Intra-uterine Cleaning During Cesarean Section

Intrauterine Cleaning After Delivery of Placenta During Cesarean Section

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"

Study Overview

• Status: Unknown
• Conditions: Pregnancy
• Intervention / Treatment: Procedure: Cleaning of uterine cavity

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

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 02
    • Recruiting
    • Ain Shams University
    • Contact: Dr yasser Abou talib, Professor; Phone Number: 01001449556; Email: Yasseraboutalib@yahoo.au
    • Contact: Ahmed Hussein, Lecturer; Phone Number: 01205055563; Email: AhmadMahmoud82@yahoo.com
  • Cairo, Egypt, 02
    • Not yet recruiting
    • Faculty of Medicine-Ainshams University
    • Contact: Dr yasser Abou talib, Professor; Phone Number: 01001449556; Email: Yasseraboutalib@yahoo.au

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary postpartum hemorrhage	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 ]	Within 6 weeks

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: Dr yasser Abou talib, Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2018
• Primary Completion (Anticipated): July 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: December 28, 2017
• First Submitted That Met QC Criteria: January 7, 2018
• First Posted (Actual): January 16, 2018

Study Record Updates

• Last Update Posted (Actual): February 27, 2018
• Last Update Submitted That Met QC Criteria: February 26, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: Dr Raghda

Drug and device information, study documents

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