Nifedipine Compared to Atosiban for Treating Preterm Labor

Condition(s) targeted: Labor, Premature

Intervention: Atosiban (Drug); Nifedipine (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: HaEmek Medical Center, Israel

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

Overall contact:
Gali Garmi, MD, Phone: 972-4-6494031, Email: galit_ga@clalit.org.il

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

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

Study design: Treatment, Randomized, Open Label, Crossover Assignment, Safety/Efficacy Study

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)

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

Gali Garmi, MD, Phone: 972-4-6494031, Email: galit_ga@clalit.org.il

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

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: July 19, 2008