NCT01827124

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2013

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

April 5, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 9, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

October 8, 2013

Status Verified

April 1, 2013

Enrollment Period

7 months

First QC Date

April 5, 2013

Last Update Submit

October 7, 2013

Conditions

CARBETOCIN FOR PREVENTION OF PLACENTAL RETAINED

Keywords

CARBETOCIN AND OXYTOCIN AND SECOND TRIMESTER INTERRUPTION

Outcome Measures

Primary Outcomes (1)

  • Record duration of spontaneous placental expulsion after delivery of fetus in second trimester interruption

    at the time of delivery

Secondary Outcomes (1)

  • 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).

    at time of delivery

Study Arms (2)

carbetocin and placebo

EXPERIMENTAL

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

Drug: CarbetocinDrug: oxytocin

oxytocin and placebo

EXPERIMENTAL

20Interntional unit oxytocin infusion and 1cc normal saline IV

Drug: CarbetocinDrug: oxytocin

Interventions

CarbetocinDRUG
Also known as: pabal
carbetocin and placebooxytocin and placebo
oxytocinDRUG
Also known as: syntocinon
carbetocin and placebooxytocin and placebo

Eligibility Criteria

Age16 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams university maternity hospital department of obstetrics and gynacology

Cairo, Tertiary, Egypt

RECRUITING

MeSH Terms

Interventions

carbetocinOxytocin

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Central Study Contacts

WAFAA UTHMAN AHMED, M.B.CH.B

CONTACT

00201119760754WAFAA.UTHMAN@YAHOO.COM

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Ain shams university

Study Record Dates

First Submitted

April 5, 2013

First Posted

April 9, 2013

Study Start

April 1, 2013

Primary Completion

November 1, 2013

Study Completion

December 1, 2013

Last Updated

October 8, 2013

Record last verified: 2013-04

Locations

EG(1)