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Evaluation of the Efficacy of Atosiban in Pregnant Women with Threatened Preterm Labor Associated with Assisted Reproductive Technology

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Evaluation of the Efficacy of Atosiban in Pregnant Women with Threatened Preterm Labor Associated with Assisted Reproductive Technology European Review for Medical and Pharmacological Sciences 2016; 20: 1881-1887 Evaluation of the efficacy of atosiban in pregnant women with threatened preterm labor associated with assisted reproductive technology Y.-J. XU, L.-M. RAN, S.-S. ZHAI, X.-H. LUO, Y.-Y. ZHANG, Z.-Y. ZHOU, Y.-H. LIU, L.-D. REN, T. HONG, R. LIU Department of Obstetrics, The Third Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province, China Abstract. – OBJECTIVE: The present study CONCLUSIONS: Administration of atosiban has aimed to investigate the effectiveness of ato- a comparatively better effect than that of ritodrine siban in treating women with threatened preterm on pregnant women who underwent ART and is labor who had become pregnant through assist- safe and effective at preventing immediate preterm ed reproductive technology (ART) and the corre- birth. Atosiban is significantly better than ritodrine sponding pregnancy outcomes. at reducing the rates of perinatal mortality and neo- PATIENTS AND METHODS: Seventy preg- natal pneumonia, and the perinatal outcomes for nant women with threatened preterm labor af- those who began to use atosiban at a gestational ter ART were randomly divided into two groups, age of fewer than 28 weeks were even better. with 35 cases in the atosiban group and 35 in the Key Words ritodrine group. The post-treatment effects and Assisted reproductive technology, Preterm birth, the corresponding pregnancy outcomes were Atosiban, Ritodrine. observed. RESULTS: The efficacy of extending gesta- tional age by 48 hours was significantly high- er in the atosiban group than in the ritodrine Introduction group (p<0.05), whereas the efficacy of extend- ing gestational age by seven days was the same in the two groups (p>0.05). There was no sig- The upper limit for preterm labor is universally nificant difference between the atosiban and ri- defined all over the world as childbirth at less than todrine groups in the average gestational age at 37 weeks of pregnancy, but the lower limit is set birth (p<0.05). The occurrence of side effects in at different gestational ages in different countries. the pregnant women was higher in the ritodrine Many developed countries and regions have set group than in the atosiban group (p<0.05), al- 20 or 24 weeks of pregnancy as the lower limit, though the prevalence of abnormal fetal heart 1 rate was not significantly different (p>0.05). but China has chosen 28 weeks . Preterm birth Both the perinatal mortality rate and the prev- is one of the main causes of perinatal illness and alence of neonatal asphyxia were significantly death. Assisted reproductive technology (ART) lower in the atosiban group than in the ritodrine has become an important means for treating in- group (p<0.05). When the medication was ap- fertility in recent years. Studies inside and outside plied at a gestational age of fewer than 28 weeks, of China indicate that the incidence of preterm the perinatal mortality rate and the prevalence of birth is significantly higher among women who neonatal pneumonia were significantly lower in the atosiban group compared with the ritodrine underwent in vitro fertilization-embryo trans- group (p<0.05). When the first drug administra- plantation (IVF-ET) than in those with natural 2,3 tion was at a gestational age of 28 weeks or lat- pregnancies . The IVF-ET procedure has thus er, the need for neonatal pediatric treatment was emerged as a new high-risk factor in the etiology significantly reduced in the atosiban group rela- of preterm birth4, but the pregnancy outcomes in tive to the ritodrine group. Independent of when such cases with threatened preterm birth are not the drug administration was initiated, there were entirely clear. This study analyzed the pregnancy no significant differences between the atosiban outcomes of pregnant women who had undergone and ritodrine groups in the occurrences of neo- natal asphyxia, acute respiratory distress syn- ART and were treated with atosiban for threat- drome (ARDS), neonatal brain injury, or neona- ened preterm birth at the Third Affiliated Hospi- tal sepsis (p>0.05). tal of Zhengzhou University. Corresponding Author: Ya-Juan Xu, MD; e-mail: [email protected] 1881 Y.-J. Xu, L.-M. Ran, S.-S. Zhai, X.-H. Luo, Y.-Y. Zhang, Z.-Y. Zhou, Y.-H. Liu, L.