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Biomedical subjects

Gian Carlo Di Renzo

Publications and source records attributed to Gian Carlo Di Renzo.

At least 19 recordsLinked to original sources

Guidelines for the management of spontaneous preterm labor.

Preterm birth is defined as delivery at <37 completed weeks of pregnancy (World Health Organization). Spontaneous preterm birth (SPB) includes preterm labor, preterm spontaneous rupture of membranes, preterm premature rupture of membranes (PPROM) and cervical weakness; it does not include indicated preterm delivery for maternal or fetal conditions. Early SPB (<32 weeks' gestation) is associated with an increased higher perinatal mortality rate, inversely proportional to gestational age. The pathophysiologic events that trigger SPB are largely unknown but include decidual hemorrhage (abruption), mechanical factors (uterine overdistention or cervical incompetence), and hormonal changes (perhaps mediated by fetal or maternal stress). In addition, several cervicovaginal infections have been associated with preterm labor. SPB is also the leading cause of long-term morbidity, including neurodevelopmental handicap, cerebral palsy, seizure disorders, blindness, deafness and non-neurological disorders, such as bronchopulmonary dysplasia and retinopathy of prematurity. Delaying delivery may reduce the rate of long-term morbidity by facilitating the maturation of developing organs and systems. The benefits of administration of antepartum glucocorticosteroids to reduce the incidence and severity of respiratory distress syndrome may be exploited by delay. Delay may also permit transfer of the fetus in utero to a center with neonatal intensive care unit facilities. There is considerable variation in the way that spontaneous preterm labor (SPTL) is diagnosed, managed and treated internationally. The development of clinical guidelines requires an evidence-based approach to improve outcome and allow more efficient use of resources. With recent advances in our understanding of the etiology and mechanisms of SPTL and the availability of safer, more specific tocolytics, it was felt that guidelines should be developed to achieve, if possible, an European consensus in patient diagnosis, management and treatment.

Anti-Bacterial Agents↗

The combined maternal administration of magnesium sulfate and aminophylline reduces intraventricular hemorrhage in very preterm neonates.

OBJECTIVE: To determine whether the adjunctive administration of aminophylline and magnesium sulfate to mothers at risk for preterm birth can reduce the rate of intraventricular hemorrhage in neonates born at less than 30 weeks of gestation. STUDY DESIGN: A prospective study was conducted to determine whether the rate of intraventricular hemorrhage was different in patients at risk for preterm delivery treated with ritodrine, magnesium sulfate, aminophylline, and corticosteroids (group A) versus patients treated with ritodrine and corticosteroids (group B). During the study period (January 1996 to December 2001), 125 patients enrolled in the study. Treatment was assigned by alternative allocation, and the study was designed to compare the rate of intraventricular hemorrhage in neonates born before the 30th week of gestation (primary outcome), 78 newborns in group A and 68 in group B. The proportion of neonates with intraventricular hemorrhage was calculated, and data were analyzed with Student t test, chi 2 , and logistic regression analysis. RESULTS: The frequency of severe respiratory distress syndrome needing surfactant replacement and high-pressure positive ventilation, patent ductus arteriosus, and retinopathy of prematurity was not different between the 2 groups. However, the rate of intraventricular hemorrhage was lower in neonates born before 30 weeks whose mothers received adjunctive aminophylline and magnesium sulphate (group A) than in the group that did not receive these 2 agents (group B). The overall frequency of intraventricular hemorrhage was 5.1% (4/78) versus 20.6% (14/68) ( P < .001), and the frequency of intraventricular hemorrhage grade 3-4 was 1.3% (1/78) versus 10.3 % (7/68; P < .001), respectively. CONCLUSION: Adjunctive maternal administration of aminophylline and magnesium sulfate was associated with a significant reduction in the rate of intraventricular hemorrhage in neonates born before 30 completed weeks.

Aminophylline↗

Different routes of progesterone administration and polycystic ovary syndrome: a review of the literature.

