A Phase 3 interventional study of Nifedipine and Atosiban in Threatened Preterm Labor, sponsored by Hospital Clinico Universitario de Santiago. Withdrawn. Open to female participants. Per ClinicalTrials.gov, last updated 2014-07-29.
Sponsored by Hospital Clinico Universitario de Santiago · Phase 3, Interventional, and Treatment
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.
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.
2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.
Browse Premature Birth studies →Hospital Clinico Universitario de Santiago is the lead sponsor of 33 studies on the registry; 11 are open to participants now.
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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:
Documented cervix changes:
Exclusion Criteria:
Exclusion criteria of the pregnant mother and intrauterine fetal:
* 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.
Drug: Nifedipine
* 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.
Drug: Atosiban
* Oral Treatment with Nifedipine capsules (10mg) * 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.
* 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.
Neonatal Respiratory Distress Syndrome (RDS) at birth
* 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.
Time frame: Measured in the newborn at birth and at 30 days after labor
Prolongation of the pregnancy in women with Threatened Preterm Labor
It will be evaluated as a delay in the labor: hours after starting the treatment: more than 48 hours/more than 7 days of prolongation.
Time frame: more than 48 hours/7 days
Obstetric results
Number of days and type of labor.
Time frame: at labor and 24 hours after delivery
Presence of the neonatal intracranial hemorrhage
Determination of the appearance and periventricular hemorrhage degree (I-IV) by transfontelar ultrasound scans.
Time frame: First assessment: in the first week.
Presence of neonatal necrotizing enterocolitis
Monitor the need of canalizing the umbilical vein or artery, the days of parenteral nutrition, days to the start of enteral nutrition, type of enteral nutrition (from the mother, artificial or mixed), start of the elimination of meconium, clinical data from the neonatal necrotizing enterocolitis(abdominal strain, vomiting, blood in the feces, septic appearance) and radiologic/ecographic (dilated bowel loops, intestinal pneumatosis, air in portal, pneumoperitoneum).
Time frame: at birth and at 30 days after labor
Presence of Retinopathy of prematurity (ROP)
Monitor the iGF1 (Insulin-like growth factor 1) levels on the 3rd week of life as well as an assessing the development of retinopathy.
Time frame: Between the 4th and 6th week of baby life.
Presence of ductus
Clinical assessment (heart murmur, jumpy pulse, worsening of the clinical basal situation), echocardiography (confirmation of the ductus, Al/Ao relation, ductal size), medical or surgical treatment necessity.
Time frame: At birth and 30 days after labor
Mother Tolerance Results
Survey to assess the tolerance to the symptomatology induced by the medicines (flush, tachycardia, digestive upsets).
Time frame: at labor and 24 hours after delivery
No study locations are listed for this record.
This study is withdrawn, as verified in Feb 2011. You cannot join it, but the record below documents what was studied.
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Hospital Clinico Universitario de Santiago