Who is sponsoring NCT05218837?

NCT05218837 is sponsored by Maria Gyhagen.

What drugs are being tested in NCT05218837?

Interventions in NCT05218837: Vaginal birth.

What condition does NCT05218837 study?

NCT05218837 studies Sphincter (Anal); Perineal Rupture, Obstetric.

Is NCT05218837 still recruiting?

NCT05218837 is currently completed. Last updated 17 February 2022.

Last reviewed 2022-02-17 · How we verify

NCT05218837

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Development and Validation of a Logistic Regression Algorithm to Predict the Risk of Obstetric Anal Sphincter Injury.

Completed Last updated 17 February 2022

What this trial tests

trial testing Vaginal birth in Sphincter (Anal); Perineal Rupture, Obstetric in 800,000 participants. Completed in 31 December 2018.

Timeline

30 October 2018

Primary endpoint
31 December 2018

31 December 2018

Quick facts

Lead sponsor	Maria Gyhagen
Status	Completed
Study type	OBSERVATIONAL
Enrollment	800,000
Start date	30 October 2018
Primary completion	31 December 2018
Estimated completion	31 December 2018
Sites	1 location across Sweden

Drugs / interventions tested

Vaginal birth

Conditions studied

Sphincter (Anal); Perineal Rupture, Obstetric — all drugs for Sphincter (Anal); Perineal Rupture, Obstetric →

Sponsor

Maria Gyhagen

Who can join

Eligibility, female only, with Sphincter (Anal); Perineal Rupture, Obstetric. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

An obstetric anal sphincter injury (OASI) occurs during the final stage of a vaginal delivery. This tissue laceration, even if adequately sutured, poses a substantial threat to bowel continence in women.1,2 In a recent register-based study we showed that following an OASI at the first birth, the risk of a repeat injury almost tripled and that the long-term prevalence of fecal incontinence (FI) doubled in women with 1 OASI and tripled in those with 2 consecutive OASIs, in comparison with nulliparous women not affected by childbirth.3 Most OASIs occur seemingly by chance in the absence of known risk markers, and there is still no prediction model that is of use to avoid OASI in the clinical setting.4 Therefore, these injuries are often excused as inevitable and impossible to foresee. The aim of this study is to develop and validate prediction models for the risk of an OASI in high- and low-risk scenarios.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05218837 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Maria Gyhagen
Last refreshed: 17 February 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05218837.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing