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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
300
Per vagina administration of 100 mg followed by a second 100 mg dosage the following day
Per os administration according to current protocol of 20mg each 20 minutes for 1 hour followed by 20 mg q8 for 48 hours.
Time to delivery
The time from administration of intervention do delivery
Time frame: through study completion, approximately 1 year
Gestational age
Days from last menstrual period
Time frame: through study completion, approximately 1 year
Rate of preterm deliveries
Rate of deliveries under 37+0/7 weeks of gestation
Time frame: through study completion, approximately 1 year
Rate of remote from term deliveries
Rate of deliveries under 34+0/7 weeks of gestation
Time frame: through study completion, approximately 1 year
Rate of extreme preterm deliveries
Rate of deliveries under 28+0/7 weeks of gestation
Time frame: through study completion, approximately 1 year
neonatal immediate outcomes
Neonatal Apgar scores
Time frame: through study completion, approximately 1 year
Neonatal immediate outcome
Neonatal umbilical cord pH levels
Time frame: through study completion, approximately 1 year
Neonatal birth weight
birth wight as recorded in chart in grams
Time frame: through study completion, approximately 1 year
Neonatal outcomes
neonatal intensive care unit administration rate
Time frame: through study completion, approximately 1 year
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