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A Randomized, Open-label, Positive-controlled, Multicenter Clinical Study on the Efficacy and Safety of Different Doses of Ergometrine Combined with Oxytocin in Preventing Postpartum Hemorrhage and Promoting Uterine Involution

A Randomized, Open-label, Positive-controlled, Multicenter Clinical Study on the Efficacy and Safety of Different Doses of Ergometrine Combined with Oxytocin in Preventing Postpartum Hemorrhage and Promoting Uterine Involution

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600125651
Enrollment
Unknown
Registered
2026-05-29
Start date
2026-06-01
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Postpartum hemorrhage

Interventions

Control group:"1-dose regimen"of ergometrine maleate combined with oxytocin
Experimental group:A "2-dose regimen" of ergometrine maleate combined with oxytocin

Sponsors

Chongqing Health Center for Women and Children
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1.Age 20-40 years; 2.Singleton, term pregnancy (gestational age >=37 weeks); 3.Those with any of the following risk factors for postpartum hemorrhage: macrosomia (estimated weight >= 4000g), scarred uterus (history of cesarean section, uterine fibroid removal surgery), multiparity (number of deliveries >= 3 times), previous history of postpartum hemorrhage, or excessive uterine distension (excessive amniotic fluid, etc.); 4.Planned vaginal delivery or elective/emergency cesarean section; 5.subjects voluntarily participated and signed the written informed consent form;

Exclusion criteria

Exclusion criteria: 1) Known to be allergic to ergonovine maleate, oxytocin or any of the ergot alkaloids (e.g. bromocriptine, cabergoline); 2) Serious medical complications: severe heart disease (NYHA class III-IV), severe liver and kidney dysfunction; 3) Hypertension-related diseases: hypertensive disorders in pregnancy, chronic hypertension, preeclampsia, eclampsia; 4) History of glaucoma; 5) Sepsis or intrauterine infection; 6) Reproductive tract malformation, suspected or confirmed placenta accreta, placenta previa; 7) Prenatal hemoglobin =5cm or multiple >=2cm and >3 in number); 9) Postpartum use of drugs that may interact with ergonovine (strong inhibitors of CYP3A4 such as ketoconazole, erythromycin; other ergonovines; vasoconstrictors); 10) Participated in other drug clinical trials within the past 3 months; 11) Any other condition considered by the investigator to preclude participation in the study.

Design outcomes

Primary

MeasureTime frame
Cumulative blood loss within 48 hours postpartum;Postpartum uterine involution rate;Incidence of postpartum hemorrhage;

Secondary

MeasureTime frame
Blood pressure;

Countries

China

Contacts

Public ContactWang Lan

Chongqing Health Center for Women and Children

1415465088@qq.com+86 23 60354497

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026