Clinical trial NCT01314859: Nifedipine Treatment in Preterm Labor
Official title: ADMINISTRATION OF NIFIDEPINE VERSUS ATOSIBAN IN PREGNANT WOMEN WITH A THREAT OF PREMATURE LABOR
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Threatened Preterm Labor
Keywords: Nifedipine
Obstetric Labor
Premature
Tocolysis
Lead sponsor: Hospital Clinico Universitario de Santiago
Sponsor class: OTHER
Collaborators: name: Fundación Ramón Domínguez
First posted: 2011-03-15
Enrollment: 0
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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.

Primary outcomes:
measure: Neonatal Respiratory Distress Syndrome (RDS) at birth
timeFrame: Measured in the newborn at birth and at 30 days after labor
Secondary outcomes:
measure: Prolongation of the pregnancy in women with Threatened Preterm Labor
timeFrame: more than 48 hours/7 days
measure: Obstetric results
timeFrame: at labor and 24 hours after delivery
measure: Presence of the neonatal intracranial hemorrhage
timeFrame: First assessment: in the first week.
measure: Presence of neonatal necrotizing enterocolitis
timeFrame: at birth and at 30 days after labor
measure: Presence of Retinopathy of prematurity (ROP)
timeFrame: Between the 4th and 6th week of baby life.
measure: Presence of ductus
timeFrame: At birth and 30 days after labor
measure: Mother Tolerance Results
timeFrame: at labor and 24 hours after delivery
Other outcomes:
Locations:
Study officials:
affiliation: Hospital Clínico Universitario de Santiago, Santiago de Compostela, Spain
name: Manuel Macía Cortiñas, MD
role: STUDY_CHAIR
affiliation: Hospital Son Dureta, Mallorca, Spain
name: Lourdes González González, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Complexo Hospitalario Arquitecto Marcide- Profesor Novoa Santos, Ferrol, Spain
name: Javier Martínez Pérez-Mendaña, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Complexo Hospitalario de Pontevedra, Pontevedra, Spain
name: José Eloy Moral Santamarina, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Complexo Hospitalario de Ourense; Ourense, Spain
name: Susana Blanco Pérez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital del Barbanza; Ribeira, A Coruna, Spain
name: Luis Miguel González Seijas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital del Salnes; Vilagarcía de Arousa, Pontevedra, Spain
name: Emilio Cabo Silva, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.