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.
Conditions
Interventions
Trade Name: Crinone vaginal gel
Product Name: Crinone
Product Code: G03D A04
Pharmaceutical Form: Vaginal gel
INN or Proposed INN: Crinone 90 mg/dose
Concentration unit: % percent
Concentration type:
Sponsors
Department of Woman and Child health, Karolinska University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: Maternal systemic disease, pregnancy complication, non-simplex pregnancy, previous uterine or cervical surgery, placenta previa, planned cervical cerclage.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the impact of progesterone treatment on the endocrine, inflammatory and immunological status in mother and newborn. ;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 B. Clinical outcome - maternal, perinatal and infant (up to 1 year) morbidity | — |
Countries
Sweden
Outcome results
None listed