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

NCT06560099 | Not Yet Recruiting

• 1 other identifier: Laura 1 protocol
• Study Type: interventional
• Target: 39
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Post Partum Hemorrhage

Outcome Measures

Primary Outcomes (1)

• blood loss

  measure blood in suction, towels and pads

  at the end of the operation

Secondary Outcomes (2)

• haemoglobin

  immediate preoperative

• haemoglobin

  6 hours postoperative

Study Arms (2)

Group A (standard oxytocin dose)

ACTIVE COMPARATOR

Drug: Oxytocin

Group B (high dose oxytocin)

ACTIVE COMPARATOR

Drug: Oxytocin

Interventions

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.

Group A (standard oxytocin dose); Group B (high dose oxytocin)

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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

You may not qualify if:

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

Sponsors & Collaborators

• Ain Shams University: lead

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesia

Study Record Dates

• First Submitted: August 15, 2024
• First Posted: August 19, 2024
• Study Start: August 25, 2024
• Primary Completion: April 25, 2025
• Study Completion: April 25, 2025
• Last Updated: August 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share