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Trial registered on ANZCTR


Registration number
ACTRN12620000596909p
Ethics application status
Submitted, not yet approved
Date submitted
21/04/2020
Date registered
22/05/2020
Date last updated
22/05/2020
Date data sharing statement initially provided
22/05/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Progesterone after mifepristone, for women whose decision has changed after commencing a medical termination of pregnancy - a pilot clinical trial
Scientific title
Progesterone after mifepristone – pilot for efficacy and reproducibility (PAMper Trial): a prospective single-arm clinical trial of progesterone after mifepristone for women whose decision has changed regarding medical termination of their pregnancy.
Secondary ID [1] 301063 0
Nil known
Universal Trial Number (UTN)
U1111-1250-6075
Trial acronym
PAMper Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pregnancy continuation after mifepristone 317119 0
Condition category
Condition code
Reproductive Health and Childbirth 315280 315280 0 0
Other reproductive health and childbirth disorders
Reproductive Health and Childbirth 315517 315517 0 0
Abortion

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will take 4 x 100 mg progesterone capsules orally twice a day for 3 days then once a day at night (bedtime) for 16 days. Treatment with progesterone must be initiated within 72 hours of taking mifepristone. To monitor adherence participants will be asked to complete a medication record sheet and asked about progesterone use during their last follow up conversation with their prescriber.
Intervention code [1] 317366 0
Treatment: Drugs
Comparator / control treatment
This is a single-arm study to be compared against published efficacy for pregnancy rates when women take mifepristone only for medical termination of pregnancy (MTOP).
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323522 0
Viable pregnancy as determined by ultrasound.
Timepoint [1] 323522 0
Two weeks after intervention commencement.
Secondary outcome [1] 382150 0
Comparison of viable pregnancies 14 days after commencing treatment with progesterone with live births within this cohort.
Timepoint [1] 382150 0
End of pregnancy.
Secondary outcome [2] 382151 0
The effect of elapsed time (hours) between mifepristone ingestion and first dose of progesterone on continuing pregnancy.
Elapsed time calculated from self reported time and date of both ingestion of mifepristone and first dose of progesterone.
Continuing pregnancy determined by ultrasound scan,


Timepoint [2] 382151 0
14 days post intervention commencement.
Secondary outcome [3] 382152 0
Gestational age at birth (timepoint: recording of gestational age at delivery of liveborn infant). Assessed by patient provided formal report/discharge.
Timepoint [3] 382152 0
End of pregnancy.
Secondary outcome [4] 382153 0
Adverse events - self reported medication issues, Self-reported by use of formal medication diary
Timepoint [4] 382153 0
During intervention and end of pregnancy
Secondary outcome [5] 382154 0
Emotional state assessed using DASS21
Timepoint [5] 382154 0
Day 2 after intervention commencement and week 22-24 of gestation
Secondary outcome [6] 382155 0
Level of conflict in the decision to use progesterone assessed with the Decisional Conflict Scale
Timepoint [6] 382155 0
Day 1 prior to referral to primary care clinician.
Secondary outcome [7] 382156 0
Level of regret in the decision to use progesterone if the outcome was a non-viable pregnancy assessed using the Decision Regret Scale
Timepoint [7] 382156 0
Exit interview following miscarriage.
Secondary outcome [8] 382157 0
Exploration of women's experience of MTOP and seeking to keep their pregnancy after initiating MTOP using open ended interview questions. Data collected through open ended interviews with participants and analysed using Grounded Theory methodology.
Timepoint [8] 382157 0
At 4 defined times ( Day 1 (baseline), Day 2, 22-24 weeks gestation and 44 weeks gestation) and at other times when facilitated by the participant.
Secondary outcome [9] 382718 0
The effect gestational age at time of ingestion of mifepristone has on continuing pregnancy.
Gestational age at mifepristone ingestion – based on the best available ultrasound report
Continuing pregnancy determined by ultrasound scan,
Timepoint [9] 382718 0
14 days post intervention commencement,
Secondary outcome [10] 382796 0
Miscarriage (timepoint: below 20 weeks gestation) Assessed by patient provided formal ultrasound or self-report.
Timepoint [10] 382796 0
End of pregnancy..
Secondary outcome [11] 382805 0
Stillbirth (timepoint: any point from 20 weeks till diagnosis). Assessed by patient provided formal report/ultrasound or self-report.
Timepoint [11] 382805 0
End of pregnancy..
Secondary outcome [12] 382807 0
Livebirth (timepoint: any point after 23 weeks gestation). Assessed by patient provided formal report/discharge or self-report.
Timepoint [12] 382807 0
End of pregnancy..
Secondary outcome [13] 382809 0
Birth weight (timepoint: weight in grams recorded at time of birth). Assessed by patient provided formal report/discharge or self-report..
Timepoint [13] 382809 0
End of pregnancy..
Secondary outcome [14] 382814 0
Adverse events - Congenital anomalies, Assessed by patient provided formal report/discharge.
Timepoint [14] 382814 0
End of pregnancy.
Secondary outcome [15] 382815 0
Adverse events - Neonatal morbidity composite (respiratory distress of the newborn, intensive or special care nursery admission). Assessed by patient provided formal report/discharge.
Timepoint [15] 382815 0
End of pregnancy.

