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Intra-uterine Cleaning During Cesarean Section

Intrauterine Cleaning After Delivery of Placenta During Cesarean Section

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03398863
Enrollment
400
Registered
2018-01-16
Start date
2018-02-05
Completion date
2018-12-31
Last updated
2018-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy

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

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

Interventions

PROCEDURECleaning 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

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 35 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Postpartum endometritisWithin weeksEndomyometritis 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

MeasureTime frameDescription
Primary postpartum hemorrhageWithin 6 weeksPost 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. \[ Time Frame: Within 6 weeks post delivery \]

Countries

Egypt

Contacts

Primary ContactDr yasser Abou talib, Professor
Yasseraboutalib@yahoo.au01001449556
Backup ContactDr ahmed Hussein, Lecturer
AhmadMahmoud82@yahoo.com01205055563

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026