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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05948436
Enrollment
99
Registered
2023-07-17
Start date
2023-07-10
Completion date
2023-10-02
Last updated
2024-01-12

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

Conditions

Cesarean Section Complications, Postpartum Hemorrhage

Keywords

postpartum hemorrhage, cesarean section

Brief 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.

Detailed 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.

Interventions

PROCEDUREClamping 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.

Sponsors

Istanbul University - Cerrahpasa
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
The rate of blood lossduring C-sectionby measuring the suction canister

Secondary

MeasureTime frameDescription
Operation timeduring C-sectionminutes
Postoperative complicationspostoperative 48 hoursneed for relaparatomy, vascular or organ injury
neonatal outcomesduring C-sectionAPGAR scores

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026