Study Results
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Basic Information
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TERMINATED
NA
5 participants
INTERVENTIONAL
2019-06-06
2021-09-07
Brief Summary
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While there are proven treatments such as cerclage and progesterone that can improve pregnancy outcomes, many women are advised to limit their activity, are put on bed rest, or admitted to hospital for inpatient management. Presently, there is no evidence that hospital admission of women with short cervix is beneficial and prolongs the pregnancy.
The investigators propose to examine whether inpatient management results in comparable outcomes to outpatient management for women with short cervix.
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Detailed Description
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This project's objective is to examine whether inpatient or outpatient care results in similar pregnancy outcomes for women with short cervix.
This is a multi-centre, non-inferiority randomized controlled trial in women with a singleton pregnancy and isolated short cervix (SC) (≤1.5cm by transvaginal scan (TVS)) at 23-28 weeks at Sunnybrook Health Sciences Centre (SHSC) and North York General Hospital (NYGH), in Toronto, Ontario, Canada. The intervention involves randomizing women to either inpatient or outpatient management and examining whether gestational age at delivery in women with SC (≤1.5cm by TVS) is comparable between arms. The investigators hypothesize that there will be no difference in the preterm birth rate and gestational age at delivery between the two groups.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Inpatient Management
Women in this arm will follow the standard of care for admission to high-risk units at Sunnybrook Health Sciences Centre or North York General Hospital.
Inpatient Management
Admission for a minimum of three days, administration of betamethasone, and clinical reassessment by obstetrician after three days. After the initial three day admission, further management will be at the discretion of their obstetrician who will continue their care and decide if further admissions are needed.
Weekly cervical length assessment will be performed until 28 weeks and patient readmission will be decided by their Obstetrician.
Post-intervention, women in both arms will receive the same standard of care (weekly clinic or inpatient follow-up appointments) and will be followed to delivery. Prior to delivery, participants will complete a patient Quality of Life survey and at delivery, primary and secondary outcomes will be collected.
Outpatient Management
Women in this arm will be encouraged to follow the standard of care established in the high-risk clinics at Sunnybrook Health Sciences Centre or North York General Hospital.
Outpatient Management
Avoid heavy lifting and core exercise, avoid intercourse, weekly assessment of cervical length by ultrasound and administration of betamethasone. Patients will continue with outpatient management for the remainder of their pregnancy with no admission unless the patient develops contractions, PPROM, bleeding, or the cervix is dilated to ≥1cm.
Post-intervention, women in both arms will receive the same standard of care (weekly clinic or inpatient follow-up appointments) and will be followed to delivery. Prior to delivery, participants will complete a patient Quality of Life survey and at delivery, primary and secondary outcomes will be collected.
Interventions
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Inpatient Management
Admission for a minimum of three days, administration of betamethasone, and clinical reassessment by obstetrician after three days. After the initial three day admission, further management will be at the discretion of their obstetrician who will continue their care and decide if further admissions are needed.
Weekly cervical length assessment will be performed until 28 weeks and patient readmission will be decided by their Obstetrician.
Post-intervention, women in both arms will receive the same standard of care (weekly clinic or inpatient follow-up appointments) and will be followed to delivery. Prior to delivery, participants will complete a patient Quality of Life survey and at delivery, primary and secondary outcomes will be collected.
Outpatient Management
Avoid heavy lifting and core exercise, avoid intercourse, weekly assessment of cervical length by ultrasound and administration of betamethasone. Patients will continue with outpatient management for the remainder of their pregnancy with no admission unless the patient develops contractions, PPROM, bleeding, or the cervix is dilated to ≥1cm.
Post-intervention, women in both arms will receive the same standard of care (weekly clinic or inpatient follow-up appointments) and will be followed to delivery. Prior to delivery, participants will complete a patient Quality of Life survey and at delivery, primary and secondary outcomes will be collected.
Eligibility Criteria
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Inclusion Criteria
* SC (≤1.5cm) determined by TVS
* Vaginal progesterone treatment
* Cervical dilatation of ≤1cm
* Located within 45 minute drive from recruitment site (Sunnybrook Health Sciences Centre or North York General Hospital)
Exclusion Criteria
* Preterm premature rupture of membranes (PPROM), vaginal bleeding, infection, high blood pressure (defined as 140/90 mm Hg or higher)
* Regular uterine contractions or active labour
* Vaginal bleeding
* Cervical dilatation of \>1cm
* Fetal anomalies
18 Years
FEMALE
No
Sponsors
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North York General Hospital
OTHER
Sunnybrook Health Sciences Centre
OTHER
Responsible Party
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Principal Investigators
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Ori Nevo, MD
Role: PRINCIPAL_INVESTIGATOR
Sunnybrook Health Sciences Centre
Locations
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North York General Hospital
Toronto, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Countries
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References
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Shea AK, Simpson AN, Barrett J, Ladhani N, Nevo O. Pregnancy Outcomes of Women Admitted to a Tertiary Care Centre with Short Cervix. J Obstet Gynaecol Can. 2017 May;39(5):328-334. doi: 10.1016/j.jogc.2017.01.012.
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Copyright © 2013, SAS Institute Inc., Cary, NC, USA.
Other Identifiers
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ShortCxTrial
Identifier Type: -
Identifier Source: org_study_id
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