Nifedipine Compared to Atosiban for Treating Preterm Labor - Full Text View

Sponsored by:	HaEmek Medical Center, Israel
Information provided by:	HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:	NCT00599898

Purpose

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

Condition	Intervention	Phase
Labor, Premature	Drug: Atosiban Drug: Nifedipine	Phase IV

Drug Information available for: Nifedipine Atosiban Indomethacin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Crossover Assignment, Safety/Efficacy Study
Official Title:	Nifedipine Compared to Atosiban for Treating Preterm Labor. A Randomized Controlled Trial.

Further study details as provided by HaEmek Medical Center, Israel:

Primary Outcome Measures:

delaying labor [ Time Frame: for more than 48 hours after starting treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

drugs side effects [ Time Frame: within the first 48 hours after treatment ] [ Designated as safety issue: Yes ]
obstetrical (number of days to delivery, gestational age at delivery, mode of delivery) [ Time Frame: within 24 hours after delivery ] [ Designated as safety issue: No ]
neonatal (Apgar score, sepsis, IVH, NEC, RDS, DEATH) [ Time Frame: within 30 days from delivery ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	140
Study Start Date:	January 2008
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Atosiban Atosiban group will receive an atosiban bolus (6.75 mg) over 1 min then an intravenous infusion of 300mcg/min for 3 h followed by 100mcg/min for another 45h. If contractions continue or recur within 48 hours or the dilatation of the cervix progresses by 1 cm or more within 48 hours, atosiban will be stopped and the women will receive nifedipine as a 2nd line (see arm 2). If the second line fails and gestational age is less than 28 weeks, indomethacin will be administered as a 3rd line.
2: Experimental	Drug: Nifedipine Nifedipine group: the initial dose will be 20 mg (one tab) orally every 20 min for 3 doses. If the contractions is inhibited, a maintenance dose of 20 - 40 mg every 6 h up to 48 h will be followed. If contractions continue or recur within 48 hours or the dilatation of the cervix progresses by 1 cm or more within 48 hours, nifedipine will be stopped and the women will receive atosiban as a 2nd line (see arm 2). If the second line fails and gestational age is less than 28 weeks, indomethacin will be administered as a 3rd line.

Arms

Assigned Interventions

1: Experimental

Drug: Atosiban

Atosiban group will receive an atosiban bolus (6.75 mg) over 1 min then an intravenous infusion of 300mcg/min for 3 h followed by 100mcg/min for another 45h. If contractions continue or recur within 48 hours or the dilatation of the cervix progresses by 1 cm or more within 48 hours, atosiban will be stopped and the women will receive nifedipine as a 2nd line (see arm 2). If the second line fails and gestational age is less than 28 weeks, indomethacin will be administered as a 3rd line.

2: Experimental

Drug: Nifedipine

Nifedipine group: the initial dose will be 20 mg (one tab) orally every 20 min for 3 doses. If the contractions is inhibited, a maintenance dose of 20 - 40 mg every 6 h up to 48 h will be followed. If contractions continue or recur within 48 hours or the dilatation of the cervix progresses by 1 cm or more within 48 hours, nifedipine will be stopped and the women will receive atosiban as a 2nd line (see arm 2). If the second line fails and gestational age is less than 28 weeks, indomethacin will be administered as a 3rd line.

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Gestational age between 24 to 34 weeks which had been documented by a definite LMP and sonography up to 20 weeks.
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%.
Provision of written informed consent

Exclusion Criteria:

Chorioamnionitis
Preterm rupture of membranes
Vaginal bleeding
Major fetal malformations
Severe hypertensive disorders
Intrauterine growth restriction (< 5th percentile).
Non-reassuring fetal heart rate
Maternal contraindications
1. Chronic hypertension
2. Systolic blood pressure < 90 mmHg
3. Cardiovascular disease
4. Elevated hepatic enzymes
Congenital or acquired uterine malformation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00599898

Contacts

Contact: Gali Garmi, MD	972-4-6494031	galit_ga@clalit.org.il
Contact: Raed Salim, MD	972-4-6494035	salim_ra@clalit.org.il

Locations

Israel
HaEmek Medical Center	Recruiting
Afula, Israel, 18100
Contact: Gali Garmi, MD 972-4-6494031 galit_ga@clalit.orgil
Contact: Raed Salim, MD 972-4-6494035 salim_ra@clalit.orgil

Sponsors and Collaborators

HaEmek Medical Center, Israel

Investigators

Principal Investigator:

Gali Garmi, MD

HaEmek Medical Center, Afula, Israel

More Information

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.

Responsible Party:	HaEmek Medical Center, Israel ( Dr. Gali Garmi )
Study ID Numbers:	EMC070048CTIL, same as unique protocol ID
Study First Received:	January 8, 2008
Last Updated:	July 19, 2008
ClinicalTrials.gov Identifier:	NCT00599898
Health Authority:	Israel: Ethics Commission; Israel: Ministry of Health

Keywords provided by HaEmek Medical Center, Israel:

Preterm labor
Atosiban
Nifedipine

Study placed in the following topic categories:

Calcium, Dietary
Pregnancy Complications
Atosiban
Obstetric Labor, Premature

Indomethacin
Obstetric Labor Complications
Nifedipine

Additional relevant MeSH terms:

Membrane Transport Modulators
Vasodilator Agents
Tocolytic Agents
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Therapeutic Uses

Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Calcium Channel Blockers
Reproductive Control Agents
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009