RESUMO
CONTEXT: A new indigenous recombinant human chorionic gonadotropin (r-hCG) has been developed in India with a comparable pharmacological profile to that of Ovitrelle® (Merck Serono). AIMS: This study aims to compare the efficacy and safety of the new r-hCG with that of Ovitrelle for induction of ovulation in women undergoing intrauterine insemination (IUI). SETTINGS AND DESIGN: Randomized (2:1), multicenter, open-label, equivalence clinical trial conducted in India. SUBJECTS AND METHODS: A total of 217 women, aged 20-37 years, undergoing IUI were administered the new r-hCG (test) 250 mcg or Ovitrelle 250 mcg (comparator) after ovarian stimulation with gonadotropins. The ovulation rate was compared as the primary outcome. In addition, pregnancy rates, incidence of adverse events (AEs), and development of immunogenicity were assessed. Statistical Analysis Used: The ovulation and pregnancy rates were compared using Chi-squared test with statistical significance at P < 0.05. RESULTS: With 144 women in the test group and 73 in the comparator group, the ovulation rate (85.4% vs. 78.1%; P = 0.17) and pregnancy rate (serum ß hCG test) (11.8% vs. 12.3%; P = 0.91) were similar in both groups. A total of 15 AEs were reported (11 in the test r-hCG group and 4 in the comparator group) in 11 women; none of these were serious, and all were judged to be unrelated to the study drug. No subject developed immunogenic reaction to the test drug. CONCLUSIONS: The new preparation of r-hCG was equivalent to the conventional preparation of r-HCG in the induction of ovulation in patients undergoing IUI.
RESUMO
AIMS: This study aimed to evaluate the effect of ropivacaine epidural analgesia on duration and outcome of labour in nulliparous parturients of India with parturient not receiving any analgesia. SETTINGS AND DESIGN: One hundred and twenty nulliparous parturient in established labour at full term with a singleton vertex presentation were assigned to the study. Parturients who request epidural analgesia were allocated in the epidural group (n=60), whereas those not enthusiastic to labour analgesia were allocated in the control group (n=60). MATERIALS AND METHODS: Epidural analgesia was provided by a bolus injection of 10 ml of ropivacaine 0.2% and 50µg fentanyl and maintained by using a continuous infusion of ropivacaine 0.1% with fentanyl 2µl/ml at a 10ml/hour rate. The outcomes were duration of labour, incidence of cesarean sections and instrumental vaginal delivery and neonatal outcome. STATISTICAL ANALYSIS USED: Statistical analysis was conducted using unpaired student t-test and chi-square test as required. All tests of significance were performed using two-tailed probability tests. Differences were considered significant when p-value was <0.05. RESULTS: The two groups were comparable in terms of socio-demographic data. The mean duration of first stage of labour was shorter in epidural group (4.83 ± 1.59 h) compared with control group (5.48 ± 1.56 h) while the duration of second stage of labour was prolong in epidural group (33.13 ± 12.78 min) as compared to control (27.53 ± 11.73 min). Instrumental vaginal or caesarean delivery rate did not increase in the epidural group. The APGAR scores at 5 min were statistically similar in both groups. CONCLUSION: Epidural analgesia by ropivacaine in Indian nulliparous resulted in shorter duration of first stage and prolongs duration of second stage of labour compared with parturients without analgesia; however, instrumental vaginal or caesarean delivery rate does not increase in the epidural group.
RESUMO
Myotonic dystrophy is a rare heredodegenerative muscular disorder in which pregnancy is unusual. Because of the autosomal dominant inheritance of the disease, 50% of children of an affected parent may have the disease; 20% of them are asymptomatic at birth. Foetal involvement may be manifested by polyhydramnios, arthrogryposis multiplex in utero, respiratory difficulties, and floppiness at birth. A case of myotonic dystrophy with pregnancy is presented here.
