Inpatient vs Outpatient Management of Short Cervix
- Conditions
- Preterm BirthPregnancy, High Risk
- Interventions
- Other: Inpatient ManagementOther: Outpatient Management
- Registration Number
- NCT03979196
- Lead Sponsor
- Sunnybrook Health Sciences Centre
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 5
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Inpatient Management 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. Outpatient Management 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.
- Primary Outcome Measures
Name Time Method Gestational age at delivery At delivery
- Secondary Outcome Measures
Name Time Method Betamethasone treatment Before delivery Magnesium sulphate treatment Before 32 weeks gestation Intrapartum complications During delivery Any of the following: cord prolapse, postpartum hemorrhage, or fetal distress
Mode of delivery At delivery One of: vaginal delivery, caesarean section, operative delivery
Neonatal morbidity and mortality: composite measure 1-28 days post-delivery A composite of the following: Early-onset sepsis/meningitis (culture proven within first 7 days of life), Significant Intraventricular hemorrhage (IVH) (Grade III/IV, hemorrhagic venous infarct), Periventricular leukomalacia (PVL), Respiratory distress syndrome (RDS) (requiring surfactant and ventilation), Need for high frequency oscillatory ventilation (HFO) on Day 1, Need for inhaled nitric oxide (iNO) on Day 1, Pneumothorax (requiring needle aspiration or chest tube drainage), Chronic lung disease (requiring oxygen at discharge/transfer or at corrected gestational age (CGA) 36 weeks), Death, retinopathy of prematurity(ROP) (\>Stage 2), necrotizing enterocolitis (NEC) (finding of pneumatosis, portal vein gas or free peritoneal air on abdominal radiograph), patent ductus arteriosus (PDA) (presence of PDA diagnosed by echocardiography or clinical suspicion treated with medication or surgery)
Patient Quality of Life 1 week after randomization 36-Item Short Form Health Survey: 36-item, self-administered survey takes 5 minutes and is designed to measure health on eight multi-item dimensions, including functional status, well-being, and overall evaluation of health.
Trial Locations
- Locations (2)
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada
North York General Hospital
🇨🇦Toronto, Ontario, Canada