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 |
| Protocol serial number | RN04OB007 |
| Sponsor | Greater Glasgow Health Board (North Glasgow University Hospitals Division) and the University of Glasgow (UK) |
| Funder | Chief Scientist's Office, Scottish Executive (ref no CZH/4/200) (UK) |
- 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 of protocol
Not provided at time of registration
Contact information
Dr Jane Norman
Scientific
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 |
|---|---|
| j.e.norman@clinmed.gla.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Double blind randomised placebo controlled trial of progesterone for the prevention of preterm birth in twins |
| Study acronym | STOPPIT |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | Preterm delivery |
| Intervention | Vaginal progesterone, 90 mg daily for ten weeks from 24 weeks gestation versus placebo |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Progesterone |
| Primary outcome measure(s) |
Proportion of women in each group delivering before 34 weeks gestation |
| Key secondary outcome measure(s) |
Pregnancy duration, maternal complication rates, neonatal complication rates, maternal side effects, acceptability of treatment, subject perception of alternatives, perinatal mortality, perinatal morbidity |
| Completion date | 30/10/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 500 |
| Key inclusion criteria | 1. Women with twin pregnancy 2. Gestation established by scan before 20 weeks gestation 3. Known chorionicity |
| Key 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 |
| Date of first enrolment | 01/11/2005 |
| Date of final enrolment | 30/10/2008 |
Locations
Countries of recruitment
- United Kingdom
- Scotland
Study participating centre
University of Glasgow Division of Developmental Medicine
Glasgow
G31 2ER
United Kingdom
G31 2ER
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
12/01/2016: Publication reference added.
