Evaluation of mechanical and nonmechanical methods of cervix ripening in women with pre-labor rupture of membranes: a randomized controlled trial.

BACKGROUND: Pre-labor rupture of membranes occurs in 8% of pregnancies. In the absence of spontaneous labor, induction of labor is considered an appropriate strategy for term pregnant women with pre-labor rupture of membranes. There are several approaches for preinduction cervical ripening, including mechanical methods, such as Foley catheterization, and nonmechanical methods, such as oral misoprostol. OBJECTIVE: This study aimed to evaluate and compare the effects of oral misoprostol and Foley catheterization in pregnant women with pre-labor rupture of membranes at ≥34 weeks of gestation who underwent induction of labor. STUDY DESIGN: A randomized clinical trial was conducted. The inclusion criteria included nulliparous and multiparous pregnant women at ≥34 weeks of gestation with singleton pregnancies, cephalic presentation, and confirmed amniotic fluid leakage for more than 60 minutes. A total of 104 participants were randomly allocated into 2 groups, one receiving sublingual misoprostol and the other receiving transcervical Foley catheter for cervical ripening. The primary outcome was time from intervention to delivery, and the secondary outcomes included delivery method, maternal and neonatal results (chorioamnionitis, Apgar score, neonatal sepsis, and asphyxia), and arterial blood gas analysis of the umbilical cord. RESULTS: The mean time from induction of labor to delivery (11.6±1.98 hours for Foley catheter vs 10.16±2.35 hours for misoprostol; P=.007) and the median duration of cervical ripening (4.5 hours [interquartile range, 0.0-6.0] for Foley catheter vs 4.0 hours [interquartile range, 1.5-6.0] for misoprostol; P=.04) were longer in the Foley catheter group than in the misoprostol group. There was no statistically significant difference in the cesarean delivery rate between the 2 groups (29.6% for Foley catheter vs 38.5% for misoprostol; P=.2). There was no case of chorioamnionitis or asphyxia in the 2 groups. There was no significant difference between the 2 groups in terms of umbilical cord pH and the 1- and 5-minute Apgar scores (P=.1, P=.4, and P=.1); nevertheless, these values were higher in the Foley catheter group. There was no statistically significant difference among additional secondary outcomes. CONCLUSION: In pre-labor rupture of membranes cases, cervical ripening with a Foley catheter was associated with a longer duration of ripening and time from induction to delivery than cervical ripening with misoprostol. The cesarean delivery rate and the maternal and neonatal infection rates were not different between these methods.

Relationship Between Serum Vitamin D Level and Ectopic Pregnancy: A Case-Control Study.

Objective: To compare the difference in Vitamin D level between women with ectopic pregnancy and control group. Materials and methods: In the present case-control study, 150 patients with ectopic pregnancy were included as case group and 150 women with normal pregnancy as a control group. Then, serum vitamin D levels were measured in both groups and they were then compared with each other. P less than 0.05 was considered statistically significant. Results: The mean age in ectopic pregnancy group was 28.12 ± 5.91 and 27.35 ± 6.21 years old in control group; the difference between two groups was not statistically significant (p = 0.43). The vitamin D level in control group was higher than that of ectopic pregnancy group (p = 0.002). Of all patients, 182 patients (60.66%) had vitamin D deficiency and 64 patients (21.33%) had vitamin D insufficiency. Conclusion: Serum vitamin D level among patients with ectopic pregnancy was statistically lower than women with normal pregnancy.

Comparison Between Effect of Letrozole Plus Misoprostol and Misoprostol Alone in Terminating Non-Viable First Trimester Pregnancies: A Single Blind Randomized Trial.

