CClinicalTrials.gg
Status unknownNCT03576950URIDAUpdated Nov 5, 2020

Uterine Rupture International Data Acquisition

An observational study in Uterine Rupture Gravid, sponsored by Università degli Studi dell'Insubria. Status unknown. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2020-11-05.

Sponsored by Università degli Studi dell'Insubria · Observational

The sponsor has not verified this record recently (last verified Nov 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
100
Ages
18 Years to 50 Years
Sex
Female
01

Study summary

Uterine rupture represents an uncommon event: it is is a life-threatening obstetric complication with high maternal and perinatal morbidity and mortality. Indeed, uterine rupture may cause catastrophic maternal and fetal complications (uterine hemorrhage, hysterectomy with consequent fertility loss, maternal and fetal death or cerebral palsy) which are hardly acceptable within the context of a natural event such as birth.

Uterine rupture can occur during pregnancy, early in labor or following a prolonged labor, most frequently near or at term and, rarely, during early to mid-pregnancy. Its prevalence ranges between 0.006% for women without previous cesarean section (CS) in the western countries, to 25% for women with obstructed labor in African countries.

Pregnancy after myomectomy or CS, vaginal delivery after cesarean sections (VBACs) and vaginal delivery after myomectomy are potentially "at risk" of uterine rupture.

Despite uterine rupture is widely considered a life-threatening condition, so far most of published data refer to case reports or very small case series. In this scenario, the "Uterine Rupture International Data Acquisition" study group would like to collect a large number of events, in order to identify the potential risk factors among different populations through a multivariate analysis.

02

Conditions studied

  • Uterine Rupture Gravid

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Keywords

  • Uterine rupture
  • Cesarean section
  • Labour
  • Myomectomy
  • Delivery
03

In context

Rupture

557 studies on the registry are indexed under Rupture; 97 are open to participants now.

This study's planned enrollment of 100 is close to the median of 100 across 203 observational studies indexed under Rupture.

Browse Rupture studies →

Lead sponsor

Università degli Studi dell'Insubria is the lead sponsor of 67 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Sampling method
Non-probability sample

Study population

Women with uterine rupture occurred during pregnancy.

Inclusion criteria

  • Women with uterine rupture occurred during pregnancy.

Exclusion criteria

Exclusion Criteria:

  • None.
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • Uterine rupture

    Women with uterine rupture occurred during pregnancy.

06

What researchers measure

Primary outcomes

  1. Uterine rupture

    Women with uterine rupture occurred during pregnancy.

    Time frame: A retrospective analysis of 10 years.

Secondary outcomes

  1. Gestational age at uterine rupture

    Gestational age, calculated as weeks and days, in which uterine rupture occurred.

    Time frame: A retrospective analysis of 10 years.

  2. Parity

    The number of previous delivery.

    Time frame: A retrospective analysis of 10 years.

  3. Body Mass Index

    The Body Mass Index of each patient in which uterine rupture occurred.

    Time frame: A retrospective analysis of 10 years.

  4. Presence of myomas

    The occurrence of myomas in each patient in which uterine rupture occurred.

    Time frame: A retrospective analysis of 10 years.

  5. Hysterectomy

    The number of cases in which it was necessary to perform hysterectomy after uterine rupture.

    Time frame: A retrospective analysis of 10 years.

  6. Hospital stay

    The hospital stay from the admission to the discharge, expressed in days.

    Time frame: A retrospective analysis of 10 years.

  7. Neonatal complications

    The occurrence of neonatal complications, included neonatal deaths.

    Time frame: A retrospective analysis of 10 years.

07

Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 5, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03576950
Lead sponsor
Università degli Studi dell'Insubria
Responsible party
Antonio Simone Laganà (Medical Doctor, Università degli Studi dell'Insubria) — Principal investigator
First posted
Jul 5, 2018
Start date
Sep 2021 (estimated)
Primary completion
Sep 2022 (estimated)
Completion
Sep 2023 (estimated)
Last update
Nov 5, 2020

Study contacts

Andrea Tinelli, M.D.
Contact
andreatinelli@gmail.com
+393392074078
Andrea Tinelli, M.D.
study director · U.O. Ginecologia e Ostetricia, Ospedale Vito Fazzi, 73100 Lecce, Italy

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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