Status:
WITHDRAWN
Utility of Tocolytic Therapy for Maintenance Tocolysis in the Management of Threatened Preterm Delivery
Lead Sponsor:
Instituto de Investigacion Sanitaria La Fe
Conditions:
Preterm Delivery.
Eligibility:
FEMALE
18-60 years
Phase:
PHASE3
Brief Summary
Hypothesis: Both nifedipine or progesterone are widely used in clinical practice as maintenance tocolytic therapy after an episode of threatened preterm delivery. Nevertheless, there is insufficient e...
Eligibility Criteria
Inclusion
- Pregnant women with singleton pregnancies and intact membranes which have passed an episode of threatened preterm delivery (uterine contractions with cervical change) successfully treated with atosiban as acute tocolytic therapy.
- Cervical length ≤ 25 mm.
Exclusion
- ≥ 3 cm cervical dilation, multiple pregnancy, maternal medical contraindication to tocolysis with nifedipine, atosiban or progesterone, or obstetric contraindication to tocolytic treatment (severe preeclampsia, intrauterine infection, placental abruption, fetal abnormality incompatible with life, fetal death)
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01796522
Start Date
March 1 2013
End Date
May 1 2013
Last Update
July 22 2015
Active Locations (1)
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1
Hospital Universitari y Politécnic La Fe
Valencia, Valencia, Spain, 46026