Placental Blood DrainageNCT03020355
Comparison of Blood Loss in Using vs Not Using Placental Cord Drainage After Spontaneous Vaginal Delivery
A study testing Placental Blood Drainage and not Placental Blood Drainage in people with Placental Blood Drainage, run by Zeynep Kamil Maternity and Pediatric Research and Training Hospital.
Trial summary
Comparison of effectiveness of placental blood drainage after spontaneous vaginal delivery in decreasing the duration, blood loss,and complications of the third stage, against no drainage of placental blood. Read more about this study
- Who is it for?
- Ages 15 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Placental Blood Drainage
- What is being tested?
- Placental Blood Drainage and not Placental Blood Drainage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Feb 2017to Jun 2017
- 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 15 to 50 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Singleton pregnancy
- Vertex presentation
- Gestational age of 37 weeks (or) more
- No major medical (or) obstetric complications
- Spontaneous vaginal delivery
Who cannot join
- Hb\7 gm/dl
- History of APH
- Instrumental delivery
- Multiple pregnancy
- Malpresentations
- Large baby (more than 3.5 kg)
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- Polyhydramnios
- Known coagulations disorders
- Previous surgeries on the uterus
About this study
Comparison of effectiveness of placental blood drainage after spontaneous vaginal delivery in decreasing the duration, blood loss,and complications of the third stage, against no drainage of placental blood.
Read the detailed description
The patients will prospectively randomized equally into two groups (100 each in the study and control groups).
Group-A (Study group)-Placental blood was drained.
Group-B (Control group)-Placental blood was not drained.
In all the patients detailed medical and obstetric history will taken. In each patient, the pre-delivery pulse rate, blood pressure, and Hb gm% will noted. Immediately after vaginal delivery, after clamping and cutting the cord-the cord will unclamped and the blood will drained until the flow ceased. In the control group, the clamped cord will not released. Blood lost in the third stage of labour will measured by collecting the blood measuring bag.
- Conditions
- Placental Blood Drainage
- Being tested
- Placental Blood Drainage, not Placental Blood Drainage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placental Blood DrainageProcedure or surgery
Immediately after vaginal delivery, after clamping and cutting the cord-the cord will unclamped and the blood will drained until the flow ceased.
not Placental Blood DrainageProcedure or surgery
In the control group, the clamped cord will not released.
| Study group | Role | What they receive |
|---|---|---|
| Placental Blood Drainage | Experimental | Immediately after vaginal delivery, after clamping and cutting the cord-the cord will unclamped and the blood will drained until the flow ceased. Receives: Procedure: Placental Blood Drainage |
| not Placental Blood Drainage | Active comparator | In the control group, the clamped cord will not released. Receives: Procedure: not Placental Blood Drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood lost
Measured: through delivery completion, an average of 30 minutes
Secondary outcomes (1)
The duration of the third stage
The duration of the third stage will calculated using a stop watch.
Measured: through the duration of the third stage, an average 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2017 (estimated)
- Study startFeb 2017
- Primary completionMay 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Placental Blood DrainageStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zeynep Kamil Maternity and Pediatric Research and Training Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmet Eser, Zeynep Kamil Maternity and Pediatric Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03020355
- Sponsor's protocol ID
- 167
- Status last verified
- Jan 2017
- First submitted
- 22 Dec 2016
- Last updated
- 13 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Roy P, Sujatha MS, Bhandiwad A, Biswas B, Chatterjee A. Placental Blood Drainage as a Part of Active Management of Third Stage of Labour After Spontaneous Vaginal Delivery. J Obstet Gynaecol India. 2016 Oct;66(Suppl 1):242-5. doi: 10.1007/s13224-016-0857-3. Epub 2016 Mar 12.
PubMed 27651611Soltani H, Poulose TA, Hutchon DR. Placental cord drainage after vaginal delivery as part of the management of the third stage of labour. Cochrane Database Syst Rev. 2011 Sep 7;2011(9):CD004665. doi: 10.1002/14651858.CD004665.pub3.
PubMed 21901693
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Blood Loss in Using vs Not Using Placental Cord Drainage After Spontaneous Vaginal Delivery
- ClinicalTrials.gov ID
- NCT03020355
- Acronym / sponsor ID
- 167
- Conditions
- Placental Blood Drainage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Zeynep Kamil Maternity and Pediatric Research and Training HospitalUniversity, hospital or other
- Study start
- Feb 2017
- Primary completion
- May 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 13 Jan 2017 (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.
Comparison of effectiveness of placental blood drainage after spontaneous vaginal delivery in decreasing the duration, blood loss,and complications of the third stage, against no drainage of placental blood.
Detailed description
The patients will prospectively randomized equally into two groups (100 each in the study and control groups).
Group-A (Study group)-Placental blood was drained.
Group-B (Control group)-Placental blood was not drained.
In all the patients detailed medical and obstetric history will taken. In each patient, the pre-delivery pulse rate, blood pressure, and Hb gm% will noted. Immediately after vaginal delivery, after clamping and cutting the cord-the cord will unclamped and the blood will drained until the flow ceased. In the control group, the clamped cord will not released. Blood lost in the third stage of labour will measured by collecting the blood measuring bag.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placental Blood Drainage | Experimental | Procedure: Placental Blood DrainageImmediately after vaginal delivery, after clamping and cutting the cord-the cord will unclamped and the blood will drained until the flow ceased. |
| not Placental Blood Drainage | Active comparator | Procedure: not Placental Blood DrainageIn the control group, the clamped cord will not released. |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Singleton pregnancy
- Vertex presentation
- Gestational age of 37 weeks (or) more
- No major medical (or) obstetric complications
- Spontaneous vaginal delivery
Key exclusion criteria (9 listed)
- Hb\7 gm/dl
- History of APH
- Instrumental delivery
- Multiple pregnancy
- Malpresentations
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 |
|---|---|---|
| Placental Blood DrainageImmediately after vaginal delivery, after clamping and cutting the cord-the cord will unclamped and the blood will drained until the flow ceased. | Procedure or surgery | Placental Blood Drainage |
| not Placental Blood DrainageIn the control group, the clamped cord will not released. | Procedure or surgery | not Placental Blood Drainage |
Primary outcome
Blood lost
Time frame: through delivery completion, an average of 30 minutes
1 secondary outcome
The duration of the third stage
Time frame: through the duration of the third stage, an average 45 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2017.
- Results publication: PubMed 27651611Roy P, Sujatha MS, Bhandiwad A, Biswas B, Chatterjee A. Placental Blood Drainage as a Part of Active Management of Third Stage of Labour After Spontaneous Vaginal Delivery. J Obstet Gynaecol India. 2016 Oct;66(Suppl 1):242-5. doi: 10.1007/s13224-016-0857-3. Epub 2016 Mar 12.
- Results publication: PubMed 21901693Soltani H, Poulose TA, Hutchon DR. Placental cord drainage after vaginal delivery as part of the management of the third stage of labour. Cochrane Database Syst Rev. 2011 Sep 7;2011(9):CD004665. doi: 10.1002/14651858.CD004665.pub3.
- Individual participant dataSharing planned: Yes
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Placental Blood Drainage and not Placental Blood Drainage in people with Placental Blood Drainage, run by Zeynep Kamil Maternity and Pediatric Research and Training Hospital.
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 5 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 13 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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 lost (time frame: through delivery completion, an average of 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03020355, which also lists 2 linked publications.
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 2017.