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Trial details imported from

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Registration number
Ethics application status
Date submitted
Date registered
Date last updated

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
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

Study type
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

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

Key inclusion criteria
- Abortion at 14-24 weeks gestation

- Live fetus

- Medical termination with vaginal misoprostol
Minimum age
16 Years
Maximum age
50 Years
Can healthy volunteers participate?
Key exclusion criteria
- Surgical termination

- Gestation less than 14 weeks or greater than 24 weeks

Study design
Purpose of the study
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
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

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

Funding & Sponsors
Primary sponsor type
The University of Western Australia

Ethics approval
Ethics application status

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
Trial related presentations / publications
Public notes

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
Other publications