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Biomedical subjects

Fabio Facchinetti

Publications and source records attributed to Fabio Facchinetti.

At least 19 recordsLinked to original sources

Induction of labor at term using isosorbide mononitrate simultaneously with dinoprostone compared to dinoprostone treatment alone: a randomized, controlled trial.

OBJECTIVE: We aimed to determine whether isosorbide mononitrate (IMN) given simultaneously with dinoprostone in term pregnancies is superior to dinoprostone alone to promote delivery. STUDY DESIGN: One hundred and twenty nulliparous women at term were randomly assigned to receive per vaginam IMN 40 mg or placebo in addition to 3 mg dinoprostone 2 times daily for up to 2 days. Analysis was by intention to treat. RESULTS: Baseline characteristics of both groups were comparable. The induction to delivery intervals did not differ between the IMN and the placebo group (26.4 +/- 14.4 vs 23.4 +/- 14.8 hours, P = .408). IMN resulted in more headache compared to placebo (32/55 [58.2%] vs 2/55 [3.6%], P < .001). CONCLUSION: Vaginally administered IMN does not play a role in promoting delivery in term pregnancy if given at the same time as dinoprostone. This might reflect its relaxant effect on the uterine fundus, which may overcome its cervical softening effect.

Administration, Intravaginal↗

The computerized fetal heart rate analysis in post-term pregnancy identifies patients at risk for fetal distress in labour.

OBJECTIVE: To ascertain the diagnostic ability of a computerized fetal heart rate (FHR) analysis system in the identification of patients at risk of fetal distress in labour. STUDY DESIGN: Three hundred and two healthy post-term pregnancies were enrolled in a retrospective, cross-sectional study and subdivided into two groups, with (n=42) or without (n=260) fetal distress in labour. The last computerized FHR recording before onset of labour was analyzed. RESULTS: The two groups showed a significant difference only in FHR baseline and in percentage of small accelerations on total. The multivariate analysis showed that only the percentage of small accelerations was significantly related to the labour outcome. A higher diagnostic accuracy was obtained with use of neural network analysis, which allowed a sensitivity of 56%, specificity 91%, positive predictive value 53% and negative predictive value 92% with an overall accuracy of 86%. CONCLUSIONS: The increase in FHR baseline and in small FHR accelerations can be major factors in the prediction of subsequent fetal distress in healthy term fetuses. Use of neural networks seems to further improve the ability of computerized FHR analysis in the prediction of intrapartum distress.

Cardiotocography↗

Changes in cervical nitric oxide concentration correlate with Bishop score and cervical length modifications in prostaglandin E2-mediated induction of labor.

OBJECTIVE: Nitric oxide (NO) plays a fundamental role in cervical ripening and it is synthesized in the human cervix. We studied the effect of the dinoprostone on cervical NO release in pregnant women, and we investigated the relationship between cervical NO metabolites, cervical length, and Bishop score. METHODS: Seventy-seven women underwent induction of labor at > or = 37 weeks of gestation, due to post-term pregnancy (23.8%), oligohydramnios (36.3) or preeclampsia (29.9%). Cervical fluid samples for NO metabolites (NOx), Bishop score, and cervical length were assessed immediately before (time 0 [T0]) and 6 hours after (T6) the local application of dinoprostone, a commercially available prostaglandin E2 (PGE2) analog. RESULTS: The mean patients' age was 34 +/- 3.2 years, mean gestational age at enrollment was 284 +/- 9.2 days, and nulliparous represented 31.2% of the study population. At time 0, Bishop score was less than 4 in 74% (57/77) of the subjects, mean cervical length was 28.6 +/- 5.8 mm, mean NOx concentration was 208.6 +/- 103.8 microM/mL; 6 hours later, at T6, the mean cervical length decreased to 19.5 +/- 8.8 mm, and the mean NOx concentration increased up to 316.7 +/- 240.9 microM/mL. Data were unaffected by parity or by regular uterine contraction patterns. A statistically significant positive correlation was found between changes in cervical NOx levels and Bishop score modification (P < .01; r = .494), as well as between the modification of NO metabolites concentration and cervical shortening (P < .01; r = .307). CONCLUSIONS: Prostaglandin (PG)-induced cervical ripening is associated with local NO release. NO plays an active role in cervical remodeling since it positively correlates with both cervical shortening and Bishop score increase. NO oxide and PG are the two pathways that, cross activating each other, trigger the cascade of events responsible of cervical ripening.

Adult↗

Effect of L-arginine on blood pressure in pregnancy-induced hypertension: a randomized placebo-controlled trial.

