Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01320995
Other study ID # AOI/2010/VL-02
Secondary ID 2011-A00050-41
Status Terminated
Phase N/A
First received March 22, 2011
Last updated March 24, 2015
Start date September 2011
Est. completion date March 2014

Study information

Verified date March 2015
Source Centre Hospitalier Universitaire de Nimes
Contact n/a
Is FDA regulated No
Health authority France: Committee for the Protection of PersonnesFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial Summary

The main objective of this study is to compare the rate of anal incontinence (measured by the Wexner score, qualitative and quantitative (> 4)) at 3 months post partum among primiparas with vaginal tears ≥ 2nd degree who receive a sphincter injury screening at delivery by conducting a sphincter ultrasound in the delivery room versus a similar group of women who do not benefit from screening.


Recruitment information / eligibility

Status Terminated
Enrollment 111
Est. completion date March 2014
Est. primary completion date March 2014
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- The patient must have given his/her informed and signed consent

- The patient must be insured or beneficiary of a health insurance plan

- The patient is available for 3 months of follow up

- The patient is delivering her first child; vaginal delivery

- The patient has a minimum stage 2 perineal lesion

- The patient accepts perineal echography

Exclusion Criteria:

- The patient is under judicial protection, under tutorship or curatorship

- The patient refuses to sign the consent

- It is impossible to correctly inform the patient

- Cesarien section

- No perineal lesion (intact perineum)

- Emergency situation which hinders screening for anal lesions under good medical conditions

- Previous vaginal delivery

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Procedure:
Perineal ultrasound
Perineal ultrasound is performed after delivery in order to better detect sphincter lesions.

Locations

Country Name City State
France CHU de Montpellier Montpellier cedex 5
France Centre Hospitalier Universitaire de Nîmes Nîmes Cedex 09 Gard

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Presence/absence of anal incontinence Anal incontinence is defined as a Wexner score > 4 3 months No
Secondary Wexner anal incontinence score 3 months No
Secondary Visual Analog Scale for discomfort during perineal ultrasound Ranges from 0.0 to 10.0 2 hours No
Secondary Kappa coefficient for second reading of ultrasounds A second reading of each ultrasound is obtained within 30 days. The Kappa coefficient of concordance will be calculated between the two readings. 30 days No
Secondary Presence/absence of a sphincter tear Presence/absence of a sphincter tear immediately after delivery. 2 hours No
Secondary Patient requires anal sutures (yes/no) Patient requires anal sutures after delivery? 2 hours No
Secondary Presence/absence of suture infection Has an infection ocurred between delivery and the follow up visit at 3 months post partum? 3 months No
Secondary Questionnaire PFIQ 3 months No
Secondary Questionnaire PFDI 3 months No
Secondary Questionnaire SF36 3 months No
Secondary Questionnaire Euroqol 3 months No
See also
  Status Clinical Trial Phase
Completed NCT05708482 - Sling and Swing Positions to Pregnant Women N/A
Recruiting NCT04603859 - When to INDuce for OverWeight? (WINDOW) N/A
Completed NCT01131260 - Fetal ST Segment and T Wave Analysis in Labor N/A
Completed NCT01164657 - A Swedish Trial of Birth on a Birthing Seat N/A
Completed NCT03441243 - Evaluation of the Psychological Consequences of Complicated Childbirth
Completed NCT00323401 - The Influence of Antenatal Classes on Pregnancy, Birth and Parenthood N/A
Completed NCT03490682 - Gastric Emptying During the Labour N/A
Completed NCT03890276 - Field Study of Health Worker Training on Helping Mothers Survive Module 'Essential Care for Labor & Birth' in Zanzibar N/A
Completed NCT02870712 - Randomized Controlled Trial of the Effectiveness of Perineal Pain and Security of the Suture Led by the Result of Hemostasis Versus Manual Compression Routine Suture Perineal Tears of First Degree During Childbirth N/A
Not yet recruiting NCT02363036 - The Shift From Monocytes to Neutrophils in Blood Samples of Women in Labor N/A
Not yet recruiting NCT02361853 - The Role of Immature Myeloid Cells, Monocytes, Dentritic Cells and Neutrophils in Human Pregnancies as Markers for Mature Pregnancy and Spontaneous Labor N/A
Not yet recruiting NCT02493192 - Birth Ball Versus Meperidine and Haloperidol Injection for Pain Relief During First Stage of Labour Phase 4
Completed NCT04432675 - Effects of Crystal Solution and Colloid Solution on Mother and Fetus Phase 4
Recruiting NCT01051726 - Effects of Aromatherapy on Childbirth Phase 2
Completed NCT05820958 - Intensified Tactile Contact With a Newborn Andt Emotional Transformation of the Mother N/A
Completed NCT06069596 - Evaluation of the Effectiveness of Obstetric Lubricant Gel in Labor in Nulliparous and Primiparous Women: A Randomized Controlled Study Phase 4
Recruiting NCT06380400 - The Effect of Foot Bath on Birth Pain and Birth Comfort N/A
Enrolling by invitation NCT02408588 - Evaluation of Compensatory Reserve in Obstetrical Patients
Not yet recruiting NCT04657107 - The Efficacy and Safety of S-ketamine in Elective Cesarean Section N/A
Completed NCT02823418 - Neuraxial Labor Analgesia and the Incidence of Postpartum Depression