Management of DeliveryPLADRAINAGENCT01655576
Effectiveness of Placental Drainage in the Third Stage of Labor: a Randomized Clinical Trial
A study testing Placental drainage in people with Management of Delivery, run by Instituto Materno Infantil Prof. Fernando Figueira at 1 site in Brazil.
Trial summary
The purpose of this study is to determine if placental drainage shortens third period of labor and reduces postpartum blood lost. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Management of Delivery
- What is being tested?
- Placental drainage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 226 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2012to May 2013
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Low risk pregnant women
- Pregnancy at term
- Women at low risk for assisted labor / delivery and postpartum care.
- Live Fetus
Who cannot join
- Women under 18, mentally handicapped and indigenous;
- Women who agreed to participate signed the Informed Consent, but evolved to cesarean section or instrumental delivery by forceps;
- Instrumental Delivery by forceps or c-section
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine if placental drainage shortens third period of labor and reduces postpartum blood lost.
Read the detailed description
The study aims to compare the effectiveness of placental drainage versus maintenance of maternal cord clamped end in the third stage of labor to reduce postpartum blood loss.
- Conditions
- Management of Delivery
- Being tested
- Placental drainage
- Keywords
- drainage, pregnancy, active management, postpartum hemorrhage
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placental drainageProcedure or surgery
After delivery of the newborn, umbilical cord at mothers end, will be left unclamped until delivery of the placenta.
| Study group | Role | What they receive |
|---|---|---|
| Routine clamping | No intervention | After delivery of the newborn, umbilical cord at mothers end, will be left clamped until delivery of the placenta. |
| Placental drainage | Experimental | After delivery of the newborn, umbilical cord at mothers end, will be left unclamped until delivery of the placenta. Receives: Procedure: Placental drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of the third period of labor
Time from delivery of the baby to the delivery of the placenta
Measured: Six hours
Secondary outcomes (4)
Postpartum blood loss
Volume of blood lost 24 hours after birth
Measured: 24 hours
PPH
Postpartum hemorrhage
Measured: 24 hours
Need of uterotonics
use of aditional uterotonics ( prophylkatic use not included)
Measured: 24 hours
Need of blood transfusions
Need of blood transfusions
Measured: until discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Management of DeliveryStudies 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
- 226 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Materno Infantil Prof. Fernando Figueira
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leila Katz, Instituto Materno Infantil Prof. Fernando Figueira
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01655576
- Sponsor's protocol ID
- PLADRAINAGE
- Other IDs
- Pla1
- Acronym
- PLADRAINAGE
- Status last verified
- Jul 2012
- First submitted
- 31 Jul 2012
- Last updated
- 5 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Vasconcelos FB, Katz L, Coutinho I, Lins VL, de Amorim MM. Placental cord drainage in the third stage of labor: Randomized clinical trial. PLoS One. 2018 May 2;13(5):e0195650. doi: 10.1371/journal.pone.0195650. eCollection 2018.
PubMed 29718920
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Placental Drainage in the Third Stage of Labor: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01655576
- Acronym / sponsor ID
- PLADRAINAGE / PLADRAINAGE
- Conditions
- Management of Delivery
- Keywords
- drainage, pregnancy, active management, postpartum hemorrhage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 226 participants (actual)
- Lead sponsor
- Instituto Materno Infantil Prof. Fernando FigueiraUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 2 Aug 2012 (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.
The purpose of this study is to determine if placental drainage shortens third period of labor and reduces postpartum blood lost.
Detailed description
The study aims to compare the effectiveness of placental drainage versus maintenance of maternal cord clamped end in the third stage of labor to reduce postpartum blood loss.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine clamping | No intervention | –After delivery of the newborn, umbilical cord at mothers end, will be left clamped until delivery of the placenta. |
| Placental drainage | Experimental | Procedure: Placental drainageAfter delivery of the newborn, umbilical cord at mothers end, will be left unclamped until delivery of the placenta. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Low risk pregnant women
- Pregnancy at term
- Women at low risk for assisted labor / delivery and postpartum care.
- Live Fetus
Key exclusion criteria (3 listed)
- Women under 18, mentally handicapped and indigenous;
- Women who agreed to participate signed the Informed Consent, but evolved to cesarean section or instrumental delivery by forceps;
- Instrumental Delivery by forceps or c-section
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 drainageAfter delivery of the newborn, umbilical cord at mothers end, will be left unclamped until delivery of the placenta. | Procedure or surgery | Placental drainage |
Primary outcome
Duration of the third period of labor
Time frame: Six hours
Time from delivery of the baby to the delivery of the placenta
4 secondary outcomes
Postpartum blood loss
Time frame: 24 hours
PPH
Time frame: 24 hours
Need of uterotonics
Time frame: 24 hours
Need of blood transfusions
Time frame: until discharge
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 5 Jun 2013.
- Derived from this study: PubMed 29718920Vasconcelos FB, Katz L, Coutinho I, Lins VL, de Amorim MM. Placental cord drainage in the third stage of labor: Randomized clinical trial. PLoS One. 2018 May 2;13(5):e0195650. doi: 10.1371/journal.pone.0195650. eCollection 2018.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Placental drainage in people with Management of Delivery, run by Instituto Materno Infantil Prof. Fernando Figueira at 1 site in Brazil.
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 4 inclusion and 3 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 5 Jun 2013. 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 Brazil. 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?
Duration of the third period of labor (time frame: Six hours). 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 NCT01655576, which also lists 1 linked publication.
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 5 Jun 2013.