The purpose of this study is to investigate the efficacy and the safety of nifedipine compared to atosiban for treating preterm labor...
Date First Received: January 8, 2008
Last Updated: January 13, 2008
Verified by: HaEmek Medical Center, Israel, January 2008
Clinical Trial Phase: Phase 4 | Start Date: January 2008
Overall Status: Recruiting
Estimated Enrollment: 140
Brief Summary
Official Title: “Nifedipine Compared to Atosiban for Treating Preterm Labor. A Randomized Controlled Trial.”
Condition Keyword(s):
Intervention(s):
The purpose of this study is to investigate the efficacy and the safety of nifedipine compared to atosiban for treating preterm labor.
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Crossover Assignment, Safety/Efficacy Study
Outcome Measures for this Clinical Trial
Primary:
- delaying labor for more than 48 hours after starting treatment Yes
Secondary:
- drugs side effects within the first 48 hours after treatment Yes
- obstetrical (number of days to delivery, gestational age at delivery, mode of delivery) within 24 hours after delivery No
- neonatal (Apgar score, sepsis, IVH, NEC, RDS, DEATH) within 30 days from delivery Yes
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- 1. Gestational age between 24 to 34 weeks which had been documented by a definite LMP and sonography up to 20 weeks.
- 2. All women fulfilled the criteria of preterm labor. The diagnosis of preterm labor required the presence of 4 uterine contractions or more over 30 minutes, each lasting at least 30 seconds, and documented cervical change. The cervical criteria were met when either of the following was present:
- 1. Nulliparous women: a single cervical examination demonstrating dilatation of 0 cm to 4 cm and effacement of at least 50%
- 2. Multiparous women: a single cervical examination demonstrating dilatation of 1 cm to 4 cm and effacement of at least 50%.
- 3. Provision of written informed consent
Exclusion Criteria:
- 1. Chorioamnionitis
- 2. Preterm rupture of membranes
- 3. Vaginal bleeding
- 4. Major fetal malformations
- 5. Severe hypertensive disorders
- 6. Intrauterine growth restriction (< 5th percentile).
- 7. Non-reassuring fetal heart rate
- 8. Maternal contraindications
- 1. Chronic hypertension
- 2. Systolic blood pressure < 90 mmHg
- 3. Cardiovascular disease
- 4. Elevated hepatic enzymes
- 9. Congenital or acquired uterine malformation
Clinical Trials Locations, Contact Details, and Sponsors
Lead Sponsor: HaEmek Medical Center, Israel
HaEmek Medical Center
Afula 18100 Israel
Overall Clinical Trial Officials and Contacts
Gali Garmi, MD Principal Investigator HaEmek Medical Center, Afula, Israel
Overall Contact: Gali Garmi, MD 972-4-6494031 galit_ga@clalit.org.il
Related Publications
References
King JF, Flenady V, Papatsonis D, Dekker G, Carbonne B. Calcium channel blockers for inhibiting preterm labour; a systematic review of the evidence and a protocol for administration of nifedipine. Aust N Z J Obstet Gynaecol. 2003 Jun;43(3):192-8. Review.
Papatsonis DN, Van Geijn HP, Adèr HJ, Lange FM, Bleker OP, Dekker GA. Nifedipine and ritodrine in the management of preterm labor: a randomized multicenter trial. Obstet Gynecol. 1997 Aug;90(2):230-4.
Moutquin JM, Sherman D, Cohen H, Mohide PT, Hochner-Celnikier D, Fejgin M, Liston RM, Dansereau J, Mazor M, Shalev E, Boucher M, Glezerman M, Zimmer EZ, Rabinovici J. Double-blind, randomized, controlled trial of atosiban and ritodrine in the treatment of preterm labor: a multicenter effectiveness and safety study. Am J Obstet Gynecol. 2000 May;182(5):1191-9.
Additional Information
Information obtained from ClinicalTrials.gov on July 18, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00599898
Study ID Number: EMC070048CTIL
ClinicalTrials.gov Identifier: NCT00599898
Health Authority: Israel: Ethics Commission
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
