Tocolytic Therapy for Preterm Labor in Multiple Gestation
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|ClinicalTrials.gov Identifier: NCT02725736|
Recruitment Status : Unknown
Verified March 2016 by Tel-Aviv Sourasky Medical Center.
Recruitment status was: Not yet recruiting
First Posted : April 1, 2016
Last Update Posted : April 1, 2016
|Condition or disease||Intervention/treatment||Phase|
|Labor Preterm Multiple||Drug: Atosiban Drug: Nifedipine||Phase 3|
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 .
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Tocolytic Therapy for Preterm Labor in Multiple Gestation|
|Study Start Date :||March 2016|
|Estimated Primary Completion Date :||March 2018|
|Estimated Study Completion Date :||March 2018|
Women with twin pregnancy with preterm labor between 24 weeks 0 days and 32 weeks 6 days of gestation will be included and randomly assigned to the Atosiban group.
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.
Women with twin pregnancy with preterm labor between 24 weeks 0 days and 32 weeks 6 days of gestation will be included and randomly assigned to the Nifedipine group.
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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02725736
|Contact: Yariv Yogev, email@example.com|
|Principal Investigator:||Yariv Yogev, professor||Tel Aviv Medical Center|