Randomized Controlled Trial of Allylestrenol Tablets in the Prevention of Late Abortion / Preterm Birth

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100053693

Enrollment

Unknown

Registered

2021-11-27

Start date

2021-12-05

Completion date

Unknown

Last updated

2022-10-17

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

Conditions

late abortion, preterm birth

Interventions

Experimental group:Allylestrenol Tablets

Control group:Progesterone Soft Capsules (Utrogestan)

Eligibility

Sex/Gender

Female

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Women aged >=18 years; 2. Intrauterine singleton pregnancy, 16-35 weeks of gestation; 3. Meet any one of the following criteria: history of late miscarriage/preterm birth, with or without cervical length <25 mm by vaginal ultrasound before 24 weeks of pregnancy; no history of late miscarriage/preterm birth, vaginal ultrasound before 24 weeks of pregnancy Show cervical length < 20 mm; clinical manifestations of late miscarriage/prematurity; 4. The pregnant woman or her surrogate signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Known to be allergic to allyl estradiol tablets or progesterone soft capsules; 2. Sex hormone-related malignant tumors; 3. Unexplained vaginal bleeding; 4. Massive vaginal bleeding or severe abdominal pain requires surgical intervention; 5. Severe liver dysfunction, such as liver tumor (present or past history), Dubin-Johnson syndrome, Potor syndrome, and jaundice; 6. Diseases or symptoms that occur or aggravate during pregnancy or the use of sex hormones, such as gestational hypertension, gestational proteinuria, gestational diabetes, preeclampsia, severe pruritus, gestational herpes, porphyria, and otosclerosis Wait; 7. Congenital malformation or chromosomal abnormalities of the fetus; 8. Participate in other clinical trials within 1 month before screening; 9. According to the investigator's judgment, it is not suitable to participate in this clinical trial.

Design outcomes

Primary

Measure	Time frame
Delivery rate before 37 weeks (Incidence of late abortion / preterm birth);	—

Secondary

Measure	Time frame
Pregnancy duration;Extended pregnancy duration;Pregnancy outcome;Method of childbirth;Birth weight;Apgar score of newborn;incidence of adverse neonatal outcomes;	—

Countries

China

Contacts

Public ContactLi Zhen

Shengjing Hospital of China Medical University, Huaxiang Campus

Lizhen0911@126.com+86 18940257328

Outcome results

None listed

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