Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
200 participants
INTERVENTIONAL
2014-03-31
2014-12-31
Brief Summary
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Detailed Description
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The investigators will perform cesarean section according to the obstetrical indications. Lower segment uterine incision will be used during the cesarean section. After the delivery of the fetus two distinct procedures will be used in the control and study groups.
In the control group, the uterus will be left in the abdominal cavity and the placenta will be manually removed with uterine massage as soon as possible. After removal of the placenta, the uterus will be dragged out of the abdominal cavity. The cesarean incision will be sutured with no. 1 Vicryl ®. Uterus will be replaced in the abdominal cavity. Intra-abdominal cavity will be cleaned by aspirator and mounted-gauze tampon. The weight of the placenta will be measured. The weight of the gauze tampons will be measured with gravimetric method before and after use.
In the study group, at first, the uterus will be dragged out of the abdominal cavity, prior to removal of the placenta. The placenta will be manually removed with uterine massage as soon as possible. The cesarean incision will be sutured with no. 1 Vicryl ®. Uterus will be replaced in the abdominal cavity. Intra-abdominal cavity will be cleaned by aspirator and mounted-gauze tampon. The weight of the placenta will be measured. The weight of the gauze tampons will be measured with gravimetric method before and after use.
In both groups, the abdominal cavity will be closed as appropriate. The vital signs (blood pressure and heart rate) will be monitored. Postoperative blood samples for complete blood count (CBC) will be taken 24 hours after the operation. Bowel movements will be assessed every 6 hours by a stethoscope. Time of the first flatulence will be recorded. Visual Analog Scoring (VAS) survey validated in Turkey will be performed in the postoperative 1. and 2. days. The type and amount of postoperative analgesics will be recorded. The body temperature will regularly be assessed in the first 24. and 48. hours. The presence of fever will be recorded.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Intra-abdominal removal of the placenta
The uterus will be left in the abdominal cavity and the placenta will be manually removed with uterine massage as soon as possible. After removal of the placenta, the uterus will be dragged out of the abdominal cavity. The cesarean incision will be sutured with no. 1 Vicryl ®. Uterus will be replaced in the abdominal cavity. Intra-abdominal cavity will be cleaned by aspirator and mounted-gauze tampon. The weight of the placenta will be measured. The weight of the gauze tampons will be measured with gravimetric method before and after use.
No interventions assigned to this group
Extra-abdominal removal of the placenta
No drug or device is used. The uterus will be dragged out of the abdominal cavity, prior to removal of the placenta.
The placenta will be manually removed with uterine massage as soon as possible. The cesarean section will be completed as described in "No intervention" group.
Extra-abdominal removal of the placenta
The uterus will be dragged out of the abdominal cavity, prior to removal of the placenta.
Extra-abdominal removal of the placenta
The placenta will be manually removed extra-abdominally, with uterine massage as soon as possible.
Extra-abdominal removal of the placenta
The cesarean incision will be sutured with no. 1 Vicryl ®.
Extra-abdominal removal of the placenta
Uterus will be replaced in the abdominal cavity.
Interventions
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Extra-abdominal removal of the placenta
The uterus will be dragged out of the abdominal cavity, prior to removal of the placenta.
Extra-abdominal removal of the placenta
The placenta will be manually removed extra-abdominally, with uterine massage as soon as possible.
Extra-abdominal removal of the placenta
The cesarean incision will be sutured with no. 1 Vicryl ®.
Extra-abdominal removal of the placenta
Uterus will be replaced in the abdominal cavity.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Placental adhesion anomalies
* Postpartum uterine hemorrhage (\>500 ml)
* Polyhydramnios
* Uterine atony
* Women with known coagulation disorders
* Abnormal preoperative APTT, PT and INR
18 Years
50 Years
FEMALE
Yes
Sponsors
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Near East University, Turkey
OTHER
Responsible Party
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Baris KAYA
OBSTETRICS AND GYNECOLOGY CONSULTANT, MD
Principal Investigators
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Baris Kaya, MD
Role: PRINCIPAL_INVESTIGATOR
Near East University, Obstetrics and Gynecology, Lefkosa-TRNC, Mersin 10, Turkey
Locations
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Near East University, Obstetrics and Gynecology
Mersin, Trnc, Turkey (Türkiye)
Countries
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Other Identifiers
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KAYA-2013-1
Identifier Type: -
Identifier Source: org_study_id
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