ADMINISTRATION OF NIFIDEPINE VERSUS ATOSIBAN IN PREGNANT WOMEN WITH A THREAT OF PREMATURE LABOR
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- Neonatal Respiratory Distress Syndrome (RDS) at birth
研究概览
简要总结
This is a study for pregnant women who have been diagnosed with Threatened Preterm Labor. The principal aim of this study is to compare the efficacy and safety of Nifedipine treatment versus Atosiban treatment over these patients' newborn babies.
详细描述
Preterm labor is defined as the presence of uterine contractions of sufficient frequency and intensity to effect progressive effacement and dilation of the cervix prior to term gestation (between 20 and 37 weeks).
It is a major health problem of increased incidence, affecting approximately between 7-10% of pregnant women in developed countries with a high socioeconomic costs and high rates of fetal mortality, although perinatal progress.
This study may allow to establish the existence of differences in perinatal outcomes and to define the first choice drug for tocolysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The study population and the inclusion criteria is established by patients between the 24th and 33+6th weeks of pregnancy, fixed by an ecography during the first three-month period, and with a threat of preterm labor (TLP), by the American College of Obstetricians and Gynecologists (ACOG's) criteria:
- •Four contractions or more with a duration of at least 30 seconds during 30 minutes
- •Documented cervix changes:
- •The cervix changes in a nulliparous woman are: both cervix tact with 0 to 4 cm of dilatation and cervical effacement of at least a 50% (vaginal ultrasound alternative with cervix length two standard curvatures under the average for the gestational age)
- •The cervix changes in a multiparous woman are: 1 to 4 cm of dilatation and cervical effacement of at least a 50% (same ecographic alternative as the nulliparous).
- •Patient who had signed the informed consent.
排除标准
- •Exclusion criteria of the pregnant mother and intrauterine fetal:
- •Prior treatment with a different tocolytic from the ones in the protocol.
- •Chorioamnionitis.
- •Premature rupture of membranes.
- •Vaginal Bleeding.
- •Major fetal malformations.
- •Intrauterine growth retardation (IGR): IGR<percentile
- •Cardiopathies (aortic stenosis, congestive heart failure).
- •Blood Pressure lower than 100/60 mmHg.
- •High transaminase levels.
- •Uterine malformations.
- •Use of magnesium sulphate.
- •Severe hypertensive disorder, defined as blood pressure equal to or greater than 160/100 mmHg or any figure associated with severe preeclampsia.
- •Non-reassuring cardiac frequency tracing defined as category II and III of National Institute of Child Health and Human Development (NICHD).
- •Asthmatic patients treated with betamimetics.
- •Hypertensive patients treated with vasodilators.
- •Patient in treatment or treated with another product/s in investigation during the four weeks prior to randomization.
- •Hypersensitivity to any drug of the study.
研究组 & 干预措施
Nifedipine
-
Oral Treatment with Nifedipine capsules (10 mg)
-
Initial dose: 20 mg of nifedipine (2 capsules of 10 mg).
-
Maintenance Dose: 20 mg of nifedipine (2 capsules of 10 mg) every 6 hours.
-
Maximum Duration of the treatment: 48 hours.
干预措施: Nifedipine (Drug)
Atosiban
-
Intravenously Treatment with Atosiban (7.5mg/ml)
-
Initial Dose: IV bolus injection during 1 minute + Intravenous infusion 7.5 mg/ml during 3 hours.
-
Maintenance: Maintenance intravenous infusion 7.5 mg/ml at least 18 hours to a maximum of 45 hours.
-
Maximum Duration of the treatment: 48 hours.
干预措施: Atosiban (Drug)
结局指标
主要结局
Neonatal Respiratory Distress Syndrome (RDS) at birth
时间窗: Measured in the newborn at birth and at 30 days after labor
* Clinical assessment: results of the Silverman test. Existence of tachypnea, chest wall retractions, auricular flutter, expiratory grunting and chest-abdominal asynchrony. * Need of 02 at birth (maximum Fi02 in the first 24 hours to estimate the immediate distress). Measurement of pCO2 at birth. * Need of mechanic ventilation: invasive/not invasive and duration of it. * Radiologic estimation of the level of hyaline membrane disease * Need of a surfactant and number of used dosages.
次要结局
- Prolongation of the pregnancy in women with Threatened Preterm Labor(more than 48 hours/7 days)
- Presence of the neonatal intracranial hemorrhage(First assessment: in the first week.)
- Presence of ductus(At birth and 30 days after labor)
- Presence of neonatal necrotizing enterocolitis(at birth and at 30 days after labor)
- Obstetric results(at labor and 24 hours after delivery)
- Presence of Retinopathy of prematurity (ROP)(Between the 4th and 6th week of baby life.)
- Mother Tolerance Results(at labor and 24 hours after delivery)