Postpartum hemorrhage
Conditions
Interventions
A:Maternal intravenous injection of 1g of tranexamic acid after the umbilical cord is cut or clamped.
B:Maternal intravenous injection of normal saline after the umbilical cord is cut or clamped.
Sponsors
Tianjin Central Hospital of Gynecology Obstetrics
Eligibility
Sex/Gender
Female
Age
14 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Planned vaginal delivery; 2. Signed informed consent; 3. Patients with one or more PPH risk factors as follows; (1) Prenatal risk factors: 1) Parity>3; 2) BMI>=30 kg/m2; 3) Gestational diabetes; 4) Hydramnios; 5) Maternal age>=35 years or <18 years; 6) Uterine fibroids; 7) Multiple pregnancies; 8) Premature rupture of membranes; 9) Non-cephalic delivery; 10) History of uterine surgery ; 11) Placenta previa marginalis; 12) Anemia (Hb < 110g/ L); 13) The history of PPH; 14) Assisted reproductive technology; 15) Induced labor; (2) Perinatal risk factors: 1) Prolonged second stage of labor; 2) Prolonged third stage of labor; 3) Use of obstetric apparatus (fetal suction, forceps); 4) Matenal body temperature is above 38?; 5) Precipitate labour; 6) Placenta and fetal membranes retention which need to be cleared; 7) Placental adhesions and suspected implantation which require manual intervention. 8) Laceration of cervix and vagina; 9) Macrosomia; 10) Perineal trauma (laceration of grade II and above, episiotomy).
Exclusion criteria
Exclusion criteria: 1. Patients with drug contraindications for TXA; 2. A history of venous or arterial thrombosis (deep venous thrombosis; pulmonary embolism; angina, myocardial infarction, stroke and so on); thrombophilia; 3. Known cardiovascular,kidney or liver disease; autoimmune diseases; hematological system diseases and coagulation dysfunction; 4. Gestational hypertension, preeclampsia, HELLP syndrome, eclampsia; 5. History of epilepsy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of postpartum hemorrhage,defined by blood loss >= 500 mL 24h after vaginal delivery.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean blood loss 2 hours after delivery ;Incidence of severe postpartum hemorrhage,defined by blood loss >= 1000 mL 24h after vaginal delivery;The occurrence of potential mild adverse effects of TXA while in hospital,including nausea ,vomiting ,phosphenes and dizziness ; The occurrence of potential severe adverse effects of TXA 30 days after delivery. ; | — |
Countries
China
Contacts
Public ContactChen Xu
Tianjin Central Hospital of Gynecology Obstetrics
Outcome results
None listed