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NCT Number: NCT03578263

Carbetocin Versus Oxytocin and Ergometrine for the Prevention of Postpartum Hemorrhage

The cesarean section is a bloody operation, about 750 to 1000 ml are lost at most operations and over 1000 ml of blood have lost to bring them into the definition of a postpartum hemorrhage (PPH). In developing countries, PPH is the main cause of maternal deaths. Uterine atony is the most common cause of immediate heavy PPH.Multiple pregnancy ones of a common factor for uterine atony. The administration of oxytocic's after the delivery of the neonate reduces the likelihood of PPH and 5 IU oxytocin by slow intravenous injection is currently recommended for all cesarean sections. However, the use of additional oxytocic medication is common, to arrest bleeding, or prophylactically if there are risk factors for PPH . Carbetocin is a synthetic analog of human oxytocin with structural modifications that increase its half-life, thereby prolonging its pharmacological effects. Carbetocin has been approved in 23 countries for prevention of uterine atony and excessive bleeding following cesarean delivery in spinal or epidural anesthesia. Oxytocin is a peptide of nine amino acids (Nona peptide). The structure of oxytocin is very similar to that of arginine vasopressin, whose sequence differs from oxytocin by 2 amino acids. The best-known mechanism for oxytocin to exert its stimulatory effect on myometrial contractility is by increasing the intracellular concentration of calcium. Owing to its short plasma half-life (mean 3 min), a continuous intravenous infusion is required to maintain the uterus in a contracted state. The usual dose is 20 IU in 500 ml of crystalloid solution, with the dosage rate adjusted according to response. Ergometrine is a selective and moderately potent tryptaminergic receptor antagonist in various smooth muscles, being only a partially agonistic or antagonistic at tryptaminergic receptors in the central nervous system. In blood vessels, the alkaloid is only weakly antagonistic of dopaminergic receptors and partially agonistic of α-adrenergic receptors. oxytocin (19%). Blood loss>500 ml was only observed in women who received oxytocin. The aim of the investigator's study was to compare the effect of carbetocin vs. oxytocin and ergometrine for prevention of PPH during cesarean section in women with multiple pregnancies.

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Key information

About this study

Women included in the study were divided into 2 groups: Group (A): included patients who received carbetocin 100 µg diluted in 10 ml normal saline and administered slowly (over 30-60 seconds) intravenously by anesthetist after the birth of the baby. Group (B): included patients who received a combination of intraoperative oxytocin 5 I.U which was diluted in 10 ml normal saline and administered slowly over (30-60 seconds) intravenously by anesthetist and intramuscular ergometrine 0.2 mg. The slow administration has been shown to reduce the potentially harmful hemodynamic effects of oxytocin (and presumably carbetocin). Also, intramuscular injection of ergometrine did the same. All women were subjected to full history taking, general and obstetric examination and investigations in the form of preoperative routine labs and obstetric ultrasound, and postoperative serum hemoglobin %.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • women with a multiple term pregnancy undergoing elective cesarean section

Exclusion criteria

  • single gestation
  • placenta praevia and placental abruption
  • undergoing cesarean section with general anesthesia
  • women undergoing cesarean section at less than 37 weeks of gestation
  • with a severe medical disorder

Treatment and study plan

Carbetocin

Drug

Group (A): included 100 patients who received carbetocin 100 µg diluted in 10 ml normal saline and administered slowly (over 30-60 seconds) intravenously by anesthetist after the birth of the baby.

Other names: Pabal

Oxytocin

Drug

Group (B): included 100 patients who received a combination of intraoperative oxytocin 5 I.U which was diluted in 10 ml normal saline and administered slowly over (30-60 seconds) intravenously by anesthetist and

Other names: Active Comparator

ergometrine

Drug

intramuscular ergometrine 0.2 mg.

Other names: Active Comparator

Primary outcomes

  1. estimation of intraoperative blood loss (ml).

    Time frame: intraoperative

    Intraoperative blood loss was measured suction bottle and the difference in weight (in grams) between the dry and the soaked operation sheets and towels (1 gram = 1 ml.). Post-operative blood loss was measured through intraperitoneal suction drain which measured every 12 hours and on removing the drain. After that, the total blood loss was calculated by the addition of intraoperative and postoperative blood loss.and vaginal bleeding

Secondary outcomes

  1. need for blood transfusion

    Time frame: 24 hours postoperative

    need for blood transfusion

  2. Hemoglobin concentration

    Time frame: ist 24 hours postoperative]

    pre and postoperative hemoglobin estimation

Sponsors and collaborators

Lead sponsor

Aswan University Hospital

Other

Registry information

Official study title

Carbetocin Versus Oxytocin and Ergometrine for Prevention of Postpartum Hemorrhage Following a Cesarean Section in Women With Multiple Gestation

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 6, 2018
Registry last updated
Aug 5, 2020

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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