Michal Mara

Ulipristal Acetate versus Placebo for Fibroid Treatment before Surgery

BACKGROUND The efficacy and safety of oral ulipristal acetate for the treatment of symptomatic uterine fibroids before surgery are uncertain. METHODS We randomly assigned women with symptomatic fibroids, excessive uterine bleeding (a score of >100 on the pictorial blood-loss assessment chart [PBAC, an objective assessment of blood loss, in which monthly scores range from 0 to >500, with higher numbers indicating more bleeding]) and anemia (hemoglobin level of ≤10.2 g per deciliter) to receive treatment for up to 13 weeks with oral ulipristal acetate at a dose of 5 mg per day (96 women) or 10 mg per day (98 women) or to receive placebo (48 women). All patients received iron supplementation. The coprimary efficacy end points were control of uterine bleeding (PBAC score of <75) and reduction of fibroid volume at week 13, after which patients could undergo surgery. RESULTS At 13 weeks, uterine bleeding was controlled in 91% of the women receiving 5 mg of ulipristal acetate, 92% of those receiving 10 mg of ulipristal acetate, and 19% of those receiving placebo (P<0.001 for the comparison of each dose of ulipristal acetate with placebo). The rates of amenorrhea were 73%, 82%, and 6%, respectively, with amenorrhea occurring within 10 days in the majority of patients receiving ulipristal acetate. The median changes in total fibroid volume were -21%, -12%, and +3% (P=0.002 for the comparison of 5 mg of ulipristal acetate with placebo, and P=0.006 for the comparison of 10 mg of ulipristal acetate with placebo). Ulipristal acetate induced benign histologic endometrial changes that had resolved by 6 months after the end of therapy. Serious adverse events occurred in one patient during treatment with 10 mg of ulipristal acetate (uterine hemorrhage) and in one patient during receipt of placebo (fibroid protruding through the cervix). Headache and breast tenderness were the most common adverse events associated with ulipristal acetate but did not occur significantly more frequently than with placebo. CONCLUSIONS Treatment with ulipristal acetate for 13 weeks effectively controlled excessive bleeding due to uterine fibroids and reduced the size of the fibroids. (Funded by PregLem; ClinicalTrials.gov number, NCT00755755.).

Effect of a Selective Progesterone Receptor Modulator on Induction of Apoptosis in Uterine Fibroids In Vivo

Aim. To determine if hormonal treatment induces apoptosis in uterine fibroids. Methods. Immunohistochemical examination of fibroid tissue, using avidin-biotin complex and cleaved caspase-3 antibody for detecting apoptosis, was performed in premenopausal women who underwent 12-week treatment with oral SPRM (6 patients with 5 mg and 5 patients with 10 mg of ulipristal acetate per day) or gonadoliberin agonist (GnRHa, 17 patients) and subsequent myomectomy or hysterectomy for symptomatic uterine fibroids. Ten patients with no presurgical hormonal treatment were used as controls. Results. Apoptosis was present in a significantly higher proportion of patients treated with ulipristal acetate compared to GnRHa (P = 0.01) and to patients with no hormonal treatment (P = 0.01). In contrast to an AI of 158.9 in SPRM patients, the mean AI was 27.5 and 2.0 in GnRHa and control groups, respectively. No statistical difference in the AI was observed between the two groups of patients treated with ulipristal acetate (5 mg or 10 mg). Conclusion. Treatment with ulipristal acetate induces apoptosis in uterine fibroid cells. This effect of SPRM may contribute to their positive clinical effect on uterine fibroids.

Hysteroscopy after uterine fibroid embolization in women of fertile age

Aim:  Uterine artery embolization for fibroids is a controversial issue for women with incomplete reproductive plans. Ovarian failure and uterine infection are the most dreaded complications of this procedure. The purpose of the present study was to assess the types and the frequency of intrauterine abnormalities and the histological features of the endometrium after embolization.

Prevention of adhesions in gynaecological surgery: the 2012 European field guideline.

Postoperative adhesions have become the most common complication of open or laparoscopic abdominal surgery and a source of major concern because of their potentially dramatic consequences. The proposed guideline is the beginning of a major campaign to enhance the awareness of adhesions and to provide surgeons with a reference guide to adhesion prevention adapted to the conditions of their daily practice. The risk of postoperative adhesions should be systematically discussed with any patient scheduled for open or laparoscopic abdominal surgery prior to obtaining her informed consent. Surgeons should adopt a routine adhesion reduction strategy with good surgical technique. Anti-adhesion agents are an additional option, especially in procedures with a high risk of adhesion formation, such as ovarian, endometriosis and tubal surgery and myomectomy. We conclude that good surgical practice is paramount to reduce adhesion formation and that anti-adhesion agents may contribute to adhesion prevention in certain cases.

