Accurate interpretation of thyroid dysfunction during pregnancy: should we continue to use published guidelines instead of population-based gestation-specific reference intervals for the thyroid-stimulating hormone (TSH)?

BACKGROUND: Considering the changes in thyroid physiology associated with pregnancy and poor outcomes related to abnormal maternal thyroid function, international guidelines recommend using population-based trimester-specific reference intervals (RIs) for thyroid testing. If these RIs are not available in the laboratory, implementing recommended fixed cut-off values globally is still controversial. To address this issue, we aimed to establish appropriate RI of thyroid-stimulating hormone (TSH) in pregnant Turkish women for our laboratory and compare the prevalence of thyroid dysfunction based on the established and recommended criteria. METHODS: Of 2638 pregnant women, 1777 women followed in the obstetric outpatient were enrolled in the reference interval study after applying exclusion criteria related to medical and prenatal history. A retrospective study was conducted by collecting data from July 2016 to March 2019. Serum TSH was measured by UniCel DxI 800 Immunoassay System (Beckman Coulter Inc., Brea, CA, USA). The study design relied on two approaches in order to classify pregnant women: trimester-specific and subgroup-specific; the latter involved dividing each trimester into two subgroups: T1a, T1b, T2a, T2b, T3a, T3b. The lower and upper limits of the RIs were derived by the parametric method after normalizing the data distribution using the modified Box-Cox power transformation method. RESULTS: The lowest TSH value was detected at 8-12 weeks in early pregnancy, and the median value of TSH in the T1b subgroup was significantly lower than the T1a subgroup (P < 0.05). TSH levels showed a gradual trend of increase along with the pregnancy and increased significantly in the T2a, T2b, and T3b subgroups compared to the preceding subgroups (P < 0.05). Compared to the diagnostic criteria recommended by American Thyroid Association (ATA), the prevalence of thyroid dysfunction was significantly different from the established trimester- and subgroup-specific RIs throughout the pregnancy (P < 0.001). CONCLUSIONS: We conclude that establishing gestation- and laboratory-specific RIs, especially for TSH, is essential for diagnosing thyroid disorders in pregnancy, and the recommended universal cut-off values, which may contribute to the risk of a misdiagnosis or a missed diagnosis, should be taken with caution in the clinical setting. However, regarding the fluctuation of thyroid function tests throughout pregnancy, trimester-specific RIs are insufficient, and implementing split phases is required.

Long-term impact of a bonus freeze on clinical outcome: Analysis of effective and non-effective bonus freezes in cryoballoon ablation.

PURPOSE: Data on bonus freeze characteristics and their impact on complication rates and long-term clinical outcome are limited. METHODS: Pulmonary vein isolation (PVI) using a 28 mm 2nd-generation cryoballoon (CB) was performed in 169 patients (pts). The isolation temperatures, time to isolation and minimal temperatures of the cryoapplications were documented. RESULTS: The study included 92 pts who received one bonus freeze after PVI in group I and 77 pts who did not receive a bonus freeze in group II. After a mean follow-up time of 19.0±8.6 months in group I and 16.4±7.5 months in group II, 67 of 92 pts (72.8%) and 49 of 75 pts available to follow up (65.3%; p = 0.221) were free of atrial tachyarrhythmia, respectively. Phrenic nerve palsy occurred in 5.4% of the pts in group I (5/92 pts) and 1.3% of the pts in group II (1/77 pts; p = 0.22). Both the mean nadir temperatures of the bonus freezes and mean nadir temperatures of the isolation freezes differed significantly between the recurrent and non-recurrent pts in group I. The predilection sites of the reconduction for both groups were the inferior aspect of the inferior pulmonary veins. CONCLUSION: The impact of a bonus freeze on long-term clinical outcome was not significant for two reasons: 1) The necessity of a bonus freeze was low because the long-term clinical success rate without a bonus freeze was high; and 2) the majority of bonus freezes, especially at the predilection sites, such as the inferior PV, appeared to be ineffective.

Cryoballoon ablation for pulmonary vein isolation in patients with atrial fibrillation: preliminary results using novel short-tip cryoballoon.

