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 (NCT)	NCT00735137
Protocol serial number	07WH10
Sponsor	King's College Hospital NHS Foundation Trust (UK)
Funder	Fetal Medicine Foundation (UK)

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

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

Study information

Primary study design	Interventional
Study design	Multi-centre randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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(s)	Spontaneous delivery before 34 weeks of gestation
Key secondary outcome measure(s)	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
Completion date	15/04/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	1180
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

United Kingdom
England
Brazil
Chile
Colombia
Portugal
Spain

Study participating centre

King's College Hospital

London
SE5 9RS
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	01/01/2016		Yes	No
Results article	results	17/03/2016		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

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.