Preterm Delivery Clinical Trial
Official title:
Prophylactic Administration of Natural Progesterone in the Prevention of Preterm Delivery in Twin Pregnancies: A Randomized, Double-Blind, Placebo-Controlled Trial
Twin pregnancies are at substantial increased risk of preterm delivery. Prophylactic administration of progesterone in singleton pregnancies at risk of preterm delivery has been shown to be effective in reducing the rate of such complication. The aim of this study is to investigate the effect of prophylactic administration of natural progesterone in twin pregnancies on the rate of preterm births.
In a double-blind, placebo controlled study performed in our Institution, Fonseca et al.,
investigated the use of micronized natural progesterone, crafted in vaginal capsules of
100mg, for the prevention of preterm delivery. The study involved 142 singleton pregnancies
at high risk for premature birth (previous premature birth, cerclage and uterine
malformation). The progesterone was introduced from 24 weeks to 34 weeks gestation. The
authors observed a significant reduction of premature birth before 37 weeks (28,1% within
the placebo group versus 13,8% within the treated group) and below 34 weeks (18,6% within
the placebo group versus 2,8% within the treated group). Also, it was observed a reduction
in the frequency of the uterine contractions in the progesterone group.
In the only study performed specifically among twin pregnancies, Anna Lisa et al. in 1980,
administrated 250mg of 17αOH-PC or placebo (still oil) weekly, in 70 pregnant women with
twin pregnancies, beginning before 28 weeks and continuing up to 37 weeks gestation. Seric
levels of progesterone, estradiol, estriol, testosterone, and placental lactogenic hormone
were also measured weekly. The differences among the achieved results within both groups,
according the average in pregnancy duration (36,9 within the treated group, versus 37,3
within the placebo group), the average birthweight and the perimortality rate were not
significantly different, as well as the levels of progesterone, estriol, estradiol,
testosterone and placental lactogenic hormone. Nevertheless, this study was criticized for
starting the use of progesterone at a late stage of pregnancy, in a considerable number of
cases.
These studies suggest that in singleton pregnancies with a previous history of preterm birth
progesterone treatment may prevent the patients from having subsequent premature births.
Nonetheless, the results of these series must not be generalized to all pregnancies at high
risk. Additional studies to evaluate the use of progesterone ovules in multiple pregnancies
are necessary, as these pregnancies are increasing due to the advanced maternal age at the
conception time and also due to the widespread use of assisted reproductive techniques.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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