Nifedipine Treatment in Preterm Labor

NCT ID: NCT01314859

Last Updated: 2014-07-29

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2013-07-31

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.

Conditions

Threatened Preterm Labor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Nifedipine

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Atosiban

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• 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.

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fundación Ramón Domínguez

OTHER

Sponsor Role: collaborator

Hospital Clinico Universitario de Santiago

OTHER

Sponsor Role: lead

Responsible Party

Hospital Clínico de Santiago

Principal Investigators

Manuel Macía Cortiñas, MD

Role: STUDY_CHAIR

Hospital Clínico Universitario de Santiago, Santiago de Compostela, Spain

Lourdes González González, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Son Dureta, Mallorca, Spain

Javier Martínez Pérez-Mendaña, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Complexo Hospitalario Arquitecto Marcide- Profesor Novoa Santos, Ferrol, Spain

José Eloy Moral Santamarina, MD

Role: PRINCIPAL_INVESTIGATOR

Complexo Hospitalario de Pontevedra, Pontevedra, Spain

Susana Blanco Pérez, MD

Role: PRINCIPAL_INVESTIGATOR

Complexo Hospitalario de Ourense; Ourense, Spain

Luis Miguel González Seijas, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital del Barbanza; Ribeira, A Coruna, Spain

Emilio Cabo Silva, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital del Salnes; Vilagarcía de Arousa, Pontevedra, Spain

References

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.

Reference Type: DERIVED

PMID: 35947046 (View on PubMed)

Other Identifiers

2010-024122-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MMC-NIF-2010-01

Identifier Type: -

Identifier Source: org_study_id