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A Multicenter Randomized Controlled Study on Combined Oral Contraceptive for the Treatment of Post-Traumatic Stress Disorder in Spontaneous Abortion

A Multicenter Randomized Controlled Study on Combined Oral Contraceptive for the Treatment of Post-Traumatic Stress Disorder in Spontaneous Abortion

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400086247
Enrollment
Unknown
Registered
2024-06-27
Start date
2024-12-11
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Traumatic stress disorder after spontaneous abortion

Interventions

Research group:Oral contraceptive pills
Control group:None

Sponsors

Women‘s Hospital School of Medicine Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1: Women aged 18-40 with a history of spontaneous abortion and fertility requirements; 2: Spontaneous miscarriage gestational age <= 10 weeks 3: Complete natural abortion or choosing artificial abortion to terminate pregnancy due to inevitable abortion; 4: Willing to accept short-term oral contraception treatment after natural abortion, and able to cooperate with research for follow-up and data collection; 5: Willing to implement instrumental contraception simultaneously during the research period; 6: No contraindications for short acting oral contraceptives, such as liver disease, kidney disease, cardiovascular disease, cerebrovascular disease, etc; 7: Having no prior history of mental illness or mental illness, able to independently complete the psychological health assessment required for the study; 8: No severe allergic reactions or drug intolerance, able to tolerate the side effects caused by short acting oral contraceptives.

Exclusion criteria

Exclusion criteria: (1) Long term or current short-term oral contraceptive users; (2) Subjects with hormone dependent diseases or adverse reactions to short acting oral contraceptives; (3) Subjects with a history of severe mental illness or current mental illness; (4) Diagnosed with PTSD and severe symptoms, assessed by a psychiatrist as requiring psychiatric drug control; (5) During the research period, it was not allowed to use contraception tools according to regulations; (6) Subjects with contraindications to the research process or short acting oral contraceptives; (7) Subjects who are unable to cooperate in completing the study or unable to comply with the study regulations;

Design outcomes

Primary

MeasureTime frame
Improvement rate of anxiety/depression;

Secondary

MeasureTime frame
Serum sex hormone levels: estradiol (E2, pmol/L), follicle stimulating hormone (FSH, IU/L), serotoni;The incidence rate of incomplete miscarriage ;The time of menstruation relapse (days);

Countries

China

Contacts

Public ContactJiang Xiuxiu

Women‘s Hospital School of Medicine Zhejiang University

jiangxiuxiu0418@zju.edu.cn+86 571 8999 2057

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026