Oral Progesterone for Prevention of Miscarriage in Threatened Abortion

Chulalongkorn University

Status and phase: Completed; Phase 4

Conditions: Threatened Abortion

Treatments: Drug: Dydrogesterone; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04788108

177/2021

Details and patient eligibility

About

This study evaluates the effectiveness of oral dydrogesterone in preventing miscarriage in threatened abortion. Half of participants will receive oral dydrogesterone, while the other half will receive oral placebo.

Enrollment: 100 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• singleton pregnancy with gestational age 6 - 20 weeks
• threatened abortion
• confirmed intrauterine pregnancy with a viable fetus by ultrasound

Exclusion criteria

• history of recurrent miscarriage
• having endocervical polyp
• having infection such as pneumonia, pyelonephritis, septicemia
• having autoimmune diseases such as systemic lupus erythematosus, systemic sclerosis, rheumatoid arthritis
• having cancer
• having coagulation defect
• allergy to dydrogesterone

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Dydrogesterone

Active Comparator group

Description:

dydrogesterone 10 mg by mouth every 12 hours until 1 week after bleeding stops or until 6 weeks.

Treatment:

Drug: Dydrogesterone

Placebo

Placebo Comparator group

Description:

placebo by mouth every 12 hours until 1 week after bleeding stops or until 6 weeks.

Treatment:

Drug: Placebo