Evidence map›Paper›PMID 39285313›Full record

Trial reportBMC medicine2024

A novel intrauterine estrogen-releasing system for preventing the postoperative recurrence of intrauterine adhesion: a multicenter randomized controlled study.

Limin Feng, Yun Sun, Songying Zhang, Yonghong Qian, Suping Fang, Baojun Yang, Lizhen Xu, Jinghua Li, Yichao Niu, Shengpeng Zhang and 2 more

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04972032 (Prevention of Postoperative Adhesion Recurrence by Estrogen-intrauterine Stent System), which is not on this map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing 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.

NCT04972032 naunknown statusnot on this map

Prevention of Postoperative Adhesion Recurrence by Estrogen-intrauterine Stent System

TypeinterventionalSponsorLimin FengRan2020 to 2025Enrolled246ConditionsIntrauterine AdhesionArmsEstrogen Intrauterine Stent System, Foley balloon combined with self-cross-link sodium hyaluronate gel
3 · Its place in the literature

Who cites it

14 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
  4. Article
  5. Article
  6. Review
  7. Article
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  10. Review
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  12. Review
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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

12 authors.

Limin Feng *Department of Gynecology and Obstetrics, Beijing Tiantan Hospital, Capital Medical University, Beijing, China. Lucyfeng1966@163.com.
Yun Sun *Department of Gynecology and Obstetrics, Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China.
Songying ZhangDepartment of Gynecology and Obstetrics, Shaw Hospital Affiliated to Zhejiang University School of Medicine, Hangzhou, Zhejiang, China.
Yonghong QianDepartment of Gynecology and Obstetrics, Suzhou Municipal Hospital, Suzhou, Jiangsu, China.
Suping FangDepartment of Gynecology and Obstetrics, Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China.
Baojun YangDepartment of Gynecology and Obstetrics, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
Lizhen XuDepartment of Gynecology and Obstetrics, Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China.
Jinghua LiDepartment of Gynecology and Obstetrics, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
Yichao NiuDepartment of Gynecology and Obstetrics, Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China.
Shengpeng ZhangDepartment of Gynecology and Obstetrics, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
Luping ZhangDepartment of Gynecology and Obstetrics, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
Jianmin ChenDepartment of Gynecology and Obstetrics, Shaw Hospital Affiliated to Zhejiang University School of Medicine, Hangzhou, Zhejiang, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTranscervical resection of adhesions (TCRA) is the standard treatment for intrauterine adhesion (IUA). Previous studies have shown that postoperative oral estrogen or an intrauterine physical barrier could reduce the recurrence of IUA by promoting the proliferation of the endometrium or inhibiting the reformation of adhesions. Our team designed an intrauterine stent that can release estrogen within the uterine cavity slowly. In this study, we aimed to investigate the efficacy and safety of the estrogen-releasing intrauterine system in preventing the recurrence of moderate to severe IUA.

methodsThis was a multicenter prospective randomized controlled 2-arm parallel trial that included patients who were diagnosed with moderate to severe IUA and who received TCRA. A total of 250 patients were randomly assigned, at a 1:1 ratio, to receive the intrauterine estrogen-releasing system or a Foley catheter balloon combined with oral estrogen therapy after surgery. The primary outcome was the rate of adhesion reduction in the two groups. The secondary outcomes included endometrial thickness at the ovulation period, menstrual improvement rates, and other reported adverse events during follow-up.

resultsThe average daily drug release amount for all the tested stents was 0.21 mg/day. At 60 days postoperatively, the rate of adhesion reduction was significantly greater in the experimental group than in the control group (93.33% vs. 58.56%, p < 0.001). The endometrium of the experimental group was thicker than that of the control group (p < 0.001). Consistently, the rate of improvement in menstruation was greater in the experimental group than in the control group (p = 0.010). No grade 3-4 adverse events were found in the two groups during the 1-year follow-up.

conclusionsIn the cohort of patients with moderate to severe IUA, the intrauterine estrogen-releasing system was more effective at reducing adhesion than traditional oral estrogen combined with an intrauterine Foley catheter after TCRA. This novel intrauterine system provides a new option for the management of IUA after surgery.

trial registrationThe registration number is NCT04972032. Date of registration: August 15, 2021.

Indexed as

EstrogensAdultFemaleHumansPostoperative ComplicationsProspective StudiesRecurrenceSecondary PreventionTissue AdhesionsTreatment OutcomeUterine DiseasesEstrogensEstrogenIntrauterine adhesionRecurrenceReleasing systemTranscervical resection of adhesions

Identifiers

PMID39285313
PMCPMC11406833

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Registered trials

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.