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Herba Leonuri Injection for Postpartum Hemorrhage Preservation and Uterus Involution Promotion: A Phase 4,Multicentre Randomized Controlled Trial

Herba Leonuri Injection for Postpartum Hemorrhage Preservation and Uterus Involution Promotion: A Phase 4,Multicentre Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-08000136
Enrollment
Unknown
Registered
2008-08-12
Start date
2007-04-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Hemorrhage post caesarean section, spontaneous delivery and surgical abortion

Interventions

Herba Leonuri group:After fetal delivery,firstly, give Herba Leonuri 40mg into uterus by intramuscular injection, then Herba Leonuri 40mg ,q12h for 3 times by intragluteal injection.
Herba Leonuri and Oxytocin group:After fetal delivery, firstly, give Herba Leonuri 40mg and Oxytocin 10IU into uterus by intramuscular injection, then Herba Leonuri 40mg ,q12h for 3 times by intraglut
Oxytocin group:After fetal delivery,firstly, give Oxytocin 10IU into uterus by intramuscular injection and Oxytocin 10IU by intravenous drip, then Oxytocin 10IU ,q12h for 3 times by intragluteal injec

Sponsors

Renji Hospital affiliated to Medical School, Shanghai Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients meet the following criteria: 1. for caesarean section parturients: (1) age ranges from 20 to 34 years old; (2) gestational age more than 37 weeks ,less than 42 weeks; (3) underwent caesarean section; (4) agree to join in the trial and sign the informed consent document. 2. for spontaneous delivery parturients: (1) age ranges from 20 to 34 years old; (2) gestational age more than 37 weeks, less than 42 weeks, following vaginal delivery; (3) spontaneous delivery without prolongation of labor time; (4) agree to join in the trial and sign the informed consent document; 3. surgical abortion woman: (1) terminate early pregnancy with surgical abortion; (2) intrauterine gestation diagnosis by uterus ultrasonography, gestational age more than 50 days, less than 70 days; (3) agree to join in the trial and sign the informed consent document.

Exclusion criteria

Exclusion criteria: Patients meet following criteria: 1. For caesarean section and spontaneous delivery parturients: (1) hepatitis or liver dysfunction; (2) accompany with plate reduction or blood coagulation disorder; (3) receive tocolytic therapy 48 hours before operation; (4) placenta previa, placental abruption ormanual removal of placenta; (5) patients refuse to sign the informed consent document. 2. For surgical abortion woman: (1) patients with pregnancy complications; (2) hepatitis or liver dysfunction; (3) accompany with plate reduction or blood coagulation disorder; (4) patients refuse to sign the informed consent document.

Design outcomes

Primary

MeasureTime frame
Vaginal bleeding quantity within 48 hours after operation;Vaginal bleeding quantity within 24 hours after operatoin;Vaginal bleeding quantity within 12 hours after operation;Vaginal bleeding quantity within 2 hours after operation;Vaginal bleeding quantity during operation;Vaginal bleeding quantity within 72 hours after operation;

Secondary

MeasureTime frame
Supplementary tocolytic drug dosage;Hemoglobin content;Rate of postpartum haemorrhag;

Countries

China

Contacts

Public ContactLin Qide
wdryy@126.com+86 021 58752345-3417

Outcome results

None listed

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