Condition category
Pregnancy and Childbirth
Date applied
05/04/2008
Date assigned
28/05/2008
Last edited
18/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Kypros Nicolaides

ORCID ID

Contact details

Harris Birthright Research Centre for Fetal Medicine
King's College Hospital
Denmark Hill
London
SE5 9RS
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00735137

Protocol/serial number

07WH10

Study information

Scientific title

Randomised study of pessary vs standard management in women with increased chance of premature birth

Acronym

Study hypothesis

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

King's College Hospital Research Ethics Committee, 31/01/2008, ref: 08/H0808/3

Study design

Multi-centre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Prevention

Patient 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.

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

15/04/2008

Overall trial end date

15/04/2012

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

2,780 (1,180 twin pregnancies and 1,600 singleton pregnancies)

Participant 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

Recruitment start date

15/04/2008

Recruitment end date

15/04/2012

Locations

Countries of recruitment

Brazil, Chile, Colombia, Portugal, Spain, United Kingdom

Trial participating centre

King's College Hospital
London
SE5 9RS
United Kingdom

Sponsor information

Organisation

King's College Hospital NHS Foundation Trust (UK)

Sponsor details

Directorate of Research and Development
King's College Hospital
Denmark Hill
London
SE5 9RS
United Kingdom

Sponsor type

Government

Website

http://www.kch.nhs.uk

Funders

Funder type

Charity

Funder name

Fetal Medicine Foundation (UK)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United Kingdom

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

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26321037
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26981934

Publication citations

Additional files

Editorial Notes

18/03/2016: Publication reference added. This trial record has been extensively amended as of 12/08/2008. 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.