Polycystic ovary syndrome (PCOS) is a common endocrine disorder in woman of reproductive age. Although extensive studies have been performed in past decades to investigate the pathobiological mechanisms underlying the unset of this disease, its etiology remains unknown. Progesterone is a hormone of paramount importance in ovulation, implantation and luteal phase support. Low levels of progesterone have been found in the early luteal phase in PCOS patients. Granulosa cells from polycystic ovaries show an altered progesterone production. Moreover, the lack of cyclical exposure to progesterone may have a role in the development of the gonadotropin and androgen abnormalities found in PCOS patients. Ovulation failure and progesterone deficiency may facilitate the hypothalamic-pituitary abnormalities causing the associated disordered luteinizing hormone secretion in PCOS. Progesterone may be administered to PCOS patients in the following cases: to induce withdrawal bleeding, to suppress secretion of luteinizing hormone, in ovulation induction in clomiphene citrate-resistant patients and in luteal phase support in assisted reproduction. We discuss the pharmacologic characteristics of the different routes of progesterone administration with reference to these diverse indications, the therapeutic objectives and patient compliance.

Drug Administration Routes↗

Progesterone and pregnancy.

PURPOSE OF REVIEW: Progesterone is an essential hormone in the process of reproduction. Although the pharmacokinetics and pharmacodynamics of progesterone have been well studied, its use in the pathophysiology of pregnancy remains controversial. One of these concerns is the way in which the hormone is administered. RECENT FINDINGS: In obstetrics the most frequent uses of progesterone are in the treatment of threatened abortion, prevention of recurrent miscarriage, or in the support of the luteal phase in assisted reproduction programmes, and in threatened preterm labour. Randomized, controlled trials showed that women who received progesterone were statistically significantly less likely to have recurrent miscarriages before 34 weeks, to have an infant with birth weight of 2.5 kg or lower, or to have an infant diagnosed with intraventricular haemorrhage. There is currently, however, insufficient information to allow recommendations regarding the optimal dose, route and timing of administration of progesterone supplementation. SUMMARY: Progesterone has shown to be efficacious when continuation of pregnancy is hampered by immunological factors, luteinic and neuroendocrine deficiencies and myometrial hypercontractility. This may explain the reduction in the incidence of preterm birth in high-risk pregnant women using high-dosage prophylactic progesterone.

Abortion, Spontaneous↗

The quality of nifedipine studies used to assess tocolytic efficacy: a systematic review.

OBJECTIVE: To assess the quality of studies of nifedipine used to treat spontaneous preterm labor. DESIGN: A systematic review of study quality using a novel validity assessment tool, examining method-specific and topic-specific items in the domains of selection, performance and measurement biases. DATA SOURCES: Medline (1996-2003), EMBASE (1996-2003), BIOSIS (1993-2003), Current Contents (1995-2003), DERWENT DRUGFILE (1983-2003), Cochrane Database of Systematic Reviews. Bibliographies of existing meta-analyses and systematic reviews of nifedipine as a tocolytic. METHODS OF STUDY SELECTION: Forty-five studies evaluating the effectiveness of nifedipine were identified. DATA EXTRACTION: Each study was assessed for 40 method-specific and topic-specific items of quality in duplicate using piloted data extraction forms. Disagreements between assessors were settled by consensus/arbitration. DATA SYNTHESIS: Very few of the studies complied with adequacy criteria of quality for either method-specific or topic-specific items. There was no improvement in quality over time. The quality of method-specific items was significantly poorer when compared with topic-specific items of quality overall (P<0.0001) and in the domains of selection bias (P<0.0001) and performance bias (P<0.0001). CONCLUSION: Studies of the effectiveness of nifedipine as a tocolytic are of poorer quality with respect to method-specific items than topic-specific items. These deficiencies should be highlighted in meta-analyses or systematic reviews which measure efficacy and should influence the generation of guideline statements or recommendations for the use of nifedipine as a tocolytic. A large randomized trial fulfilling the quality items is necessary to assess the real efficacy of nifedipine in preterm labor.

Female↗

Endometrial effects of long-term treatment with phytoestrogens: a randomized, double-blind, placebo-controlled study.

OBJECTIVE: To determine the effects of 5 years of treatment with soy phytoestrogens on histological characteristics of endometrium in postmenopausal women. DESIGN: Randomized, double-blind, placebo-controlled study. SETTING: Centre of Perinatal and Reproductive Medicine, Department of Gynecological, Obstetrical, and Pediatric Sciences, University of Perugia, Italy. PATIENT(S): Three hundred seventy-six postmenopausal healthy women, all with intact uterus. INTERVENTION(S): Women were distributed in two different groups using randomized criteria: group A (n = 179) patients received soy tablets (150 mg of isoflavones per day) for 5 years; group B (n = 197) patients received identical appearing placebo tablets for 5 years. MAIN OUTCOME MEASURE(S): Results of endometrial histology from biopsies obtained at baseline, 30 months, and 5 years after the beginning of the treatment. RESULT(S): Two hundred ninety-eight women completed the 5-year treatment. No cases of malignancy were detected during biopsy. Seventy percent of women undergoing treatment with soy phytoestrogens had an endometrium classified as atrophic or nonassessable versus 81% receiving placebo. The occurrence of endometrial hyperplasia was significantly higher in group A (3.37% vs. 0%). CONCLUSION(S): Long-term treatment (up to 5 years) with soy phytoestrogens was associated with an increased occurrence of endometrial hyperplasia. These findings call into question the long-term safety of phytoestrogens with regard to the endometrium.

