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Optimisation of the Management of Placental Delivery in Second Trimester Pregnancy Interruption

This study has been completed.
Sponsor:
Information provided by:
The University of Western Australia
ClinicalTrials.gov Identifier:
NCT00120042
First received: July 5, 2005
Last updated: June 29, 2009
Last verified: June 2009
History of Changes
Results First Received: April 1, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Placenta, Retained
Postpartum Hemorrhage
Interventions: Drug: Misoprostol
Drug: Oxytocin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
1 No specific oxytocic to assist in placental delivery
2 Intramuscular oxytocin injection
3 Oral misoprostol to assist in placental delivery

Participant Flow:   Overall Study
    1     2     3  
STARTED     85     83     83  
COMPLETED     85     83     83  
NOT COMPLETED     0     0     0  
all completed protocl                 0                 0                 0  



  Baseline Characteristics
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Reporting Groups
  Description
1 No specific oxytocic to assist in placental delivery
2 Intramuscular oxytocin injection
3 Oral misoprostol to assist in placental delivery
Total Total of all reporting groups

Baseline Measures
    1     2     3     Total  
Number of Participants  
[units: participants]
 		  85     83     83     251  
Age  
[units: participants]
 		       
<=18 years     0     0     0     0  
Between 18 and 65 years     85     83     83     251  
>=65 years     0     0     0     0  
Age  
[units: years]
Median ( Inter-Quartile Range ) 		  32  
  ( 25.5 to 35 )   		  32  
  ( 27 to 36 )   		  30  
  ( 24 to 36 )   		  32  
  ( 26 to 36 )  
Gender  
[units: participants]
 		       
Female     85     83     83     251  
Male     0     0     0     0  
Region of Enrollment  
[units: participants]
 		       
Australia     85     83     83     251  



  Outcome Measures
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1.  Primary:   Placental Retention Rate   [ Time Frame: 3 years ]
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2.  Secondary:   Post-Delivery Blood Loss   [ Time Frame: 3 years ]
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3.  Secondary:   Endometrial Appearances Postpartum   [ Time Frame: 3 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Planned interim analysis not performed as mifepristone became available in Australia. Study ceased at 251 women and enough power available to calculate the groups as a single stage analysis.  


Results Point of Contact:  
Name/Title: Dr Jan Dickinson
Organization: The University of Western Australia
phone: 61-8-93401330
e-mail: Jan.Dickinson@uwa.edu.au


No publications provided


Responsible Party: Dr Jan Dickinson, Associate Professor
ClinicalTrials.gov Identifier: NCT00120042     History of Changes
Other Study ID Numbers: EC04-68.1
Study First Received: July 5, 2005
Results First Received: April 1, 2009
Last Updated: June 29, 2009
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration