Nifedipine Compared to Atosiban for Treating Preterm Labor

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

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

Conditions
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Labor, Premature

Intervention / Treatment
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* Drug: Atosiban
* Drug: Nifedipine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Gestational age between 24 to 34 weeks which had been documented by a definite LMP and sonography up to 20 weeks. 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: Nulliparous women: a single cervical examination demonstrating dilatation of 0 cm to 4 cm and effacement of at least 50% Multiparous women: a single cervical examination demonstrating dilatation of 1 cm to 4 cm and effacement of at least 50%. Provision of written informed consent Exclusion Criteria: Chorioamnionitis Preterm rupture of membranes Vaginal bleeding Major fetal malformations Severe hypertensive disorders Intrauterine growth restriction (< 5th percentile). Non-reassuring fetal heart rate Maternal contraindications Chronic hypertension Systolic blood pressure < 90 mmHg Cardiovascular disease Elevated hepatic enzymes Congenital or acquired uterine malformation
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Atosiban<br>* 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.<br>|
| Experimental: 2<br> | Drug: Nifedipine<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| delaying labor |  | for more than 48 hours after starting treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preterm labor, Atosiban, Nifedipine