Abstract
BackgroundPreterm birth accounts for 75% of perinatal deaths and more than 50% of long-term neurological disabilities. For a singleton pregnancy, progesterone treatment is effective in prevention of preterm birth in women with an asymptomatic short cervix or a history of preterm birth. However, a large proportion of preterm births still is not currently preventable. The aim of this study is to determine whether early universal use of oral progesterone before 14 + 0 weeks of gestation can prevent preterm birth better than universal screening of cervical length at 18 + 0 to 23 + 6 weeks of gestation, followed by progesterone treatment in those with a short cervix in singleton pregnancy.MethodsThis is a multicenter, randomized, double-blind, placebo-controlled trial registered with ClinicalTrials.gov on 12 February 2018. Eligible consecutive pregnant women with singleton gestation attending antenatal outpatient clinics will be recruited after receiving counseling and signing the written consent form. Transvaginal cervical length measurement will be performed at recruitment (before 14 + 0 weeks of gestation) and between 18 + 0 and 23 + 6 weeks of gestation. After randomization, women will be randomly assigned to either the treatment group (oral dydrogesterone 10 mg three times daily) or the placebo group, and medication will be started before 14 + 0 weeks of gestation. Assigned groups will be unblinded if the cervical length is ≤ 25 mm between 18 + 0 and 23 + 6 weeks of gestation, and the management option for short cervix will be discussed (oral progesterone, vaginal progesterone, or cervical cerclage). The primary outcome is preterm birth before 37 + 0 weeks of gestation.DiscussionProgesterone is used extensively in part of the in vitro fertilization program as luteal phase support, and it is not associated with teratogenicity. Universal progesterone supplementation may be a better approach to prevent preterm birth. This large, multicenter, randomized, double-blind, placebo-controlled trial will provide the best evidence, leading to the best strategy for the prevention of preterm birth.Trial registrationClinicalTrials.gov, NCT03428685. Registered on 12 February 2018.
Highlights
The hypothesis is that early universal progesterone treatment from before 14 + 0 weeks could decrease the risk of Preterm birth (PTB) further than progesterone treatment in women with an asymptomatic short cervix detected by universal cervical length screening
Progesterone is used extensively as part of the in vitro fertilization program as luteal phase support [24], in addition to use as treatment for prevention of PTB [12]
Universal progesterone supplementation may be a feasible approach to preventing PTB
Summary
Preterm birth accounts for 75% of perinatal deaths and more than 50% of long-term neurological disabilities. The aim of this study is to determine whether early universal use of oral progesterone before 14 + 0 weeks of gestation can prevent preterm birth better than universal screening of cervical length at 18 + 0 to 23 + 6 weeks of gestation, followed by progesterone treatment in those with a short cervix in singleton pregnancy. Preterm birth (PTB), defined as birth before 37 completed gestational weeks, is a major challenge to perinatal health. It accounts for 75% of perinatal deaths and more than 50% of long-term neurological disabilities [1, 2], and it is the second most common cause of death in children under the age of 5 years [3]. On the basis of evaluation of data from 184 countries, the estimated global mean PTB rate is approximately 11.1%, ranging from 5% to 18% in different countries [6]
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