Comparative evaluation of 25 μg and 50 μg of intravaginal misoprostol for induction of labor

Objectives

To compare the efficacy and safety of 25 μg vs 50 μg of intravaginal misoprostol for induction of labor

Methods

One hundred forty eight pregnant females requiring induction were randomly assigned to receive either 25 μg (80 cases-group A) or 50 μg (68 cases — group B) of intravaginal misoprostol every 4 hours till adequate contractions were achieved or maximum dose of the drug up to 200 μg was used.

Results

The onset of contraction was earlier in group B (3.40± 1.88) as compared to group A (4.56±2.25); 81.2% of the cases in group A and 83.8% of the cases in group B delivered vaginally. Induction to delivery interval was shorter in group B(43.9%) cases; while 29% cases in group A delivered within 12 hours. Mean dose for successful induction in group A was high compared to group B. Requirement for oxytocin infusion was higher in group A (25% vs 16.2%) (p=0.189). Abnormal contractility pattern was seen in 14.7% cases in group B as compared to 6.25% cases in group A (p=0.765). GIT side effects were common in group B (38.2%) as compared to group A (28.75%) (p=0.22). Rupture uterus did not occur in any group. In group B 34.7% neonates had apgar score <7 at 1 min. and required NICU admission as compared to only 14.9% in group A.

Conclusion

50 μg dose though more efficacious than 25 μg dose, appears to be less safe both for mother and baby due to the high incidence of tachysystole, hyperstimulation and intrauterine passage of meconium.     

Conventional vs. extended-cycle oral contraceptives on the quality of sexual life: comparison between two regimens containing 3 mg drospirenone and 20 µg ethinyl estradiol

IntroductionWomen may use new oral contraceptives (OC) having flexible extended-cycle regimens with a reduced hormone-free interval.AimTo study the changes of the quality of sexual life in users of the traditional 21/7 or extended-cycle 24/4 OC regimens both containing 3 mg drospirenone and 20 µg ethinyl estradiol.MethodsOne hundred fifteen women (age range 18–37 years) were enrolled. Fifty-four women were randomly placed on traditional OC standard regimen, administered for 21 days, followed by a 7-day hormone-free interval (group A); and 61 women were placed on extended-cycle OC regimen covering 24 days of the cycle with a 4-day hormone-free interval (group B).The Short Form-36 (SF-36) validate questionnaire to assess quality of life (QoL) and the Short Personal Experience Questionnaire (SPEQ) to measure the changes of sexual behavior were administered before starting OC intake and at the 3rd and 6th cycle follow-ups.Main Outcome MeasureThe SF-36 and the SPEQ questionnaires.ResultsGroup A women reported QoL improvement during the 6th cycle on all the scales (P < 0.05). Group B women reported QoL improvement during the 3rd and 6th cycle (P < 0.05). Satisfaction with sexual activity, arousal, orgasm, and desire increased during the 3rd cycle in women on the group B (P < 0.05). Group A women did not report any change in all SPEQ items. At the 6th cycle, group B women reported better sexual experience than baseline in all SPEQ items (P < 0.05). All subjects who were affected by dyspareunia before OC intake reported decreased genital pain associated with intercourse at the 3rd and 6th cycle of both OC regimens (P < 0.05).ConclusionWomen could use OCs in a subjective flexible modality. The extended-cycle OC might produce positive effects on the quality of sexual life, enforcing the concept of tailoring an OC to a woman. Caruso S, Iraci Sareri M, Agnello C, Romano M, Lo Presti L, Malandrino C, and Cianci A. Conventional versus extended-cycle oral contraceptives on the quality of sexual life: comparison between two regimens containing 3 mg drospirenone and 20 µg ethinyl estradiol.     

A comparison of the cycle control and tolerability of two ultra low-dose oral contraceptives containing 20 μg ethinylestradiol and either 150 μg desogestrel or 75 μg gestodene

Objective To compare the cycle control and tolerability of two oral contraceptives containing 20 μg ethinylestradiol and either 150 μg desogestrel or 75 μg gestodene.

