Nifedipine Treatment in Preterm Labor

• Status: Withdrawn
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Clinico Universitario de Santiago
• Collaborator: Fundación Ramón Domínguez
• Treatments: Atosiban; Nifedipine; Vasotocin

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.