Oxytocin Administration During Cesarean Section

NCT03344302 | Completed Phase 4

• 1 other identifier: OACS
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Cesarean delivery is defined as fetal birth through incisions in the abdominal wall and the uterine wall. This definition does not include removal of the fetus from the abdominal cavity in the case of uterine rupture or in the case of an abdominal pregnancy The guidelines of the Royal College of Obstetricians and Gynaecologists on caesarean section recommend a slow intravenous bolus dose of 5 IU of oxytocin after delivery of the infant. Intravenous oxytocin has a short half life (4-10 minutes); therefore the potential advantage of an oxytocin infusion at caesarean section is in maintaining uterine contractility throughout the surgical procedure and immediate postpartum period, when most primary haemorrhage occurs

Conditions

Postpartum Hemorrhage

Outcome Measures

Primary Outcomes (1)

• rate of blood loss

  collection of the blood in the drape below the patient

  4 hours

Study Arms (2)

study group

EXPERIMENTAL

100 women were assigned to receive an intravenous infusion of oxytocin 30 units in a rate 125 mL/hour minutes diluted into 500 mL of normal 0.9% sodium chloride) immediately after opening the visceral peritoneum just before incising the uterine wall during Cesarean section

Drug: Oxytocin

Control group

ACTIVE COMPARATOR

100 women were assigned to an intravenous infusion of oxytocin 30 units in a rate 125 mL/hour diluted into 500 mL of normal 0.9% sodium chloride) immediately after clamping the umbilical cord during cesarean section

Drug: Oxytocin

Interventions

Oxytocin DRUG

intravenous infusion of oxytocin 30 units over 5 minutes diluted into 500 mL of normal 0.9% sodium chloride

Control group; study group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Primigravida or multigravida
• Term (37 - 42 weeks),
• Singleton pregnancies
• Booked for elective caesarean section.
• Accepting to participate in the study.

You may not qualify if:

• Medical disorders involving the heart, liver, kidney or brain.
• Diabetes mellitus and hypertension.
• Blood disorders (e.g. coagulopathies, thrombocytopenia)
• Patients requiring blood transfusion due to anemia.
• Risk factors for uterine atony e.g. macrosomia, polyhydramnios and multiple pregnancy.
• Previous 2 or more cesarean section
• Placenta previa or placental abruption
• Previous major obstetric haemorrhage (\>1000 ml) in previous deliveries.
• Known fibroid or adenomyosis.
• Women who received anticoagulant therapy.
• Severe preeclampsis.
• Uterine anomalies.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut Faculty of Medicine

Asyut, Egypt

Location

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: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: November 13, 2017
• First Posted: November 17, 2017
• Study Start: October 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: September 1, 2017
• Last Updated: April 23, 2018

Record last verified: 2018-04

Locations

EG (1)