Vaginal bleeding in the first 12 weeks of pregnancy.
Conditions
Interventions
Trade Name: Utrogestan 200mg capsules
Product Name: Progesterone 200mg capsules
Pharmaceutical Form: Capsule
INN or Proposed INN: Each capsule contains
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Women presenting with vaginal bleeding in the first 12 weeks of pregnancy with an intrauterine gestation sac visible on ultrasonography. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 4150 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: Women of age less than 18 years or =40; women with life-threatening bleeding; women already taking progesterone supplementation therapy; women with contraindications to progesterone use.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Live births beyond 34 completed weeks of gestation, as a proportion of all women randomised. ;Main Objective: To test the hypothesis that in women presenting with vaginal bleeding in the first trimester, progesterone (vaginal capsules 400mg twice daily), started as soon as possible after a scan has demonstrated a visible intrauterine gestation sac and continued to 16 completed weeks of gestation, compared with placebo, increases maternities with live births beyond 34 completed weeks by at least 5%.; Secondary Objective: To test the hypothesis that progesterone improves other pregnancy and neonatal outcomes such as gestation at delivery, viable pregnancy at 12 weeks, and survival at 28 days of neonatal life. To test the hypothesis that progesterone is not associated with serious adverse effects to the mother or the neonate, including chromosomal and congenital abnormalities. To explore the effects of progesterone in prognostic subgroups, including age, fetal heart activity, gestation at presentation, amount of bleeding and body mass index. To explore the effect of progesterone on the use of healthcare resources such as antenatal, outpatient or emergency visits and inpatient admissions (nights in hospital, maternal admissions to high dependancy unit or intensive care unit, and neonatal admissions to special care baby unit or neonatal unit). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Gestation at delivery; ongoing pregnancy at 12 weeks (range 11 – 13 weeks) gestation, miscarriage rate, survival at 28 days of neonatal life, chromosomal and congenital abnormalities, and adverse events. | — |
Countries
United Kingdom
Contacts
Public ContactProfessor Arri Coomarasamy
University of Birmingham
Outcome results
None listed