OBJECTIVE: To evaluate the antihypertensive efficacy of L-arginine (L-Arg) repeated infusions in women affected by gestational hypertension. METHODS: The women were referred to obstetric units in order to assess their clinical conditions and to exclude the presence of severe fetal and/or maternal complications. Inclusion criteria were: maternal age range 16-45 years, diagnosis of gestational hypertension without proteinuria (patients normotensive until the 20th week), and gestational age ranging between 24 and 36 weeks. Each woman was allocated to receive either L-arginine (20 g/500 mL) or placebo treatment through an i.v. line. The infusion was carried out in the morning from 8 a.m. to 10 a.m. and it was repeated for the next four consecutive days. Systolic and diastolic blood pressure values as well as heart rate were recorded with the patient in an upright, seated position at 08:00, 12:00, 16:00 and 20:00 h. RESULTS: Maternal clinical features such as age, height, weight, and gestational age at inclusion were similar between groups. Both systolic and diastolic blood pressures were reduced by treatment, the effect of L-arginine being significantly higher than that of the placebo (systolic values F = 8.59, p < 0.005; diastolic values F = 3.36; p < 0.001). Twenty women assigned to the L-Arg group (32.2%) and 23 to the placebo group (37.7%) were concomitantly treated with antihypertensives before starting the study. Analyzing the subgroup of patients not receiving antihypertensive drugs we found that L-arginine was superior to placebo in lowering systolic (F = 5.42, p < 0.005) and diastolic (F = 2.20, p < 0.005) blood pressure values. CONCLUSIONS: In conclusion, these data support the use of L-Arg as an antihypertensive agent for gestational hypertension especially in view of the other beneficial effects nitric oxide donors display in pregnancy. Further, L-Arg seems well tolerated since in this sample none of the patients reported adverse effects requiring study interruption.

Adolescent↗

Hyperemesis gravidarum complicated by Wernicke encephalopathy: background, case report, and review of the literature.

Wernicke encephalopathy (WE) is a rare but known complication of severe hyperemesis gravidarum caused by thiamine deficiency. This article presents an unusual case that occurred at our institution and reviews the 48 previously published cases of WE in pregnancy. Considering all the 49 cases, the mean (+/-standard deviation) patients' age was 26.7 +/- 4.9 years, the mean gestational age when WE manifested was 14.3 +/- 3.4 weeks, and the mean duration of vomiting and feeding difficulties was 7.7 +/- 2.8 weeks. Wernicke's classic triad (confusion, ocular abnormalities, and ataxia) manifested in only 46.9% (23 of 49) of the patients. Confusion affected 63.3% (31 of 49) of the patients, ocular signs 95.9% (47 of 49) and symptoms 57.1% (28 of 49), and ataxia 81.6% (40 of 49). Deterioration of consciousness affected 53.1% (26 of 49) of the subjects and memory impairment 61.2% (30 of 49). Complete remission of the disease occurred in only 14 of 49 cases. Symptom resolution required months and permanent impairments were common. The overall pregnancy loss rate, directly (spontaneous fetal loss) and indirectly (planned abortion) attributable to WE, was 47.9% (23 of 49). The diagnosis of WE is clinical and can be rapidly confirmed by magnetic resonance imaging. We emphasize the importance of thiamine supplementation to women with prolonged vomiting in pregnancy, especially before intravenous or parenteral nutrition. We also underline the necessity to promptly replace vitamin B1 when neurologic symptoms and/or signs develop in a patient with hyperemesis gravidarum.

Adult↗

Thrombophilia is significantly associated with severe preeclampsia: results of a large-scale, case-controlled study.

The role of thrombophilia in the pathogenesis of preeclampsia is controversial. The aim of this case-controlled study was to determine whether thrombophilia increases the risk of preeclampsia or interferes with its clinical course. A total of 808 white patients who developed preeclampsia (cases) and 808 women with previous uneventful pregnancies (controls) matched for age and parity were evaluated for inherited and acquired thrombophilia (factor V Leiden; factor II G20210A; methylenetetrahydrofolate reductase C677T; protein S, protein C, and antithrombin III deficiency; anticardiolipin antibodies; lupus anticoagulant; and hyperhomocysteinemia). Odds ratios (ORs) with 95% confidence intervals (CIs) for risk of being carriers of thrombophilia in cases compared with controls and for risk of maternal life-threatening complications and adverse perinatal outcomes in preeclamptic patients with or without thrombophilia were calculated. Women with severe preeclampsia (406 cases) had a higher risk (OR, 4.9; 95% CI, 3.5 to 6.9) of being carriers of either an inherited or acquired thrombophilic factor, except for protein S, protein C, and antithrombin deficiency. In women with mild preeclampsia (402 cases), only prothrombin and homozygous methylenetetrahydrofolate reductase gene mutations were significantly more prevalent than in the controls. Thrombophilic patients with severe preeclampsia are at increased risk of acute renal failure (OR, 1.8; 95% CI, 1.5 to 2.2), disseminated intravascular coagulation (OR, 2.7; 95% CI, 1.1 to 6.4), abruptio placentae (OR, 2.6; 95% CI, 1.2 to 6.0) and perinatal mortality (OR, 1.7; 95% CI, 1.5 to 2.2) compared with nonthrombophilic preeclamptic patients. Our study demonstrates a significant association between maternal thrombophilia and severe preeclampsia in white women. Thrombophilia also augments the risk of life-threatening maternal complications and adverse perinatal outcomes in preeclamptic patients.

