Randomised study of pessary vs standard management in women with increased chance of premature birth
| ISRCTN | ISRCTN01096902 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN01096902 |
| ClinicalTrials.gov number | NCT00735137 |
| Secondary identifying numbers | 07WH10 |
- Submission date
- 05/04/2008
- Registration date
- 28/05/2008
- Last edited
- 13/03/2020
- 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
Prof Kypros Nicolaides
Scientific
Scientific
Harris Birthright Research Centre for Fetal Medicine
King's College Hospital
Denmark Hill
London
SE5 9RS
United Kingdom
Study information
| Study design | Multi-centre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Prevention |
| Participant information sheet | Patient information sheet for women with singleton pregnancies can be found at http://www.fetalmedicine.com/research/prem-single-info.htm. Patient information sheet for women with twin pregnancies can be found at http://www.fetalmedicine.com/research/prem-twins-info.htm. |
| Scientific title | Randomised study of pessary vs standard management in women with increased chance of premature birth |
| Study objectives | Current hypothesis as of 12/08/2008: Is pessary useful in reducing risk of premature birth in women with singleton pregnancies with a short cervix (cervical length of 25 mm or less at 21-24 weeks) or in twin pregnancies? Previous hypothesis: Is pessary useful in reducing the risk of premature birth in twin pregnancy? |
| Ethics approval(s) | King's College Hospital Research Ethics Committee, 31/01/2008, ref: 08/H0808/3 |
| Health condition(s) or problem(s) studied | Premature birth in women with increased risk of premature birth |
| Intervention | Treatment with insertion of vaginal pessary vs expectant management. The vaginal pessary is inserted in those allocated to this group within 5 days after the 20-24+6 weeks scan. The pessary will be removed by a simple vaginal examination before delivery. |
| Intervention type | Other |
| Primary outcome measure | Spontaneous delivery before 34 weeks of gestation |
| Secondary outcome measures | 1. Birth weight (mean, less than 2.5 kg and less than 1.5 kg) 2. Foetal or neonatal death 3. Major adverse outcomes before discharge from the hospital (intraventricular haemorrhage, respiratory distress syndrome, retinopathy of prematurity or necrotising entercolitis) 4. Need for neonatal special care (admission to a neonatal intensive care unit, ventilation, phototherapy, treatment for proven or suspected sepsis or blood transfusion). Duration of follow-up: 2 years |
| Overall study start date | 15/04/2008 |
| Completion date | 15/04/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 2,780 (1,180 twin pregnancies and 1,600 singleton pregnancies) |
| Key inclusion criteria | Current inclusion criteria as of 12/08/2008: 1. Women with singleton pregnancies and with a cervical length of 25 mm or less 2. Women with twin pregnancies Previous inclusion criteria: 1. Women with twin pregnancies undergoing routine ultrasonography at 20-24+6 weeks of gestation for examination of foetal anatomy and growth 2. Both foetuses are found to be alive with no major abnormalities, severe twin to twin transfusion syndrome or severe foetal growth restriction |
| Key exclusion criteria | Current exclusion criteria as of 12/08/2008: 1. Major foetal abnormalities (defined as those that are lethal or require prenatal or postnatal surgery), foetal death, severe twin to twin transfusion syndrome or severe foetal growth restriction in one of the foetuses (in the case of twin pregnancy) diagnosed before randomisation 2. Painful regular uterine contractions, history of ruptured membranes, or prophylactic cerclage before randomisation 3. Patients who are unconscious, severely ill, mentally handicapped or under the age of 16 years Previous exclusion criteria: 1. Major foetal abnormalities (defined as those that are lethal or require prenatal or postnatal surgery), or death of one or both of the foetuses, severe twin to twin transfusion syndrome diagnosed before randomisation 2. Painful regular uterine contractions, history of ruptured membranes, or prophylactic cerclage before randomisation 3. Patients who are unconscious, severely ill or mentally handicapped 4. Under the age of 16 years |
| Date of first enrolment | 15/04/2008 |
| Date of final enrolment | 15/04/2012 |
Locations
Countries of recruitment
- Brazil
- Chile
- Colombia
- England
- Portugal
- Spain
- United Kingdom
Study participating centre
King's College Hospital
London
SE5 9RS
United Kingdom
SE5 9RS
United Kingdom
Sponsor information
King's College Hospital NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Directorate of Research and Development
King's College Hospital
Denmark Hill
London
SE5 9RS
England
United Kingdom
| Website | http://www.kch.nhs.uk |
|---|---|
"ROR" |
https://ror.org/01n0k5m85 |
Funders
Funder type
Charity
Fetal Medicine Foundation (UK)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- FMF
- Location
- United Kingdom
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 | 01/01/2016 | Yes | No | |
| Results article | results | 17/03/2016 | Yes | No |
Editorial Notes
13/03/2020: Internal review.
18/03/2016: Publication reference added.
12/08/2008: This trial record has been extensively amended. The changes include the following:
1. The trial title has been changed from "Randomised study of pessary vs expectant management in twins" to "Randomised study of pessary vs standard management in women with increased chance of premature birth"
2. The information given in the disease/condition/study domain has been changed from "Premature birth in twins pregnancy" to "Premature birth in women with increased risk of premature birth"
3. The target number of participants has been changed from 1,180 to 2,780 (1,180 twin pregnancies and 1,600 singleton pregnancies)
Other changes are recorded in the relevant fields under the date on which the amendments were made.
