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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN18185477 |
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Date of registration:
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16/04/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Preventing preterm birth in Chinese women with a short cervix in singleton pregnancies
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Scientific title:
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Cerclage pessary for preventing preterm birth in Chinese women with a short cervix in singleton pregnancies: a randomized controlled trial |
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Date of first enrolment:
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01/10/2008 |
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Target sample size:
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4000 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN18185477 |
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Study type:
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Interventional |
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Study design:
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Randomized controlled single-centre trial (Prevention)
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Phase:
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Countries of recruitment
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Hong Kong
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Shuk Yi Annie
Hui |
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Address:
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1E, Department of OG
Prince of Wales Hospital
Shatin, N.T.
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Hong Kong |
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Women with singleton viable pregnancy undergoing routine morphology ultrasonography at 18 ? 24 weeks found to have a cervix less than 25 mm
Exclusion criteria: 1. Multiple pregnancies
2. Major fetal abnormalities defined as those that are lethal or require prenatal or postnatal surgery
3. Severe intra-uterine growth restriction (IUGR)
4. Cervical dilatation, painful uterine contractions, history of ruptured membranes, or prophylactic surgical cerclage before randomization
5. Patients who are unconscious, severely ill, mentally handicapped or under the age of 16 years
Age minimum:
Age maximum:
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Cervical insufficiency
Pregnancy and Childbirth
Incompetence of cervix uteri
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Intervention(s)
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Women invited to participate were randomized into two arms: control group or pessary group. Randomization was performed using a computer-generated sequence and the allocation results were concealed in sequentially numbered, identical, opaque, sealed envelopes and kept away from the clinic where patients were being assessed. The treatment allocation would only be revealed to the obstetrician in charge after the patient was assessed to be eligible and consented to the trial.
Follow-up visits for ultrasound assessment of fetal growth and cervical length were carried out every four weeks till 34 weeks of gestation. If after 26 weeks the cervical length was less than 10 mm, steroids (four doses of intramuscular injections of dexamethasone 6 mg 12 hours apart) were given. High vaginal swabs were repeated during each follow-up visit to look for any infection.
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Primary Outcome(s)
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Preterm rate before 34 weeks
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Secondary Outcome(s)
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Perinatal morbidities and mortality
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Secondary ID(s)
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CRE-2008.375-T
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Source(s) of Monetary Support
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Chinese University of Hong Kong (Hong Kong)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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