Methods A randomized, multicenter study was conducted in which 1016 healthy adult women received the desogestrel (n = 509) or the gestodene (n = 507) preparation for six treatment cycles.

Results No significant differences in bleeding patterns were detected between the two treatments. The incidence and duration of irregular bleeding decreased markedly, and to a similar extent, during each treatment. The occurrence of irregular bleeding per cycle decreased from 24.6 to 9.4% in the desogestrel group and from 19.7 to 8.6% in the gestodene group. Its duration fell from 1.1 to 0.2 days and from 0.9 to 0.3 days, respectively. There was a consistently low incidence of amenorrhea (1.0–2.8%). There were no significant differences between treatments for the incidence, intensity or emergence of dysmenorrhea. During both treatments, the incidence of premenstrual syndrome and complaints such as breast tenderness, nausea and headache dropped markedly.

Conclusion Ultra low-dose oral contraceptives containing desogestrel or gestodene offer equivalent, good cycle control and improvements in dysmenorrhea and premenstrual syndrome and have similar, excellent tolerability profiles.     

Administration of 400 μg of misoprostol to augment routine active management of the third stage of labor

Objective

To assess the effectiveness and safety of the administration of misoprostol, an orally active prostaglandin, in addition to routine uterotonic therapy as part of the active management of the third stage of labor.

Methods

The present study was a hospital-based, decentralized, multi-center, randomized, placebo-controlled, double-blind trial. We enrolled 1103 women (out of a target sample size of 1180) at 4 hospitals in South Africa, Uganda, and Nigeria. Participants received a sublingual dose of 400 μg of misoprostol or a placebo, in addition to standard active management of the third stage of labor, after vaginal birth.

Results

The baseline characteristics of the participants were comparable. The difference in the primary outcome of blood loss of 500 mL or more within 1 hour of randomization was not significant between the 2 groups (misoprostol 22/546 [4.0%] versus placebo 35/553 [6.3%]; relative risk, 0.64; 95% confidence interval, 0.38-1.07). Shivering and pyrexia occurred more frequently in the misoprostol group. No maternal deaths occurred.

Conclusion

The present study did not confirm a beneficial effect of administering 400 μg of misoprostol, in addition to routine uterotonic therapy, during the third stage of labor, but was consistent with other trials showing a cumulative modest benefit. Where routine uterotonics are available for prophylactic use, any potential benefit of misoprostol might not outweigh the likelihood of adverse effects. Trial registered on clinical trials.gov: NCT 00124540.     

A comparative study of the hemostatic effects of two monophasic oral contraceptives containing 30 μg ethinylestradiol and either 2 mg chlormadinone acetate or 150 μg desogestrel

Objectives To determine the effect of two low-dose monophasic oral contraceptives containing either 2 mg chlormadinone acetate or 150 μg desogestrel on blood clotting and fibrinolysis.

Methods In vivo markers of intravascular coagulatory and fibrinolytic activity were measured in 45 volunteers randomly assigned to a 6-month treatment with one of the two study preparations.

Results During oral contraceptive use, the procoagulatory activity increased (increased prothrombin fragment 1+2), the anticoagulatory capacity changed (increased protein C activity, decreased activated protein C sensitivity, decreased protein S activity and decreased antithrombin III activity) and the fibrinolytic system was activated (increased concentrations of plasmin-antiplasmin complexes and d-dimer as well as total fibrin degradation products). There were no relevant differences between the two medication groups.

Conclusion Our results demonstrate that both oral contraceptive preparations have comparable effects on the hemostatic system. There was a shift towards a new equilibrium of hemostatic activities, both coagulatory and fibrinolytic, at a higher turnover rate. Changes did not exceed the range of normal variation and were comparable to the published effects of other low-dose oral contraceptives. There was no evidence of a differential risk of deep vein thrombosis between the two preparations.     

