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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03344302
Other study ID # OACS
Secondary ID
Status Completed
Phase Phase 4
First received November 13, 2017
Last updated April 20, 2018
Start date October 2016
Est. completion date September 2017

Study information

Verified date April 2018
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date September 2017
Est. primary completion date August 2017
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 40 Years
Eligibility Inclusion Criteria:

- Primigravida or multigravida

- Term (37 - 42 weeks),

- Singleton pregnancies

- Booked for elective caesarean section.

- Accepting to participate in the study.

Exclusion Criteria:

- • 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Egypt Assiut Faculty of Medicine Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary rate of blood loss collection of the blood in the drape below the patient 4 hours
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