PURPOSE: In this study, we aimed to report our preliminary experience regarding the impact of the novel short-tip (ST) cryoballoon (CB) on procedural efficacy and signal quality during pulmonary vein (PV) isolation for both paroxysmal and persistent atrial fibrillation. METHODS: Between March, 2015, and August, 2015, we enrolled a total of 64 patients (47 patients male, 73 %) with a mean age of 60 ± 11 years. In the study population, 31 patients (48 %) underwent PVI using Advance (ADV) CB and 33 (52 %) patients with ST CB. In all patients, a 28-mm balloon was used. RESULTS: Acute procedural success rates were 100 % for the entire study population. A statistically insignificant increase in the percentage of PV signal recordings was observed with ST CB in all PVs compared to ADV CB [88 vs. 81 % for left superior PV (LSPV), 82 vs. 78 % for left inferior PV (LIPV), 85 vs. 84 % for right superior PV (RSPV), 82 vs. 71 % for right inferior PV (RIPV), p < 0.05]. Additionally, the difference in minimum temperature reached during the procedure per PV was not statistically significant between ST CB and ADV CB except the LIPV (LSPV -44.2 ± 5.9 vs. -45.6 ± 5.3 °C, p = 0.970; LIPV -38.7 ± 4.6 °C vs -44.6 ± 6.8 °C, p < 0.001; RSPV -45.6 ± 7.4 °C vs.-47.2 ± 6.1 °C, p = 0.168; RIPV -41.4 ± 5.1 °C vs.-43.7 ± 6.3 °C, p = 0.360). Time to isolation for each PV was similar between ST and ADV CB (p > 0.05). CONCLUSION: Our preliminary findings indicated similar acute procedural success for the novel ST CB compared with second generation ADV CB. The increase in the ratio of PV signal recordings obtained during the PVI using the novel ST CB was not significant.

Characterization of Electrical Reconnection Following Pulmonary Vein Isolation Using First- and Second-Generation Cryoballoon.

BACKGROUND: Second-generation cryoballoon (CB-2) is associated with improved outcomes for pulmonary vein isolation (PVI) compared to first generation (CB-1). However, data regarding the predictors of pulmonary vein (PV) electrical reconnection are limited. In this study, we aimed to characterize the predilection sites and predictors of reconnection in patients with recurrent atrial tachyarrhythmia (ATa) after PVI using CB-1 and CB-2. METHODS: A total of 59 patients (mean age: 62 ± 11 years and 66% male) with recurrent ATa after previous CB-PVI, using either a 28-mm CB-1 or CB-2, underwent repeat ablation. PV reisolation was performed by irrigated radiofrequency ablation using three-dimensional electroanatomical mapping systems. RESULTS: Electrical PV reconnection was detected in 10 of 11 (91%) of CB-1 patients compared to 41 of 48 (85%) of CB-2 patients. Time to redo procedure after index CB-1 was 8.9 ± 10.2 months and 11.2 ± 7.0 months in CB-2. Bonus freeze was applied in all patients with CB-1 and 41% of the patients with CB-2. Superior quadrants of both superior PVs and inferior quadrants of the both inferior PVs exhibited higher predilection for conduction compared to other quadrants (P < 0.001). Multivariate binary logistic analysis revealed that right inferior PV (RIPV; odds ratio [OR]: 1.52, 95% confidence interval [CI]: 1.09-2.13, P = 0.014) and minimum temperature (OR: 1.09, 95% CI: 1.03-1.15, P = 0.004) were the independent predictors of electrical reconnection after CB-2 ablation. CONCLUSION: Conduction gaps after CB-1 and CB-2 were higher in inferior PVs compared to superior PVs. The RIPV and minimum CB temperature were independent predictors of PV electrical reconnection after CB-2.

The Total Incidence of Complications and the Impact of an Anticoagulation Regime on Adverse Events After Cryoballoon Ablation of Atrial Fibrillation: A Single-Center Study of 409 Patients.