First-trimester pregnancy termination with 800 μg of vaginal misoprostol every 12 h

The objective of the study was to evaluate the efficacy and safety of 800 μg of misoprostol every 12 h, for a period of 36 h for pharmacological abortion. A group of 162 volunteer women with gestations between 50 and 63 days received misoprostol every 12 h up to a maximum of three doses for abortion. Outcome measures assessed included: successful abortion (complete abortion without requiring surgery), side effects, and a decrease in hemoglobin, mean time of vaginal bleeding, mean expulsion time and mean time of returning of menses. Complete abortion occurred in 148 of 162 (91%, 95% confidence interval 87.95) patients. The mean decrease in hemoglobin was statisticaly significant (p = 0.001). Vaginal bleeding lasted 8.0 ± 3.2 days, spotting 8.0 ± 3.5 days, and total bleeding 16 ± 4.0 days. The mean expulsion time was 8.5 ± 4.0 h. According to the observed outcomes, 800 μg of misoprostol vaginally could be a valid method to terminate pregnancies up to 9 weeks of gestation.     

Effects on body weight and body composition of a low-dose oral estroprogestin containing ethinyl estradiol 20 μg plus levonorgestrel 100 μg

Weight gain is a common problem reported by users of estroprogestins (EPs) and is a frequent reason for EP discontinuation, even if this problem is not confirmed in several clinical studies. We studied the impact of a EP containing ethinyl estradiol (EE) 20 μg plus levonorgestrel (LNG) 100 μg on body weight (BW) and body composition in 47 treated women and 31 women as controls. Also, we studied the effect of this association on metabolic parameters (glycemia, lipid profile). EE20/LNG100 had no significant impact on body weight, body composition (fat mass, fat-free mass, total body water, intracellular water, extracellular water) or metabolic profile in comparison with no treatment. Thus, the use of EE20/LNG100 showed no impact on metabolic parameters, body weight and body composition. This could be important not only for the safety profile of this combination, but also in increasing patient compliance.     

A randomised controlled trial of two feeding schedules in neonates weighing ≤1750 g

Objectives.?To study the incidence of feed intolerance, apnea and hypoglycemia in neonates weighing ≤1750 g given 3 hourly feeds as against 2 hourly feeds.

Methods.?Ninety-two neonates, weighing ≤1750 g and medically fit to receive feeds, were randomised to receive feeds either at 3 hourly or 2 hourly intervals.

Results.?The incidence of feed intolerance was not different between 3 hourly and 2 hourly feeding groups [13%vs. 19%, OR 0.69 (95% CI 0.19–2.49)]. The incidence of apnea was 25 and 28%[OR 0.86 (95% CI 0.3–2.48)] and that of hypoglycemia was 21 and 26%[OR 0.75 (95% CI 0.24–2.3)] in 3 hourly and 2 hourly feeding groups, respectively. The incidence of necrotising enterocolitis was also similar (7%) in both the feeding groups. The total nursing time spent on feeding per day was significantly less in 3 hourly group.

Conclusions.?In comparison to a 2 hourly schedule, a 3 hourly feeding schedule did not decrease the incidence of feed intolerance; it, however, did not increase the incidence of hypoglycemia or apnea. For practical convenience, a 3 hourly feeding schedule may be preferred over 2 hourly schedule in neonates weighing ≤1750 g.     

Evaluation of the outcomes of laparoscopic hysterectomy for normal and enlarged uterus (>280 g)

Purpose

The aim of this study was to evaluate intraoperative and postoperative outcomes of laparoscopic hysterectomy (LH) with routine intraoperative cystoscopy (CYS) for enlarged uterus (>280 g).

Methods

The patients, who underwent LH procedure in the Department of Obstetrics and Gynecology in Düzce University Faculty of Medicine between July 2012 and July 2013, were included in this study. Perioperative outcomes were compared between patients with and without enlarged uterus.

Results

Uterus weight of the operated patients ranges between 38 and 700 g. Mean uterus weight was 196.40 ± 142.32 g. Although we found longer operation time (148.75 ± 32.37 vs. 128.28 ± 27.58) and higher delta hemoglobin (2.98 ± 3.09 vs. 1.61 ± 1.29) in patients with enlarged uterus undergoing LH, these findings were not statistically significant (p = 0.077 and 0.058). No significant difference was found between the two groups in terms of need for insertion of pelvic drainage (p = 0.664), duration of bladder catheterization (p = 0.673), time of first postoperative flatus (p = 0.509) and the duration of hospitalization (p = 0.844). None of the patients had postoperative fever. The two groups were not significantly different in terms of postoperative body temperature (p = 0.736). In normal uterus group, 1 patient developed ureterovaginal fistula and 1 patient required re-operation. No major complication was observed in large uterus group.

