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NCT Number: NCT06560099

Standard Oxytocin Versus High Dose Oxytocin to Control Postpartum Hemorrhage in High Risk Pregnancy During Elective Cesarean Section

Controlling hemorrhage during and after a cesarean section reduces significantly maternal mortality and morbidity and the present study is important for detection of the effectiveness of routinely increasing the oxytocin dose instead of using the standard dose only in preventing postpartum hemorrhage and additional use of uterotonics in the first 24 hours after cesarean section for high risk pregnancy.

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Key information

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • - Medical disorders ie: Hypertensive diseases with pregnancy - Diabetes Mellitus - Collagen diseases - Coagulopathies - Cardiac diseases - Anemia
  • History of postpartum hemorrhage
  • Placental disorders ie: placenta previa
  • Infertility and ICSI
  • High Parity
  • History of Endometriosis
  • Fetal disorders (IUGR, IUFD, Preterm, Congenital anomalies, oligohydramnios or polyhydramnios, macrosomia)
  • Preterm labor on uterine relaxants
  • Twins pregnancy
  • Patients on antiplatelets and anticoagulants
  • Uneventful antenatal care

Exclusion criteria

  • - Oxytocin Allergy
  • Normal uncomplicated pregnancy
  • Emergency cesarean section
  • Exhausted uterus due to trial of normal labor
  • Couvelaire uterus

Treatment and study plan

Oxytocin

Drug

will receive 10 IU oxytocin intravenous bolus over one min and infusion of 10 IU oxytocin in 500 ml of 0.9 saline over four hours.

Primary outcomes

  1. blood loss

    Time frame: at the end of the operation

    measure blood in suction, towels and pads

Secondary outcomes

  1. haemoglobin

    Time frame: immediate preoperative

    by laboratory asessment

  2. haemoglobin

    Time frame: 6 hours postoperative

    by laboratory asessment

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 19, 2024
Registry last updated
Aug 19, 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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