The presence of short cervix during pregnancy is a risk factor for preterm birth though in many cases women will eventually deliver at term or near term.
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.
Condition or disease | Intervention/treatment | Phase |
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Preterm Birth Pregnancy, High Risk | Other: Inpatient Management Other: Outpatient Management | Not Applicable |
Preterm birth, defined as the birth of a baby at less than 37 weeks' gestation, is a significant burden to society that is on the rise. Although many risk factors contribute to preterm birth, a short cervix is a well-established risk factor.The most common management for short cervix in Canada is vaginal progesterone, cervical cerclage, and hospital admission. Evidence suggests that vaginal progesterone and cervical cerclage improve outcomes, but there is very limited research on hospital admission or its efficacy. Due to the increased risk of preterm birth associated with cervical length ≤15 mm, some patients are admitted to hospital for observation even though labour is not imminent. The role of inpatient versus outpatient management is unclear and has not been explored. Hospital admission or modified activity has not been shown to improve pregnancy outcomes however, due to the increased risk of preterm birth, many women with short cervix are admitted for inpatient management.
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 134 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Inpatient vs Outpatient Management of Women With Short Cervix: A Randomized Controlled Trial (RCT) |
Actual Study Start Date : | June 6, 2019 |
Estimated Primary Completion Date : | March 2021 |
Estimated Study Completion Date : | March 2021 |
Arm | Intervention/treatment |
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Active Comparator: 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.
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Other: 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. |
Active Comparator: 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.
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Other: 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. |
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Susan O'Rinn, BA | 416-480-6100 ext 87716 | susan.orinn@sunnybrook.ca | |
Contact: Ori Nevo, MD | 416-480-6100 ext 87704 | ori.nevo@sunnybrook.ca |
Canada, Ontario | |
North York General Hospital | Recruiting |
Toronto, Ontario, Canada, M2K 1E1 | |
Contact: Elad Mei-Dan, MD (647) 891-2707 Elad.Mei-Dan@nygh.on.ca | |
Principal Investigator: Elad Mei-Dan, MD | |
Sunnybrook Health Sciences Centre | Recruiting |
Toronto, Ontario, Canada, M4N 3M5 | |
Contact: Ori Nevo, MD (416) 480 6100 ext 87704 ori.nevo@sunnybrook.ca | |
Contact: Susan O'Rinn, BA (416) 480 6100 ext 87716 susan.orinn@sunnybrook.ca | |
Principal Investigator: Ori Nevo, MD | |
Sub-Investigator: Jon FR Barrett, MD | |
Sub-Investigator: Stefania Ronzoni, MD, PhD | |
Sub-Investigator: Alex Kiss, PhD | |
Sub-Investigator: Aimee Santoro, NP | |
Sub-Investigator: Susan O'Rinn, BA |
Principal Investigator: | Ori Nevo, MD | Sunnybrook Health Sciences Centre |
Tracking Information | |||||||||
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First Submitted Date ICMJE | June 5, 2019 | ||||||||
First Posted Date ICMJE | June 7, 2019 | ||||||||
Last Update Posted Date | October 1, 2019 | ||||||||
Actual Study Start Date ICMJE | June 6, 2019 | ||||||||
Estimated Primary Completion Date | March 2021 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Gestational age at delivery [ Time Frame: At delivery ] | ||||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Inpatient vs Outpatient Management of Short Cervix | ||||||||
Official Title ICMJE | Inpatient vs Outpatient Management of Women With Short Cervix: A Randomized Controlled Trial (RCT) | ||||||||
Brief Summary |
The presence of short cervix during pregnancy is a risk factor for preterm birth though in many cases women will eventually deliver at term or near term. 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 |
Preterm birth, defined as the birth of a baby at less than 37 weeks' gestation, is a significant burden to society that is on the rise. Although many risk factors contribute to preterm birth, a short cervix is a well-established risk factor.The most common management for short cervix in Canada is vaginal progesterone, cervical cerclage, and hospital admission. Evidence suggests that vaginal progesterone and cervical cerclage improve outcomes, but there is very limited research on hospital admission or its efficacy. Due to the increased risk of preterm birth associated with cervical length ≤15 mm, some patients are admitted to hospital for observation even though labour is not imminent. The role of inpatient versus outpatient management is unclear and has not been explored. Hospital admission or modified activity has not been shown to improve pregnancy outcomes however, due to the increased risk of preterm birth, many women with short cervix are admitted for inpatient management. 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. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Not Applicable | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
134 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | March 2021 | ||||||||
Estimated Primary Completion Date | March 2021 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Canada | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03979196 | ||||||||
Other Study ID Numbers ICMJE | ShortCxTrial | ||||||||
Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Sunnybrook Health Sciences Centre | ||||||||
Study Sponsor ICMJE | Sunnybrook Health Sciences Centre | ||||||||
Collaborators ICMJE | North York General Hospital | ||||||||
Investigators ICMJE |
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PRS Account | Sunnybrook Health Sciences Centre | ||||||||
Verification Date | September 2019 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |