Extra-abdominal Removal of Placenta During CS

Difference Between Pre- and Post-operative CBC Clinical Trial

Official title:

Evaluation of the Effects of Extra-abdominal Removal of the Placenta During Cesarean Section on the Amount of Bleeding Into the Abdominal Cavity.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02101450
• Other study ID #: KAYA-2013-1
• Status: Completed
• Phase: N/A
• First received: March 15, 2014
• Last updated: January 9, 2015
• Start date: March 2014
• Est. completion date: December 2014

Study information

• Verified date: January 2015
• Source: Near East University, Turkey
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

During cesarean section, it is important to provide hemostasis as well as to decrease the amount of hemorrhagic fluid and fibrin in the abdominal cavity. Hemorrhagic fluid and fibrin together may cause adhesion formation and therefore postoperative ileus, retardation in regaining the gastrointestinal functions as well as prolongation of the operation itself. Dragging the uterus out of the abdominal cavity during cesarean section before removing the placenta (extra-abdominal removal of the placenta) may decrease the amount of blood flowing into the abdominal cavity during removal of placenta. In this study the investigators aimed to evaluate the influence of intra abdominal vs extra abdominal removal of placenta on duration of operation, the amount of aspirated fluid during the operation, difference between postoperative hemoglobin and hematocrit levels, postoperative pain score, additional need of analgesia, postoperative bowel movements, postoperative endometritis and wound infection.

Description:

In this study the investigators will recruit 200 pregnant women; 100 women in the study group and 100 women in the control group. The women will be randomly allocated in two groups. The odd numbered women will be in the study group and even numbered women will be in the control group.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Women undergoing cesarean section according to the obstetrical indications.

Exclusion Criteria:

• Uterine anomalies such as didelphys, bicornis, etc.

• Placental adhesion anomalies

• Postpartum uterine hemorrhage (>500 ml)

• Polyhydramnios

• Uterine atony

• Women with known coagulation disorders

• Abnormal preoperative APTT, PT and INR

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Difference Between Pre- and Post-operative CBC
• Duration of Operation
• the Amount of Aspirated Fluid During the Operation
• the Influence of Intra- vs Extra-abdominal Removal of Placenta

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Turkey	Near East University, Obstetrics and Gynecology	Mersin	Trnc

Sponsors (1)

Lead Sponsor	Collaborator
Near East University, Turkey

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The amount of aspirated fluid during the cesarean section	The amount of aspirated fluid during the cesarean section in mililiters	3 months	No
Secondary	Difference between preoperative and postoperative hemoglobin levels	Difference between preoperative and postoperative hemoglobin levels expressed as g/dL	3 months	No
Secondary	The weight of the gauze before and after use in cesarean section	The weight of the gauze before and after use in cesarean section, described in miligrams	3 months	No