NCT04566705

Brief Summary

Although a rare event, uterine rupture during labour is one of the most serious obstetric complications because of the dramatic maternal-fetal consequences that can result. Identifying the risk factors associated with uterine rupture would enable gynecologists to provide patients with risks of uterine rupture in the event of attempted vaginal delivery. The aim of our study is to determine risks factors for uterine rupture during labour in patients with a previous cesarean delivery who have not given birth since and to assess the occurrence of maternal-fetal comply-cations compared to patients with a previous cesarean delivery without uterine rupture.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2020

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2020

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 28, 2020

Completed
Last Updated

November 18, 2020

Status Verified

September 1, 2020

Enrollment Period

29 days

First QC Date

September 14, 2020

Last Update Submit

November 17, 2020

Conditions

Uterine RuptureMode of Delivery

Keywords

Risks factorsUterine rupture after a previous cesarean deliveryVaginal birth after cesareanPrior cesareanPerinatal outcome

Outcome Measures

Primary Outcomes (1)

  • Assess the risks factors of uterine rupture

    Assess the risks factors of uterine rupture Assess the risks factors of uterine rupture using obstetric measures

    1 day

Secondary Outcomes (1)

  • Number of Participants with Assess the maternal and perinatal complications and outcomes

    1 day

Study Arms (2)

Women with uterine rupture

Women with uterine rupture

Women without uterine rupture

Women without uterine rupture

Other: Risks factors, maternal and neonatal outcomes/complications

Interventions

Risks factors, maternal and neonatal outcomes/complicationsOTHER

Risks factors, maternal and neonatal outcomes/complications

Women without uterine rupture

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women with uterine rupture after previous cesarean delivery versus women without uterine rupture after previous cesarean delivery

You may qualify if:

  • Singleton pregnancy \> 24 weeks of gestation
  • Second or multiparous with a previous cesarean section without vaginal delivery since
  • Cephalic presentation or completed breech
  • Uterine rupture during labor

You may not qualify if:

  • Incomplete uterine rupture
  • Multiple gestation
  • Transverse presentation or complete breech
  • Vaginal delivery after cesarean
  • Non-low transverse cesarean section
  • Placenta praevia
  • Antepartum intrauterine fetal death
  • History of uterine surgery (myomectomy)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Uterine Rupture

Condition Hierarchy (Ancestors)

Uterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesObstetric Labor ComplicationsPregnancy ComplicationsGenital DiseasesRuptureWounds and Injuries

Study Officials

  • Florent FUCHS, PUPH

    University Hospital, Montpellier

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2020

First Posted

September 28, 2020

Study Start

March 1, 2020

Primary Completion

March 30, 2020

Study Completion

April 1, 2020

Last Updated

November 18, 2020

Record last verified: 2020-09

Locations

FR(1)