Evidence map›Paper›PMID 39645254›Full record

ArticleBMJ open2024

Impact of caesarean scar defects on the success of assisted human reproduction: the NICHE-ART prospective French cohort study protocol.

Audrey Astruc, Delphine Deseine, Andrew Spiers, Magalie Boguenet, Pascale May-Panloup, Pierre Emmanuel Bouet, Guillaume Legendre

Registry-linked trialAbstract readMulticenter Study
In one paragraph

Article in BMJ open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04869007 (The Impact of Cesarean Scar Defects on the Success of Assisted Human Reproduction), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

NCT04869007 active not recruitingnot on this map

The Impact of Cesarean Scar Defects on the Success of Assisted Human Reproduction: The Prospective NICHE-ART Study

TypeobservationalSponsorUniversity Hospital, AngersRan2022 to 2026Enrolled250ConditionsCesarean Section, DehiscenceArmshysterosonography
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. 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.

Audrey AstrucDepartment of Gynecology and Obstetrics, Angers University Hospital, Angers, France Audrey.Astruc@chu-angers.fr.ORCID http://orcid.org/0000-0001-8341-509X
Delphine DeseineDepartment of Gynecology and Obstetrics, Angers University Hospital, Angers, France.
Andrew SpiersDepartment of Gynecology and Obstetrics, Angers University Hospital, Angers, France.
Magalie BoguenetDepartment of Reproductive Medicine, Angers University Hospital, Angers, France.
Pascale May-PanloupDepartment of Reproductive Medicine, Angers University Hospital, Angers, France.
Pierre Emmanuel BouetDepartment of Gynecology and Obstetrics, Angers University Hospital, Angers, France.
Guillaume LegendreDepartment of Gynecology and Obstetrics, Angers University Hospital, Angers, France.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe global increase in caesarean sections (CS), currently at 21.1% of all deliveries, has led to a rise in uterine scar defects, or 'niches', at the hysterotomy site. These niches, detectable in 13%-84% of cases via transvaginal ultrasound (TVS) and 42%-84% through sonohysterography (SHG), may contribute to gynaecological complications, including abnormal uterine bleeding, chronic pain and secondary infertility. Niche-associated risks for in vitro fertilisation (IVF) outcomes remain underexplored, and this study aims to evaluate their impact on clinical pregnancy rates. METHODS AND ANALYSIS: This multicentre, prospective, non-interventional study will involve 250 women with a history of CS and secondary infertility undergoing IVF in 14 reproductive units of French Hospital. Participants will be assessed using SHG and TVS to determine niche presence (measurements of the length, depth and width of the niche, and residual myometrial thickness (RMT)). A niche is diagnosed by an indentation of at least 2 mm at the site of the caesarean scar, with a large niche defined as RMT <3 mm. The primary outcome is clinical pregnancy rate, with secondary outcomes including live birth rates, biochemical pregnancies and obstetric complications. Multivariate logistic regression will control for confounders. The duration of the inclusion period is estimated to be 42 months. ETHICS AND DISSEMINATION: The study protocol was approved by the relevant French medical review board, 'Comité de Protection des Personnes Sud Méditerranée IV', on 10 November 2020 and recorded prospectively (before the inscription of the first participant) under the number ID-RCB: 2020-A02068-31. The study will be conducted according to the guidelines of the Declaration of Helsinki. Informed consent will be obtained from all participants. The findings will be published in peer-reviewed journals and presented at relevant meetings. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov, ID: NCT04869007. Registered on 16 August 2020.

Indexed as

Cesarean SectionCicatrixAdultFemaleFertilization in VitroFranceHumansMulticenter Studies as TopicPregnancyPregnancy RateProspective StudiesUltrasonographyCesarean SectionPregnancyReproductive medicineSubfertility

Identifiers

PMID39645254
PMCPMC11628977

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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.