Clinical trial NCT03979196: Inpatient vs Outpatient Management of Short Cervix
Official title: Inpatient vs Outpatient Management of Women With Short Cervix: A Randomized Controlled Trial (RCT)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Preterm Birth
Pregnancy, High Risk
Keywords: Preterm Birth
Pregnancy, High Risk
Short Cervix
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: North York General Hospital
First posted: 2019-06-07
Enrollment: 5
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Gestational age at delivery
timeFrame: At delivery
Secondary outcomes:
measure: Betamethasone treatment
timeFrame: Before delivery
measure: Magnesium sulphate treatment
timeFrame: Before 32 weeks gestation
measure: Intrapartum complications
timeFrame: During delivery
measure: Mode of delivery
timeFrame: At delivery
measure: Patient Quality of Life
timeFrame: 1 week after randomization
measure: Neonatal morbidity and mortality: composite measure
timeFrame: 1-28 days post-delivery
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: North York General Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Ori Nevo, MD
role: PRINCIPAL_INVESTIGATOR
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