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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03357783
Other study ID # CHRD0315
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 1, 2011
Est. completion date February 1, 2014

Study information

Verified date July 2019
Source Centre Hospitalier René Dubos
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to determine the prevalence of macroscopic deciduosis found randomly in Cesarean sections and the secondary objective to determine the association with any obstetrical complications or adverse effects.


Description:

Ectopic decidua or deciduosis is defined as the extrauterine location of decidual tissue and can occur in the cervix, vagina and various abdominal organs like the ovary omentum, appendix, peritoneum, the pelvic lymph nodes. Other rare sites with deciduosis include the kidneys , the lungs and even the skin . Decidualization is a physiologic process during pregnancy, under the influence of ovarian and placental steroid secretion, with total involution in the four to six week post partum period.


Recruitment information / eligibility

Status Completed
Enrollment 31
Est. completion date February 1, 2014
Est. primary completion date February 1, 2014
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

- All cesarean section

Exclusion Criteria:

- Patients refusing to participate

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Macroscopic deciduosis
Deciduosis is a benign lesion during pregnancy that is not correlated with obstetrical complications. Our study has shown that this physiological phenomenon is more frequent that originally thought, being present in 10% of the Cesarean sections, and is associated with abdominal pain during pregnancy.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier René Dubos

Outcome

Type Measure Description Time frame Safety issue
Primary All cases of cesarean section. The purpose of this study is to measure the number of participants who developed macroscopic decidosis in caesareans. During cesarean section.