Case-Control Studies↗

Evidence that natural benzodiazepine-like compounds increase during spontaneous labour.

Natural benzodiazepine-like compounds (NBDZ) are present in the blood of normal people free of commercial benzodiazepine medication. In this work, we evaluated the levels of NBDZ in maternal/foetal serum during delivery after spontaneous labour (VD) or caesarean section (CS). For both the VD (n=11) and the CS (n=11) groups (VD+CS=22), three blood samples were collected at three different times: the first was collected three days before labour, the second immediately after delivery or at fetal abdominal extraction and the third one was obtained at second day post-partum. NBDZ were measured by radioreceptor binding assay after HPLC extraction and purification while cortisol was measured through radioimmunoassay. In the VD group, a significant increase of NBDZ levels occurred at labour in comparison with the levels found in pre- and post-partum periods. By the contrary, no differences in NBDZ levels were found in the CS group at the three different times. The levels of cortisol in the VD group were found to be higher at labour than that determined at pre- and post-partum. Again no significant changes were found in the CS group. These findings suggest for the first time that labour is associated with a marked increase of NBDZ which could be envisaged as a stress-related event.

Adult↗

Comparison of two preparations of dinoprostone for pre-induction of labour in nulliparous women with very unfavourable cervical condition: a randomised clinical trial.

The aim of this study was to compare the clinical effects of preinduction cervical ripening by using two ways of dinoprostone administration. In a prospective, open-label trial, 144 consecutive nulliparous women with a Bishop score <4 who required induction of labour at term were randomised to receive dinoprostone via either a vaginal insert (10 mg over 12 h) or a cervical gel (0.5 mg, twice in 12 h). If labour did not start by 24 h after this preinduction, patients received 2 mg vaginal dinoprostone gel followed 6 h later by oxytocin infusion. The main outcome measure was the rate of caesarean sections (CS). Secondary measures were: changes in Bishop score at 6 h and 12 h, delivery within 12 h and 24 h, need for oxytocin for induction, failure of induction (delivery after >48 h), need for pharmacological interventions to manage tachysystole/hyperstimulation, length of stay in hospital. The CS rate was lower in the vaginal insert group (22.9%) than in the cervical gel group (34.3%), though the difference did not reach statistical significant difference (P = 0.13). The indications for CS overlapped between the groups. The rate of vaginal delivery within 12 h and 24 h was similar, as was the rate of failure of induction. More women in the gel group (41.4% versus 24.3%) required the use of oxytocin (OR = 2.21; 95% CI = 1.07-4.55). Tachysystole or hyperstimulation in the vaginal insert group (7) was twice that with cervical gel (4). Four women in the vaginal insert group and three in the cervical gel group reported infectious complications. A long stay in hospital (>4 days) was less frequent with vaginal inserts (21.4 versus 38.6%; OR = 0.43, 95% CI = 0.19-0.97). The more challenging preinductions of labour at term are associated with increased obstetric interventions such as a high CS rate and a more frequent requirement for oxytocin inductions. In terms of success and failure, vaginal inserts releasing dinoprostone do not differ from dinoprostone given by the traditional cervical route. However, the use of vaginal inserts reduces the need for obstetric interventions and allows shorter periods in hospital.

Administration, Intravaginal↗

Second trimester abortion using isosorbide mononitrate in addition to gemeprost compared with gemeprost alone: a double-blind randomized, placebo-controlled multicenter trial.

