NCT03979196

Inpatient vs Outpatient Management of Short Cervix

Inpatient vs Outpatient Management of Women With Short Cervix: A Randomized Controlled Trial (RCT)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Sunnybrook Health Sciences Centre · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Preterm Birth
• Pregnancy, High Risk

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2019-06-06
• Primary completion: 2020-03-30
• Completion: 2021-09-07
• First posted: 2019-06-07
• Last updated: 2024-04-22

Locations

2 sites across 1 country: Canada