Uterine Rupture During Labor Among Women With a Prior Cesarean Delivery

Mode of Delivery Clinical Trial

Official title:

Uterine Rupture During Labor Among Women With a Prior Cesarean Delivery : Risks Factors, Maternal and Perinatal Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04566705
• Other study ID #: RECHMPL20_0142
• Status: Completed
• Start date: March 1, 2020
• Est. completion date: April 1, 2020

Study information

• Verified date: September 2020
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: April 1, 2020
• Est. primary completion date: March 30, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• 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

Exclusion criteria:

• 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)

Related Conditions & MeSH terms

• Mode of Delivery
• Rupture
• Uterine Rupture

Intervention

Other:
• Risks factors, maternal and neonatal outcomes/complications
Risks factors, maternal and neonatal outcomes/complications

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Participants with Assess the maternal and perinatal complications and outcomes	Number of Participants withAssess the maternal and perinatal complications and outcomes : looking for maternal complications (chorioamnionitis , transfusion, post-partum hemorrhage, surgery for blad-der wound, maternal death,…) and neonatal comply-cations (apgar<7 at 5minutes, pH <7,15, neonatal intein-sive care unit and perinatal death)	1 day