Abstract
BackgroundMiscarriage is a common complication of pregnancy occurring in 15–20 % of all clinically recognized pregnancies. Currently, there is still no good scientific evidence to support the routine use of progestogens for the treatment of threatened miscarriage because the existing studies were not large enough to show a significant difference and some of them were not randomized or double-blind.MethodsThis is a double-blind, randomized controlled trial. A total of 400 patients presenting with first-trimester threatened miscarriage will be enrolled. They will be randomized to take dydrogesterone 40 mg per os, followed by 10 mg per os three times a day or placebo until twelve completed weeks of gestation or 1 week after the bleeding has stopped, whichever is longer. The primary outcome is the percentage of miscarriage before 20 weeks of gestation.DiscussionWe postulate that the dydrogesterone therapy will significantly reduce the risk of miscarriage in women with threatened miscarriage.Trial registrationThis study is registered at ClinicalTrials.gov, NCT02128685. Registered on 29 April 2014.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1509-8) contains supplementary material, which is available to authorized users.
Highlights
Miscarriage is a common complication of pregnancy occurring in 15–20 % of all clinically recognized pregnancies
Threatened miscarriage is manifested by vaginal bleeding, with or without abdominal pain, while the cervix is closed and the fetus remains viable inside the uterine cavity
A recent Cochrane review assessing the efficacy and safety of progestogens in threatened miscarriage identified four trials to be included in a meta-analysis, involving 421 participants, which compared progesterone with either placebo or no medication [15]
Summary
Trial design (Table 1) This is a double-blind, randomized controlled trial. The study will be conducted in two public hospitals in Hong Kong: Queen Mary Hospital and Kwong Wah Hospital. Treatment will be stopped if the vaginal bleeding becomes severe and requires surgical intervention, or a diagnosis of silent miscarriage is confirmed upon a followup scan (i.e., the gestational sac or fetal pole fails to grow after 1 week, or there is no cardiac activity in a fetal pole with crown-rump length of ≥7 mm). The secondary outcomes are the live birth rate; the proportion of heavy vaginal bleeding or severe abdominal pain requiring surgical intervention (after 20 weeks); and obstetric complications including antepartum hemorrhage, placenta previa, pregnancy-induced hypertension, intrauterine death, congenital abnormality, preterm labor, and low birth weight at term. Women with missing primary outcome data will not be included in the primary analysis This presents a risk of bias, and secondary sensitivity analyses will be undertaken to assess the possible impact of the risk, including the assumption that all women lost to follow-up have miscarriages before 20 weeks. To allow for drop out, we plan to recruit 400 subjects in total with 200 patients in each arm
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