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A decision-making tool for the precise use of progestin suppositories based on a preterm birth cohort and its effectiveness evaluation

A decision-making tool for the precise use of progestin suppositories based on a preterm birth cohort and its effectiveness evaluation

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600124594
Enrollment
Unknown
Registered
2026-05-14
Start date
2026-05-14
Completion date
Unknown
Last updated
2026-05-18

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

Conditions

Preterm Labor

Interventions

Intervention:Decision tools
control group:The control group consisted of women who received progesterone for the empirical prevention of preterm birth

Sponsors

Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Singleton pregnancies where prenatal checkups and delivery were conducted at Shanghai First Maternity and Infant Hospital between September 2023 and September 2024 and who are included in the preterm birth disease database; 2.Pregnant women with a history of spontaneous preterm birth (or mid-pregnancy miscarriage) who did not undergo cervical cerclage based on their medical history and started using progestin suppositories (200 mg daily) before 16 weeks of gestation; or those who require vaginal monitoring of cervical length due to other high-risk factors for preterm birth, and whose cervix is ??shortened (CL<=25 mm) before 28 weeks of gestation and who are using progestin suppositories (200 mg daily);

Exclusion criteria

Exclusion criteria: 1.No vaginal discharge sample was collected before progesterone treatment (i.e., <16 weeks of gestation); 2.Specific details of progesterone use could not be determined (including gestational week of initiation, dosage, and duration of use); 3.Cervical cerclage or other measures were taken before the use of progesterone suppositories during pregnancy; 4.Multiple pregnancy or fetal reduction surgery, twin pregnancy with one stillbirth, etc.; severe fetal malformations or abnormal amniotic fluid volume, etc. 5.History of acute/chronic infection, severe cardiovascular or cerebrovascular disease, diabetes, rheumatic disease, malignant tumor, etc. 6.Other circumstances preventing participation in the intervention follow-up or disagreement to participate in this study.

Design outcomes

Primary

MeasureTime frame
pretem labor;

Secondary

MeasureTime frame
Gestaional Week at Delivery;Prevalence of Preterm Labor;Cervical Cerclage;Percentage of NICU admission;Prevalence of Newborn Complications;mechanical ventilation rate;

Countries

China

Contacts

Public ContactHao Ying

Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine

stephenying_2011@163.com+86 21 20261211

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 22, 2026