The main objective of this study will be to assess the efficacy of natural progesterone at a daily dose of 25 mg/bid in the maintenance of early pregnancy in women with symptoms of threatened abortion. The secondary objectives will be the efficacy of progesterone in reducing both pain and uterine contractions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
4
subcutaneous injection of progesterone solution will be performed twice à day from onset of threatened abortion symptoms until week 12 of pregnancy.
subcutaneous injection of placebo solution will be performed twice à day from onset of threatened abortion symptoms until week 12 of pregnancy.
"F. Miulli" Regional General Hospital
Bari, BA, Italy
P.O.G. Salesi
Ancona, Italy
Ospedale Cervesi
Cattolica, Italy
Presidio Ospedale S'Anna
Torino, Italy
Ongoing pregnancy rate at 12 weeks of gestation
Time frame: 12 weeks
Reduction of the frequency of uterine contractions;
Time frame: 15 days
Pain reduction (using a Numerical Rating Scale);
Time frame: 15 days
Reduction of subchorionic haematoma;
Size of subchorionic haematoma will be measured (in mm) at screening and after treatment.
Time frame: 15 days
Number of subjects with onset of new threatened abortion
Time frame: 12 weeks
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