Threatened abortion complicated with subchorionic hematoma in early pregnancy
Conditions
Interventions
Experimental Group:Allylestrenol tablets, orally administered, 5 mg per dose, three times daily for 4 weeks.
Control Group:Progesterone capsules, orally administered, 100 mg per dose, twice daily for 4 weeks.
Sponsors
SUN YAT-SEN MEMORIAL HOSPITAL,SUN YAT-SEN UNIVERSITY
Eligibility
Sex/Gender
Female
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: (1) Females aged >= 18 years and <= 40 years; (2) Intrauterine singleton pregnancy at 7–12 weeks of gestation; (3) Diagnosed with threatened miscarriage complicated by subchorionic hematoma (SCH); (4) Signed informed consent form by the patient or their legal guardian.
Exclusion criteria
Exclusion criteria: (1) Multiple pregnancy (twin or higher-order gestation); (2) Ectopic pregnancy; (3) Heavy vaginal bleeding or severe abdominal pain requiring surgical intervention; (4) Chromosomal abnormality in either parent; (5) Concurrent reproductive system malformations, uterine fibroids, or adenomyosis; (6) Current or history of: diabetes mellitus, hypertension, untreated or active cancer, liver disease, kidney disease, neurological disorders requiring medication, uncontrolled hypothyroidism, uncontrolled epilepsy, or psychiatric disorders; (7) Concurrent genitourinary infections (e.g., vaginitis, cervicitis, urinary tract infection); (8) Concomitant autoimmune diseases (including systemic lupus erythematosus, rheumatoid arthritis, antiphospholipid syndrome, etc.); (9) History of =3 consecutive spontaneous abortions; (10) Known allergy to allylestrenol or progesterone; (11) Participation in other clinical trials affecting efficacy evaluation within 30 days prior to enrollment; (12) Investigator’s judgment of unsuitability for the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in SCH/Gestational Sac Ratio at 4 Weeks of Treatment versus Baseline;Neonatal outcomes; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pregnancy outcomes (miscarriage, preterm delivery, preterm premature rupture of membranes [PPROM], term delivery, stillbirth, etc.);Mode of delivery (spontaneous vaginal delivery, instrumental vaginal delivery, cesarean delivery);SCH size and SCH/gestational sac ratio at 2, 4, and 8 weeks post-enrollment;Change in SCH/gestational sac ratio from baseline at 2 and 8 weeks post-enrollment; Resolution of clinical symptoms (vaginal bleeding, abdominal pain) and symptom duration at 2 and 4 weeks post-enrollment;Clinical efficacy at 2 and 4 weeks post-enrollment;Pregnancy complications; | — |
Countries
China
Contacts
Public ContactHui Chen
SUN YAT-SEN MEMORIAL HOSPITAL,SUN YAT-SEN UNIVERSITY
Outcome results
None listed