the Influence of Intra- vs Extra-abdominal Removal of PlacentaNCT02101450
Extra-abdominal Removal of Placenta During CS
A study testing Extra-abdominal removal of the placenta in people with the Influence of Intra- vs Extra-abdominal Removal of Placenta and Duration of Operation, run by Near East University, Turkey at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- the Influence of Intra- vs Extra-abdominal Removal of Placenta, Duration of Operation, the Amount of Aspirated Fluid During the Operation
- What is being tested?
- Extra-abdominal removal of the placenta
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 2014to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women undergoing cesarean section according to the obstetrical indications.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Near East University, Obstetrics and Gynecology
Mersin, Trnc, 10
About this study
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.
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.
Read the detailed 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.
- Conditions
- the Influence of Intra- vs Extra-abdominal Removal of Placenta, Duration of Operation, the Amount of Aspirated Fluid During the Operation, Difference Between Pre- and Post-operative CBC
- Being tested
- Extra-abdominal removal of the placenta
- Keywords
- extra-abdominal, intra-abdominal, removal of placenta, cesarean section, bleeding
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extra-abdominal removal of the placentaProcedure or surgery
The uterus will be dragged out of the abdominal cavity, prior to removal of the placenta.
Extra-abdominal removal of the placentaProcedure or surgery
The placenta will be manually removed extra-abdominally, with uterine massage as soon as possible.
Extra-abdominal removal of the placentaProcedure or surgery
The cesarean incision will be sutured with no. 1 Vicryl ®.
Extra-abdominal removal of the placentaProcedure or surgery
Uterus will be replaced in the abdominal cavity.
| Study group | Role | What they receive |
|---|---|---|
| Intra-abdominal removal of the placenta | No intervention | 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. |
| Extra-abdominal removal of the placenta | Experimental | 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. Receives: Procedure: Extra-abdominal removal of the placenta |
What is being measured
The primary outcome is the main question the study is designed to answer.
The amount of aspirated fluid during the cesarean section
The amount of aspirated fluid during the cesarean section in mililiters
Measured: 3 months
Secondary outcomes (2)
Difference between preoperative and postoperative hemoglobin levels
Difference between preoperative and postoperative hemoglobin levels expressed as g/dL
Measured: 3 months
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionApr 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for the Influence of Intra- vs Extra-abdominal Removal of PlacentaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Near East University, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Baris KAYA, Near East University, Turkey
- Investigators
- Baris Kaya, MD, Principal investigator, Near East University, Obstetrics and Gynecology, Lefkosa-TRNC, Mersin 10, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02101450
- Sponsor's protocol ID
- KAYA-2013-1
- Status last verified
- Jan 2015
- First submitted
- 15 Mar 2014
- Last updated
- 13 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02101450
- Acronym / sponsor ID
- KAYA-2013-1
- Conditions
- the Influence of Intra- vs Extra-abdominal Removal of Placenta, Duration of Operation, the Amount of Aspirated Fluid During the Operation, Difference Between Pre- and Post-operative CBC
- Keywords
- extra-abdominal, intra-abdominal, removal of placenta, cesarean section, bleeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Near East University, TurkeyUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Apr 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 2 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intra-abdominal removal of the placenta | No intervention | –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. |
| Extra-abdominal removal of the placenta | Experimental | Procedure: Extra-abdominal removal of the placentaNo 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women undergoing cesarean section according to the obstetrical indications.
Key exclusion criteria (7 listed)
- Uterine anomalies such as didelphys, bicornis, etc.
- Placental adhesion anomalies
- Postpartum uterine hemorrhage (>500 ml)
- Polyhydramnios
- Uterine atony
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extra-abdominal removal of the placentaThe uterus will be dragged out of the abdominal cavity, prior to removal of the placenta. | Procedure or surgery | Extra-abdominal removal of the placenta |
| Extra-abdominal removal of the placentaThe placenta will be manually removed extra-abdominally, with uterine massage as soon as possible. | Procedure or surgery | Extra-abdominal removal of the placenta |
| Extra-abdominal removal of the placentaThe cesarean incision will be sutured with no. 1 Vicryl ®. | Procedure or surgery | Extra-abdominal removal of the placenta |
| Extra-abdominal removal of the placentaUterus will be replaced in the abdominal cavity. | Procedure or surgery | Extra-abdominal removal of the placenta |
Primary outcome
The amount of aspirated fluid during the cesarean section
Time frame: 3 months
The amount of aspirated fluid during the cesarean section in mililiters
2 secondary outcomes
Difference between preoperative and postoperative hemoglobin levels
Time frame: 3 months
The weight of the gauze before and after use in cesarean section
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Baris Kaya, MD principal investigator
Near East University, Obstetrics and Gynecology, Lefkosa-TRNC, Mersin 10, Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extra-abdominal removal of the placenta in people with the Influence of Intra- vs Extra-abdominal Removal of Placenta and Duration of Operation, run by Near East University, Turkey at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The amount of aspirated fluid during the cesarean section (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2015.