Condition category
Pregnancy and Childbirth
Date applied
10/06/2005
Date assigned
25/07/2005
Last edited
12/01/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

https://medserv.abdn.ac.uk/stoppit/index.php

Contact information

Type

Scientific

Primary contact

Dr Jane Norman

ORCID ID

Contact details

University of Glasgow Division of Developmental Medicine
4th Floor
Queen Elizabeth Building
Glasgow Royal Infirmary
10 Alexandra Parade
Glasgow
G31 2ER
United Kingdom
+44 (0)141 211 4708
j.e.norman@clinmed.gla.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RN04OB007

Study information

Scientific title

Double blind randomised placebo controlled trial of progesterone for the prevention of preterm birth in twins

Acronym

STOPPIT

Study hypothesis

Vaginal progesterone gel, 90 mg daily from 24-34 weeks gestation, reduces the rate of preterm delivery in twin pregnancy.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Patient information can be found at: https://medserv.abdn.ac.uk/stoppit/pis.php

Condition

Preterm delivery

Intervention

Vaginal progesterone, 90 mg daily for ten weeks from 24 weeks gestation versus placebo

Intervention type

Drug

Phase

Not Specified

Drug names

Progesterone

Primary outcome measures

Proportion of women in each group delivering before 34 weeks gestation

Secondary outcome measures

Pregnancy duration, maternal complication rates, neonatal complication rates, maternal side effects, acceptability of treatment, subject perception of alternatives, perinatal mortality, perinatal morbidity

Overall trial start date

01/11/2005

Overall trial end date

30/10/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Women with twin pregnancy
2. Gestation established by scan before 20 weeks gestation
3. Known chorionicity

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

500

Participant exclusion criteria

1. Known signficiant structural or chromosomal fetal abnormality
2. Contraindications to progesterone
3. Planned cervical suture
4. Planned elective delivery before 34 weeks gestation
5. Intervention for twin to twin transfusion before 22 weeks

Recruitment start date

01/11/2005

Recruitment end date

30/10/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Glasgow Division of Developmental Medicine
Glasgow
G31 2ER
United Kingdom

Sponsor information

Organisation

Greater Glasgow Health Board (North Glasgow University Hospitals Division) and the University of Glasgow (UK)

Sponsor details

Research and Development Office
4th Floor
Walton Building
Glasgow Royal Infirmary
84 Castle Street
Glasgow
G4 OSF
United Kingdom
+44 (0)141 211 0475
fiona.graham.gri@northglasgow.scot.nhs.uk

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Chief Scientist's Office, Scottish Executive (ref no CZH/4/200) (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19523680
2016 follow-up results in http://www.ncbi.nlm.nih.gov/pubmed/25881289

Publication citations

  1. Results

    Norman JE, Mackenzie F, Owen P, Mactier H, Hanretty K, Cooper S, Calder A, Mires G, Danielian P, Sturgiss S, MacLennan G, Tydeman G, Thornton S, Martin B, Thornton JG, Neilson JP, Norrie J, Progesterone for the prevention of preterm birth in twin pregnancy (STOPPIT): a randomised, double-blind, placebo-controlled study and meta-analysis., Lancet, 2009, 373, 9680, 2034-2040, doi: 10.1016/S0140-6736(09)60947-8.

Additional files

Editorial Notes

12/01/2016: Publication reference added.