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Real-world evaluation of safety and effectiveness of dydrogesterone in the management of threatened abortion:A prospective study

Real-world evaluation of safety and effectiveness of dydrogesterone in the management of threatened abortion:A prospective study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600118091
Enrollment
Unknown
Registered
2026-02-02
Start date
2026-03-15
Completion date
Unknown
Last updated
2026-02-09

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

Conditions

Threatened miscarriage

Interventions

Observation group:None

Sponsors

The First Affiliated Hospital of Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1) women between 18 and 40 years of age; 2) positive blood or urine pregnancy test; 3) intrauterine singleton pregnancy with heart tube pulsation; 4) the gestational age of ultrasound diagnosis was >=6 weeks and <=12 weeks; 5) vaginal bleeding with or without lower abdominal pain or low back pain; 6) cervical closure without rupture of membranes; 7) patients taking or about to take dydrogesterone tablets for treatment; 8) Patients provided written informed consent for study participation.

Exclusion criteria

Exclusion criteria: 1) recurrent miscarriage history (defined as at least 3 consecutive miscarriages); 2) ovulation stimulation using assisted reproductive technology; 3) parental chromosomal abnormalities; 4) severe vaginal bleeding requiring surgical intervention; 5) Vaginal ultrasound showed that the crown-rump length of the fetus was =7 mm without heart tube pulsation; 6) history of hCG or progesterone therapy before enrollment; 7) with severe uterine malformation and uterine fibroids; 8) allergy to study drugs; 9) accompanied by tumors, liver and kidney dysfunction, diabetes, autoimmune diseases, such as systemic lupus erythematosus, systemic sclerosis, rheumatoid arthritis, etc.

Design outcomes

Primary

MeasureTime frame
Ongoing pregnancy rate within 12 weeks of gestation;

Secondary

MeasureTime frame
Proportion of severe vaginal bleeding or severe abdominal pain requiring surgical intervention (pregnancy Within 12 weeks' gestation);Reduced frequency of uterine contractions, abdominal pain relief ratio case;

Countries

China

Contacts

Public ContactFeng Lin

The First Affiliated Hospital of Wenzhou Medical University

13868328972@139.com+86 577 88069224

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 15, 2026