Thyroid disorders in pregnancy are important causes of adverse pregnancy outcome. So it is very pertinent that thyroid function is maintained in normal range during pregnancy. Serum thyroid-stimulating hormone (TSH) value is the best indicator for assessing and monitoring thyroid function. The increasing metabolic demands of pregnancy alter the thyroid physiology in early pregnancy; hence, it becomes necessary to define trimester-specific reference range. Several reports and guidelines have been published recommending varied TSH cutoffs in different studies. The most significant guidelines which created controversy about TSH cutoffs was that of American Thyroid Association (ATA) (Stagnaro-Green et al. in Thyroid 21:1081– 1125, 2011) followed by Endocrine Society clinical practice guideline (De Groot et al. in J Clin Endocrinol 97:2543–2565, 2012). Both these gave stricter TSH cutoffs as .1 to 2.5 mIU/L in first trimester, .2 to 3.0 mIU/L in second trimester and .3 to 3 mIU/L in third trimester. Subsequently many reports, meta-analysis and systematic reviews were published which recommended higher cutoffs. With due consideration, ATA revised the guidelines in 2017, recommending the upper cutoff limit .5 mIU/L less than the preconception TSH value or as 4.0 mIU/L when local population-specific reference range is not available (Alexander et al. Thyroid 27(3):315–389, 2017). The controversy is not yet completely resolved specially regarding management of subclinical hypothyroidism. This editorial addresses this ongoing controversy.
Ovum donation (OD) pregnancies are becoming increasingly common. Obstetric complications with IVF pregnancies are well documented. However, until recently OD had not previously been investigated as a separate subtype of this. It could be postulated that there may be more complications with OD pregnancies as the embryo is immunologically different to the mother. The subsequent allograft reactions can cause problems with placental development and function leading to pathology. Initial studies investigating OD pregnancies were inadequate due to small sample size and inappropriate control groups. Studies specifically comparing to spontaneous pregnancies alone are not suitable when we already know that IVF in itself increases the risk to both mother and baby. Recent research has optimised the control group by using women undergoing IVF with autologous ovum. Ovum donation has now been shown to be an independent risk factor for hypertensive disease in pregnancy, post-partum haemorrhage and increased risk of caesarean section. Neonatal outcomes are less clear-cut, although there is some evidence to suggest there is increased risk of small for gestational age babies and preterm delivery. It is now clear that OD pregnancies are higher risk than IVF pregnancies with autologous ovum and they should be treated as such. Women with ovum donation pregnancies should have obstetric-led care, in a unit which has ready access to both blood transfusion and cell salvage. Future research should investigate how to reduce the risk of ovum donation to these women.
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.
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.
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.
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.
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.
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%.
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
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 anaestheticsObjectives: Infection of male genital tract leads to leukocytospermia which may have a detrimental effect on semen quality. This study was conducted to evaluate whether seminal IL-8 level can be used as a marker of leukocytospermia and does it have any correlation with semen parameters in infertile couples?
Methods: This cross-sectional study was conducted in an infertility clinic of a tertiary care hospital including 150 male partners of infertile couples who underwent semen analysis (WHO laboratory manual for the examination and processing of human semen, 5th edn, World Health Organization, Geneva, p 271, 2010), semen culture sensitivity and seminal IL-8 levels. Independent t-test, Mann– Whitney U test and Chi-square test were applied for analysis.
Results: Mean seminal plasma IL-8 level of patients with leukocytospermia was significantly higher than patients without leukocytospermia (1143.67 ± 887.03 vs. 267.174 ± 242.29, p value\0.001). Strong positive correlation was found between seminal plasma IL-8 levels and pus cells in the semen (r = 0.950, p\0.001); AUC for seminal plasma IL-8 was 0.985 (CI 0.972–0.988), and a cutoff value of 399 pg/ml was determined to diagnose leukocytospermia. This value had high sensitivity (91.8%), specificity (94.5%), positive predictive value (94.4%) and diagnostic accuracy (93.2%) for detecting leukocytospermia. Seminal IL-8 levels correlated negatively with sperm motility (r = - 0.29, p\0.001) and morphology (r = - 0.230, p\0.01).
