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A randomized controlled trial for efficacy of esomeprazole in the treatment of early-onset preeclampsia

A randomized controlled trial for efficacy of esomeprazole in the treatment of early-onset preeclampsia

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900026972
Enrollment
Unknown
Registered
2019-10-27
Start date
2020-01-01
Completion date
Unknown
Last updated
2019-10-28

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

Conditions

preeclampsia

Interventions

Experimental group:40 mg of esomeprazole+Standard treatment
control group:Standard treatment

Sponsors

Shanghai First Maternity and Infant Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 45 Years

Inclusion criteria

Inclusion criteria: Pregnant women that agree to participate in the trial and meet all the following conditions: 1. Gestational age between 26 + 0 weeks and 33+ 6 weeks; 2. Diagnosis of pre-eclampsia, gestational hypertension with evidence of preeclampsia, undefined hypertension with proteinuria; 3. No suspicions of major fetal anomaly or malformation (Major fetal anomaly is defined as anomalies or malformations that create significant medical problems for the patient or require specific surgical or medical management. Major anomalies or malformations are not considered a variation of the normal spectrum); 4. Estimated fetal weight by ultrasound >=500g; 5. Agree for expectant management and standardized care.

Exclusion criteria

Exclusion criteria: Patients that are unwilling to give consent, or present any of the following at presentation: 1. Having a history of eclampsia; 2. Termination of pregnancy at one's own request; 3.Cerebrovascular accident; 4. Severe renal or hepatic impairment presented as creatinine level of greater or equal to 125 µmol/l or liver transaminases greater than or equal to 500 IU/L; 5. Pulmonary edema; 6. Signs of left ventricular failure; 7. Disseminated intravascular coagulation defined as an INR greater than 2; 8. Platelet count at presentation less than 50x10^9; 9. Previous hypersensitivity reaction or contraindications to the use of PPIs; 10. Current use of a drug that may be affected by PPIs.

Design outcomes

Primary

MeasureTime frame
gestational weeks;

Secondary

MeasureTime frame
sFLt-1;sENG;

Countries

China

Contacts

Public ContactXiaolin Hua

Shanghai First Maternity and Infant Hospital

huaxiaolin_sh@163.com+86 13764509708

Outcome results

None listed

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