Nifedipine Treatment in Preterm Labor

Hospital Clinico Universitario de Santiago

Status and phase: Withdrawn; Phase 3

Conditions: Threatened Preterm Labor

Treatments: Drug: Nifedipine; Drug: Atosiban

Study type: Interventional

Funder types: Other

Identifiers

NCT01314859

MMC-NIF-2010-01

2010-024122-37 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Nifedipine

Experimental group

Description:

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.

Treatment:

Drug: Nifedipine

Atosiban

Active Comparator group

Description:

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.

Treatment:

Drug: Atosiban