Biopsy↗

Recombinant versus urinary follicle-stimulating hormone in intrauterine insemination cycles: a prospective, randomized analysis of cost effectiveness.

OBJECTIVE: To compare the clinical results and the cost effectiveness of urinary FSH and recombinant FSH in ovarian stimulation for IUI cycles. DESIGN: Prospective, randomized trial. SETTING: University Hospital, Perugia, and A.G.UN.CO. Obstetrics and Gynaecology Centre, Rome, Italy. PATIENT(S): IUI cycles were performed in 67 infertile patients. INTERVENTION(S): Protocols of ovarian stimulation with urinary FSH or recombinant FSH were randomly assigned, for a total of 138 cycles performed (67 and 71, respectively). MAIN OUTCOME MEASURE(S): Number of mature follicles, days of stimulation, number of ampules, and IU used per cycle, biochemical/clinical pregnancy rates and cost-effectiveness ratio. RESULT(S): Follicular development, length of stimulation, pregnancy and delivery rates were not statistically different. Although in the urinary FSH group a significantly higher number of IU of gonadotropins were used (815.5 +/- 284.9 vs. 596.0 +/- 253.8), the cost per cycle remained significantly lower (220.73 +/- 94.72 vs. 318.50 +/- 125.21). The cost-effectiveness ratio was 1,848.61 euro in the urinary FSH group and 2,512.61 euro in the recombinant FSH group. CONCLUSION(S): Urinary FSH and recombinant FSH are both effective in ovarian stimulation in IUI cycles. The urinary preparation is more cost effective due to the difference of its cost per IU.

Cost-Benefit Analysis↗

Phytoestrogens may improve the pregnancy rate in in vitro fertilization-embryo transfer cycles: a prospective, controlled, randomized trial.

OBJECTIVE: To compare the effectiveness of i.m. P and i.m. P plus oral phytoestrogens for luteal phase support in patients undergoing IVF-ET cycles. DESIGN: Prospective, controlled, randomized trial. SETTING: University Hospital, Perugia, Italy. PATIENT(S): Two hundred thirteen infertile patients undergoing IVF-ET were included in the study. The inclusion criteria were use of a GnRH agonist for pituitary down-regulation and age <40 years. The total number of cycles performed was 274. INTERVENTION(S): Patients were assigned to receive either i.m. P (50 mg daily) plus placebo or P (50 mg daily) plus phytoestrogen supplementation (1,500 mg daily) for luteal phase support starting from the evening of oocyte retrieval until either a serum pregnancy test result was negative or embryonic heartbeat was sonographically confirmed. MAIN OUTCOME MEASURE(S): The outcomes of IVF-ET were evaluated in both study groups in terms of implantation rate, biochemical pregnancy rate (PR), clinical PR, spontaneous abortion rate, and ongoing pregnancy/delivered rate. RESULT(S): Statistically significant higher values for implantation rate, clinical PR, and ongoing pregnancy/delivered rate were recorded in the patients who received P plus phytoestrogens for luteal phase support in comparison with patients receiving P and placebo. CONCLUSION(S): Although the results of this study encourage the use of phytoestrogens for luteal phase support in patients undergoing IVF-ET program, more studies are necessary to support the hypothesis that phytoestrogens have a beneficial effect in IVF cycles.

Adult↗

High dose of phytoestrogens can reverse the antiestrogenic effects of clomiphene citrate on the endometrium in patients undergoing intrauterine insemination: a randomized trial.

