Evidence map›Paper›PMID 40889979›Full record

ArticleBMJ open2025

Development and validation of a dynamic prediction model for single-dose methotrexate treatment success in tubal ectopic pregnancy: a multicentre cohort study in Chinese hospitals.

Yunyun Hu, Wei Zhang, Zhitao Yao, Liyun Deng, Qinghong Guan, Xinyan Wang

Abstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2025. 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
–field-weighted citation impact
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.

  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

6 authors.

Yunyun HuDepartment of Gynaecology and Obstetrics, The First Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, Zhejiang, China 20173613@zcmu.edu.cn 13989843487@163.com.ORCID http://orcid.org/0009-0002-2098-1419
Wei ZhangDepartment of Obstetrics, Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University, Hangzhou, Zhejiang, China.
Zhitao YaoDepartment of Gynaecology and Obstetrics, The First Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, Zhejiang, China.
Liyun DengDepartment of Gynaecology and Obstetrics, Affiliated Anji Branch Hospital, The First Affiliated Hospital of Zhejiang Chinese Medical University, Huzhou, Zhejiang, China.
Qinghong GuanDepartment of Gynaecology and Obstetrics, Affiliated Qingyuan Branch Hospital, The First Affiliated Hospital of Zhejiang Chinese Medical University, Qingyuan, Zhejiang, China.
Xinyan WangDepartment of Gynaecology and Obstetrics, The First Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, Zhejiang, China 20173613@zcmu.edu.cn 13989843487@163.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionTubal ectopic pregnancy (TEP) frequently presents as a gynaecological emergency, often necessitating prompt medical intervention. Although methotrexate therapy offers the advantage of being non-invasive, it still poses the risk of tubal rupture and consequent haemorrhage, which may require emergency surgery. The major challenges encountered in practice are the lack of reliable methods to anticipate the likelihood of failure of single-dose methotrexate therapy and identify associated risk factors and thereby preclude unnecessary medical procedures. Effective counselling, therefore, remains a pivotal step in clinical management. This study is aimed at developing a predictive model to assess response to single-dose methotrexate therapy in cases of TEP by employing a dynamic prediction model approach based on the clinical data of a large cohort. METHODS AND ANALYSIS: This multicentre study will encompass 100 and 900 participants for the prospective and retrospective cohorts with TEP, respectively. Between 2010 and 2024, eligible patients who are diagnosed with TEP and opt for single-dose methotrexate therapy will be recruited as part of a retrospective cohort, from three participating hospitals in Zhejiang province, China. The comprehensive medical and obstetric histories of the patients will be collected, along with their clinical data, including the results of serological tests following the initial consultation. The control group will comprise patients who achieve uneventful, complete resolution of TEP, as evidenced by serum human chorionic gonadotropin level of <5 IU/L, without necessitating further treatment. The case group will include individuals requiring additional medical (further methotrexate) or surgical interventions. The dynamic prediction model developed in this manner will be employed on the longitudinal data. Additionally, data will be collected from two other hospitals between 2024 and 2026, as an external prospective cohort to validate the accuracy of the prediction model. ETHICS AND DISSEMINATION: Ethical approval for data collection has been obtained from the Ethics Committee of the First Affiliated Hospital of Zhejiang Chinese Medical University (No. 2024-KLS-346-02), Hangzhou First People's Hospital (No. ZN-20240627-0219-01), Anji Hospital of Chinese Medicine (No. 20255), Qingyuan Hospital of Chinese Medicine (No. (2024)(9)) and Beilun Hospital of Chinese Medicine (No. 202412). Additionally, written informed consent will be obtained from all participants and they will retain the right to withdraw from the study at any stage. The findings of this study will be disseminated through publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: ChiCTR2400085829.

Indexed as

Abortifacient Agents, NonsteroidalMethotrexatePregnancy, TubalAdultChinaFemaleHumansMulticenter Studies as TopicPregnancyProspective StudiesRetrospective StudiesTreatment OutcomeAbortifacient Agents, NonsteroidalMethotrexateDrug TherapyPregnancyPregnant Women

Identifiers

PMID40889979
PMCPMC12406884

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Registered trials

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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.