Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Intra-uterine Cleaning During Cesarean Section

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03398863
Recruitment Status : Recruiting
First Posted : January 16, 2018
Last Update Posted : February 27, 2018
Sponsor:
Information provided by (Responsible Party):
Raghda Elsayed Ghonem, Ain Shams University

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"

Condition or disease Intervention/treatment Phase
Pregnancy Procedure: Cleaning of uterine cavity Not Applicable

Detailed Description:

Caesarean section is the most common major surgical procedure performed in obstetric practice. The American College of Obstetricians and Gynecologists (ACOG) estimates that in 2011 alone, one in three women who gave birth in the United States did so by cesarean delivery. Compared to vaginal births, the increasing rate of caesarean births worldwide is a well known cause of maternal morbidity, including hemorrhage, anesthetic complications, shock, cardiac arrest, acute renal failure, assisted ventilation, venous thromboembolism and increased risk of major postpartum infection.

With increasing cesarean section rates and its associated complications, obstetricians are challenged to reduce perioperative and postoperative morbidity by adapting their surgical skills and techniques. Over the years, randomized clinical trials have tried to answer many questions surrounding the safety of several cesarean section techniques that impart maternal morbidity. For example, the optimal type of cesarean section skin incision, whether or not to create a bladder flap, one layer versus two later closure of the uterus, irrigating the abdominal cavity, closure versus non closure of the parietal peritoneum, and suture versus staples for skin closure at cesarean section.

Cleaning the uterine cavity following cesarean section is a routine practice by many obstetricians. To ensure that the entire placenta and membranes are removed after delivery of the placenta at cesarean, the uterine cavity is usually cleaned with one hand holding a dry sponge to remove any remaining membranes or placental tissue, while the other hand is placed on the fundus to stabilize the uterus. However, despite the lack of evidence to support a policy of routine intrauterine cleaning after placental delivery at cesarean section, the benefits of intrauterine cleaning as a routine practice during cesarean sections remains uncertain. Obstetricians who do not routinely clean the uterine cavity after placental delivery argue that this procedure is not performed routinely after vaginal deliveries, and thus is a justification not to do so during cesarean sections


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Intrauterine Cleaning After Delivery of Placenta During Cesarean Section
Actual Study Start Date : February 5, 2018
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
Active Comparator: Cleaning of uterine cavity
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
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

No Intervention: Not cleaning of uterine cavity
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.



Primary Outcome Measures :
  1. Postpartum endometritis [ Time Frame: Within weeks ]

    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.



Secondary Outcome Measures :
  1. Primary postpartum hemorrhage [ Time Frame: Within 6 weeks ]

    Post partum hemorrhage [ Time Frame: Within 6 weeks after delivery ] Mean surgical time [ Time Frame: Immediately post cesarean ]

    Calculated blood loss [ Time Frame: Within 6 weeks post delivery ] Hospital length of stay [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 4 days postpartum ] Return of gastrointestinal function [ Time Frame: Participants will be followed for the duration to return of bowel function, an expected average of 2 days postpartum ] Repeat surgery [ Time Frame: Within 6 weeks post delivery ] Hospital readmission rates. [ Time Frame: Within 6 weeks post delivery ]




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03398863


Contacts
Layout table for location contacts
Contact: Dr yasser Abou talib, Professor 01001449556 Yasseraboutalib@yahoo.au
Contact: Dr ahmed Hussein, Lecturer 01205055563 AhmadMahmoud82@yahoo.com

Locations
Layout table for location information
Egypt
Ain shams University Recruiting
Cairo, Egypt, 02
Contact: Dr yasser Abou talib, Professor    01001449556    Yasseraboutalib@yahoo.au   
Contact: Ahmed Hussein, Lecturer    01205055563    AhmadMahmoud82@yahoo.com   
Faculty of Medicine-Ainshams University Not yet recruiting
Cairo, Egypt, 02
Contact: Dr yasser Abou talib, Professor    01001449556    Yasseraboutalib@yahoo.au   
Sponsors and Collaborators
Ain Shams University
Investigators
Layout table for investigator information
Principal Investigator: Dr yasser Abou talib Ain Shams University

Layout table for additonal information
Responsible Party: Raghda Elsayed Ghonem, Principle investigator, Ain Shams University
ClinicalTrials.gov Identifier: NCT03398863     History of Changes
Other Study ID Numbers: Dr Raghda
First Posted: January 16, 2018    Key Record Dates
Last Update Posted: February 27, 2018
Last Verified: February 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No