Eligibility
Key inclusion criteria
Women who:
- have ingested mifepristone within the last 72 hours to initiate MTOP
- have not taken any misoprostol;
- have no contraindications for use of progesterone, including known allergy or hypersensitivity to progesterone or to any of the excipients, severe hepatic dysfunction, undiagnosed vaginal bleeding, known missed miscarriage or ectopic pregnancy, mammary or genital tract carcinoma, thromboembolic disorders, thrombophlebitis, cerebral haemorrhage, or porphyria.
- live in Australia;
- provide the name of their usual or nominated medical practitioner; and
- understand English, or utilise the assistance of an accredited interpreter if appropriate.
Minimum age
18 Years
Maximum age
45 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women who
- are unable to take their first dose of progesterone within 72 hours of taking mifepristone;
- are not living in Australia;
- wish to continue with MTOP and take misoprostol; or
- declined permission for communication between the trial coordinator and their usual or nominated medical practitioner regarding trial participation.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Single group
Other design features
The primary outcome data (viability at 2 weeks post commencement of intervention) will be coded by the Trial coordinator so that those involved with the quantitative data analysis will not know the outcome groups. The quantitative data will be unblinded after the analysis is complete.
Phase
Phase 2
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Continuation of pregnancy has been reported to be 0-25% if mifepristone is used alone. Assuming a clinically significant response being continuing viability of 50% after oral progesterone, a sample size of 26 is required. Allowing for a previously published 50% attrition rate, 52 women would need to be enrolled.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 305505 0
University
Name [1] 305505 0
University of New England
Address [1] 305505 0
University of New England
Armidale NSW 2351
Country [1] 305505 0
Australia
Funding source category [2] 305507 0
Other
Name [2] 305507 0
Australasian Pharmaceutical Science Association (APSA)
Address [2] 305507 0
info@apsa-online.org
Country [2] 305507 0
Australia
Primary sponsor type
University
Name
University of New England
Address
University of New England
Armidale NSW 2351
Country
Australia
Secondary sponsor category [1] 305906 0
None
Name [1] 305906 0
Address [1] 305906 0
Country [1] 305906 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 305817 0
University of New England Human Research Ethics Committee
Ethics committee address [1] 305817 0
University of New England
Armidale NSW 2351
humanethics@une.edu.au
Ethics committee country [1] 305817 0
Australia
Date submitted for ethics approval [1] 305817 0
29/04/2020
Approval date [1] 305817 0
Ethics approval number [1] 305817 0

Summary
Brief summary
Medical termination of pregnancy (MTOP) is a two stage process, women take mifepristone first, then take misoprostol 36 to 48 hours later. If women do not take misoprostol after taking mifepristone the continuing pregnancy rate varies from 0 to 25%.[1] There is evidence that some women decide they want to continue their pregnancy after initiating a MTOP. Currently there are no clinical guidelines for managing these women.
The PAMper Trial aims to assess the efficacy of progesterone after mifepristone as % of viable pregnancies 2 weeks after initiation of progesterone, as determined by ultrasound, and % of live births. It will also report on relevant clinical factors associated with the use of progesterone after mifepristone and explore the experiences of women who take mifepristone then decide they want to continue their pregnancy. Participants will be women who have taken mifepristone then contact the trial centre because they now want to continue their pregnancy. It is expected that the pregnancy continuation rate 2 weeks after commencing treatment will be statistically greater than 25% and could be be over 50%.
[1] Davenport ML, Delgado G, Harrison MP, Khauv V Embryo survival after mifepristone: a systematic review of the literature. Issues in Law & Medicine. 2017;32(1):3-18.
Trial website
https://pamtrial.org.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 101702 0
A/Prof M Joy Spark
Address 101702 0
School of Rural Medicine
University of New England
Armidale NSW 2351
Country 101702 0
Australia
Phone 101702 0
+61 2 6773 1705
Fax 101702 0
Email 101702 0
jspark@une.edu.au
Contact person for public queries
Name 101703 0
A/Prof M Joy Spark
Address 101703 0
School of Rural Medicine
University of New England
Armidale NSW 2351
Country 101703 0
Australia
Phone 101703 0
+61 2 6773 1705
Fax 101703 0
Email 101703 0
jspark@une.edu.au
Contact person for scientific queries
Name 101704 0
A/Prof M Joy Spark
Address 101704 0
School of Rural Medicine
University of New England
Armidale NSW 2351
Country 101704 0
Australia
Phone 101704 0
+61 2 6773 1705
Fax 101704 0
Email 101704 0
jspark@une.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Initiating an abortion and then deciding to continue with the pregnancy is a controversial topic. There is a chance that de-identified data could be identifiable so IPD will not be shared.
What supporting documents are/will be available?
No other documents available
Summary results
No Results