Conclusions

In our study, we compared the outcomes of LH in patients with large uterus measuring up to 700 g. and patients with normal uterus, and we achieved successful results by making minor changes in the operation technique and performing diagnostic CYS at the end of the operation.     

Is retinopathy of prematurity increasing among infants less than 1250 g birth weight?

OBJECTIVE: Retinopathy of prematurity (ROP) is a complication seen in many very low birth weight infants. Severe ROP has been called a "marker" for severe disability. The purpose of this study was to evaluate the occurrence and severity of ROP among infants < or =1250 g birth weight treated in the Special Care Nursery at Women & Infants' Hospital over a period of 7 years from 1994 to 2000. STUDY DESIGN: This was a retrospective review of ROP data combined with neonatal follow-up data. Of the 1002 infants born with birth weights <1250 g, ophthalmologic data were available for 739 of 839 survivors. Analysis of variance and chi2 along with logistic regression were used to analyze outcomes. RESULTS: An increase in the overall occurrence of ROP was identified (40% to 54% linear trend, p=0.007). The occurrence of threshold ROP ranged from 2% to 5% (NS). Infants at greatest risk of ROP were those micropremies with birth weights <750 g (p<0.001). CONCLUSION: Severe ROP continues to be a significant morbidity among infants <750 g.     

270例妊娠期糖尿病患者50g GCT和75g OGTT结果分析

妊娠期糖尿病(gestational d iabetesm ellitus,GDM)是指妊娠期间首次发生或发现的糖代谢异常,是一种常见的妊娠并发症,患GDM的孕妇常无症状,空腹血糖也正常,需借助葡萄糖耐量试验(OGTT)确诊。目前GDM筛查、确诊的方法及标准尚未统一,是产科临床有争议的问题。本研究对270例GDM     

Randomized double-blind placebo controlled study of preinduction cervical priming with 25 µg of misoprostol in the outpatient setting to prevent formal induction of labour

Objective

To compare the efficacy of preinduction outpatient use of a single dose of 25 μg vaginal misoprostol between 38^1/2 and 40 weeks with that of placebo, to decrease the interval from intervention to delivery after stretch and sweep in low-risk gravid women with Bishop’s score <4.

Method

Sixty three women received 25 μg vaginal misoprostol and 63 women received placebo after stretch and sweep.

Results

The duration from intervention to delivery was 3.35 (1.12–9.46) days in the misoprostol group and 5.42 (2.39–10.11) days in the placebo group which was statistically significant (p = 0.029). Spontaneous labor was seen in 39 women (61.9 %) in the misoprostol group and 35 women (55.6 %) in the placebo group (p = 0.531). Eight women in the misoprostol group and 18 in the placebo group had Lower Segment Caesarean Section (LSCS) and this difference was also statistically significant (p = 0.027). There were no major maternal and neonatal complications in both groups.

Conclusion

Preinduction use of 25 μg vaginal misoprostol after stretch and sweep in the outpatient setting decreased the intervention to delivery interval when compared to placebo.

     

Body weight change during use of a monophasic oral contraceptive containing 20 μg ethinylestradiol and 75 μg gestodene with a comparison of the women who completed versus those who prematurely discontinued intake

