Complications; Cesarean SectionNCT02405663
Methods of Placental Delivery and the Amount of Blood Loss During Cesarean Section
A study testing manual removal and cord traction in people with Complications; Cesarean Section, run by Benha University at 1 site in Saudi Arabia.
Trial summary
To compare between the effect of controlled cord traction and manual removal of the placenta on blood loss among women undergoing caesarean sections Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Complications; Cesarean Section
- What is being tested?
- manual removal and cord traction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Apr 2015to Jul 2016
- 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 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- All informed and consented women undergoing elective or emergency CS will be legible for enrollment into the study
Who cannot join
- Multiple gestation.
- Pregnancy below 34 weeks.
- Severe maternal anemia.
- Severe pre-eclampsia
- Prolonged labor.
- Prolonged rupture of the membranes with fever.
Show all 11Show fewer
- Placental abruption.
- Placenta previa.
- Placenta accreta.
- Clotting disorders.
- Current or previous history of a significant disease including heart disease, liver, renal disorders.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
Postpartum ward of Armed Forces Hospital, Southern Region
Khamis Mushait, 'Asir Region, 101
About this study
Official title: How Can Methods of Placental Delivery Affect the Amount of Blood Loss During Cesarean Section?
To compare between the effect of controlled cord traction and manual removal of the placenta on blood loss among women undergoing caesarean sections
Read the detailed description
Cesarean section (CS) is one of the most commonly performed major abdominal operations in women worldwide and its rate is increasing dramatically every year.
Some of the reported short-term morbidities include hemorrhage, postoperative fever and endometritis. The method of delivering the placenta is one procedure that may contribute to an increase or decrease in the morbidity of CS.
On an average 0.5-1 liter of blood is lost during CS, many variable techniques have been tried to reduce this blood loss. Such techniques include finger splitting versus scissor cutting of incision, in situ stitching verses exteriorization and stitching of uterus , and finally spontaneous or manual removal of the placenta.
Two common methods used to deliver the placenta at CS are cord traction and manual removal.
Manual removal of the placenta which the obstetrician introduce his hand into the uterine cavity to cleave the placenta from the decidua basalis as soon as possible after the delivery of the infant and controlled cord traction in which the obstetrician do external uterine massage and gentle traction on the exposed umbilical cord to facilitate placental delivery.
Opinions differ about the best for placental delivery technique at CS. Some trials showed a reduced risk of blood loss with controlled cord traction (3) and others showed that manual removal of placenta at CS do not increase perioperative blood loss.
Authors concluded that manual delivery of the placenta was significantly associated with greater operative blood loss and greater decrease in postoperative hemoglobin levels and postpartum maternal infectious morbidity but with shorter operative time compared with spontaneous placental separation .
In addition, it is known that the blood loss at CS delivery is difficult to estimate, and numerous different methods including serial change in hematocrit (Hct), hemoglobin (Hb) level, visual estimation and the gravimetric method are described.
A low, but significant, correlation was found between visually estimated blood loss and perioperative hemoglobin change in women delivering by CS. However, hemoglobin , hematocrit levels and visual estimation are the most commonly used technique for estimating blood loss at delivery.
- Conditions
- Complications; Cesarean Section
- Being tested
- manual removal, cord traction
- Keywords
- blood loss, caesarean section, placental delivery
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
manual removalProcedure or surgery
one of the standard procedures for placental delivery during caesarean section the surgeon will introduce his hand into the uterine cavity to cleave the placenta from the decidua basalis as soon as possible after the delivery of the baby
cord tractionProcedure or surgery
one of the standard procedures for placental delivery during caesarean section the surgeon do external uterine massage and gentle traction on the exposed umbilical cord to facilitate placental delivery
| Study group | Role | What they receive |
|---|---|---|
| manual removal group | Experimental | Group will be assigned for manual removal of the placenta as the surgeon will introduce his hand into the uterine cavity to cleave the placenta from the decidua basalis as soon as possible after the delivery of the baby by caesarean section Receives: Procedure: manual removal |
| cord traction group | Experimental | Group will be assigned for controlled cord traction as the surgeon do external uterine massage and gentle traction on the exposed umbilical cord to facilitate placental delivery after the delivery of the baby by caesarean section Receives: Procedure: cord traction |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood loss assessment after placental delivery
Determine estimated blood loss after placental delivery either by cord traction or manually during caesarean section through comparing pre and postoperative hemoglobin and haematocrit measurements
Measured: 12 hours
Secondary outcomes (6)
Placental delivery time.
time needed to deliver the placenta calculated from time of full baby delivery to the time of full placental delivery
Measured: 30 minutes
Duration of operation
time calculated from first skin incision to the time of last stitch
Measured: 2 hours
Need to use ecbolics
documentation of the type, the dose of different ecbolics needed to stop any possible bleeding
Measured: 30 minutes
Need of blood transfusion
documentation of the need and the amount needed of packed red blood cells packs or any other blood products if patient general condition required
Measured: 12 hours
Blood loss > 1000 ml
counting down the cases of estimated blood loss more than 1000ml
Measured: 12 hours
postoperative endometritis and puerperal pyrexia
counting down the cases of puerperal pyrexia after exclusion of all other etiologies rather than endometritis
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionJun 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complications; Cesarean SectionStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 288 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Collaborators
- Armed Forces Hospitals, Southern Region, Saudi Arabia
- Responsible party
- Principal investigator, ahmed abdulmoneim altraigey, Benha University
- Investigators
- mohammed ellaithy, Principal investigator, Ain Shams Universityhaytham atia, Principal investigator, Zagazig Universitynuzhat amer, Principal investigator, Armed Forces Hospitals, Southern Region, Saudi Arabiaahmed altraigey, Study director, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02405663
- Sponsor's protocol ID
- afhsr-1-3-2015
- Status last verified
- May 2017
- First submitted
- 18 Mar 2015
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Can Methods of Placental Delivery Affect the Amount of Blood Loss During Cesarean Section?
