Chan 2020.
Study characteristics | ||
Methods | 2‐arm placebo‐controlled randomised trial | |
Participants | 406 women were randomised in a hospital setting in Hong Kong from March 2016 to May 2018. The population comprised women aged 18 to 40 years of age, presence of intrauterine gestational sac(s) only if a urine pregnancy test was first positive within the past 2 weeks or presence of intrauterine fetus(es) with positive fetal heart pulsations or presence of intrauterine fetus(es) with crown‐rump length of < 7 mm and no fetal pulsation on pelvic scanning; and absence of fever (temperature 38.5o C). Exclusion criteria comprised women that history of recurrent miscarriage defined as 3 or more consecutive spontaneous miscarriages; history of known parental chromosomal abnormalities; heavy vaginal bleeding or severe abdominal pain requiring surgical intervention; absence of cardiac pulsation in a fetal pole with crown‐rump length of 7 mm on transvaginal scanning; use of hCG or progestogen for threatened miscarriage prior to recruitment; or women with current or suspected breast or genital cancers, hepatic disease or tumours. | |
Interventions | 40 mg dydrogesterone orally, followed by 30 mg dydrogesterone 3 times a day versus placebo. | |
Outcomes | The study recorded the following outcomes relevant for this review: live birth, miscarriage (< 20 weeks)*, preterm birth, stillbirth, congenital abnormalities and adverse drug events. *different time point to that specified in the protocol (miscarriage defined as < 24 weeks). |
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Notes | Contact with study authors for additional information: yes. Additional data from authors: no. This study was funded by the Health and Medical Research Fund, HKSAR (reference number 12132341). The authors declare that they have no competing interests. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated in 1:1 ratio in blocks of 10. |
Allocation concealment (selection bias) | Low risk | Used sequentially numbered, sealed, opaque envelopes. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Study participants and caregivers were blinded to treatment allocations. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Assessors were blinded to treatment allocations. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Attrition bias was < 10%. |
Selective reporting (reporting bias) | High risk | The study report matches the study protocol that was registered prospectively (NCT02128685). However, results for 1 of the prespecified outcomes, i.e. proportion of heavy vaginal bleeding or severe abdominal pain requiring surgical intervention (< 20 weeks), were not reported. |
Other bias | Low risk | This study was funded by the Health and Medical Research Fund, HKSAR (reference number 12132341). |