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Article: A randomized double-blind controlled trial of the use of dydrogesterone in women with threatened miscarriage in the first trimester: study protocol for a randomized controlled trial

TitleA randomized double-blind controlled trial of the use of dydrogesterone in women with threatened miscarriage in the first trimester: study protocol for a randomized controlled trial
Authors
Issue Date2016
PublisherBioMed Central Ltd. The Journal's web site is located at http://www.trialsjournal.com/
Citation
Trials, 2016, v. 17, p. 408:1-6 How to Cite?
AbstractBACKGROUND: Miscarriage 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. METHODS: This 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. DISCUSSION: We postulate that the dydrogesterone therapy will significantly reduce the risk of miscarriage in women with threatened miscarriage. TRIAL REGISTRATION: This study is registered at ClinicalTrials.gov, NCT02128685 . Registered on 29 April 2014.
Persistent Identifierhttp://hdl.handle.net/10722/234127
ISSN
2015 Impact Factor: 1.859
2015 SCImago Journal Rankings: 1.077

 

DC FieldValueLanguage
dc.contributor.authorChan, MKD-
dc.contributor.authorCheung, KW-
dc.contributor.authorYung, SF-
dc.contributor.authorLee, VCY-
dc.contributor.authorLi, RHW-
dc.contributor.authorNg, EHY-
dc.date.accessioned2016-10-14T06:59:13Z-
dc.date.available2016-10-14T06:59:13Z-
dc.date.issued2016-
dc.identifier.citationTrials, 2016, v. 17, p. 408:1-6-
dc.identifier.issn1745-6215-
dc.identifier.urihttp://hdl.handle.net/10722/234127-
dc.description.abstractBACKGROUND: Miscarriage 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. METHODS: This 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. DISCUSSION: We postulate that the dydrogesterone therapy will significantly reduce the risk of miscarriage in women with threatened miscarriage. TRIAL REGISTRATION: This study is registered at ClinicalTrials.gov, NCT02128685 . Registered on 29 April 2014.-
dc.languageeng-
dc.publisherBioMed Central Ltd. The Journal's web site is located at http://www.trialsjournal.com/-
dc.relation.ispartofTrials-
dc.rightsTrials. Copyright © BioMed Central Ltd.-
dc.rightsCreative Commons: Attribution 3.0 Hong Kong License-
dc.titleA randomized double-blind controlled trial of the use of dydrogesterone in women with threatened miscarriage in the first trimester: study protocol for a randomized controlled trial-
dc.typeArticle-
dc.identifier.emailChan, MKD: dcmanka@hku.hk-
dc.identifier.emailCheung, KW: kawang@hku.hk-
dc.identifier.emailYung, SF: ssfyung@hkucc.hku.hk-
dc.identifier.emailLee, VCY: v200lee@hku.hk-
dc.identifier.emailLi, RHW: raymondli@hku.hk-
dc.identifier.emailNg, EHY: nghye@hku.hk-
dc.identifier.authorityYung, SF=rp00287-
dc.identifier.authorityLi, RHW=rp01649-
dc.identifier.authorityNg, EHY=rp00426-
dc.description.naturepublished_or_final_version-
dc.identifier.doi10.1186/s13063-016-1509-8-
dc.identifier.hkuros267403-
dc.identifier.volume17-
dc.identifier.spage408:1-
dc.identifier.epage6-
dc.publisher.placeUnited Kingdom-

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