Hysteroscopy after uterine fibroid embolization: Evaluation of intrauterine findings in 127 patients

Aim:  Several atypical hysteroscopy findings have been described in association with uterine artery embolization (UAE). The purpose of this study was to evaluate the types and frequency of these findings in the largest published series of patients.

Fetal Anemia, Thrombocytopenia, Dilated Umbilical Vein, and Cardiomegaly due to a Voluminous Placental Chorioangioma

We report a case of voluminous placental chorioangioma diagnosed by ultrasound and color Doppler imaging during the 20th week of pregnancy. The size of the tumor was enlarging progressively (up to 10 cm in the 32nd week), and during this time the signs of fetal intrauterine volume overload and blood cell consumption, such as cardiomegaly, umbilical vein dilation, hydramnios, anemia, and thrombocytopenia, were observed. In the 32nd week of pregnancy, the signs of uteroplacental insufficiency and fetal hypoxia appeared; therefore, the pregnancy was terminated by cesarean section, and a female infant weighing 1,870 g was delivered. She was discharged, fully recovered, after 48 days. Histopathological examination of the placental tumor showed a benign, vascular-type chorioangioma.

Changes in markers of anemia and iron metabolism and how they are influenced by antianemics in postpartum period

Background. The object of this study was to examine the occurrence of iron deficiency anemia in women after spontaneous delivery, changes in clinical and laboratory indicators of anemia in postpartum period and their possible control by administration of peroral antianemics.

Laparoscopic uterine artery occlusion versus uterine fibroid embolization.

crying, fatigability, increased appetite, palpitations, and bloating showed a significant decrease, with anxiety showing the greatest reduction (−0.15±0.35). A comparison between the severity of psychiatric symptoms after treatment with pyridoxine and placebo showed a significant decrease following the 2 forms of treatment (paired t test, P<0.05), but the reduction was significantly greater in the pyridoxine group (Table 1). The comparison between the severity of somatic symptoms after and before treatment with pyridoxine and placebo showed a significant reduction after both forms of treatment (paired t test, P<0.05), but there was no significant difference between the 2 groups (Table 1). Finally, there was a significant reduction in PMS severity following both forms of treatment (paired t test, P<0.05), and a comparison between the 2 groups also showed a significantly greater reduction in the pyridoxine group than in the placebo group (P<0.05, t test). In conclusion, as a follow-up on the several studies [3,4] undertaken on the effect of pyridoxine on the symptoms of PMS, pyridoxine can be suggested as a treatment for PMS, at least for the psychiatric symptoms.

Embolization of uterine fibroids from the point of view of the gynecologist: pros and cons

Uterine artery embolization (UAE) is a minimally invasive procedure with large symptomatic potential in treatment of women with uterine leiomyomas. Due to specificities of this method and possible complications the appropriate indication is crucial. Patient’ symptoms, age, plans for pregnancy, and surgical and reproductive history play a major role in decision-making regarding appropriate subjects for UAE. Close cooperation between the gynecologist and the interventional radiologist is necessary. UAE is usually offered as an alternative to surgical treatment. In patients with no fertility plans, it is a less invasive option than abdominal hysterectomy, with a comparable effect on fibroid-related symptoms and quality of life. The need for reintervention is markedly greater in patients after UAE (up to 35% within 5 years) than after hysterectomy. Women with large symptomatic fibroids wishing to retain the uterus and ineligible for minimally invasive (laparoscopic or vaginal) hysterectomy are good candidates for UAE. However, studies comparing UAE with minimally invasive hysterectomy are lacking. Use of UAE in younger women desiring pregnancy is more controversial, mainly because of the significant risk of miscarriage (as high as 64% in some studies) as well as the increased risk of other complications of pregnancy, such as preterm delivery, abnormal placentation, and post-partum hemorrhage. The risk of infertility or subfertility following UAE is unknown. Even poor candidates for myomectomy should be carefully selected for UAE after counseling about all possible adverse effects on fertility. Good prospective studies focused on fertility comparing UAE with no treatment or with myomectomy are needed but would be ethically questionable. This review summarizes the current knowledge regarding the benefits and potential risks of UAE from the point of view of the gynecologist, who should be responsible for proper indication of this treatment.

Adhesions after abdominal, pelvic and intra-uterine surgery and their prevention

We here present the full text of a patient leaflet we have designed, and routinely use, to provide preoperative education about adhesions to patients undergoing open or laparoscopic gynaecological surgery. The leaflet presents appropriate, patient-orientated information on the nature of adhesions, their causes and the health risks they may involve as well as on adhesiolysis and modern methods of adhesion prevention. As adhesion formation is not specific to gynaecological surgery, the leaflet can also be adapted for the purposes of general abdominal surgery.