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 significantly more effective than placebo and postpone labor for 7-10 days,
prolong pregnancies above 37 weeks of gestation and reduce numbers of small for gestational
age neonates.
Nifedipine is a calcium channel blocker agent that has been shown to reduce rates of labor
within 48 hours from treatment.
Previous studies comparing rectal Indometacin to oral nifedipine were inconclusive.
Prostaglandins are synthesized in the uterus and the uterine cervix and therefore local
administration of Indometacin may be more effective than other forms of administration, as
been shown in a previous study.
In this study we aim to compare vaginal Indometacin administration to a commonly used
tocolytic agent, nifedipine.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Hadassah Medical Organization
Collaborators:
Sheba Medical Center Soroka University Medical Center