Nifedipine Compared to Atosiban for Treating Preterm Labor

Phase 4

Completed

• Conditions: Labor, Premature
• Interventions: Drug: Atosiban; Drug: Nifedipine

• Registration Number: NCT00599898
• Lead Sponsor: Raed Salim

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-01-08
• Study First Submitted QC: 2008-01-13
• Study First Posted: 2008-01-24
• Primary Completion: 2011-12
• Study Completion: 2012-02
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-12
• Last Update Posted: 2012-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 145

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Atosiban	-
2	Nifedipine	-

Primary Outcome Measures

Name	Time	Method
delaying labor	for more than 48 hours after starting treatment

Secondary Outcome Measures

Name	Time	Method
drugs side effects	within the first 48 hours after treatment
obstetrical (number of days to delivery, gestational age at delivery, mode of delivery)	within 24 hours after delivery
neonatal (Apgar score, sepsis, IVH, NEC, RDS, DEATH)	within 30 days from delivery

Trial Locations

Locations (1)

HaEmek Medical Center; 🇮🇱 Afula, Israel