Randomized Clinical Trial for Comparison Of Intravenous Carbeitocin Versus Oxytocin In Management Of Placental Delivery In Second Trimester Interruption

October 7, 2013 updated by: Wafaa Uthman Ahmed
Intravenous Carbetocin is more efficient than intravenous infusion oxytocin in management of placental delivery in 2nd trimester interruption.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

140

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Tertiary
      • Cairo, Tertiary, Egypt
        • Recruiting
        • Ain Shams university maternity hospital department of obstetrics and gynacology
        • Contact:
        • Contact:
        • Principal Investigator:
          • WAFAA UT AHMED, M.B.CH.M

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Age:16-50 years
  • Pregnancy duration: 14-24weeks
  • Spontaneous abortion or medical induced abortion at 14-24weeks

Exclusion Criteria:

  • Age less than 16years and more than 50 years
  • Surgical termination
  • Placenta previa
  • Uterine fibroid

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: carbetocin and placebo
100microgram carbetocin IV and 1cc normal saline(placebo)infusion
Drug: oxytocin
Other Names:
  • syntocinon
Drug: Carbetocin
Other Names:
  • pabal
Experimental: oxytocin and placebo
20Interntional unit oxytocin infusion and 1cc normal saline IV
Drug: oxytocin
Other Names:
  • syntocinon
Drug: Carbetocin
Other Names:
  • pabal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Record duration of spontaneous placental expulsion after delivery of fetus in second trimester interruption
Time Frame: at the time of delivery
at the time of delivery

Secondary Outcome Measures

Outcome Measure
Time Frame
Estimation of blood loss in each group by weighing all pads put under the patient after delivery of fetus tell expulsion of placenta( before and after using of pads).
Time Frame: at time of delivery
at time of delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wafaa Uthman Ahmed

Collaborators

Ain Shams Maternity Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Anticipated)

November 1, 2013

Study Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

April 5, 2013

First Submitted That Met QC Criteria

April 8, 2013

First Posted (Estimate)

April 9, 2013

Study Record Updates

Last Update Posted (Estimate)

October 8, 2013

Last Update Submitted That Met QC Criteria

October 7, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ain Shams U

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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