods: A randomized controlled study was conducted. Sixty-four women were included in the study and were randomly divided into two groups. Intervention group received combined maneuvers such as intraperitoneal normal saline infusion, pulmonary recruitment maneuver and local bupivacaine instillation at port sites after laparoscopic surgery. Control group received routine care.

Main Outcome Measures: Upper abdominal pain, shoulder pain and incision site pain were noted in both groups at 3, 6, 12, 24 and 48 h postoperatively.

Results: The median interquartile range (in centiles) of upper abdominal pain score 3, 6 and 12 h postoperatively in the intervention group was 1.0 (0.25–1.0), 1.0 (0.0–1.0) and 0.50 (0.0–1.0), and in the control group, the values were 2.0 (2.0–1.0), 2.0 (2.0–1.0) and 1.0 (0–1.0) at 3, 6 and 12 h, respectively (p < 0.000). The median interquartile range of shoulder pain score 3, 6 and 12 h postoperatively in the intervention group was 0.0 (0.0–1.0), 0.0 (0.0–0.75) and 0.0 (0.0–1.0), and in the control group, the values were 1.0 (0.0–2.0), 1.0 (0.0–1.75) and 1.0 (0–1.0) at 3, 6, and 12 h. The upper abdominal pain and shoulder pain relief was significantly more in the intervention group than in the control group in the first 12 h of surgery.

Conclusion: Combined maneuvers could significantly reduce post-laparoscopic upper abdominal and shoulder pain. Clinical Trial CTRI Registration Number-CTRI/2017/07/0089, web address of CTRI—http://ctri.nic.in

Post laparoscopic shoulder pain, Upper abdomen pain, Pulmonary recruitment maneuver, Intraperitoneal normal saline infusion, Incision site pain, Local anaesthetics
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