Status
Unknown
Phase
Phase 3
Enrollment
140
Locations
0
Results
Not posted
Publications
1
Study summary
To compare the tocolytic efficacy oxytocin receptor antagonist (Atosiban) with that of calcium channel blockers (Nifedipine) among women with multiple gestation who present with threatened preterm labor.
Preterm birth remains the principal cause of early neonatal death. Infants born preterm (before 37 weeks' gestation) often suffer significant immediate morbidity and need lengthy stays in neonatal intensive care units. Moreover, there is a significant risk of long-term neurological morbidity in a proportion of the survivors. Patients with a multiple gestation are at significant risk for preterm labor and delivery as approximately 60% of all those pregnancies will be delivered preterm. A number of oxytocin receptor antagonists have been developed, and of these, three, atosiban, barusiban and retosiban have been investigated in humans as tocolytic agents. To date, only atosiban is in use outside of clinical trials. Atosiban is an oxytocin receptor antagonist which was specifically developed for the treatment of preterm labor. Early reports of the use of Atosiban for tocolysis showed promise both in vitro and in animal studies, and preliminary studies in pregnant and non-pregnant humans suggested a very low incidence of maternal side effects .
Interventions
DRUG
After random allocation to a treatment group, women will receive Atosiban as follows: Atosiban was given as a single loading intravenous dose, 6.75 mg in 0.9% sodium chloride solution, followed by an intravenous infusion of 300 micrograms/min in 0.9% sodium chloride solution for the first 3 hours and then 100 micrograms/min for another 45 hours. The choice of the dose regimen for Atosiban was consistent with the recommendations of the product labeling.
DRUG
After random allocation to a treatment group, women will receive Nifedipine as follows: Nifedipine was given as a loading dose of 20 mg orally followed by another two doses of 20 mg, 20-30 minutes apart as needed. Maintenance was started after 6 hours with 20-40 mg four times a day for a total of 48 hours.
Timeline
First posted
Apr 1, 2016
Study start
Mar 2016
Primary completion
Mar 2018
Study completion
Mar 2018
Results posted
Not reported
Registry updated
Apr 1, 2016
Outcomes
Duration of labor
Time frame · 48 hours
Infant morbidity
Time frame · 28 days
Defined as the number of infant morbidity up to 28 days from birth.
Chronic lung disease
Time frame · 28 days
Defined as the number of participants with need for supplemental oxygen at 28 days of life
Eligibility
Inclusion Criteria: 1. Twin pregnancy 2. Gestational age between 24+0 and 32+6 weeks 3. Intact amniotic membranes 4. Threatened preterm labor 5. Age 18-50. Exclusion Criteria: 1. Rupture of membranes 2. Vaginal bleeding resulting from placenta previa or placental abruption 3. Fever above 38°C 4. Severe preeclampsia 5. Maternal cardiovascular or liver diseases 6. Systolic blood pressure less than 90 mm Hg 7. Known uterine malformation 8. Intrauterine growth restriction below the fifth percentile 9. Non-reassuring fetal status 10. Antepartum diagnosis of major fetal malformations 11. Fetal death 12. Previous tocolytic therapy or Betamethasone treatment
Study locations
No country data reported. Showing up to 24 locations stored in the fast local snapshot.
No study locations reported.
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