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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00120042
Registration number
NCT00120042
Ethics application status
Date submitted
5/07/2005
Date registered
14/07/2005
Date last updated
9/07/2009
Titles & IDs
Public title
Optimisation of the Management of Placental Delivery in Second Trimester Pregnancy Interruption
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Scientific title
Optimisation of the Management of Placental Delivery in Second Trimester Pregnancy Interruption
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Secondary ID [1]
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EC04-68.1
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Placenta, Retained
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Postpartum Hemorrhage
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Condition category
Condition code
Reproductive Health and Childbirth
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0
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Fetal medicine and complications of pregnancy
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Misoprostol
Treatment: Drugs - Oxytocin
No intervention: 1 - No specific oxytocic to assist in placental delivery
Active comparator: 2 - Intramuscular oxytocin injection
Active comparator: 3 - Oral misoprostol to assist in placental delivery
Treatment: Drugs: Misoprostol
600 mcg misoprostol swallowed after delivery of fetus
Treatment: Drugs: Oxytocin
10 units oxytocin administered intramuscularly after delivery fetus
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Placental Retention Rate
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Assessment method [1]
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If spontaneous expulsion of the placenta within 60 minutes of fetal delivery did not occur, digital exploration of the uterus in the operating room was planned.
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Timepoint [1]
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3 years
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Secondary outcome [1]
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Post-Delivery Blood Loss
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Assessment method [1]
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Blood loss was assessed by weighing of pads and sheets in addition to clot
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Timepoint [1]
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3 years
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Secondary outcome [2]
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Endometrial Appearances Postpartum
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Assessment method [2]
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Timepoint [2]
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3 years
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Eligibility
Key inclusion criteria
* Abortion at 14-24 weeks gestation
* Live fetus
* Medical termination with vaginal misoprostol
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Minimum age
16
Years
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Maximum age
50
Years
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Surgical termination
* Gestation less than 14 weeks or greater than 24 weeks
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/02/2005
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/12/2007
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Sample size
Target
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Accrual to date
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Final
251
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
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King Edward Memorial Hospital - Perth
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Recruitment postcode(s) [1]
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6008 - Perth
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Funding & Sponsors
Primary sponsor type
Other
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Name
The University of Western Australia
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Interruption of a pregnancy after 14 weeks gestation may be required when the fetus is dead, severely malformed or in cases of maternal illness. This process is usually conducted medically in Australia, using the prostaglandin E1 analogue misoprostol. This prostaglandin, although not specifically licensed for use in pregnancy termination, is now a common abortifacient with a lot of accumulated experience both within Australia and internationally. Since 1996, misoprostol, a synthetic prostaglandin, has been used at King Edward Memorial Hospital as the principal agent for second trimester pregnancy termination. This agent is administered vaginally, and in its current form and dosage regimen results in 75-80% of women delivering within 24 hours. As experience with this agent has grown, it has been observed that in approximately 40% of women the placenta is either completely retained or incompletely delivered, necessitating operative removal and an increased potential for maternal blood loss. In this study, it is planned, in a randomized controlled clinical trial, to evaluate three regimens for the management of placental delivery in women undergoing second trimester pregnancy interruption. The primary intention of this study is to develop a third stage management protocol to reduce the incidence of placental retention in second trimester medical pregnancy termination. The secondary aim of this study is to assess the ultrasound appearance of the uterus and its cavity within 24 hours of second trimester pregnancy termination. The ultrasound appearances of the uterus following second trimester pregnancy loss have not been previously investigated in detail. Previous ultrasound studies of the term postpartum uterus have demonstrated a high incidence of echogenic material within the uterine cavity soon after an uncomplicated vaginal delivery. These findings have been of concern as the ultrasound appearances may erroneously imply a need for operative intervention. The investigators wish to ascertain if this high incidence of echogenic tissue presence is also true in the second trimester. Ultrasound is frequently used by clinicians to define placental completeness and the potential requirement for surgical curettage. The data from this single sonographic examination of the uterus will provide baseline data for a planned longitudinal study of uterine appearances following second trimester pregnancy loss and their correlation with clinical symptoms.
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Trial website
https://clinicaltrials.gov/study/NCT00120042
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Jan E. Dickinson, MD
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Address
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The University of Western Australia
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00120042
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