Threatened Miscarriage
Conditions
Keywords
progesterone, threatened abortion
Brief summary
The purpose of the study is to assess the efficacy of vaginal micronized progesterone in the treatment of threatened miscarriage. All eligible pregnant women will be randomized to either receive vaginal progesterone or no treatment.Evaluation will be two weeks after intervention, then every 4 weeks up to 28 weeks gestation or termination of pregnancy.
Interventions
DRUGVaginal Progesteron
Sponsors
Omar Mamdouh Shaaban
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
1. Pregnant with gestational age less than 24 weeks 2. Presented by bleeding with or without pain 3. Single viable fetus (confirmed by Ultrasound examination) 4. Accepting to have vaginal medication
Exclusion criteria
1. Currently under medication for any chronic diseases (DM, thyroid, liver, renal, cardiac and autoimmune disease). 2. Hypersensitivity to progesterone 3. Any documented congenital fetal anomaly in the current pregnancy 4. Women received hormonal treatment in the current pregnancy 5. Patients conceived via ART
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Miscarriage rate up to 28 weeks of gestation | Completed 28th week |
Secondary
| Measure | Time frame |
|---|---|
| Gestational age at delivery or termination of pregnancy | Number of completed weeks at the time of delivery |
Countries
Egypt
Contacts
Primary ContactOmar M Shaaban, MD
Backup ContactHany Abdel-aleem, MD
Outcome results
None listed