Nifedipine Treatment in Preterm Labor
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||ADMINISTRATION OF NIFIDEPINE VERSUS ATOSIBAN IN PREGNANT WOMEN WITH A THREAT OF PREMATURE LABOR|
- Neonatal Respiratory Distress Syndrome (RDS) at birth [ Time Frame: Measured in the newborn at birth and at 30 days after labor ] [ Designated as safety issue: No ]
- 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.
- Prolongation of the pregnancy in women with Threatened Preterm Labor [ Time Frame: more than 48 hours/7 days ] [ Designated as safety issue: No ]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.
- Obstetric results [ Time Frame: at labor and 24 hours after delivery ] [ Designated as safety issue: No ]Number of days and type of labor.
- Presence of the neonatal intracranial hemorrhage [ Time Frame: First assessment: in the first week. ] [ Designated as safety issue: Yes ]Determination of the appearance and periventricular hemorrhage degree (I-IV) by transfontelar ultrasound scans.
- Presence of neonatal necrotizing enterocolitis [ Time Frame: at birth and at 30 days after labor ] [ Designated as safety issue: Yes ]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).
- Presence of Retinopathy of prematurity (ROP) [ Time Frame: Between the 4th and 6th week of baby life. ] [ Designated as safety issue: Yes ]Monitor the iGF1 (Insulin-like growth factor 1) levels on the 3rd week of life as well as an assessing the development of retinopathy.
- Presence of ductus [ Time Frame: At birth and 30 days after labor ] [ Designated as safety issue: Yes ]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.
- Mother Tolerance Results [ Time Frame: at labor and 24 hours after delivery ] [ Designated as safety issue: No ]Survey to assess the tolerance to the symptomatology induced by the medicines (flush, tachycardia, digestive upsets).
|Study Start Date:||July 2011|
|Estimated Study Completion Date:||July 2013|
|Estimated Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
Active Comparator: Atosiban
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01314859
|Study Chair:||Manuel Macía Cortiñas, MD||Hospital Clínico Universitario de Santiago, Santiago de Compostela, Spain|
|Principal Investigator:||Lourdes González González, MD||Hospital Son Dureta, Mallorca, Spain|
|Principal Investigator:||Javier Martínez Pérez-Mendaña, MD, PhD||Complexo Hospitalario Arquitecto Marcide- Profesor Novoa Santos, Ferrol, Spain|
|Principal Investigator:||José Eloy Moral Santamarina, MD||Complexo Hospitalario de Pontevedra, Pontevedra, Spain|
|Principal Investigator:||Susana Blanco Pérez, MD||Complexo Hospitalario de Ourense; Ourense, Spain|
|Principal Investigator:||Luis Miguel González Seijas, MD||Hospital del Barbanza; Ribeira, A Coruna, Spain|
|Principal Investigator:||Emilio Cabo Silva, MD||Hospital del Salnes; Vilagarcía de Arousa, Pontevedra, Spain|