Inpatient vs Outpatient Management of Short Cervix

NCT03979196 | Terminated

• 1 other identifier: ShortCxTrial
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 2

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.

Conditions

Preterm Birth; Pregnancy, High Risk

Keywords

Preterm Birth; Pregnancy, High Risk; Short Cervix

Outcome Measures

Primary Outcomes (1)

• Gestational age at delivery

  At delivery

Secondary Outcomes (6)

• Betamethasone treatment

  Before delivery

• Magnesium sulphate treatment

  Before 32 weeks gestation

• Intrapartum complications

  During delivery

• Mode of delivery

  At delivery

• Patient Quality of Life

  1 week after randomization

Study Arms (2)

Inpatient Management

ACTIVE COMPARATOR

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.

Other: Inpatient Management

Outpatient Management

ACTIVE COMPARATOR

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.

Other: Outpatient Management

Interventions

Inpatient Management OTHER

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.

Inpatient Management

Outpatient Management OTHER

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.

Outpatient Management

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Singleton pregnancy between 23 weeks 0 days - 28 weeks 6 days gestational age
• 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)

You may not qualify if:

• Multiple pregnancy
• 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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• North York General Hospital: collaborator

Study Sites (2)

North York General Hospital

Toronto, Ontario, M2K 1E1, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Related Publications (30)

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  BACKGROUND

• Copyright © 2013, SAS Institute Inc., Cary, NC, USA.

  BACKGROUND

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Ori Nevo, MD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2019
• First Posted: June 7, 2019
• Study Start: June 6, 2019
• Primary Completion: March 30, 2020
• Study Completion: September 7, 2021
• Last Updated: April 22, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)