Prophylactic Administration of Natural Progesterone in the Prevention of Preterm Delivery in Twin Pregnancies
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Prophylactic Administration of Natural Progesterone in the Prevention of Preterm Delivery in Twin Pregnancies: A Randomized, Double-Blind, Placebo-Controlled Trial|
- gestational age at delivery [ Time Frame: once at the end of study ] [ Designated as safety issue: No ]
|Study Start Date:||June 2007|
|Study Completion Date:||June 2014|
|Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
Placebo Comparator: placebo
group taking placebo
Active Comparator: study group
group taking progesterone
ovules, 200mg per vagina, once a day from 18 weeks
Other Name: utrogestan
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01031017
|Hospital das Clinicas|
|São Paulo, SP, Brazil, 05403000|
|Principal Investigator:||Maria Brizot, PhD||Department of Obstetrics, São Paulo University Medical School|