Objectives: Evaluation of the impact of an oral contraceptive on body weight with a comparison of women who completed versus women who prematurely discontinued intake. Methods: Data on body weight were retrospectively analyzed from four large prospective clinical trials with an oral contraceptive containing 20 μg ethinylestradiol and 75 μg gestodene (EE/GSD). A total of 1971 young fertile women were included in the evaluation, and 1467 completed 12 cycles. Results: We found no clinically relevant change of body weight during treatment with an oral contraceptive containing 20 μg ethinylestradiol and 75 μg gestodene in the vast majority of users after 12 treatment cycles. The mean change of body weight was less than 0.3 kg in this time period for all users. Nearly 70% of women experienced a minor change in their body weight of ± 2 kg. An additional 13% lost more than 2 kg body weight in the course of 12 treatment cycles. A total of 11% increased their weight by 2-4 kg. A total of 1255 (85.5%) of women had a body mass index (BMI) of ≤ 25 at baseline compared to 1253 (85.4%) after 12 cycles of treatment. There was no significant difference in the change of body weight between the women completing 12 cycles of treatment and those who prematurely discontinued EE/GSD. Conclusions: This retrospective analysis confirms that there was only a negligible change of body weight during intake of an oral contraceptive containing 20 μg ethinylestradiol and 75 μg gestodene. There was no difference in weight change between the women completing the study or discontinuing intake.     

A multicenter,randomized comparative trial of the clinical effects on cycle control of two 21-day regimens of oral contraceptives containing 20 μg EE

Purpose: This multicenter, randomized, open-label comparative study was designed to evaluate the effects on cycle control of the only two oral contraceptives (OCs) containing 20 μg ethinyl estradiol (EE) that are available in North America.Methods: Women of childbearing age who desired OCs for birth control were eligible to enroll in this study. Sixty-two subjects were randomly assigned to receive Alesse™ (levonorgestrel 0.1 mg and EE 20 μg) or Loestrin Fe 1/20® (norethindrone acetate 1.0 mg and EE 20 μg).Results: At the time of the interim analysis data cut-off 32 subjects had completed 3 cycles of Alesse and 30 had completed 3 cycles of Loestrin Fe 1/20. The groups were similar with regard to age, weight, height, race, and prior OC usage. A total of 22% of the subjects in the levonorgestrel group and 27% of those subjects in the norethindrone group had never used OCs. The remainder had not used OCs for at least 3 months before entering the trial. During the third cycle of use, the percentage of normal cycles was significantly greater in the levonorgestrel group (P < .05). Moreover, the rate of intermenstrual bleeding (breakthrough bleeding and/or spotting) in the norethindrone group (62.9%) was more than double that in the levonoregestrel group (29.0%). Cumulatively, from cycles 1 to 3, there was a higher incidence of absence of withdrawal bleeding with norethindrone when compared with levonorgestrel (27.7% vs 5.3%).Conclusion: The results of this study demonstrate that good cycle control can be achieved with an OC containing 20 μg EE. The superior cycle control of Alesse compared with Loestrin Fe 1/20 is consistent with that found in comparative studies of the cycle control of levonorgestrel, norethindrone, and norethindrone acetate containing OCs that had a higher dose of EE.     

Effect of vitamin D deficiency on the 75 g oral glucose tolerance test screening and insulin resistance

Abstract

Gestational diabetes mellitus (GDM), is the most common medical complications of pregnancy. This study aimed to clarify the effect of second-trimester vitamin D deficiency on the 75?g oral glucose tolerance test (OGTT) screening and insulin resistance. A total of 120 pregnant women with a singleton pregnancy at a gestational age of 26–28?weeks were analyzed. Participants were divided into two groups according to 25-hydroxyvitamin D levels; vitamin D deficiency, and control groups. For GDM scan, 75?g OGTT was preferred. GDM prevalence was 17.5% in vitamin D deficiency group and 13.75% in control group, there is no significant difference in GDM prevalence (p?=?0.149). Fasting plasma glucose and 1-h plasma glucose levels were significantly higher in the vitamin D deficiency group than in the control group (p?<?.001 and p?<?.001, respectively). No significant differences were observed between 2-hour plasma glucose levels (p?=?.266). The HOMA-IR level was significantly higher in the vitamin D deficiency group than in the control group (p?<?.001). The findings of the present study suggested that vitamin D deficiency in the second trimester was inversely correlated with fasting and 1-h plasma glucose after 75?g glucose challenge test; also, low 25 OHD₃ levels were associated with insulin resistance.