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

ISRCTN	ISRCTN35782581
DOI	https://doi.org/10.1186/ISRCTN35782581
Secondary identifying numbers	RN04OB007

Submission date: 10/06/2005
Registration date: 25/07/2005
Last edited: 12/01/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Study website

Contact information

Dr Jane Norman
Scientific

University of Glasgow Division of Developmental Medicine
4th Floor, Queen Elizabeth Building
Glasgow Royal Infirmary
10 Alexandra Parade
Glasgow
G31 2ER
United Kingdom

Phone	+44 (0)141 211 4708
Email	j.e.norman@clinmed.gla.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Prevention
Participant information sheet	Patient information can be found at: https://medserv.abdn.ac.uk/stoppit/pis.php
Scientific title	Double blind randomised placebo controlled trial of progesterone for the prevention of preterm birth in twins
Study 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(s)	Not provided at time of registration
Condition	Preterm delivery
Intervention	Vaginal progesterone, 90 mg daily for ten weeks from 24 weeks gestation versus placebo
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Progesterone
Primary outcome measure	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 study start date	01/11/2005
Overall study end date	30/10/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	500
Participant inclusion criteria	1. Women with twin pregnancy 2. Gestation established by scan before 20 weeks gestation 3. Known chorionicity
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

Scotland
United Kingdom

Study participating centre

University of Glasgow Division of Developmental Medicine

Glasgow
G31 2ER
United Kingdom

Sponsor information

Greater Glasgow Health Board (North Glasgow University Hospitals Division) and the University of Glasgow (UK)
Hospital/treatment centre

Research and Development Office
4th Floor, Walton Building
Glasgow Royal Infirmary
84 Castle Street
Glasgow
G4 OSF
United Kingdom

Phone	+44 (0)141 211 0475
Email	fiona.graham.gri@northglasgow.scot.nhs.uk
"ROR"	https://ror.org/05kdz4d87

Funders

Funder type

Government

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	13/06/2009		Yes	No
Results article	follow-up results	16/04/2015		Yes	No

Editorial Notes

12/01/2016: Publication reference added.