Overview

Nifedipine Compared to Atosiban for Treating Preterm Labor

Status:
Completed

Trial end date:
2012-02-01

Target enrollment:
0

Participant gender:
Female

Summary

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

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Raed Salim

Treatments:

Atosiban
Nifedipine
Vasotocin

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