-D. Ren, et al. Patients and Methods treatment effects, adverse reactions, and perina- tal results of each group of pregnant women were Clinical Data of Patients observed. Seventy pregnant women who had under- Upon admission into the hospital, each preg- gone ART and were diagnosed with the threat of nant woman was immediately given a single preterm labor and consequently hospitalized at the course of glucocorticoid treatment. This medica- Third Affiliated Hospital of Zhengzhou Universi- tion was discontinued in those women with more ty between June 2011 and June 2015 were selected than 3 cm cervical dilation or a ruptured fetal and randomly divided into two groups, with 35 membrane. The patients in the two groups did not cases in the atosiban treatment group and 35 in use a combination of medications. In certain cas- the ritodrine treatment group. The inclusion cri- es, the atosiban or ritodrine treatment was repeat- teria were as follows: (1) uterine contractions (du- ed in pregnant women who experienced a recur- ration ≥30 seconds, rate ≥4 times/30 minutes), a rence of preterm birth symptoms after the uterine cervical canal length of less than 20 mm by trans- contractions had been successfully inhibited. vaginal ultrasound measurement, or progressive shortening of the endocervical canal length; (2) Observation Indicators patient age ≥18 years old; (3) gestational age 26 1) The efficacy of the two treatments in extend- to 33 weeks plus 6 days. The exclusion criteria ing the gestational age by 48 hours or by seven included vaginal bleeding; severe preeclampsia or days and the average gestational age at birth. For hypertension; fever (body temperature >37.5°C); a treatment to be deemed ‘effective’, application urinary tract infection; abnormalities in the fetus, of the medication had to be followed by a gradu- placenta, or amniotic fluid (e.g., fetal malforma- al cessation of uterine contractions and cervical tions, chorioamnionitis, polyhydramnios, fetal dilation, with continuation of the pregnancy for growth restriction, or placenta previa); serious more than 48 hours. The treatment was consid- maternal diseases (e.g., cardiovascular disease, ered ‘ineffective’ in those cases in which uterine hyperthyroidism, diabetes, pheochromocytoma, contractions did not weaken and for whom child- or asthma attacks); and any contraindication to birth occurred within 48 hours. 2) Potential ad- β-receptor agonists. verse reactions in the mother or fetus included the following: tachycardia, constipation, nausea, Drug Administration Methods headache, tremor, hypotension, anxiety, and dif- A first dose of 6.75 mg atosiban (Ferring Phar- ficulty breathing in the mother; tachycardia and maceuticals, Switzerland: Tractocile) was specified abnormal fetal heart rate (FHR) in the fetus; 3) and intravenously injected in under one minute. Perinatal prognosis included the following: aver- Next, 20 ml of atosiban solution (7.5 mg/ml) was age body weight of the newborn, perinatal mor- added to 180 ml of 0.9% sodium chloride or 5% tality (defined as fetal death, stillbirth, or death glucose and intravenously infused at 300 µg/ml for within seven days of birth for all singleton preg- three hours. Thereafter, a 100 µg/min drip rate was nancies born at a gestational age ≥28 weeks), neo- used until the expected uterine contraction-inhib- natal asphyxia rate (Apgar score of 1 minute ≤7 iting effect was achieved. The entire course of a points), the need for pediatric treatment for the single treatment did not exceed 45 hours, and the newborn (neonatal asphyxia, aspiration pneu- total amount did not exceed 330 µg. monia, decreased responsiveness, preterm birth, In the second group, 100 mg of ritodrine (Bio- swallowing syndrome, birth defects, jaundice, tech Co., Ltd., Taiwan, China: Anpo) was added gastrointestinal bleeding), acute respiratory dis- to a 5% glucose solution for intravenous infusion. tress syndrome (ARDS), neonatal brain injury, The drip rate was closely observed and adjusted neonatal pneumonia, and neonatal sepsis. through a controllable infusion device or by al- tering the number of drops per minute. Initially, Statistical Analysis the drip rate was controlled to achieve a dosage SPSS 17.0 software (SPSS Inc., Chicago, IL, of 0.05 mg/min, increasing by 0.05 mg/min (in- USA) was used to analyze the data. The enumer- crease of 5 drops/min) every 10 minutes until ated data were analyzed as percentages by the the expected effect was achieved. The drip rate chi-square test. The measurement data are ex- was generally maintained at 0.15 mg/min to 0.35 pressed as x ±s and were compared using t-tests mg/min (15-35 drops/min) until at least 12 to 18 or corrected t’-tests, with p<0.05 considered sta- hours after the uterine contractions stopped. The tistically significant. 1882 Atosiban treatment for pregnant women who underwent ART Table I. Comparison of the protective effects of atosiban and ritodrine on the fetus in pregnant women who had undergone ART Atosiban group Ritodrine group (n=35 cases) (n=35 cases) p Age of the pregnant women (years) 31.51±5.00 31.60±5.08 0.943 Primipara (cases, %) 32 (91.4%) 31 (88.6%) 1.000 Premature rupture of the fetal membrane (cases, %) 10 (28.6%) 12 (34.3%) 0.607 Singleton pregnancy
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