Comparison of Sublingual Misoprostol and Intravenous Oxytocin in Active Management of the Third Stage of Labor

Postpartum Hemorrhage Prevention by Using Oxytocin Verses Misoprostol Clinical Trial

Official title:

Comparison of Sublingual Misoprostol and Intravenous Oxytocin in Active Management of the Third Stage of Labor

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01612390
• Other study ID #: hit 1234
• Status: Not yet recruiting
• Phase: Phase 0
• First received: June 2, 2012
• Last updated: June 4, 2012
• Start date: August 2012
• Est. completion date: December 2013

Study information

• Verified date: June 2012
• Source: Ain Shams University
• Contact: Rasha mohamed, M.B;B.CH
• Email: abosalma_82[@]yahoo.com
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Health and Population
• Study type: Observational

Clinical Trial Summary

Sublingual misoprostol is superior to oxytocin in reduction of blood loss during the third and fourth stages of labor

Description:

Sublingual misoprostol is superior to oxytocin in reduction of blood loss during the third and fourth stages of labor as The data from a pharmacokinetics study suggested that the bioavaiblitiy of misoprostol after sub-lingual administration was higher than those after oral or vaginal administration

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: December 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Women with aheathy singleton pregnancy in spontaneous or induced labor at term .

Exclusion Criteria:

• Hypersensitivity/Contraindication to prostaglandins Antepartum hemorrhage Multiple pregnancy Cardiac disease Malpresentation Rhesus- negative mother hypersensitive disorders Severe anaemia(hemoglobin<7g/dl)

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Hemorrhage
• Postpartum Hemorrhage Prevention by Using Oxytocin Verses Misoprostol

Locations

Country	Name	City	State
Egypt	AinShamsU	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
Rasha Mohammed Mohammed Badawi	Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reduce blood loss during third and fourth stages of labor.	reduce blood loss during third and fourth stages of labor by using misopristol is better than using oxytocin	1 year	No
Secondary	the duration of the third stage of labor ,need for oxytocics ,blood transfusion and any adverse effects of the drugs	the duration of the third stage of labor ,needed for oxytocics ,blood transfusion and any adverse effects of the drug will be reduced with mesopristol	1 year	No