Conclusion: Seminal plasma IL-8 levels were found to be almost five times higher in male partners with leukocytospermia than in non-leukocytospermia group, and it appears to be a promising tool to detect leukocytospermia. Seminal IL-8 level correlated negatively with semen parameters including sperm motility and morphology.
Objective: To verify the prevalence of chromosomal abnormalities in women with primary amenorrhoea in India aiming at appropriate genetic counselling.
Methods: In a 16-year retrospective (2001–2016) study, 3776 women with primary amenorrhoea were evaluated. Chromosomal analysis of all the cases was done by GTG banding. Clinical history and other laboratory findings were taken into consideration to determine the diagnosis.
Results: The karyotype results revealed 31.2% cases with chromosomal abnormalities (n = 1177/3776). In patients with abnormal chromosome complement, 31.2% exhibited numerical aberrations (n = 367) and 34.9% with structural aberrations (n = 411). About 33.9% of cases were with XY male karyotype (n = 399).
Conclusion: As per the literature till date, this study is the largest with high incidence of chromosomal abnormalities; early detection of abnormalities is necessary for guidance to reproductive management and genetic counselling.
Primary amenorrhoea, Mosaicism, Autosome–autosome translocations, Balanced translocations, Genetic counsellingBackground: The patient scenario of a tertiary hospital changes with the implementation of various national programmes in any country. These programmes are conceived after understanding the felt need of the society. Though IUCD was available as an interval method of contraception in the past also and was meant to be effective for 10 years, the prerequisite to come again to the medical facility after 6 weeks of childbirth for insertion resulted in almost all patients to dropout and only the highly motivated would come on their own. Post-partum insertion of IUCD at the time of childbirth or within 48 h has addressed the need of contraception in the post-partum period as well as omitted the need for second visit to a health set-up. Earlier, after achieving the desired family goal of children, tubectomy was the preferred choice, irrespective of age of children but PPIUCD seems to have come up as a long-term reversible method of contraception.
Objective: The present study was conceived to study the shift of method of long-term contraception from tubal sterilization and vasectomy to PPIUCD over a period of 8 years from 2010 to 2017.
Method: This study was a retrospective analytical study conducted at the Department of Obstetrics and Gynaecology in Safdarjung Hospital between the years 2010 and 2017. The number of IUCDs inserted post-placental (i.e. within 10 min of delivery of placenta) and within 48 h (of vaginal childbirth) and intra-caesarean (intrauterine insertion while performing caesarean) were recorded and analysed. Also, sterilizations (tubectomy) and interval IUCD insertions done during this time period were compared.
Results: With the introduction of PPIUCD in national family programme, more women are inclining towards long-term spacing method and not resorting to sterilizations. PPIUCD is preferred over interval IUCD.
Conclusion: PPIUCD is there to stay as a method of long-term contraception.
Bilateral tubal ectopic pregnancy is very rare, spontaneous cases being exceptional. Here, the authors report a case of spontaneous bilateral tubal ectopic pregnancy of 10-weeks gestation diagnosed and managed at Bharatratna Dr. Babasaheb Ambedkar Municipal and General Hospital, Kandivali, Mumbai. A 29-year-old, G2P1L1 patient presented in the emergency department with 3-months amenorrhea, abdominal pain and vaginal bleeding. Urine pregnancy test was positive, and an emergency ultrasound done revealed bilateral tubal ectopic pregnancies of 10-weeks size with hemoperitoneum. Emergency exploration was done, and a right-sided ruptured ampullary ectopic pregnancy with a left-sided ruptured fimbrial ectopic pregnancy was found with hemoperitoneum. Bilateral salpingectomy was performed, and patient recovered well postoperatively.
See Figs 1 and 2.