Objective: To evaluate the effect of letrozole plus misoprostol to terminate non-viable pregnancies in first trimester compared with the use of misoprostol alone. Materials and methods: In a single-blind clinical trial, 128 women over 18 years old referred to Educational-Medical centers of Tabriz University of Medical Science (Tabriz, Iran), for abortion in first trimester of non-viable pregnancies, were randomly selected in two intervention and control groups using Rand list (version 1.2) software. To complete abortion both groups received 600 mcg of misoprostolorally. The intervention group received letrozole 10 mg daily for 3 days before receiving misoprostolorally. Complete abortion rate and the side effects of both groups were recorded. Results: Mean pregnancy age based on LMP in intervention group and control group were 7.74 ± 0.95 and 8.52 ± 1.29 weeks respectively. Complete abortion rate in the intervention group was 93.7%, and in control group was 68.7% which was significantly higher in intervention group (p = 0.001). Abdominal pain in the intervention group is also significantly lower than that of the control group (p = 0.013). Intervention group also had significantly lower duration of bleeding rather than control group (p = 0.006). Conclusion: Based on the findings of this study, letrozole pretreatment with misoprostol for first-trimester medical abortion can increase complete abortion rate significantly without increasing side effects compared to use of misoprostol alone.

Effects of vitamin D supplementation on metabolic indices and hs-CRP levels in gestational diabetes mellitus patients: a randomized, double-blinded, placebo-controlled clinical trial.

BACKGROUND/OBJECTIVES: Vitamin D plays an important role in the etiology of gestational diabetes mellitus (GDM). This study evaluated the effect of vitamin D supplementation on metabolic indices and hs-C-reactive protein (CRP) levels in GDM patients. SUBJECTS/METHODS: The study was a randomized, placebo-controlled, double-blinded clinical trial. Seventy-six pregnant women with GDM and gestational age between 24-28 weeks were assigned to receive four oral treatments consisting of 50,000 IU of vitamin D3 (n = 38) or placebo (n = 38) once every 2 weeks for 2 months. Fasting blood glucose (FG), insulin, HbA1c, 25-hydroxyvitamin D, lipid profile, hs-CRP, and homeostasis model assessment-insulin resistance (HOMA-IR) were measured before and after treatment. Independent and paired t-tests were used to determine intra- and intergroup differences, respectively. ANCOVA was used to assess the effects of vitamin D supplementation on biochemical parameters. RESULTS: Compared with the placebo group, in the vitamin D group, the serum level of 25-hydroxyvitamin D increased (19.15 vs. -0.40 ng/ml; P < 0.01) and that of FG (-4.72 vs. 5.27 mg/dl; P = 0.01) as well as HbA1c (-0.18% vs. 0.17%; P = 0.02) decreased. Improvements in the lipid profiles were observed in the vitamin D group, but without statistical significance. Significant increases in concentrations of hs-CRP, FG, HbA1c, total cholesterol, and LDL cholesterol were observed in the placebo group. No significant change in fasting insulin and HOMA-IR was observed in either group. CONCLUSIONS: In GDM patients, vitamin D supplementation improved FG and HbA1c but had no significant effects on lipid profile or hs-CRP.

Comparison effect of intravenous tranexamic acid and misoprostol for postpartum haemorrhage.

BACKGROUND: Postpartum haemorrhage (PPH) is the third-most common cause of maternal death in the United States and it is still the first prevalent cause of maternal death in developing countries. Active prevention of haemorrhage with an uterotonic or other new drugs leads to a decrease in postpartum vaginal haemorrhage. The aim of this study was to compare anti-haemorrhagic effect of Tranexamic acid (TXA) and Misoprostol for PPH. PATIENTS AND METHODS: In a double-blinded randomised control clinical trial, 200 women were included after Caesarean or natural vaginal delivery with abnormal PPH. They were divided into two equal intervention and control groups. Effect of intravenous TXA and Misoprostol for postpartum haemorrhage was examined. RESULTS: The mean age of patients was 26.7 ± 6.5 years which ranged from 14 to 43 years. The sonographic gestational age in the group treated with TXA was 37.7 ± 3.4 weeks and it was 37.4 ± 3.3 weeks for the other group (P = 0.44). The haemorrhage in the TXA and Misoprostol groups was 1.2 ± 0.33 litres and 1.18 ± 0.47 litres, respectively (P = 0.79). The haemoglobin levels after 6-12 hours of labour, in TXA group was more than that of the Misoprostol group, but this difference was not statistically significant (P = 0.22 and P = 0.21, respectively). CONCLUSION: Regarding to the superior results in Misoprostol group in one hand and lack of significant differences between two groups in haemorrhage during labour, post-partum haemoglobin level and discharge haemoglobin level, we can state that Misoprostol has no specific preferences to TXA, but more studies with greater population are needed.