Status:
UNKNOWN
Vaginal Indomethacin for Preterm Labor
Lead Sponsor:
Hadassah Medical Organization
Collaborating Sponsors:
Sheba Medical Center
Soroka University Medical Center
Conditions:
Obstetric Labor, Premature
Eligibility:
FEMALE
16-60 years
Phase:
PHASE2
PHASE3
Brief Summary
Indometacin is a cyclooxygenase agent from the NSAID family that has been used to treat preterm contractions since the 70's by preventing the synthesis of prostaglandins. It has been shown to be signi...
Eligibility Criteria
Inclusion
- Singe fetus
- Gestational age between 24+0/7 and 31+6/7
- At least one uterine contraction in ten minutes for at least 20 minutes upon tocography admission
- Cervical parameters: 1 cm dilation or more or 80% cervical effacement or cervical length 20mm or less
Exclusion
- Rupture of membranes
- Vaginal bleeding
- Cervical dilation ≥5cm
- Known fetal malformations
- Fetal heart rate abnormalities
- Suspected placental abruption of adherent placental syndrome
- Known sensitivity to one of the drugs used in the study (Indometacin and nifedipine)
- Maternal hypotension and known aortic or mitral stenosis
- Presence of cervical cerclage
- Previous administration of tocolytic drugs in current pregnancy
Key Trial Info
Start Date :
October 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2025
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04404686
Start Date
October 1 2020
End Date
April 1 2025
Last Update
August 11 2020
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