Condition category
Pregnancy and Childbirth
Date applied
11/02/2015
Date assigned
11/02/2015
Last edited
11/10/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
One in five pregnancies miscarry, and the loss of an unborn baby has the potential to cause both physical harm and psychological distress. A recently launched NICE guideline has urged that a large and robust randomised controlled clinical trial should be done to clarify whether progesterone treatment for women with bleeding in early pregnancy reduces the risk of miscarriage.

Who can participate?
Women between the ages of 18-39 who have bleeding in early pregnancy (up to 12 weeks).

What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 are given progesterone capsules to place into their vagina twice a day to up to 16 weeks of pregnancy. Those in group 2 are given placebo capsules to be administered in the same way. The main outcome of the study is live birth beyond 34 weeks of pregnancy. A number of other key outcome measures, including gestation at birth, miscarriage rates and the condition of the baby at 28 days of life, are also collected and analysed and we gather resource-use outcomes to perform a health economic evaluation.

What are the possible benefits and risks of participating?
We do not know whether each participant will benefit personally from taking part in this study, but the knowledge gained thanks to their help will inform future treatment and potentially lead to improved antenatal care and pregnancy outcomes for women in the future. Previous studies using progesterone treatment during pregnancy have found very little evidence of risks for the mother or the baby. However, some women may experience swollen hands or feet, bloating, headache, sleeplessness, diarrhoea or jaundice.

Where is the study run from?
12 NHS hospitals in the UK

When is the study starting and how long is it expected to run for?
October 2014 to September 2017

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Professor Arri Coomarasamy

Trial website

Contact information

Type

Scientific

Primary contact

Ms Arri Coomarasamy

ORCID ID

Contact details

Birmingham Women's Hospital
Metchley Park Road
Edgbaston
Birmingham
B15 2TG
United Kingdom

Additional identifiers

EudraCT number

2014-002348-42

ClinicalTrials.gov number

Protocol/serial number

18314

Study information

Scientific title

Effectiveness of progesterone to prevent miscarriage in women with early pregnancy bleeding: A randomised placebo-controlled trial (PRISM Trial: PRogesterone In Spontaneous Miscarriage Trial)

Acronym

PRISM

Study hypothesis

The aim of this trial is to clarify the evidence that progesterone treatment for women with bleeding in early pregnancy can reduce the risk of miscarriage.

Ethics approval

NRES Committee South Central – Oxford C, 26/11/2014, ref: 14-SC-1345

Study design

Randomised; Interventional; Design type: Not specified, Prevention

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a patient information sheet

Condition

Topic: Reproductive health and childbirth; Subtopic: Reproductive Health and Childb (all Subtopics); Disease: Reproductive Health & Childbirth

Intervention

1. Placebo: The placebo will be a vaginal capsule, encapsulated in the same form as the IMP, and identical in colour, shape and weight
2. Progesterone: The Investigational Medicinal Product (IMP) is progesterone at a dose of 400mg to be taken as vaginal pessaries twice daily from confirmation of an intrauterine gestation sac visible on ultrasonography until 16 completed weeks of pregnancy or until miscarriage is confirmed

Intervention type

Drug

Phase

Drug names

Progesterone

Primary outcome measures

Live birth beyond 34 completed weeks of gestation; Timepoint(s): Pregnancy end

Secondary outcome measures

1. Adverse events; Timepoint(s): Throughout pregnancy and up to 28 days of neonatal life
2. Antenatal complications; Timepoint(s): Until pregnancy end
3. APGAR score; Timepoint(s): Pregnancy end beyond 24 weeks
4. Arterial cord pH; Timepoint(s): Pregnancy end beyond 24 weeks
5. Birthweight; Timepoint(s): Pregnancy end beyond 24 weeks
6. Chromosomal and congenital abnormalities; Timepoint(s): Pregnancy end
7. Gestation at delivery; Timepoint(s): Pregnancy end
8. Miscarriage; Timepoint(s): Up to 24 weeks of gestation
9. Mode of delivery; Timepoint(s): Pregnancy end beyond 24 weeks
10. Neonatal complications; Timepoint(s): Live birth
11. Neonatal survival; Timepoint(s): 28 days of neonatal life
12. Ongoing pregnancy at 12 weeks of gestation; Timepoint(s): 11-13 weeks of gestation
13. Requirements for resuscitation; Timepoint(s): Pregnancy end beyond 24 weeks
14. Resource use; Timepoint(s): Throughout pregnancy and up to 28 days of neonatal life
15. Surfactant use; Timepoint(s): Live birth
16. Venous cord pH; Timepoint(s): Pregnancy end beyond 24 weeks
17. Ventilation support; Timepoint(s): Live birth

Overall trial start date

01/10/2014

Overall trial end date

30/06/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Women presenting with vaginal bleeding in the first 12 weeks of pregnancy with an intrauterine gestation sac visible on ultrasonography
2. Upper Age Limit 39 years
3. Lower Age Limit 18 years

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Planned Sample Size: 4150; UK Sample Size: 4150

Participant exclusion criteria

1. Women of age less than 18 years or more than 40
2. Women with life-threatening bleeding
3. Women already taking progesterone supplementation therapy
4. Women with contraindications to progesterone use

Recruitment start date

01/03/2015

Recruitment end date

31/05/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Birmingham Women's Hospital
Metchley Park Road Edgbaston
Birmingham
B15 2TG
United Kingdom

Trial participating centre

Queen Charlotte's and Chelsea Hospital
London
W12 0HS
United Kingdom

Trial participating centre

Royal Infirmary of Edinburgh
Edinburgh
EH16 4SA
United Kingdom

Trial participating centre

Liverpool Women's Hospital
Liverpool
L8 7SS
United Kingdom

Trial participating centre

Birmingham Heartlands Hospital
Birmingham
B9 5SS
United Kingdom

Trial participating centre

University College London Hospital
London
NW1 2BU
United Kingdom

Trial participating centre

Chelsea and Westminster Hospital
London
SW15 2QJ
United Kingdom

Trial participating centre

St Michael’s University Hospital
Bristol
BS2 8UG
United Kingdom

Trial participating centre

Queen's Medical Centre
Nottingham
NG7 2UH
United Kingdom

Trial participating centre

Sunderland Royal Hospital
Sunderland
SR4 7TP
United Kingdom

Trial participating centre

Princess Royal Hospital
Glasgow
G31 2ER
United Kingdom

Trial participating centre

University Hospital Coventry
Coventry
CV2 2DX
United Kingdom

Sponsor information

Organisation

University of Birmingham

Sponsor details

Edgbaston
Birmingham
B15 2TT
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

A meeting will be held after the end of the study to allow discussion of the main results among the collaborators prior to publication in an open access journal.

Intention to publish date

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

11/10/2016: Overall study end date changed from 30/09/2017 to 30/06/2018. Recruitment end date changed from 01/04/2016 to 31/05/2017