AIM: Data evaluating the complications of pulmonary vein isolation (PVI) using second-generation cryoballoons (CB) related to different anticoagulation regimes are limited. This study evaluates the total complications and the impact of novel oral anticoagulants (NOACs) compared to phenprocoumon on adverse events in the setting of PVI using CB. METHODS AND RESULTS: PVI was performed using second-generation CB by two experienced investigators. A total of 409 patients (58.9% male; mean age = 61 ± 10 years) with atrial fibrillation were included in this study. In group I, 150/409 (36.7%) patients received phenprocoumon therapy, and in group II, 259/409 (63.3%) patients were treated with NOACs (rivaroxaban: n = 193; dabigatran: n = 48; and apixaban: n = 18). In both groups, the rates of major complications were similar (group I [phenprocoumon]: four pts (2.7%) vs. Group II [NOACs]: seven pts (2.7%); P = 0.999). In this cohort, 275 patients were ablated with the bonus freeze protocol, and 134 patients were ablated without bonus freezes. The procedure duration significantly decreased with the bonus freeze protocol from 102.3 ± 24.6 min to 68.5 ± 16.2 min (P < 0.001). The impact of the bonus freeze on the postprocedural increase of C-reactive protein (CRP) levels was significant compared to the postprocedural CRP levels after procedures without the bonus freeze protocol (postprocedural CRP level+ bonus protocol: 1.6 ± 1.2 mg/L vs. postprocedural CRP level+ nonbonus protocol: 1.3 ± 1.3 mg/L; P = 0.04). CONCLUSION: The incidence of adverse events in PVI using the second-generation CB with the periprocedural administration of NAOCs was not significantly different compared to phenprocoumon. Further, large-scale randomized studies are needed to evaluate the safety of two anticoagulation regimes comparing vitamin K antagonists and NOACs, as well as different NOAC regimes, in patients undergoing PVI using cryoballoon ablation.

Rotational Angiography Based Three-Dimensional Left Atrial Reconstruction: A New Approach for Transseptal Puncture.

AIM: Rotational angiography is a well-known method for the three-dimensional (3-D) reconstruction of left atrium and pulmonary veins during left-sided atrial arrhythmia ablation procedures. In our study, we aimed to review our experience in transseptal puncture (TSP) using 3-D rotational angiography. METHODS: We included a total of 271 patients who underwent atrial fibrillation ablation using cryoballoon. Rotational angiography was performed to get the three-dimensional left atrial and pulmonary vein reconstructions using cardiac C-arm computed tomography. The image reconstruction was made using the DynaCT Cardiac software (Siemens, Erlangen, Germany). RESULTS: The mean age of the study population was 61 ± 10 years. The indications for left atrial arrhythmia ablation were paroxysmal AF in 140 patients (52%) and persistent AF patients in 131 (48%) patients. The success rate of TSP using only rotational guidance was (264/271 patients, 97.4%). In the remaining seven patients, transesophageal guidance was used after the initial attempt due to thick interatrial septum in five patients and difficult TSP due to abnormal anatomy and mild pericardial effusion in the remaining two patients. Mean fluoroscopy dosage of the rotational angiography was 4896.4 ± 825.3 µGym(2). The mean time beginning from femoral vein puncture to TSP was 12.3 ± 5.5 min. CONCLUSION: TSP guided by rotational angiography is a safe and effective method. Our results indicate that integration of rotational angiographic images into the real-time fluoroscopy can guide the TSP during the procedure.

Cryoballoon Ablation for Pulmonary Vein Isolation in Patients With Persistent Atrial Fibrillation: One-Year Outcome Using Second Generation Cryoballoon.

