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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00864799




Registration number
NCT00864799
Ethics application status
Date submitted
18/03/2009
Date registered
19/03/2009
Date last updated
24/07/2013

Titles & IDs
Public title
Techniques to Improve Efficacy of Second Trimester Medical Termination
Scientific title
Comparison of 3 Regimens Using Mifepristone and Misoprostol for Second Trimester Pregnancy Interruption.
Secondary ID [1] 0 0
1624/EW
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pregnancy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Misoprostol

Active Comparator: Vaginal misoprostol - Women allocated to the vaginal misoprostol management protocol will receive a loading dose of 800 mcg misoprostol vaginally followed in 4 hours by 400 mcg vaginal misoprostol, the latter repeated every 4 hours for a maximum of 4 doses.
If abortion does not occur within 24 hours of commencement of this regimen, the sequence will be repeated.
If delivery is not accomplished within 48 hours of prostaglandin commencement, a transcervical Foley catheter will be inserted and a solution of prostaglandin F2 alpha infused 2-hourly until delivery occurs.

Active Comparator: Oral misoprostol - Women allocated to the standard management protocol will receive a loading dose of 800 mcg misoprostol vaginally followed in 3 hours by 400 mcg misoprostol orally, the latter repeated every 3-hours to a maximum of 4 oral doses.
If abortion does not occur within 24 hours of commencement of this regimen, the sequence will be repeated.
If delivery is not accomplished within 48 hours of prostaglandin commencement, a transcervical Foley catheter will be inserted and a solution of prostaglandin F2 alpha infused 2-hourly until delivery occurs.

Active Comparator: Sublingual misoprostol - Women allocated to the sublingual misoprostol protocol will receive a loading dose of 800 mcg misoprostol vaginally followed in 3 hours by 400 mcg sublingual misoprostol, the latter repeated every 3 hours for a maximum of 4 doses.
If abortion does not occur within 24 hours of commencement of this regimen, the sequence will be repeated.
If delivery is not accomplished within 48 hours of prostaglandin commencement, a transcervical Foley catheter will be inserted and a solution of prostaglandin F2 alpha infused 2-hourly until delivery occurs.


Treatment: Drugs: Misoprostol
Comparison of 3 routes of administration of misoprostol for termination of pregnancy 14-24 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To compare the efficacy of the vaginal and sublingual administration of the synthetic prostaglandin misoprostol with the currently used oral administration route in second trimester pregnancy termination.
Timepoint [1] 0 0
Induction to delivery interval
Secondary outcome [1] 0 0
To compare the incidence of maternal side-effects between the three routes of prostaglandin administration.
Timepoint [1] 0 0
Admission to hospital discharge
Secondary outcome [2] 0 0
To compare the incidence of placental retention and need for curettage between the three groups
Timepoint [2] 0 0
Delivery of fetus to delivery of placenta interval
Secondary outcome [3] 0 0
To compare the impact of gestation of the duration of abortion within these three misoprostol regimens.
Timepoint [3] 0 0
Interval from commencement of prostaglandin to delivery of fetus

Eligibility
Key inclusion criteria
- 14-24 weeks pregnant

- planned medical termination

- able to speak and understand English

- no contraindication to prostaglandins
Minimum age
16 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- gestation < 13 weeks

- allergy/contraindication to misoprostol

- allergy/contraindication to mifepristone

- fetal demise

Study design
Purpose of the study
Treatment
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
1/04/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2013
Sample size
Target
Accrual to date
Final
302
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
King Edward Memorial Hospital
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 synthetic prostaglandin E1 analogue misoprostol. This
prostaglandin, although not licensed for use in pregnancy termination, is now a common
abortifacient with a large accumulated experience both within Australia and internationally.
Since 1996, misoprostol has been used at King Edward Memorial Hospital as the principal agent
for second trimester pregnancy termination.

Misoprostol may be administered vaginally, orally, sublingually or buccally in the process of
pregnancy termination. Each route of administration has its own advantages and disadvantages.
The most appropriate route of administration, with the shortest duration of abortion and
lowest side-effect profile has not been determined for all circumstances.

The combination of mifepristone and misoprostol is an established and effective method for
second trimester pregnancy termination. Prior studies have demonstrated a significant
reduction in the duration of abortion with misoprostol when mifepristone priming is used. In
November 2007, the TGA (Therapeutic Goods Administration) approved an application by the
Principal Investigator of this planned study for Authorised Prescriber status for use of the
antiprogesterone agent mifepristone. Since January 2008 the combination of mifepristone and
misoprostol has been used at KEMH for first and second trimester pregnancy termination of
pregnancy, predominantly for circumstances of severe fetal abnormality.

There is however limited data on the impact of gestation on the duration of second trimester
termination. Almost all published studies to date have recruited women in the early second
trimester (typically with a median of 16 weeks gestation). However, most terminations of
pregnancy for fetal abnormality (the most frequent reason for pregnancy interruption of a
live fetus at KEMH) occur at 18-24 weeks gestation. The investigators' experience indicates a
significant impact of increasing gestation with prolongation of the duration of pregnancy
termination. In this study the investigators aim to evaluate three misoprostol regimens for
second trimester pregnancy termination following mifepristone priming with the primary
intention to develop a protocol which results in a delivery rate within 24 hours for 95% of
women at gestations <24 weeks.

Secondary aims of this study will be to assess the incidence of maternal side-effects for
each of the three regimens, the placental retention rates and the need for curettage for
retained placental tissue. As the investigators will be using 3 different methods of
misoprostol administration, the investigators will also review women's satisfaction with the
three regimens for pregnancy termination.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00864799
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/ct2/show/NCT00864799