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Nifedipine Compared to Atosiban for Treating Preterm Labor

Information source: HaEmek Medical Center, Israel
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Labor, Premature

Intervention: Atosiban (Drug); Nifedipine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Raed Salim

Official(s) and/or principal investigator(s):
Gali Garmi, MD, Principal Investigator, Affiliation: HaEmek Medical Center, Afula, Israel

Summary

The purpose of this study is to investigate the efficacy and the safety of nifedipine compared to atosiban for treating preterm labor.

Clinical Details

Official title: Nifedipine Compared to Atosiban for Treating Preterm Labor. A Randomized Controlled Trial.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: delaying labor

Secondary outcome:

drugs side effects

obstetrical (number of days to delivery, gestational age at delivery, mode of delivery)

neonatal (Apgar score, sepsis, IVH, NEC, RDS, DEATH)

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Female.

Criteria:

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

Locations and Contacts

HaEmek Medical Center, Afula 18100, Israel
Additional Information

Related publications:

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.

Starting date: January 2008
Last updated: March 12, 2012

Page last updated: August 23, 2015

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