BACKGROUND: Data regarding the freedom from atrial fibrillation (AF) in the follow-up of persistent AF patients is limited. The second-generation cryoballoon has better cooling properties compared with first-generation cryoballon. In this study, we aimed to assess the medium-term efficacy of second-generation cryoballoon in patients with persistent AF. METHODS AND RESULTS: A total of 100 patients (63±10 years, 80% male) with symptomatic persistent AF, despite ≥1 antiarrhythmic drug(s), who were scheduled for pulmonary vein isolation using second-generation cryoballoon were enrolled in this study. Follow-up was based on outpatient clinic visits, including Holter ECGs. Recurrence was defined as a symptomatic or documented arrhythmia episode of >30 seconds excluding a 3-month blanking period. As a result, 393 pulmonary veins (7 patients with common ostium) were successfully isolated. Mean procedural and fluoroscopy times were 96.2±21.3 and 19.7±6.7 minutes, respectively. Phrenic nerve palsy occurred in 3% (3/100) of the patients. At a mean follow-up duration of 10.6±6.3 months, 67% of the patients were in sinus rhythm. Stepwise multivariable Cox proportional hazard regression analysis showed that early AF recurrence (hazard ratio 3.83, 95% confidence interval 1.91-7.68, P<0.001) was the only independent predictor for late AF recurrence apart from other clinical and echocardiographic variables. CONCLUSIONS: Our findings indicated that second-generation cryoballoon use is associated with favorable outcomes in patients with persistent AF. Recurrence at blanking period was the only predictor of long-term AF recurrence.

Purse-string double-layer closure: a novel technique for repairing the uterine incision during cesarean section.

AIM: To compare the classical double-layer uterine closure to a double-layer purse-string uterine closure (Turan technique) in cesarean section regarding short- and long-term results. METHODS: Patients were randomized into either the double-layer purse-string uterine closure arm (study group, 84 patients) or the classical double-layer uterine closure arm (control group, 84 patients). For short-term comparison, a detailed transvaginal ultrasound examination was planned in all patients 6 weeks after the operation and a wedge-shaped defect in the uterine incision scar was accepted as uterine scar defect and recorded. For the long-term comparison, subsequent pregnancies of these patients were followed up for any complication. RESULTS: The number of patients with ultrasonographically visible uterine scar defect was 12 (23.5% of all scar defects) in the study group whereas it was 39 (76.5% of all scar defects) in the control group (P < 0.001, χ(2) = 15.42). Demographic data, operation time, hospitalization time, preoperative and postoperative hemoglobin values were not significantly different between the groups. During the 2-year of the follow-up period, five patients in the study group and six patients in the control group became pregnant again. No complication during their pregnancies and second cesarean operation were encountered. CONCLUSION: With the Turan technique, the uterine incision length becomes shorter, and the frequency of uterine scar defect is lower regarding short-term results. More data is needed for long-term results. ClinicalTrials.gov NCT01287611.

Challenges in patient selection for the parachute device implantation.

BACKGROUND: A novel percutaneous ventricular restoration therapy (PVRT) has been recently proposed to treat patients with ischemic heart failure (IHF) and antero-apical regional wall motion abnormalities after myocardial infarction (MI). In this prospective, single center, non-randomized study, we herein propose safety and feasibility evaluation of the device, in which a different patient selection strategy was used. MATERIAL AND METHODS: A three-stage evaluation was adopted in a series of patients referred for a Parachute Ventricular Partitioning Device (Parachute™). After an initial clinical evaluation, a secondary screening step was performed according to echocardiographic functional (LVEF<40%, apical/anterior akinesia/dyskinesia) and anatomical criteria [diameter of LV-apex (LVAD) = 4.0 × 5.0 cm, left ventricular end diastolic diameter (LVEDD)>56 mm, left ventricular end systolic diameter (LVESD)>38 mm]. Patients encountering the echocardiographic criteria were selected for 3D cardiac CT (architecture, geometry, and trabeculation of the left ventricle) and eventually treated with the Parachute™. RESULTS: Fifty patients were screened according to the echocardiographic criteria. Twenty-seven of those that met the echo inclusion criteria underwent further cardiac CT imaging. After CT imaging, eight patients were scheduled for Parachute™ implantation. The device was successfully implanted in all eight patients with no in-hospital mortality. A 3-month follow-up echocardiography showed LV-volume reduction [95% CI; LVEDV: -76.5 (-116; -36.8), P = 0.002 and LVESV: -47.4 (-63.8; -30.9), P = 0.003] and improvement of global EF [95% CI; global EF: 6.87 (5.36; 8.39), P = 0.008]. CONCLUSION: Selection criteria for Parachute™ placement should include left ventricular functional and anatomical parameters. When preprocedural echocardiography and cardiac CT are adequately implemented, satisfactory periprocedural and short term follow-up results may be achieved after Parachute™ implantation.

