Intra-uterine Cleaning During Cesarean Section

Pregnancy Clinical Trial

Official title:

Intrauterine Cleaning After Delivery of Placenta During Cesarean Section

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03398863
• Other study ID #: Dr Raghda
• Status: Recruiting
• Phase: N/A
• First received: December 28, 2017
• Last updated: February 26, 2018
• Start date: February 5, 2018
• Est. completion date: December 2018

Study information

• Verified date: February 2018
• Source: Ain Shams University
• Contact: Dr yasser Abou talib, Professor
• Phone: 01001449556
• Email: Yasseraboutalib[@]yahoo.au
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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"

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy

Intervention

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

Locations

Country	Name	City	State
Egypt	Ain shams University	Cairo
Egypt	Faculty of Medicine-Ainshams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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