OBJECTIVE: We aimed to determine whether second-trimester abortion using isosorbide mononitrate (IMN) in addition to gemeprost is more effective and reduces side effects compared with gemeprost alone. STUDY DESIGN: Eighty women who were age 13 to 23 weeks' gestation were randomly assigned to receive per vaginam either IMN 40 mg (group 1, 40 women) or placebo (group 2, 40 women) in addition to gemeprost 1 mg up to 3 times daily 3 hours apart for 2 days. Analysis of variance, a chi 2 test, and a multivariate analysis were performed. RESULTS: Of the 72 women analyzed, 68% (group 1) and 38% (group 2) underwent abortion within day 1 (P < .05). However, group 1 was associated with more headache (18% of women) 3 hours after induction compared to group 2 (0% of women, P = .038). CONCLUSION: IMN in addition to gemeprost is effective for second-trimester abortion, but is associated with more headache compared with gemeprost alone.

Abortifacient Agents, Nonsteroidal↗

Efficacy of Cimicifuga racemosa on climacteric complaints: a randomized study versus low-dose transdermal estradiol.

OBJECTIVE: To investigate, in a randomized clinical study, the efficacy of an isopropanolic aqueous extract of Cimicifuga racemosa (CR) on climacteric complaints in comparison with low-dose transdermal estradiol (TTSE2). Hormonal parameters, lipid profile and endometrial thickness were also evaluated. METHODS: Sixty-four postmenopausal women were enrolled and over the course of 3 months filled in a diary recording the number of hot flushes per day. Other climacteric symptoms (vasomotor and urogenital symptoms) as well as anxiety and depression, were evaluated at baseline and after 3 months. Gonadotropins (follicle-stimulating hormone (FSH), luetinizing hormone (LH)), prolactin (PRL), 17 beta-estradiol (17beta-E2) and cortisol, lipid profile (total cholesterol high-density lipoprotein (HDL)/low-density lipoprotein (LDL)-cholesterol, triglycerides, liver function (glutamic-oxalacetic transaminase, glutamic-pyruvic transaminase) and endometrial thickness were measured. Patients were randomly allocated to receive, for 3 months, either 40 mg isopropanolic aqueous CR extract daily or 25 microg TTSE2 every 7 days plus dihydrogesterone 10 mg/day for the last 12 days of the 3-month estradiol treatment. RESULTS: Both CR and low-dose TTSE2 significantly reduced the number of hot flushes per day (p < 0.001) and vasomotor symptoms (p < 0.001), starting at the first month of treatment. Such a positive effect was maintained throughout the 3 months of observation, without any significant difference between the two treatments. An identical effect was evident also for both anxiety (p < 0.001) and depression (p < 0.001) which were significantly reduced following 3 months of both CR and low-dose TTSE2. Total cholesterol was unchanged by CR treatment but significantly (p < 0.033) reduced by 3 months of low-dose TTSE2. A slight but significant increase of HDL-cholesterol (p < 0.04) was found only in women treated with CR, while LDL-cholesterol levels were significantly lowered by 3 months of both CR (p < 0.003) and low dose TTSE2 (p < 0.002). Triglycerides were not affected by both treatments, nor was liver function. FSH, LH and cortisol were not significantly affected after the 3-month treatment, while PRL (p < 0.005) and 17 beta-E2 (p < 0.001) were increased slightly only by low-dose TTSE2. Endometrial thickness was not affected by either CR or low-dose TTSE2. CONCLUSIONS: CR (40 mg/day) may be a valid alternative to low-dose TTSE2 in the management of climacteric complaints in those women who cannot be treated with or just refuse conventional strategies.

Administration, Cutaneous↗

Induction of labor in women with oligohydramnios.

OBJECTIVE: To prospectively evaluate the outcome of labor induction in women with oligohydramnios at term. METHODS: This was a prospective case-control study which included 120 consecutive patients with Amniotic Fluid Index (AFI) < or =5 undergoing labor induction. One hundred and sixteen patients with normal amniotic fluid matched for gestational age (+/- 3 days) and Bishop-score served as controls. Inclusion criteria were: requirement of labor induction, singleton pregnancy, nulliparity, Bishop score <5, gestational age > or =266. Preinduction treatment included the use of up to 3 successive doses of dinoprostone intracervical gel (0.5 mg). Vaginal dinoprostone (2 mg) and/or oxytocin were then applied to induction labor, if necessary. RESULTS: The rate of cesarean section in AFI < or = 5 group (38.3%) was not significantly different to that in control group (34.2%). The interval from induction to vaginal delivery was not significantly different for AFI < or =5 group (1499 +/- 895 min.) and control group (1398 +/- 852 min.). The changes in Bishop score evaluated at 6th and 12th hour after dinoprostone were not significantly different in control and AFI< or =5 group. More women in the latter group (11.7% vs 3.3%, Chi Square:4.86, p = 0.027) required the use of drugs in order to manage tachysystole/hyperstimulation allowing a OR = 3.83 (95%C.I. = 1.13-14.27). The length of stay at hospital was 4.2 +/- 1.8 days for AFI < or =5 group and 4.3 +/- 1.3 for control group. CONCLUSIONS: Oligohydranmios at term did not influence the outcome of induction of labour in nulliparous women with unfavorable cervix.