In-hospital outcome of patients with severe mitral valve regurgitation classified as inoperable and treated with the MitraClip® device.

BACKGROUND: To evaluate the short-term outcome of patients predominantly at high risk treated with the MitraClip® device for severe mitral valve regurgitation (MR) using one or more clips. METHODS: We prospectively analyzed patients with highly symptomatic MR classified as inoperable (logistic EuroSCORE 24.16 ± 13.64%; STS-score 29.9 ± 14.5%) but subject to mitral valve repair with MitraClip® between May 2010 and January 2011. Thirty-three consecutive patients (57.6% male; age 77.8 ± 6.7 years) were enrolled and treated with either 1 (n = 7; 21.2%), 2 (n = 20; 60.6%), 3 (n = 4; 12.1%), or 4 (n = 2, 6.1%) clips. Grading of MR was performed by two-dimensional transesophageal echocardiography (2D-TEE) prior to TEE-guided clipping and before discharge. RESULTS: MR was classified as functional in 23 (69.7%) and organic in 10 (30.3%) of the patients with MR-grade ≥ 3+ in 32 (97%) and = 4 in 1 patients (3%) before repair. Reduction in MR grade to grade ≤1+ was achieved in 81.7% and to 2 in 12.1% (P = 0.00072). Invasive pulmonary artery systolic pressure (PAPsyst) and pulmonary capillary wedge pressure (PCWP) v-wave decreased from 59.2 ± 18.6 to 46.9 ± 15.3 mmHg (P = 0.00014) and 21.2 ± 6.7 to 8.0 ± 3.3 mmHg (P = 0.0093), respectively, as measured immediately after clipping. Functional NYHA class improved from mean 3 (range 3 [90.9%] to 4 [9.1%]) to 2 in 84.9% (P = 0.00081) as obtained at discharge. CONCLUSIONS: Mitral valve repair with MitraClip® using multiple clips is appropriate and safe in unselected patients resulting in reduced MR with positive impact on short-term functional capacity.

Comparison of success rates of 'transvaginal aspiration and tetracycline sclerotherapy' versus 'only aspiration' in the management of non-neoplastic ovarian cysts.

AIM: To investigate the value of tetracycline sclerotherapy for management of recurrent or persisting non-neoplastic ovarian cysts in comparison to the aspiration without sclerotherapy. MATERIAL AND METHODS: Ninety-six patients with proven non-neoplastic ovarian cysts were randomized into two groups. Group 1 patients underwent cyst aspiration together with tetracycline sclerotherapy (n=48). Group 2 patients underwent only cyst aspiration without tetracycline sclerotherapy (n=48). Then, all patients were followed up monthly with ultrasonography for 12months. The procedure was considered to have failed if the recurring cyst, detected by ultrasound, was 4cm in size or greater. RESULTS: There were no differences between the two groups regarding demographic data, initial cyst volume and tumor markers. Recurrence rates within 12months were 14.6% in group 1 and 50% in group 2 (P<0.001). CONCLUSION: Based on the recurrence rates, we suggest transvaginal aspiration together with tetracycline sclerotherapy rather than only simple transvaginal aspiration in the management of non-neoplastic ovarian cysts.

The effectiveness of bilateral hypogastric artery ligation for obstetric hemorrhage in three different underlying conditions and its impact on future fertility.

OBJECTIVE: To evaluate the effectiveness of bilateral hypogastric artery ligation (BHAL) according to the underlying cause and future fertility in these women. METHOD: Fifty-eight women who underwent BHAL operation in our department between 1997 and 2008 were further divided into three subgroups in accordance with the underlying disease. Group 1: Severe preeclampsia with coagulapathy (n:24). Group 2: Postpartum hemorrhage (PPH) due to uterine atony (n:24). Group 3: Massive hemorrhage due to inadequate surgical control of bleeding and/or uterine rupture (n:10). Effectiveness of BHAL according to the underlying cause and future fertility after BHAL were evaluated. RESULTS: Success rate of BHAL was found to be 87.9% (51 out of 58 patients). Complication rates of the groups were 25%, 12.5%, and 10%, respectively. There was one maternal death in each group. Mean hospital stay, blood and blood products transfusion need were similar for all groups. Thirty women out of 58 had desired future fertility, and 17/30 (56.7%) of them became pregnant within less than 1 year. CONCLUSION: BHAL is a safe, effective, life-saving procedure in controlling massive PPH. It preserves future fertility and must be the first choice operation for PPH in young women whichever the underlying condition is.

