Nifedipine Treatment in Preterm Labor

NCT01314859 | Withdrawn Phase 3

• 2 other identifiers: MMC-NIF-2010-012010-024122-37
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Threatened Preterm Labor

Keywords

Nifedipine; Obstetric Labor; Premature; Tocolysis

Outcome Measures

Primary Outcomes (1)

• Neonatal Respiratory Distress Syndrome (RDS) at birth

  * 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.

  Measured in the newborn at birth and at 30 days after labor

Secondary Outcomes (7)

• Prolongation of the pregnancy in women with Threatened Preterm Labor

  more than 48 hours/7 days

• Obstetric results

  at labor and 24 hours after delivery

• Presence of the neonatal intracranial hemorrhage

  First assessment: in the first week.

• Presence of neonatal necrotizing enterocolitis

  at birth and at 30 days after labor

• Presence of Retinopathy of prematurity (ROP)

  Between the 4th and 6th week of baby life.

Study Arms (2)

Nifedipine

EXPERIMENTAL

* 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

Atosiban

ACTIVE COMPARATOR

* 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

Interventions

Nifedipine DRUG

* 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.

Nifedipine

Atosiban DRUG

* 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.

Atosiban

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Clinico Universitario de Santiago: lead
• Fundación Ramón Domínguez: collaborator

Related Publications (1)

• 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.

  PMID: 35947046 DERIVED

MeSH Terms

Conditions

Premature Birth

Interventions

Nifedipine; atosiban

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Manuel Macía Cortiñas, MD

  Hospital Clínico Universitario de Santiago, Santiago de Compostela, Spain

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 14, 2011
• First Posted: March 15, 2011
• Study Start: July 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2013
• Last Updated: July 29, 2014

Record last verified: 2011-02