Nifedipine Treatment in Preterm Labor - Full Text View

Purpose

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.

Condition	Intervention	Phase
Labor Preterm Threatened	Drug: Nifedipine Drug: Atosiban	Phase 3

Study Type:	Interventional
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

Resource links provided by NLM:

Drug Information available for: Nifedipine Atosiban Atosiban acetate

U.S. FDA Resources

Further study details as provided by Hospital Clinico Universitario de Santiago:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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).

Estimated Enrollment:	196
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)

Arms	Assigned Interventions
Experimental: 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.	Drug: Nifedipine 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.
Active Comparator: 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.	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.

Detailed Description:

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.

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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:
- 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.

Exclusion Criteria:

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 5.
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01314859

Contacts

Contact: Manuel Macía Cortiñas, MD	(+34) 981 951222	manuel.macia.cortinas@sergas.es
Contact: María Teresa Oreiro García, PhD	(+34) 981 95 50 39	maria.teresa.oreiro.garcia@sergas.es

Locations

Spain
Hospital Clínico de Santiago	Not yet recruiting
Santiago de Compostela, A Coruña, Spain, 15706
Contact: Manuel Macía Cortiñas, MD (+34) 981 95 12 22 manuel.macia.cortinas@sergas.es
Contact: María Teresa Oreiro García, PhD (+34) 981 95 50 39 maria.teresa.oreiro.garcia@sergas.es
Principal Investigator: Manuel Macía Cortiñas, MD

Sponsors and Collaborators

Hospital Clinico Universitario de Santiago

Investigators

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

More Information

No publications provided

Responsible Party:	Manuel Macía Cortiñas, MD, Hospital Clínico de Santiago
ClinicalTrials.gov Identifier:	NCT01314859 History of Changes
Other Study ID Numbers:	MMC-NIF-2010-01, 2010-024122-37
Study First Received:	March 14, 2011
Last Updated:	March 14, 2011
Health Authority:	Spain: Spanish Agency of Medicines Spain: Ethics Committee

Keywords provided by Hospital Clinico Universitario de Santiago:

Nifedipine
Obstetric Labor
Premature
Tocolysis

Additional relevant MeSH terms:

Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Nifedipine
Atosiban
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions

Therapeutic Uses
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Vasodilator Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on May 16, 2013