Nifedipine Compared to Atosiban for Treating Preterm Labor

Raed Salim

Status and phase: Completed; Phase 4

Conditions: Labor, Premature

Treatments: Drug: Nifedipine; Drug: Atosiban

Study type: Interventional

Funder types: Other

Identifiers

NCT00599898

EMC070048CTIL

same as unique protocol ID

Details and patient eligibility

About

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

Enrollment: 145 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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145 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: Atosiban

2

Experimental group

Treatment:

Drug: Nifedipine