Randomized trial of the efficacy of intravaginal ulinastatin administration for the prevention of preterm birth in women with a singleton pregnancy and both cervical shortening and inflammation of lower genital tract.

AIM: To assess the preventive effect on preterm birth of intravaginal ulinastatin (urinary trypsin inhibitor; UTI) administration during the mid-trimester in women with singleton pregnancy and both cervical shortening and lower genital infections. METHODS: Pregnant women with a short cervical length < 25 mm between 16 and 26 weeks of gestation and who had been diagnosed with a lower genital infection were randomly assigned for intravaginal UTI administration or placebo. All of the women were screened for infection or inflammation of the lower genital tract, and women with negative results were excluded. RESULTS: Of the 92 patients with a short cervical length who were assessed for eligibility for this study, 86 singleton patients were enrolled. All patients were randomized to one of two treatment groups: patients administered UTI (n = 35) and placebo (n = 35). There were no differences between the two groups in the incidence of preterm delivery before 28, 30, 32, 34 and 37 weeks of gestation and in perinatal outcomes. CONCLUSION: For women diagnosed with a short cervical length < 25 mm) between 16 and 26 weeks of gestation and lower genital infection, who were at risk of preterm birth, administration of transvaginal UTI with vaginal irrigation showed no apparent benefit. Future research on the efficacy of UTI should evaluate modified modes of UTI application.

Improving the Accuracy of Diagnosing Placenta Previa on Transvaginal Ultrasound by Distinguishing between the Uterine Isthmus and Cervix: A Prospective Multicenter Observational Study.

OBJECTIVE: To clarify whether distinguishing between the uterine isthmus and cervix can improve the accuracy of diagnosing placenta previa at term. METHODS: A multicenter prospective observational study was conducted among pregnant women with suspected placenta previa at 20-24 weeks' gestation. Subjects were divided into the open isthmus group and closed isthmus group. The accuracy of diagnosing placenta previa at term was compared between the 2 groups. RESULTS: We screened 9,341 patients, and 53 (0.6%) met the inclusion criteria. Nineteen cases with an open isthmus and 34 with a closed isthmus were followed. The accuracy for diagnosing placenta previa or a low-lying placenta at term was 94.7% in the open isthmus group and 26.5% in the closed isthmus group (p < 0.001). Elective or emergency Cesarean section was required in 100% of cases in the open isthmus group and 20.6% in the closed isthmus group (p < 0.001). CONCLUSION: A high prediction rate of placenta previa was obtained by using transvaginal ultrasound at 20-24 weeks' gestation after the isthmus opened by carefully distinguishing between the cervix and isthmus.

Randomized trial of ultrasound-indicated cerclage in singleton women without lower genital tract inflammation.

AIM: This is the first report of a randomized trial of cerclage on pure cervical shortening without vaginosis or cervicitis. The objective of our multicenter randomized controlled trial was to assess the benefits of ultrasound-indicated cervical cerclage in the mid-trimester to prevent preterm birth in women who have no signs of infection or inflammation of the lower genital tract. MATERIAL AND METHODS: Women with a short cervical length < 25 mm between 16 and 26 weeks of gestation were randomly assigned to receive a Shirodkar cerclage, McDonald cerclage, or bedrest (no cerclage). Before being randomly assigned to one of the three groups, all women were screened for infection/inflammation of the lower genital tract; those with positive results were excluded from the study. The ratio of preterm delivery as a primary end-point was evaluated in the groups. RESULTS: A total of 106 singleton patients with a short cervical length were assessed for study eligibility; 106 patients were randomized to the three treatment options. Ultimately, 98 patients (in the Shirodkar [n = 34], McDonald [n = 34] and bedrest [n = 30] groups) were analyzed. No differences in preterm delivery or perinatal outcomes were found between the three groups. Significantly fewer patients in the Shirodkar group required hospitalization for treatment of threatened preterm labor when compared to patients in the bedrest group. CONCLUSION: For women with a short cervical length < 25 mm between 16 and 26 weeks of gestation, Shirodkar cerclage might be considered to reduce the occurrence of threatened preterm labor.

A nationwide investigation on gestational age specific birthweight and mortality among Japanese twins.

