The Impact of Mechanical Methods on the Postpartum Haemorrhage Prophylaxis During Caesarean Section

Cesarean Section Complications Clinical Trial

Official title:

The Impact of Mechanical Methods on the Postpartum Haemorrhage Prophylaxis During Caesarean Section; A Randomized-Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05948436
• Other study ID #: 37612
• Status: Completed
• Phase: N/A
• Start date: July 10, 2023
• Est. completion date: October 2, 2023

Study information

• Verified date: January 2024
• Source: Istanbul University - Cerrahpasa (IUC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The rate of heavy blood loss is higher in Cesarean delivery compared to vaginal deliveries. Since postpartum hemorrhage is a life threatening situation to decrease the maternal mortality and morbidity rates, precautions should be taken. In this study, we aim to decrease the amount of postpartum hemorrhage by clamping the uterine artery after the delivery of the baby during Cesarean delivery.

Description:

Obstetrical hemorrhage, is the most common cause of maternal mortality and morbidity that could be prevented. It can appear at early and late stage of delivery and after delivery. It Is defined as loss of more than 500 mL of blood in vaginal deliveries, whereas more than 1L of blood during C-section. The rate of heavy blood loss is higher in Cesarean delivery compared to vaginal deliveries. The incidence of postpartum anemia in Europe is 50% while in developing countries like Turkey it rises up to 50-80%. Since postpartum hemorrhage is a life threatening situation to decrease the maternal mortality and morbidity rates, precautions should be taken. To preserve the hemoglobin concentrations and hemostasis and to optimize the patient's results, evidence-based methods should be performed. Given these circumstances, interventions using pharmacological, mechanical and surgical methods are necessary to minimize the blood loss. Uteroronics are the first line treatment options followed by fundal massage, controlled traction of cord and delivery of placenta, bimanual compression, intrauterine hydrostatic balloon. After these interventions, surgical interventions such as compression sutures, bilateral uterine artery ligation, hysterectomy and pelvic tamponade could be performed. In this study, we aim to decrease the amount of preoperative part of postpartum hemorrhage by clamping the uterine artery by Darmklemmen clamp after the delivery of the baby before the delivery of placenta during Cesarean delivery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: October 2, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Women gave birth >37 GW
• singleton pregnancy
• with normal fetal development
• Not emergency C-section

Exclusion Criteria:

• C/sections with indications of plasenta prevue or placenta acrreta spectrum
• with amniotic fluid abnormalities
• multiple pregnancies
• threatened preterm labor
• who have preeclampsia or other type of obstetrical complications
• maternal obesity (BMI>30kg/m2)
• maternal cardiovascular disease, hypertension, coagulation defects, women who use anticoagulants
• patients who underwent Cesarean section during active labor

Related Conditions & MeSH terms

• Cesarean Section Complications
• Hemorrhage
• Postpartum Hemorrhage

Intervention

Procedure:
• Clamping the uterine artery bilaterally during Cesarean section
We clamped the uterine artery by Darmklemmen clamp, which grasps the tissue delicately without damage, after the delivery of the baby before the delivery of placenta. The clamp is released after the suturing of Munro-Kerr incision is finished, before bleeding control. The duration of clamping time is recorded.

Locations

Country	Name	City	State
Turkey	Istanbul University-Cerrahpasa	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University - Cerrahpasa (IUC)

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of blood loss	by measuring the suction canister	during C-section
Primary	The rate of blood loss	by weighting the gauze+abdominal compress+under pads used during C-section after subtracting the tare	during C-section
Primary	The rate of blood loss	by comparing the preoperative and postoperative hemoglobin and hematocrit values	24 hours
Secondary	Operation time	minutes	during C-section
Secondary	Postoperative complications	need for relaparatomy, vascular or organ injury	postoperative 48 hours
Secondary	neonatal outcomes	APGAR scores	during C-section