Adolescent↗

Diclofenac pyrrolidine versus Ketoprofen for the relief of pain from episiotomy: a randomized controlled trial.

BACKGROUND: The treatment of pain from episiotomy or from tearing of perineal tissues during childbirth is often unapplied, although discomfort may be severe. We performed a randomized double-blind controlled trial to compare the effectiveness and side-effects of two analgesics in the management of postpartum perineal pain. Patient preference toward the two medications was also analyzed. METHODS: A total of 261 women were randomly assigned to receive either Diclofenac hydroxyethyl pyrrolidine (100 mg) (n = 133) or Ketoprofen (100 mg) (n = 128), both given orally every 12 hr up to 48 hr, as necessary. Inclusion criteria were vaginal birth with episiotomy and/or a second- to third-degree tear. Pain ratings were recorded before the administration of the drugs and at 1, 4, 12, and 24 hr after the first dose, according to a 10-cm visual-analog scale. Side-effects and overall opinion on the two treatments were assessed at 24 hr. RESULTS: Diclofenac hydroxyethyl pyrrolidine and Ketoprofen had similar analgesic properties in the first 24 hr postpartum [mean pain rating 3.1 +/- 1.8 and 3.4 +/- 2.0, mean number of doses in 24 hr 1.4 +/- 1.4 and 1.3 +/- 1.5, and proportion of treatment failures 12.8% (17/133) and 16.4% (21/128), respectively]. Significantly fewer subjects in the Diclofenac hydroxyethyl pyrrolidine group than in the Ketoprofen group experienced side-effects (6.8% versus 15.6%; p = 0.038) with an odd risk = 0.39(95% C.I. 0.16-0.95). There were no significant differences in overall patient satisfaction between the two groups. CONCLUSIONS: No main differences were found concerning the relief of pain between the two treatments. Diclofenac hydroxyethyl pyrrolidine may be the preferred choice because it is associated with less adverse reactions, together with a faster action in the relief of pain.

Administration, Oral↗

Changes in the cervical competence in preterm labour.

Cervical competence is a key function in normal and abnormal labour. Remodelling of the cervical structure, by reorientation and changes in the integrity of collagen fibres by an alteration in the content of water, proteoglycans and hyaluronic acid, takes place before parturition. Such morphological changes have been associated with the activation of several biochemical pathways, sharing those of an apyretic, proinflammatory reaction, including the inducible isoform of the nitric oxide synthase (NOS). Nitric oxide (NO) is believed to be the final mediator in the mechanisms that allow ripening of the cervix. A reduction of NO activity in the uterus, together with its activation in the cervix, is hypothesised to be a facilitating factor in human parturition. The local application of NO donors in both animals and humans induces ultrastructural changes similar to those occurring during physiological cervical maturation. NO donors have proven to be clinically effective in facilitating first trimester dilation and curettage. Preliminary data also suggest that in women presenting with threatening preterm labour, there is increased activity of NO in the cervix, which is associated with shortening. A complex interaction between cytokines, prostaglandins (PGs) and NO is the key biochemical pathway accounting for the preterm ripening of the cervix.

Cervical Ripening↗

A small randomised trial of low-dose aspirin in women at high risk of pre-eclampsia.

OBJECTIVE: To determine if aspirin (ASA) therapy reduces the incidence of pre-eclampsia in women at high risk of this condition. STUDY DESIGN: Randomised clinical trial. We recruited pregnant women with gestational age at randomisation <14 weeks, who satisfied the following criteria: chronic hypertension, history of severe pre-eclampsia or eclampsia or intrauterine growth retardation (IUGR) or intrauterine foetal death. Nineteen women in the no-treatment group and 16 in the ASA group were successfully followed up. RESULTS: The mean birthweight was higher in the ASA group than in the no-treatment group (2790 g (S.D. 340 g) versus 2616 g (S.D. 779 g)), but the difference was not statistically significant. We found no statistically significant differences between the groups in the proportion of infants with birthweight below 2500 g (13.3% versus 29.4%) and the number of cases with pregnancy-induced hypertension (PIH)/pre-eclampsia (31.3% versus 36.8%). CONCLUSION: These limited data give some support to the potential favourable effect of early treatment with ASA in pregnant women at risk of PIH and IUGR.

Administration, Oral↗