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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-024122-37 | EudraCT Number |
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| Name | Class |
|---|---|
| Fundación Ramón DomÃnguez | OTHER |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nifedipine | Experimental |
|
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| Atosiban | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nifedipine | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Neonatal Respiratory Distress Syndrome (RDS) at birth |
| Measured in the newborn at birth and at 30 days after labor |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | more than 48 hours/7 days |
| Obstetric results |
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Inclusion Criteria:
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:
Patient who had signed the informed consent.
Exclusion Criteria:
Exclusion criteria of the pregnant mother and intrauterine fetal:
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| Name | Affiliation | Role |
|---|---|---|
| Manuel MacÃa Cortiñas, MD | Hospital ClÃnico Universitario de Santiago, Santiago de Compostela, Spain | Study Chair |
| Lourdes González González, MD | Hospital Son Dureta, Mallorca, Spain | Principal Investigator |
| Javier MartÃnez 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; VilagarcÃa de Arousa, Pontevedra, Spain | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35947046 | Derived | Wilson A, Hodgetts-Morton VA, Marson EJ, Markland AD, Larkai E, Papadopoulou A, Coomarasamy A, Tobias A, Chou D, Oladapo OT, Price MJ, Morris K, Gallos ID. Tocolytics for delaying preterm birth: a network meta-analysis (0924). Cochrane Database Syst Rev. 2022 Aug 10;8(8):CD014978. doi: 10.1002/14651858.CD014978.pub2. |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D009543 | Nifedipine |
| C047046 | atosiban |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Atosiban | Drug |
|
|
Number of days and type of labor.
| 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. | 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). | 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. | 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. | 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). | at labor and 24 hours after delivery |
| D000091642 | Urogenital Diseases |