Improvement of cardiac function by intracoronary freshly isolated bone marrow cells transplantation in patients with acute myocardial infarction.

BACKGROUND: We analyzed in the present study the influence of intracoronary autologous freshly isolated bone marrow cells transplantation (BMCs-Tx) on cardiac function in patients with acute myocardial infarction (AMI). METHODS AND RESULTS: The 32 patients with AMI were enrolled in this prospective nonrandomized study to either freshly isolated BMC-Tx or to a control group without cell therapy. Global left ventricular ejection fraction (LVEF) and the size of infarct area were determined by left ventriculography. We observed in patients with autologous freshly isolated BMCs-Tx at 6 months follow up a significant reduction of infarct size as compared to control group. Moreover, we found a significant increase of LVEF as well as infarct wall movement velocity at 6 months follow up in cell therapy group as compared to control group. In the control group there was no significant difference of LVEF, infarct size and infarct wall movement velocity between baseline and 6 months after AMI. CONCLUSIONS: These results demonstrate for the first time that intracoronary transplantation of autologous freshly isolated BMCs by use of a point of care system is safe, and may lead to improvement of cardiac function in patients with AMI.

Cervical polyps: evaluation of routine removal and need for accompanying D&C.

OBJECTIVE: To estimate prevalence of malignancy and dysplasia in cervical polyps and to judge whether cervical polyps need to be removed routinely. Also to investigate if a cervical polyp is an indicator of endometrial pathology and to assess the necessity of performing dilatation and curettage (D&C). MATERIALS AND METHODS: We retrospectively reviewed hospital records of 4,063 cervical polyp cases. Patients' age, menopausal status and pathological findings were recorded. Descriptive statistics, Pearson's χ(2), Fisher's exact test were used for statistical analysis. P value of ≤ 0.05 was accepted significant. RESULTS: Among 4,063 cervical polyps, only 3 (0.1%) cases of malignancy were encountered which were metastasis from endometrium. There were also dysplastic (0.4%), metaplastic (2.1%), inflammatory (1%) changes. Accompanying endometrial pathologies were: endometrial cancer (0.3%), hyperplasia without atypia (1.3%), endometrial polyp (6.6%). There was statistically significant relation between menopausal status and malignancy of cervical polyps (P = 0.055) malignancy of endometrial cavity (P = 0.0001). CONCLUSION: Routine removal of cervical polyps, although not mandatory, seems clinically prudent because pathological evaluation is needed to confirm the diagnosis and to rule out other possibilities. 10.9% of postmenopausal patients and 7.8% of premenopausal patients were diagnosed with any endometrial pathology accompanying cervical polyp. Therefore, cervical polyps can be a sign of endometrial disease, especially in postmenopausal women with cervical polyp endometrium should be evaluated more carefully.

Improved mobilization of the CD34(+) and CD133(+) bone marrow-derived circulating progenitor cells by freshly isolated intracoronary bone marrow cell transplantation in patients with ischemic heart disease.

Cell therapy is a promising novel option for treatment of cardiovascular disease. Because the role of bone marrow-derived circulating progenitor cells (BM-CPCs) after cell therapy is less clear, we analyzed in this randomized, controlled study the influence of intracoronary autologous freshly isolated bone marrow cell transplantation (BMC-Tx) by using a point-of-care system on cardiac function and on the mobilization of BM-CPCs in patients with ischemic heart disease (IHD). Fifty-six patients with IHD were randomized to either receive freshly isolated BMC-Tx or a control group that did not receive cell therapy. Peripheral blood concentrations of CD34/45(+) and CD133/45(+) CPCs were measured by flow cytometry pre-, immediately post-, and at 3, 6, and 12 months postprocedure in both groups. Global ejection fraction and the size of infarct area were determined by left ventriculography. We observed in patients with IHD after intracoronary transplantation of autologous freshly isolated BMCs-Tx at 3 and 12 months follow-up a significant reduction of the size of infarct area and increase of global ejection fraction as well as infarct wall movement velocity. The mobilization of CD34/45(+) and CD133/45(+) BM-CPCs significantly increased at 3, 6, and 12 months after cell therapy when compared with baseline in patients with IHD, although no significant changes were observed between pre- and immediately postintracoronary cell therapy administration. In the control group without cell therapy, there was no significant difference of CD34/45(+) and CD133/45(+) BM-CPCs mobilization between pre- and at 3, 6, and 12 months postcoronary angiography. Intracoronary transplantation of autologous freshly isolated BMCs by using a point-of-care system in patients with IHD may enhance and prolong the mobilization of CD34/45(+) and CD133/45(+) BM-CPCs in peripheral blood and this might increase the regenerative potency in IHD.

