Labor, Premature
Conditions
Keywords
Preterm labor, Atosiban, Nifedipine
Brief summary
The purpose of this study is to investigate the efficacy and the safety of nifedipine compared to atosiban for treating preterm labor.
Interventions
DRUGAtosiban
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.
DRUGNifedipine
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.
Sponsors
Raed Salim
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| delaying labor | for more than 48 hours after starting treatment |
Secondary
| Measure | 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 |
Countries
Israel
Outcome results
None listed