Preterm Birth Clinical Trial
Official title:
Inpatient vs Outpatient Management of Women With Short Cervix: A Randomized Controlled Trial (RCT)
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.
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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