- ClinicalTrials.gov ID
- NCT02405663
- Acronym / sponsor ID
- afhsr-1-3-2015
- Conditions
- Complications; Cesarean Section
- Keywords
- blood loss, caesarean section, placental delivery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 288 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Collaborators
- Armed Forces Hospitals, Southern Region, Saudi Arabia
- Study start
- Apr 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 1 Apr 2015 (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.
To compare between the effect of controlled cord traction and manual removal of the placenta on blood loss among women undergoing caesarean sections
Detailed description
Cesarean section (CS) is one of the most commonly performed major abdominal operations in women worldwide and its rate is increasing dramatically every year.
Some of the reported short-term morbidities include hemorrhage, postoperative fever and endometritis. The method of delivering the placenta is one procedure that may contribute to an increase or decrease in the morbidity of CS.
On an average 0.5-1 liter of blood is lost during CS, many variable techniques have been tried to reduce this blood loss. Such techniques include finger splitting versus scissor cutting of incision, in situ stitching verses exteriorization and stitching of uterus , and finally spontaneous or manual removal of the placenta.
Two common methods used to deliver the placenta at CS are cord traction and manual removal.
Manual removal of the placenta which the obstetrician introduce his hand into the uterine cavity to cleave the placenta from the decidua basalis as soon as possible after the delivery of the infant and controlled cord traction in which the obstetrician do external uterine massage and gentle traction on the exposed umbilical cord to facilitate placental delivery.
Opinions differ about the best for placental delivery technique at CS. Some trials showed a reduced risk of blood loss with controlled cord traction (3) and others showed that manual removal of placenta at CS do not increase perioperative blood loss.
Authors concluded that manual delivery of the placenta was significantly associated with greater operative blood loss and greater decrease in postoperative hemoglobin levels and postpartum maternal infectious morbidity but with shorter operative time compared with spontaneous placental separation .
In addition, it is known that the blood loss at CS delivery is difficult to estimate, and numerous different methods including serial change in hematocrit (Hct), hemoglobin (Hb) level, visual estimation and the gravimetric method are described.
A low, but significant, correlation was found between visually estimated blood loss and perioperative hemoglobin change in women delivering by CS. However, hemoglobin , hematocrit levels and visual estimation are the most commonly used technique for estimating blood loss at delivery.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| manual removal group | Experimental | Procedure: manual removalGroup will be assigned for manual removal of the placenta as the surgeon will introduce his hand into the uterine cavity to cleave the placenta from the decidua basalis as soon as possible after the delivery of the baby by caesarean section |
| cord traction group | Experimental | Procedure: cord tractionGroup will be assigned for controlled cord traction as the surgeon do external uterine massage and gentle traction on the exposed umbilical cord to facilitate placental delivery after the delivery of the baby by caesarean section |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All informed and consented women undergoing elective or emergency CS will be legible for enrollment into the study
Key exclusion criteria (11 listed)
- Multiple gestation.
- Pregnancy below 34 weeks.
- Severe maternal anemia.
- Severe pre-eclampsia
- Prolonged labor.
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 |
|---|---|---|
| manual removalone of the standard procedures for placental delivery during caesarean section the surgeon will introduce his hand into the uterine cavity to cleave the placenta from the decidua basalis as soon as possible after the delivery of the baby | Procedure or surgery | manual removal group |
| cord tractionone of the standard procedures for placental delivery during caesarean section the surgeon do external uterine massage and gentle traction on the exposed umbilical cord to facilitate placental delivery | Procedure or surgery | cord traction group |
Primary outcome
blood loss assessment after placental delivery
Time frame: 12 hours
Determine estimated blood loss after placental delivery either by cord traction or manually during caesarean section through comparing pre and postoperative hemoglobin and haematocrit measurements
6 secondary outcomes
Placental delivery time.
Time frame: 30 minutes
Duration of operation
Time frame: 2 hours
Need to use ecbolics
Time frame: 30 minutes
Need of blood transfusion
Time frame: 12 hours
Blood loss > 1000 ml
Time frame: 12 hours
postoperative endometritis and puerperal pyrexia
Time frame: one week
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 30 May 2017.
Related trials for Complications; Cesarean Section
Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
Postpartum Hemorrhage, Uterine Atony
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
RecruitingPhase 1
Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Pain, Postpartum Depression
Recruiting
Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
Not yet recruiting
The Mepilex Cesarean Delivery Trial / MEPIDEL
Surgical Site Infection
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.
mohammed ellaithy principal investigator
Ain Shams University
haytham atia principal investigator
Zagazig University
nuzhat amer principal investigator
Armed Forces Hospitals, Southern Region, Saudi Arabia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing manual removal and cord traction in people with Complications; Cesarean Section, run by Benha University at 1 site in Saudi Arabia.
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 11 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 30 May 2017. 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 Saudi Arabia. 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?
blood loss assessment after placental delivery (time frame: 12 hours). 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 30 May 2017.