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A multi-center, randomized, double-blind, controlled trial for revaluation of the effect of Ergometrine Maleate Injection in the prevention of postpartum hemorrhage

A multi-center, randomized, double-blind, controlled trial for revaluation of the effect of Ergometrine Maleate Injection in the prevention of postpartum hemorrhage

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800018488
Enrollment
Unknown
Registered
2018-09-20
Start date
2018-10-01
Completion date
Unknown
Last updated
2018-09-24

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

Conditions

postpartum hemorrhage

Interventions

Group A(vaginal delivery):ergometrine maleate + oxytocin injection
Group B(vaginal delivery):oxytocin injection
Group C(cesarean delivery):ergometrine maleate + oxytocin injection
Group D(cesarean delivery):oxytocin injection

Sponsors

West China Second University Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1) The subjects is voluntarily participated, and the informed consent form is signed in person or by the legal guardian; 2) Aged 20-40 years old; 3) Parturient woman with natural labor and cesarean delivery: gestational weeks were 37 weeks to 41 weeks + 6 days.

Exclusion criteria

Exclusion criteria: 1) Patients with severe medical complications (heart disease, liver disease, kidney disease, etc.); abnormal liver and kidney function; or alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) values is exceeding 2 times of the upper limit of normal value; or creatinine (Cr) is greater than the upper limit of normal; 2) Those with severe endocrine diseases (pre-pregnancy diabetes, hyperthyroidism, etc.); 3) Pregnancy-induced hypertension and sepsis; 4) genital malformations, uterine infections; 5) placenta implant or sinister placenta previa; 6) failure of trial production, transfer to cesarean section; 7) abdominal surgery= 2 times, delivery= 4 times; 8) hemoglobin 3, a single fibroid = 2cm; 11) subjects who are taking HIV protease inhibitors; 12) Those who are allergic to oxytocin or ergometrine maleate; 13) Those who have participated in other clinical research within the first three months of the selection; 14) The investigator believes that it is not suitable for the participants.

Design outcomes

Primary

MeasureTime frame
blood loss;

Countries

China

Contacts

Public ContactLiu Xinghui

West China Second University Hospital of Sichuan University

xinghuiliu@163.com+86 13881883798

Outcome results

None listed

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