Real-world utilization pattern of dydrogesterone in 7287 Indian women with obstetric and gynecological conditions: data from multicentric, retrospective study

Abstract Objective: Despite the literature on dydrogesterone, studies on dydrogesterone utilization patterns are largely lacking in Indian patients. Methods: This was a multi-center, retrospective, observational, cross-sectional, and descriptive study across 817 centers in India. Data of patients who received dydrogesterone in past and provided consent for future use of their medical record for research purpose was were retrieved and analyzed. Results: Data of 7287 subjects (aged 29.55±4.84 years) was analyzed. Threatened abortion was the most common indication for which the subjects received dydrogesterone (46.9%) followed by recurrent pregnancy loss. Polycystic ovary syndrome (PCOS), thyroid disorders and anemia were the most common comorbid conditions and prior pregnancy loss, advanced maternal age and obesity were the most common risk factors seen in subjects who received dydrogesterone. Total 27.5% of subjects received a loading dose of dydrogesterone, and majority (64%) received 40 mg as loading dose. 10 mg dose was used as maintenance or regular dose in 81.4% of the subjects. Twice daily (BID) was the most common dosing frequency (66.6%). The most common concomitant medications being taken by the subjects on dydrogesterone included folic acid (45.1%), iron supplements (30.3%) and calcium and vitamin D3 supplements (25.5%). Another progesterone preparation (oral, injection, vaginal, tubal) other than dydrogesterone was used concurrently in 7.8% of subjects. Conclusion: The study helped to identify the patient population that is benefitted by dydrogesterone and the preferred indications, risk factors, comorbid conditions and concomitant medication used in this patient population at real-life scenario.

Comparison of pelvic floor dysfunction in primiparous and nulliparous women and its relation to pelvic floor muscle strength

Background: The pelvic floor muscles (PFM) play an important role in supporting the pelvic and abdominal organs and controlling urinary and fecal continence, in addition to their role in the sexual function. The objective of this study was to compare pelvic floor muscle strength in primiparous 6 months after delivery and nulliparous women, to evaluate pelvic floor dysfunction (PFD) in these women and to find the association of PFD with pelvic floor muscle strength (PFMS).Methods: A total of 100 women were recruited in the cross-sectional study which included 28 nulliparous and 72 primiparous women 6 months after delivery. The assessment included general physical examination (GPE), POP-Q and assessment of pelvic floor muscle strength by modified oxford score and perineometer.Results: Endurance of PFMS measured by duration of contraction and number of contractions/min was higher in nulliparous. Mean of the duration of contraction was significantly higher in nulliparous group as compared to primipara i.e., 28.61 seconds and 23.9 seconds in nulliparous and primiparous group respectively (p=0.005). Mean of the number of contractions performed in one minute was significantly higher in nulliparous group as compared to primipara i.e., 31.04 and 19.97 in nulliparous and primiparous group respectively (p<0.0001). None of the nulliparous women had any PFD symptoms, while 4.17% of the primiparous patients had PFD in the form of bladder symptoms and 1.39% of them had PFD in the form bowel symptoms. Vaginal squeeze pressure was found to be affected by mode of delivery. It was lowest in instrumental delivery. It was 39.78±13.33 cmH20 in vaginal delivery, 51.42±12.88 cmH2O in Caesarean section and 31.67±14.36 cmH2O in instrumental delivery (p-0.039).Conclusions: Endurance of PFMS measured by duration of contraction and number of contractions/min was higher in nulliparous. Vaginal squeeze pressure was found to be affected by mode of delivery. It was lowest in instrumental delivery.

Intravenous oxytocin bolus and infusion versus infusion alone on the blood loss during caesarean section

Background: PPH is one of the leading causes of maternal mortality in the world. In India >30% maternal mortality is because of PPH.Methods: 250 females posted for LSCS were randomised into 2 groups. Group A: 5U oxytocin bolus + 40U oxytocin infusion @125 ml/hour in 500 ml saline. Group B: 5 ml Saline bolus + 40 U oxytocin infusionPrimary outcome was to measure blood loss (objective and subjective). Secondary outcomes were time for uterine hardening, additional uterotonic agents, hemodynamic changes, side effects and need for blood transfusion within 24 hours of LSCS.Results: Blood loss was significantly less in Group A in objective as well as subjective assessment (p<0.001). Requirement for additional oxytocin bolus was significantly higher in Group B as compared Group A (p=0.025). Postoperative hematocrit of Group A was higher than that of Group B (p<0.001). Transfusion requirement was significantly higher (p=0.04) in Group B (9.6% versus 3.2%). There was no significant difference in hemodynamics between the groups in the intraoperative period (p>0.05). However, during the postoperative period increase in heart rate was noted in Group B (p<0.05). Vomiting was the only major side effect observed, which was higher in Group A (5.6% versus 3.2%).Conclusions: Combination of 5U oxytocin bolus followed by an infusion of 40 U oxytocin given over 4 hours routinely in ASA grade I and ASA grade II parturient significantly decreases the operative blood loss during LSCS without causing any hemodynamic variability. This regimen provides better uterine contractility, lesser need for additional utero-tonic agents and lesser requirement of blood transfusion.

Pelvic floor muscle training with and without biofeedback in treatment of overactive bladder

Background: Overactive bladder (OAB) is a commonly encountered problem in gynaecological practice. It has profound effect on quality of life (QOL), affecting simple daily activities as well. Prevalence rates of OAB in Asians are 53.1%. The first line management of OAB is behaviour modification and pelvic floor muscle training (PFMT). Objective of this study was to comparative assessment of biofeedback assisted PFMT (BAPFMT) versus PFMT alone in treatment of OAB using strength of pelvic floor muscle and QOL before and after treatment.Methods: A prospective comparative randomized controlled trial was conducted to compare the effect of PFMT versus BAPFMT on OAB symptoms over period of 12 weeks. Total of 100 patients fulfilling inclusion and exclusion criteria were selected. Randomization of patients was done into two groups of 50 patients each; half of them were subjected to PFMT and other half to BAPFMT. Appropriate statistical test were applied.Results: At the end of 12 weeks of intervention, there was a significant improvement in pelvic floor muscle strength and QOL in both groups (p<0.001). The improvement in pelvic floor muscle strength was more with BAPFMT; however there was no difference in improvement of QOL between the groups.Conclusions: Addition of biofeedback to PFMT may be a useful adjunct in OAB patients.

Idiopathic thrombocytopenic purpura complicating pregnancy.

Idiopathic thrombocytopenic purpura is a relatively common but unrecognised auto-immune disorder among women of child bearing age. Nearly one-third of patients present with bleeding tendency in pregnancy. Management necessitates care of mother during pregnancy and delivery and care of the baby. Steroids remain the chief, economical and effective method of raising platelet counts, but platelet transfusion and human intravenous high dose alpha-globulin may be required. Neonatal thrombocytopenia must be expected and managed. Management of patient, since it concerns two lives, should be individualised and carefully planned in consultation with haematologist and paediatrician.