Progesterone at imminent premature birthProgesteron vid hotande förtidsbörd
- Conditions
- In this randomised, placebo-controlled pilot study the treatment group (n=30) will recieve a daily application of vaginal gel containing progesterone 90 mg/dose (Crinone, Seronomerck) until rupture of fetal membranes, partus or 34 gestational weeks. The control group (n=30) will recieve a daily application of vaginal gel (Replens, Campus Pharma), which is identical to Crinone except for progesterone hormone, until rupture of fetal membranes, partus or 34 gestational weeks.
- Registration Number
- EUCTR2007-003348-31-SE
- Lead Sponsor
- Department of Woman and Child health, Karolinska University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- Not specified
Inclusion Criteria
Pregnant women with imminent premature birth 24+0 to 34+0 gestational weeks.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Maternal systemic disease, pregnancy complication, non-simplex pregnancy, previous uterine or cervical surgery, placenta previa, planned cervical cerclage.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate the impact of progesterone treatment on the endocrine, inflammatory and immunological status in mother and newborn.<br>;Secondary Objective: To investigate the impact of progesterone treatment on the clinical outrcome including incidence of premature birth, maternal and perinatal morbidity. ;Primary end point(s): A. Endocrinological, inflammatory and immunological status in mother and newborn <br>B. Clinical outcome - maternal, perinatal and infant (up to 1 year) morbidity<br>
- Secondary Outcome Measures
Name Time Method