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Not yet recruiting NCT06560099

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

No phase Interventional Post Partum Hemorrhage

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Oxytocin.
Who it may be relevant to
Registry conditions: Post Partum Hemorrhage. Basic parameters: 20 years — 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Drug Oxytocin
    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 outcome measures

  • blood loss [Time frame: at the end of the operation]
Secondary outcome measures (2)
  • haemoglobin [Time frame: immediate preoperative]
  • haemoglobin [Time frame: 6 hours postoperative]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06560099 · Laura 1 protocol

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