Gestational age specific birthweight has been used as an important indicator to identify the health status of neonates and to provide appropriate neonatal care services to those at high risk. To identify the gestational age specific birthweight of twins born in secondary and tertiary hospitals in Japan and to explore factors affecting mortality, we used a nationwide obstetric database in Japan. Liveborn twins from 2001 to 2005 in the database, which was established with the national Perinatal Health Care Project, were enrolled (n=22,240). Obstetric data from the medical records were collected and analysed. Approximately 60% of liveborn twins were delivered between weeks 33 and 38, most frequently at 36 and 37 weeks. The mean birthweight of liveborn twins was 2084 g and the mean gestational age was 34.9 weeks. Intrauterine growth differed by parity, mode of delivery, birth order, chorionicity and sex. Using logistic regression, lower gestational age, small for gestational age, monochorionic twins and vaginal delivery tended to have higher risks of mortality.

Birthweight discordance, risk factors and its impact on perinatal mortality among Japanese twins: data from a national project during 2001-2005.

Our aims were to assess the incidence of birthweight discordance of twins, to explore risk factors and its impact on perinatal mortality, and to quantify the risks at different severity of birthweight discordance in Japan, by using a nationwide obstetric database. There were 10,828 pairs of twins, born from 2001 to 2005 recorded in the database of the national Perinatal Health Care Project, fully enrolled. The overall incidence of birthweight discordance was 47.34%. The incidence of mild, severe and extremely severe discordance was 19.26%, 10.21% and 17.87%, respectively. The incidence of birthweight discordance in Japan is much higher than that in other countries, particularly at higher severity level. By linear regression model, our study added independent factors of primiparity (p < .001), sex composition (p < .001), chorionicity (p < .001), gestational age (p < .001), and delivery mode (p < .001) in determining birthweight discordance percentage. Maternal age and application of assisted reproduction technologies (ART) didn't significantly influence the birthweight discordance. The birthweight discordance is closely associated with gestational age and affected discharge mortality. From 25% of birthweight discordance, risk to discharge mortality tended to significantly increase, suggesting it should be added as a reference for clinical practices.

Erythematous and bullous rash strongly indicating toxic epidermal necrolysis associated with the use of intravenous ritodrine hydrochloride.

Toxic epidermal necrolysis (TEN) is a very rare drug reaction associated with a high mortality rate. This condition warrants prompt recognition, diagnosis and treatment. Only one case report of TEN that was possibly induced by ritodrine hydrochloride, a tocolytic agent, was found in English literature. Here, we report the case of a 26-year-old pregnant woman who was suspected with TEN following the intravenous administration of ritodrine hydrochloride in the 35(th) week of gestation. An emergency cesarean section was performed because the labor pains caused systemic intolerable haphalgesia. After the surgery, intensive dermatological treatment commenced, which helped her recover from the serious condition. The result of the drug-induced lymphocyte stimulation test for ritodrine hydrochloride was positive. When a skin eruption appears during the administration of ritodrine, we must consider the benefits as well as the risks of continuous use of tocolytic agents because there is a risk of Stevens-Johnson syndrome or TEN.

[Anaphylaxia induced by etoposide--a case report].

A 32-year-old woman, gravida 4, para 2, visited Teikyo University Hospital with complaints of abnormal uterine bleeding and lower abdominal pain. Urine hCG level was 1,024 x 10(3) IU/l. MRI examination showed a vascular, rich solid mass 10 cm in diameter at the posterior region of the uterus. Under the clinical diagnosis of choriocarcinoma, she underwent total hysterectomy with right salpingooophorectomy. The ovarian choriocarcinoma was confirmed by pathologic examination. Additional chemotherapy was planned using the combined regimen of etoposide, methotrexate, actinomycin D, cyclophosphamide and oncovin. After 2 min of etoposide administration (100 mg/m2), the patient complained of acute dyspnea, which was caused by bronchospasms and cutaneous flushing. Etoposide infusion was immediately stopped, and anti-anaphylaxic treatment was done by administering hydroxyzine hydrochloride. Five min after the episode had occurred, the patient recovered. This episode was thought to have been induced by etoposide, but etoposide was a key agent for choriocarcinoma. Thus, we devised a modified chemotherapy using etoposide as follows. The regimen was hydrocortisone 100 mg i.v. q6 h and promethazine hydrochloride 50 mg i.m. q6 h for 24 h before infusion of etoposide. The etoposide concentration was diluted to 50%, and the drug administration rate reduced by half. With the modified regimen, the patient showed no anaphylaxic symptoms. The few reports on anaphylaxic reactions to chemotherapeutic agents induced by side effects must be taken into account when we use these drugs.