OBJECTIVE: To compare the effectiveness of clomiphene citrate (CC) alone or combined with phytoestrogens (PE) in ovulation induction in patients who had intrauterine insemination in a randomized, double-blind study. METHODS: A total of 134 women aged 25-35 years, who were infertile for at least 2 years and who had oligomenorrhea or amenorrhea associated with a positive menstrual response to the intramuscular progesterone-challenge test were enrolled. They were randomly treated with CC (100 mg daily for 5 days) and CC (100 mg daily for 5 days) in combination with PE (1500 mg daily for 10 days). We estimated the difference in uterine artery pulsatily index, number of preovulatory follicles, endometrial thickness, and pregnancy rate. RESULTS: Both treatments increased follicle-stimulating hormone, luteinizing hormone, and 17beta-estradiol plasma concentrations, but the differences were not statistically significant. However, the differences in endometrial thickness of the two groups were statistically significant. No significant differences in the pulsatility index values and in the number of preovulatory follicles were noted. CONCLUSION: A high dose of phytoestrogens can reverse the deleterious effects of clomiphene citrate on endometrial thickness and could contribute to higher pregnancy rates.

Abortion, Spontaneous↗

Ovulation induction with urinary FSH or recombinant FSH in polycystic ovary syndrome patients: a prospective randomized analysis of cost-effectiveness.

The aim of this prospective, randomized trial was to compare the clinical results and the cost-effectiveness of urinary FSH (uFSH) and recombinant FSH (rFSH) in ovarian stimulation for intrauterine insemination (IUI) cycles in polycystic ovary syndrome (PCOS) patients. One-hundred and seventy PCOS infertile patients undergoing IUI were enrolled, and protocols of ovarian stimulation with uFSH or rFSH were randomly assigned. The total number of cycles performed was 379 (182 and 197, respectively). The main outcome measures were the number of mature follicles, the days of stimulation, the number of ampoules and IU used per cycle, the biochemical/clinical pregnancy rates, the number of multiple pregnancies and the cost-effectiveness. No statistically significant differences were found in the follicular development, length of stimulation, pregnancy rates, delivery rates and multiple pregnancies between the two groups. In the uFSH group, the cost per cycle remained significantly lower (218.51 +/- 88.69 versus 312.22 +/- 118.12; P < 0.0001), even though a significantly higher number of IU of gonadotrophins were used (809.3 +/- 271.9 versus 589.1 +/- 244.7; P < 0.0001). The cost-effectiveness (i. e. within a group, the total cost of all cycles divided by no. of clinical pregnancies) was 1729.08 in the uFSH group and 3075.37 in the rFSH group. In conclusion, uFSH and rFSH demonstrated the same effectiveness in ovarian stimulation in IUI cycles in PCOS patients. The urinary preparation is more cost-effective due to the difference of its cost per IU.

Adult↗

Main clinical analyses on amniotic fluid.

BACKGROUND AND AIM OF THE WORK: To suggest a series of clinical analyses performable on amniotic fluid, in different medical complications occurring during pregnancy. METHODS: Various methodology, for different obstetrics situations, were compared among them. RESULTS: The main indication for late amniocentesis are the tests for fetal lung maturity. The most broadly accepted is the L/S ratio, which has become the "gold standard", although this chromatographic technique is labor intensive compared to several other procedures proposed and used. CONCLUSIONS: By amniocentesis, accurate fetal diagnosis has become possible. Clinical diagnostic tests are critical for many obstetric situations including premature rupture of membranes, management of pre-eclampsia, prevention of RDS. More recently, the widespread use of amniocentesis has led to study different aspects of fetal metabolism and/or fetal molecules whose functions remain to be established.

Amniocentesis↗

Genetic amniocentesis: a risk factor for preterm delivery?

OBJECTIVE: To determine whether genetic amniocentesis performed in the second trimester of pregnancy is associated with the risk of preterm delivery. STUDY DESIGN: Case-control study performed in several departments of obstetrics and gynaecology of nine European countries. Three thousand and ninety-one preterm births and 5298 controls randomly selected from singleton births born at term during 1994-1997 were analysed. Logistic regression models were used to compare preterm births altogether and, separately, spontaneous preterm delivery and induced preterm delivery. RESULTS: An increased risk of preterm delivery was found in women having second trimester genetic amniocentesis after taking account of other risk factors and confounding variables (odds ratios (OR)=1.59, 95% confidence intervals (95% CI): 1.31-1.92). The association was statistically significant and similar for spontaneous preterm delivery and induced preterm delivery. CONCLUSION: The study shows an association between preterm delivery and genetic amniocentesis. In view of the wide use of amniocentesis, further research on the etiologic role of this prenatal diagnostic technique is needed.

Adult↗