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

NCT ID: NCT01827124

Last Updated: 2013-10-08

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2013-12-31

Brief Summary

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Intravenous Carbetocin is more efficient than intravenous infusion oxytocin in management of placental delivery in 2nd trimester interruption.

Detailed Description

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Conditions

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CARBETOCIN FOR PREVENTION OF PLACENTAL RETAINED

Keywords

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CARBETOCIN AND OXYTOCIN AND SECOND TRIMESTER INTERRUPTION

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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carbetocin and placebo

100microgram carbetocin IV and 1cc normal saline(placebo)infusion

Group Type EXPERIMENTAL

Carbetocin

Intervention Type DRUG

oxytocin

Intervention Type DRUG

oxytocin and placebo

20Interntional unit oxytocin infusion and 1cc normal saline IV

Group Type EXPERIMENTAL

Carbetocin

Intervention Type DRUG

oxytocin

Intervention Type DRUG

Interventions

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Carbetocin

Intervention Type DRUG

oxytocin

Intervention Type DRUG

Other Intervention Names

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pabal syntocinon

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams Maternity Hospital

OTHER

Sponsor Role collaborator

Wafaa Uthman Ahmed

OTHER

Sponsor Role lead

Responsible Party

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Wafaa Uthman Ahmed

Ain shams university

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Ain Shams university maternity hospital department of obstetrics and gynacology

Cairo, Tertiary, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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WAFAA UTHMAN AHMED, M.B.CH.B

Role: CONTACT

Phone: 00201119760754

Email: [email protected]

Facility Contacts

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Ahmed M Ibrahim, ass. prof

Role: primary

Mohamed SE El-safty 002, lecturer

Role: backup

Other Identifiers

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Ain Shams U

Identifier Type: -

Identifier Source: org_study_id