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A randomized, open-label trial to evaluate metformin to prevention preterm pre-eclampsia in Chinese overweight pregnancies

A randomized, open-label trial to evaluate metformin to prevention preterm pre-eclampsia in Chinese overweight pregnancies.

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100051255
Enrollment
Unknown
Registered
2021-09-17
Start date
2021-09-01
Completion date
Unknown
Last updated
2022-05-30

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

Conditions

pre-eclampsia

Interventions

Blank Control Group:standard care
Positive Control Group:aspirin

Sponsors

Peking University Third Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Confirmed pregnancy; 2. Pregnancy time = 24 kg/m2.

Exclusion criteria

Exclusion criteria: 1. Aged < 18 years; 2. Severe vomiting during pregnancy; 3. Bleeding diseases; 4. Peptic ulcer; 5. Allergic to aspirin and metformin; 6. Long-term use of non-steroidal anti-inflammatory drugs before enrollment; 7. Contraindications of metformin and aspirin and other serious diseases, including but not limited to: renal dysfunction caused by heart failure (shock), acute myocardial infarction and sepsis; congestive heart failure and other serious heart and lung diseases requiring drug treatment Severe infection and trauma, major surgical operation, clinical hypotension and hypoxia, etc. 4 weeks before screening; acute or chronic metabolic acidosis, including diabetic ketoacidosis and diabetic ketoacidosis with or without coma Insulin treatment is required; 4 weeks before screening, those who received intravascular injection of iodinated contrast agent; 8. Participated in another concurrent experiment within 28 days.

Design outcomes

Primary

MeasureTime frame
Incidence of preeclampsia in Chinese overweight pregnancies;

Secondary

MeasureTime frame
Placental growth factor (PLGF)/soluble fms-like tyrosine kinase-1 (sFlt-1) ratio);Maternal outcomes;Offspring outcomes;

Countries

China

Contacts

Public ContactWei Yuan

Peking University Third Hospital

weiyuanbysy@163.com+86 15611908609

Outcome results

None listed

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