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Completed

NCT Number: NCT05948436

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clamping the uterine artery bilaterally during Cesarean section

Procedure

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.

Primary outcomes

  1. The rate of blood loss

    Time frame: during C-section

    by measuring the suction canister

  2. The rate of blood loss

    Time frame: during C-section

    by weighting the gauze+abdominal compress+under pads used during C-section after subtracting the tare

  3. The rate of blood loss

    Time frame: 24 hours

    by comparing the preoperative and postoperative hemoglobin and hematocrit values

Secondary outcomes

  1. Operation time

    Time frame: during C-section

    minutes

  2. Postoperative complications

    Time frame: postoperative 48 hours

    need for relaparatomy, vascular or organ injury

  3. neonatal outcomes

    Time frame: during C-section

    APGAR scores

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 17, 2023
Registry last updated
Jan 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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