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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]

EC04-68.1

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Placenta, Retained

Postpartum Hemorrhage

Condition category

Condition code

Reproductive Health and Childbirth

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]

Treatment: Drugs

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Placental Retention Rate

Timepoint [1]

3 years

Secondary outcome [1]

Post-Delivery Blood Loss

Timepoint [1]

3 years

Secondary outcome [2]

Endometrial Appearances Postpartum

Timepoint [2]

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?

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)

Recruitment hospital [1]

King Edward Memorial Hospital - Perth

Recruitment postcode(s) [1]

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

Jan E. Dickinson, MD

Address

The University of Western Australia

Country

Phone

Fax

Contact person for public queries

Name

Address

Country

Phone

Fax

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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Trial Review

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00120042