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JAPANESE
国立保健医療科学院
JRCT ID: jRCTs041210153

Registered date:02/03/2022

A prospective study comparing the effects of intramyometrial and continuous intravenous injection of oxytocin

Basic Information

Recruitment status Not Recruiting
Health condition(s) or Problem(s) studiednone
Date of first enrollment25/04/2022
Target sample size24
Countries of recruitment
Study typeInterventional
Intervention(s)Patients undergoing cesarean section will receive oxytocin uterine infusion or continuous intravenous oxytocin after delivery of the baby, and total blood loss will be assessed up to 2 hours after return to the ward. Assignment will be done by randomization.

Outcome(s)

Primary OutcomeTotal blood loss from intraoperative to 2 hours after returning to the ward
Secondary Outcome1. frequency of postpartum hemorrhage (total blood volume >1000 mL) 2. degree of uterine contractions (2 hours after return to the ward) 3. presence of additional oxytocin and total additional dose (from intraoperative to 2 hours after return to the ward) 4. uterine contractions other than oxytocin (methyl erythrocyte) 4. use of uterine contractions other than oxytocin (methylergometrine, prostaglandin F2) 5. surgical intervention (B-Lynch suture, balloon tamponade, gauze tamponade, vascular ligation, hysterectomy, arterial embolization (Interventional Radiology:IVR)) 6. presence and frequency of fundus massage 7.Number of cases of refractory flaccid hemorrhage 8.Blood transfusion 9.Length of hospital stay 10. total dose of phenylephrine after delivery of the child 11. changes in vital signs (blood pressure, heart rate, cardiac output, and cardiac output per cycle)

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum<= 40age old
GenderFemale
Include criteria1. Preoperative ASA-PS (ASA physical status) 2 2. Singleton 3. 37 weeks or more gestation 4.Patients scheduled for elective cesarean section with spinal stem anesthesia 5.Those who are between 20 and 40 years old at the time of obtaining consent. 6.Those who have given their consent for this study by signing the consent form.
Exclude criteria1. Obvious obstetric diseases (uterine fibroids, uterine adenomyosis, endometriotic cysts, giant baby, excessive amniotic fluid, gestational hypertension), cardiac diseases 2. Patients with obvious obstetrical diseases (uterine fibroids, endometrial cysts, giant babies, excessive amniotic fluid, gestational hypertension), cardiac diseases, blood coagulation abnormalities, and spinal diseases that would make it difficult to perform spinal stem anesthesia Those who are in labor. 3. Those whose water has broken. 4.Those with abnormal placental position 5. Those with other placental abnormalities 6. Those with multiple pregnancies 7.Those with uterine malformation 8.Those with oxytocin allergy 9. Obesity (BMI above 30 at 35-36 weeks gestation) 10. Those who have had 3 or more deliveries 11.Those who have a history of postpartum hemorrhage. 12.Those who are judged by the principal investigator or sub-investigator to be inappropriate for inclusion in this study.

Related Information

Contact

Public contact
Name Satoshi Naruse
Address 1-20-1,Handayama,Chuo-ku,Hamamatsu,Shizuoka Shizuoka Japan 431-3192
Telephone +81-53-435-4176
E-mail 07483931@hama-med.ac.jp
Affiliation Hamamatsu University Hospital
Scientific contact
Name Satoshi Naruse
Address 1-20-1,Handayama,Chuo-ku,Hamamatsu,Shizuoka Shizuoka Japan 431-3192
Telephone +81-53-435-4176
E-mail 07483971@hama-med.ac.jp
Affiliation Hamamatsu University Hospital