Comparison Study of Oxytocin Versus Tranexamic Acid and Etamsylaye Versus Placebo(Saline)

NCT ID: NCT05273632

Last Updated: 2023-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-20

Study Completion Date

2022-09-30

Brief Summary

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Comparison Study Between Oxytocin Versus Tranexamic Acid and Ethamsylate Versus Normal Saline as Pre-operative Administration.

Detailed Description

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Comparison Study Between Oxytocin Versus Tranexamic Acid and Ethamsylate Versus Normal Saline to reduce intra operative bleeding and postoperative bleeding during elective Cesarean Delivery.

Conditions

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Blood Loss, Surgical Blood Loss, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Oxytocin

Pre- Operative Oxytocin is given intravenously 5-10 minutes slowly before skin incision

Group Type ACTIVE_COMPARATOR

Oxytocin

Intervention Type DRUG

trial of reduction of losing blood intra operative or post operative during Cesarean Delivery

Tranexamic acid and Etamsylate

Tranexamic acid and Etamsylate are slowly given intravenously 10 minutes before start of Cesarean Delivery

Group Type ACTIVE_COMPARATOR

Oxytocin

Intervention Type DRUG

trial of reduction of losing blood intra operative or post operative during Cesarean Delivery

Saline

Normal saline (about 200 ml) is given intravenously 10 minutes before start of Cesarean Section

Group Type PLACEBO_COMPARATOR

Oxytocin

Intervention Type DRUG

trial of reduction of losing blood intra operative or post operative during Cesarean Delivery

Interventions

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Oxytocin

trial of reduction of losing blood intra operative or post operative during Cesarean Delivery

Intervention Type DRUG

Other Intervention Names

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Tranexamic acid and Etamsylate

Eligibility Criteria

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Inclusion Criteria

* Pregnant females admitted for Elective Cesarean Section.
* Gestational age of pregnancy (38 weeks To 40 weeks).
* the average height of 145 to 160 cm,average body weight of 45 to 85 kgs.
* Singleton living fetus.
* No medical disorders.
* Informed Oral Consent From The Patient.

Exclusion Criteria

* Severe medical and surgical disorders as thyroid dysfunction, which was excluded by routine thyroid function test (free T3, free T4, and thyroid stimulating hormone(TSH), all of them should be within normal limits).
* Bleeding tendency, for example, disseminated intravascular coagulopathy, which was excluded by platelet count, coagulation time, bleeding time, prothrombin time, partial thromboplastin time, and thrombin time (all should be within normal).
* Acute liver or kidney diseases; blood disorders, such as anaemia.
* Allergy to Tranexamic acid.
* Risk factors for PPH, such as polyhydramnios, fetal macrosomia, antepartum haemorrhage.
* Ante partum Hemorrhage such placental abruption.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Egymedicalpedia

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sayed Galal Hospital, Alhusein Hospital, Alzahraa Hospital

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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EL-SAYED EL-DESOUKY

Identifier Type: -

Identifier Source: org_study_id

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