Nifedipine Compared to Atosiban for Treating Preterm Labor

Labor, Premature Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00599898
• Other study ID #: EMC070048CTIL
• Secondary ID: same as unique p
• Status: Completed
• Phase: Phase 4
• First received: January 8, 2008
• Last updated: March 12, 2012
• Start date: January 2008
• Est. completion date: February 2012

Study information

• Verified date: March 2012
• Source: HaEmek Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics CommissionIsrael: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: February 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Labor, Premature
• Obstetric Labor, Premature

Intervention

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.
• 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.

Locations

Country	Name	City	State
Israel	HaEmek Medical Center	Afula

Sponsors (1)

Lead Sponsor	Collaborator
Raed Salim

Country where clinical trial is conducted

Israel, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	delaying labor		for more than 48 hours after starting treatment	Yes
Secondary	drugs side effects		within the first 48 hours after treatment	Yes
Secondary	obstetrical (number of days to delivery, gestational age at delivery, mode of delivery)		within 24 hours after delivery	No
Secondary	neonatal (Apgar score, sepsis, IVH, NEC, RDS, DEATH)		within 30 days from delivery	Yes