Oral Progesterone for Prevention of Miscarriage in Threatened Abortion

Oral Progesterone for Prevention of Miscarriage in Threatened Abortion: a Randomized, Double-blinded, Placebo-controlled Trial

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04788108

Enrollment

100

Registered

2021-03-09

Start date

2021-08-01

Completion date

2022-08-31

Last updated

2023-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Threatened Abortion

Keywords

threatened abortion

Brief summary

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.

Interventions

DRUGDydrogesterone

Dydrogesterone tablet

DRUGPlacebo

Placebo tablet

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
continue pregnancy more than 20 weeks gestation	at 20 weeks gestation	percentage of cases with continue pregnancy more than 20 weeks gestation

Secondary

Measure	Time frame	Description
preterm delivery less than 37 weeks	at 37 weeks gestation	percentage of delivery less than 37 weeks
placenta previa	31 weeks	percentage of placenta previa
abruptio placenta	31 weeks	percentage of abruptio placenta
Intrauterine growth restriction	31 weeks	percentage of intrauterine growth restriction
preterm delivery less than 34 weeks	at 34 weeks gestation	percentage of delivery less than 34 weeks
side effects	6 weeks	percentage of side effects such as headache, nausea/vomiting
compliance	6 weeks	percentage of complete drug use
maternal satisfaction	6 weeks	percentage of good satisfaction
time until bleeding stops	6 weeks	time from first bleeding until bleeding stops
neonatal complications	31 weeks	percentage of newborn with respiratory distress syndrome, intraventricular hemorrhage, necrotizing enterocolitis, death

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026