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

JRCT ID: jRCTs041210153

Registered date:02/03/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: none
• Date of first enrollment: 02/03/2022
• Target sample size: 24
• Study type: Interventional
• 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 Outcome: Total blood loss from intraoperative to 2 hours after returning to the ward

Secondary Outcome

1. 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
• Gender: Female

Include criteria

1. 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 criteria

1. 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

• Primary Sponsor: Naruse Satoshi