Postpartum HaemorrhageNCT01931423
The Influence of Placental Drainage of Management of the Third Stage of Labor:a Randomized Controlled Study
A study testing Placental cord drainage in people with Postpartum Haemorrhage, run by Istanbul Bakirkoy Maternity and Children Diseases Hospital at 1 site in Turkey (Türkiye).
Trial summary
To determine whether early placental drainage plus cord traction reduces the incidences of manual removal and blood loss, and to determine the risk factors associated with blood loss after delivery. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- Postpartum Haemorrhage
- What is being tested?
- Placental cord drainage
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 485 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Nov 2013to Mar 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 44 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- greater than 37 gestational weeks
- single pregnancy
- vaginal delivery
- estimated fetal weight 2500-4500 gr.
Who cannot join
- PPROM
- 37 or lower gestational week
- multiple pregnancy
- grand multiparıty (greater than 5)
- coagulation defects (HELLP, ablation placenta, previa, pre-eclampsia)
- a history of any bleeding during pregnancy
Show all 13Show fewer
- caesarean delivery or any uterine scar
- a history of postpartum haemorrhage
- hydramnios
- known uterine anomalies
- suspected abnormal placentation (accreta, increta, or percreta)
- prepartum hemoglobin concentration less than 8 g/dL
- history of anticoagulant drugs and prolongation of the first stage of labor longer than 15 hours
Trial locations and contacts
1 site in 1 country.
About this study
To determine whether early placental drainage plus cord traction reduces the incidences of manual removal and blood loss, and to determine the risk factors associated with blood loss after delivery.
- Conditions
- Postpartum Haemorrhage
- Being tested
- Placental cord drainage
- 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 cord drainageBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Drainage Group | Placebo comparator | early placental drainage plus cord traction Receives: Behavioral: Placental cord drainage |
| Controlled Group | No intervention | spontaneous removal placenta |
What is being measured
The primary outcome is the main question the study is designed to answer.
postpartum blood loss
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2013 (estimated)
- Study startNov 2013
- Primary completionFeb 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum HaemorrhageStudies 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
- 485 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Bakirkoy Maternity and Children Diseases Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Osman Aşıcıoğlu, Istanbul Bakirkoy Maternity and Children Diseases Hospital
- Investigators
- Osman Aşıcıoğlu, M.D., Principal investigator, T.C.S.B. Şişli Etfal Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01931423
- Sponsor's protocol ID
- Aşıcıoğlu-06
- Status last verified
- Nov 2013
- First submitted
- 26 Aug 2013
- Last updated
- 10 Mar 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Placental Drainage of Management of the Third Stage of Labor:a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT01931423
- Acronym / sponsor ID
- Aşıcıoğlu-06
- Conditions
- Postpartum Haemorrhage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 485 participants (actual)
- Lead sponsor
- Istanbul Bakirkoy Maternity and Children Diseases HospitalOther government
- Study start
- Nov 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 29 Aug 2013 (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 determine whether early placental drainage plus cord traction reduces the incidences of manual removal and blood loss, and to determine the risk factors associated with blood loss after delivery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drainage Group | Placebo comparator | Behavioral: Placental cord drainageearly placental drainage plus cord traction |
| Controlled Group | No intervention | –spontaneous removal placenta |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- greater than 37 gestational weeks
- single pregnancy
- vaginal delivery
- estimated fetal weight 2500-4500 gr.
Key exclusion criteria (13 listed)
- PPROM
- 37 or lower gestational week
- multiple pregnancy
- grand multiparıty (greater than 5)
- coagulation defects (HELLP, ablation placenta, previa, pre-eclampsia)
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 cord drainage | Behavioural | Drainage Group |
Primary outcome
postpartum blood loss
Time frame: 24 hours
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 10 Mar 2014.
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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.
Osman Aşıcıoğlu, M.D. principal investigator
T.C.S.B. Şişli Etfal Research Hospital
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 cord drainage in people with Postpartum Haemorrhage, run by Istanbul Bakirkoy Maternity and Children Diseases Hospital 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 4 inclusion and 13 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 10 Mar 2014. 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. Some participants in this study may receive a placebo. 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?
postpartum blood loss (time frame: 24 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 10 Mar 2014.