Intra-uterine Cleaning During Cesarean Section

NCT03398863 | Unknown DMC

• 1 other identifier: Dr Raghda
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 2

Brief Summary

400 women who came to our Department for Cesarean Section delivery will be divided into 2 groups: Group1:Cleaning the uterine cavity "200 patients" Group2:No Cleaning of uterine cavity "200 patients"

Conditions

Pregnancy

Outcome Measures

Primary Outcomes (1)

• Postpartum endometritis

  Endomyometritis after delivery \[ Time Frame: Within 6 weeks after delivery \] Endomyometritis will be diagnosed by the presence of two or more of the following: abnormally tender uterus on examination, temperature more than 38.0°C at any time postoperatively, and unexplained maternal tachycardia more than 100 beats per minute (bpm). A diagnosis of endomyometritis will be criteria for initiating treatment with antibiotics. Endomyometritis after delivery \[ Time Frame: Within 6 weeks after delivery \] Endomyometritis will be diagnosed by the presence of two or more of the following: abnormally tender uterus on examination, temperature more than 38.0°C at any time postoperatively, and unexplained maternal tachycardia more than 100 beats per minute (bpm). A diagnosis of endomyometritis will be criteria for initiating treatment with antibiotics.

  Within weeks

Secondary Outcomes (1)

• Primary postpartum hemorrhage

  Within 6 weeks

Study Arms (2)

Cleaning of uterine cavity

ACTIVE COMPARATOR

Cleaning of uterine cavity: participants will have their uterine cavities cleaned with a dry laparotomy sponge after delivery of the placenta. Per standard protocol, the uterus will be explored with one hand holding a sponge to remove any remaining membranes or placental tissue, while the other hand is placed on the fundus to stabilize the uterus

Procedure: Cleaning of uterine cavity

Not cleaning of uterine cavity

NO INTERVENTION

These participants will have their uterine cavities left alone after complete delivery of the placenta. The placenta will be inspected after delivery to make sure it is complete, including the membranes.

Interventions

Cleaning of uterine cavity PROCEDURE

Procedure: Cleaning the uterine cavity These participants will have their uterine cavities cleaned with a dry laparotomy sponge after delivery of the placenta. Per standard protocol, the uterus will be explored with one hand holding a sponge to remove any remaining membranes or placental tissue, while the other hand is placed on the fundus to stabilize the uterus

Cleaning of uterine cavity

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• women age from 20 to35 years old with intact membrane women with singleton or multiple pregnancy women with cephalic or breech presentation

You may not qualify if:

• premature rupture of membranes chorioamnionitis Diabetes mellitus Immunosuppressive disorder or therapy Fetal demise

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (2)

Ain shams University

Cairo, 02, Egypt

RECRUITING

Faculty of Medicine-Ainshams University

Cairo, 02, Egypt

NOT YET RECRUITING

Study Officials

• Dr yasser Abou talib

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr yasser Abou talib, Professor

CONTACT

01001449556; Yasseraboutalib@yahoo.au

Dr ahmed Hussein, Lecturer

CONTACT

01205055563; AhmadMahmoud82@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: December 28, 2017
• First Posted: January 16, 2018
• Study Start: February 5, 2018
• Primary Completion: July 1, 2018
• Study Completion: December 1, 2018
• Last Updated: February 27, 2018

Record last verified: 2018-02

Locations

EG (2)