Prediction of Intra-abdominal Adhesion Before CS

Prediction of Intra-abdominal Adhesion Before CS: A Diagnostic Test Study

Recognition of intraabdominal adhesion before doing repeated cesarean section is helpful for the surgeon and patients.

Study Overview

• Status: Unknown
• Conditions: Intra-Abdominal; Adhesion
• Intervention / Treatment: Diagnostic test: sliding test

Detailed Description

the repeated cesarean section is associated with recorded maternal morbidity including placenta preavia and accreta , liability to injuries to the bladder, intestine or vascular injuries. The anticipation of the problem is important for decreasing its adverse effect . preoperative diagnosis of pelvic adhesion between the uterus and anterior abdominal wall, bladder, intestine or omentum could b of help to give time for a surgeon to prepare senior staff obstetrician or others and theatre requirements to overcome any problem happened.

• Study Type: Observational
• Enrollment (Anticipated): 27

Contacts and Locations

• Study Contact: Name: nahed allam, MD; Phone Number: +0201121116136; Email: nahedallam16@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 39 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

pregnant women in their 9th-month singleton planned for elective repeated CS and had a history of previous CS

Description

Inclusion Criteria:

• pregnant in their 9th-month singleton, planned for elective CS and had a history of previous CS

Exclusion Criteria:

• included multiple pregnancies, preterm labour, emergency CS, skin burn at the site of CS

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
repeated caesarean section; full term pregnant women with singleton baby with a history of at least previous one caesarean section	Diagnostic test: sliding test; ultrasound detected sliding test before doing repeated caesarean section; Other Names: ultrasound detected sliding test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
intra-abdominal adhesion	presence of adhesion between uterus and abdominal wall or intestine on bladder	intra-operative period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
skin to uterine incision time	time consumed by surgeon from skin incision to uterine incision in minutes	intra-operative period
need to insert intra-peritoneal drain	if there in marked adhesion and vascular injury a drain could be inserted	intraoperative period

Collaborators and Investigators

• Sponsor: Nahed allam
• Investigators: Study Chair: Taiseer Maarouf, MD, ALAZHAR UNIVERSITY

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2019
• Primary Completion (Anticipated): August 1, 2019
• Study Completion (Anticipated): August 1, 2019

Study Registration Dates

• First Submitted: January 9, 2019
• First Submitted That Met QC Criteria: January 9, 2019
• First Posted (Actual): January 11, 2019

Study Record Updates

• Last Update Posted (Actual): January 14, 2019
• Last Update Submitted That Met QC Criteria: January 10, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: sliding test , ceaserean section
• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix; Tissue Adhesions
• Other Study ID Numbers: Prediction of intra-abdominal

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: It is not yet known if there will be a plan to make IPD available.discussion with the other authors after completion of recruitment of patients

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No