Evidence map›Paper›PMID 35105623›Full record

ArticleBMJ open2022

Prospective open-label non-inferiority randomised controlled trial comparing letrozole and mifepristone pretreatment in medical management of first trimester missed miscarriage: study protocol.

Libei Du, Raymond Hang Wun Li, Kristina Gemzell-Danielsson, Yan Hong Du, Li Zhang, Wei Yu Diao, Pak Chung Ho

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.6field-weighted citation impact, top 33% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 3 citations in OpenAlex.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 3 institutions in 3 countries.

Libei DuDepartment of Obstetrics and Gynecology, University of Hong Kong-Shenzhen Hospital, Shenzhen, China.ORCID 0000-0003-3541-5006
Raymond Hang Wun LiDepartment of Obstetrics and Gynecology, University of Hong Kong-Shenzhen Hospital, Shenzhen, China raymondli@hku.hk.ORCID 0000-0002-7957-7798
Kristina Gemzell-DanielssonDepartment of Obstetrics and Gynecology, University of Hong Kong-Shenzhen Hospital, Shenzhen, China.
Yan Hong DuDepartment of Obstetrics and Gynecology, University of Hong Kong-Shenzhen Hospital, Shenzhen, China.
Li ZhangDepartment of Obstetrics and Gynecology, University of Hong Kong-Shenzhen Hospital, Shenzhen, China.
Wei Yu DiaoDepartment of Obstetrics and Gynecology, University of Hong Kong-Shenzhen Hospital, Shenzhen, China.
Pak Chung HoDepartment of Obstetrics and Gynecology, University of Hong Kong-Shenzhen Hospital, Shenzhen, China.
University of Hong Kong - Shenzhen Hospital · CNQueen Mary Hospital · CNKarolinska University Hospital · SE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionMedical treatment is a less invasive alternative to surgical management of missed miscarriage. Studies have shown that pretreatment with mifepristone can increase the complete abortion rate in management of first-trimester missed miscarriage compared with misoprostol alone. Two studies have also shown that pretreatment with letrozole could increase the efficacy compared with misoprostol alone. So far, there is no trial comparing letrozole and mifepristone pretreatment for missed miscarriage. We designed this randomised controlled trial to test the hypothesis that for first-trimester missed miscarriage, letrozole pretreatment is non-inferior to mifepristone pretreatment followed by misoprostol in terms of complete abortion rate. METHODS AND ANALYSIS: This is a prospective open-label non-inferiority randomised controlled trial conducted in a single centre. In total, 294 women diagnosed with first-trimester missed miscarriage opting for medical treatment is recruited with informed consent. They are randomly assigned to receive mifepristone or letrozole pretreatment. In the mifepristone group, each woman takes 200 mg mifepristone orally followed 24-48 hours later by 800 µg misoprostol vaginally. In the letrozole group, each woman takes 10 mg letrozole orally per day for 3 days, followed by 800 µg misoprostol vaginally on the third day of letrozole administration. Follow-up is conducted on days 15 and 42 after misoprostol administration. The primary outcome is the overall complete abortion rate. Secondary outcomes include side effects and complications during the study period. Data will be analysed with both intention-to-treat and per protocol approaches. A p<0.05 will be considered as indicating statistical significance. ETHICS AND DISSEMINATION: Ethics approval has been obtained from the Institutional Review Board of the University of Hong Kong-Shenzhen Hospital with approval number: (2020)166. Findings will be disseminated in a peer-reviewed journal and in national and/or international meetings to guide future practice. TRIAL REGISTRATION NUMBER: ChiCTR2000041480.

Indexed as

Abortion, InducedAbortion, SpontaneousMisoprostolEquivalence Trials as TopicFemaleHumansLetrozoleMifepristonePregnancyPregnancy Trimester, FirstProspective StudiesRandomized Controlled Trials as TopicTreatment OutcomeLetrozoleMifepristoneMisoprostolclinical trialshealth & safetymaternal medicineprotocols & guidelinesreproductive medicine

Identifiers

PMID35105623
PMCPMC8808382
OpenAlexW4210803753

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.