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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
Scientific title
Optimisation of the Management of Placental Delivery in Second Trimester Pregnancy Interruption
Secondary ID [1] 0 0
EC04-68.1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Placenta, Retained 0 0
Postpartum Hemorrhage 0 0
Condition category
Condition code
Reproductive Health and Childbirth 0 0 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Placental Retention Rate
Timepoint [1] 0 0
3 years
Secondary outcome [1] 0 0
Post-Delivery Blood Loss
Timepoint [1] 0 0
3 years
Secondary outcome [2] 0 0
Endometrial Appearances Postpartum
Timepoint [2] 0 0
3 years

Eligibility
Key inclusion criteria
* Abortion at 14-24 weeks gestation
* Live fetus
* Medical termination with vaginal misoprostol
Minimum age
16 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* Surgical termination
* Gestation less than 14 weeks or greater than 24 weeks

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2007
Sample size
Target
Accrual to date
Final
251
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
King Edward Memorial Hospital - Perth
Recruitment postcode(s) [1] 0 0
6008 - Perth

Funding & Sponsors
Primary sponsor type
Other
Name
The University of Western Australia
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT00120042
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jan E. Dickinson, MD
Address 0 0
The University of Western Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00120042