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Nifedipine Treatment in Preterm Labor

Information source: Hospital Clinico Universitario de Santiago
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Threatened Preterm Labor

Intervention: Nifedipine (Drug); Atosiban (Drug)

Phase: Phase 3

Status: Withdrawn

Sponsored by: Hospital Clinico Universitario de Santiago

Official(s) and/or principal investigator(s):
Manuel Macía Cortiñas, MD, Study Chair, Affiliation: Hospital Clínico Universitario de Santiago, Santiago de Compostela, Spain
Lourdes González González, MD, Principal Investigator, Affiliation: Hospital Son Dureta, Mallorca, Spain
Javier Martínez Pérez-Mendaña, MD, PhD, Principal Investigator, Affiliation: Complexo Hospitalario Arquitecto Marcide- Profesor Novoa Santos, Ferrol, Spain
José Eloy Moral Santamarina, MD, Principal Investigator, Affiliation: Complexo Hospitalario de Pontevedra, Pontevedra, Spain
Susana Blanco Pérez, MD, Principal Investigator, Affiliation: Complexo Hospitalario de Ourense; Ourense, Spain
Luis Miguel González Seijas, MD, Principal Investigator, Affiliation: Hospital del Barbanza; Ribeira, A Coruna, Spain
Emilio Cabo Silva, MD, Principal Investigator, Affiliation: Hospital del Salnes; Vilagarcía de Arousa, Pontevedra, Spain

Summary

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.

Clinical Details

Official title: ADMINISTRATION OF NIFIDEPINE VERSUS ATOSIBAN IN PREGNANT WOMEN WITH A THREAT OF PREMATURE LABOR

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Neonatal Respiratory Distress Syndrome (RDS) at birth

Secondary outcome:

Prolongation of the pregnancy in women with Threatened Preterm Labor

Obstetric results

Presence of the neonatal intracranial hemorrhage

Presence of neonatal necrotizing enterocolitis

Presence of Retinopathy of prematurity (ROP)

Presence of ductus

Mother Tolerance Results

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

Minimum age: N/A. Maximum age: N/A. Gender(s): Female.

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

- 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.

Locations and Contacts

Additional Information

Starting date: July 2011
Last updated: July 28, 2014

Page last updated: August 23, 2015

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