Macrosomic newborns: a 3-year review.

The objective of this study was to determine the incidence, perinatal complications and the outcome of macrosomic infants. A retrospective analysis was made of macrosomic deliveries and of those admitted into the Neonatology Unit. A control group of 854 deliveries weighing between 2500-4000 g was randomly composed. The incidence of macrosomic deliveries, stillbirth rates, sex, parity, maternal age, mode of delivery, perinatal complications like birth traumas, hypoglycemia, polycythemia, asphyxia, admission rate into the neonatal intensive care unit (NICU), and outcome were analyzed. Among a total of 11,827 deliveries, 829 (7%) were macrosomic neonates. Statistical analysis showed male predominance (p = 0.0001), a significant increase in cesarean section (p = 0.0001), and higher parity for the macrosomic group (p = 0.0001). The mothers of macrosomic newborns were older (p = 0.0001). The admission frequency of macrosomic deliveries into the NICU was almost two-fold. Birth injuries were found in 53 (6.4%) macrosomic infants, and macrosomic deliveries had a two-fold risk for birth injuries. Statistical analysis showed a significant difference between macrosomics and the control group for the frequency of birth traumas (p = 0.0007), hypoglycemia (p = 0.0001) and polycythemia (p = 0.0006). There were two deaths in macrosomic group versus one among control cases. Regarding the high birth trauma and NICU admission rates of macrosomic infants, it is important to emphasize the significance of prenatal diagnosis of fetal macrosomia and of management of these high-risk pregnancies in tertiary level hospitals.

Effectiveness of short-term maintenance treatment with cabergoline in microadenoma-related and idiopathic hyperprolactinemia.

OBJECTIVE: This study aimed to determine the effectiveness of short-term maintenance treatment with cabergoline and to find out minimum effective dosage of cabergoline during maintenance treatment for patients with microadenoma-related and idiopathic hyperprolactinemia. STUDY DESIGN: Cabergoline was administered orally at a dose of 0.5 mg twice per week to 164 de novo hyperprolactinemic patients until serum prolactin level normalized. After this initial treatment phase, patients started on maintenance phase for which they were previously randomized. No maintenance treatment (Group I, n = 36) or cabergoline 0.5 mg (Group II, n = 46), 0.25 mg (Group III, n = 39), 0.125 mg (Group IV, n = 43) was administered twice per week for 8 weeks as maintenance treatment. Then, maintenance phase was finalized and patients were followed up for 6 months. Mean serum prolactin levels through maintenance treatment phase and follow-up period were assessed between groups and within groups. RESULTS: Except for group I, all the groups showed a similar pattern with fast decrease of serum prolactine level during maintenance phase and slower increase during the follow-up period. Notably, the average prolactin level was significantly lower at the last follow-up visit than at the diagnosis time in all of the groups. Stable normoprolactinemia of the groups at the end of follow-up period were 47.2, 37, 48.7, and 34.9%, respectively. CONCLUSIONS: The results indicate that short maintenance treatment in idiopathic and microadenoma-related hyperprolactinemia seems as effective as long maintenance treatment in the present study. But, further studies with larger study population and longer follow-up period are needed to make a decision about early treatment withdrawal. Also, during the maintenance treatment administration of medicine to patients should be tapered down to the lowest dose that will maintain prolactin levels normal.