Placental BleedingNCT03542292
Placental Drainage Versus no Placental Drainage After Vaginal Delivery in the Management of Third Stage of Labour
A study testing placental drainage in people with Placental Bleeding, run by Zeynep Kamil Maternity and Pediatric Research and Training Hospital.
Trial summary
In this randomized controlled study, 222 pregnant women who admitted to Zeynep Kamil Women and Children's Health Training and Research Hospital from December 2016 and July 2017 were included. They were randomized into study(111) or control(111) group when they delivered vaginally. 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
- Placental Bleeding
- What is being tested?
- placental drainage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 222 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Jul 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- >37 weeks of gestation, singleton, alive pregnancy, with vertex presentation expected to have spontaneous vaginal delivery -
Who cannot join
- fetal malpresentation, history of postpartum hemorrhage, preterm delivery, multiple pregnancy, fetal anomaly, uterine malformation, fetal demise, women with immediate delivery indications, unable to give written informed consent, a clinically estimated fetal weight >4500, preeclampsia, antepartum hemorrhage, previous cesarean section, instrumental delivery known coagulation disorders.
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About this study
Official title: Doğumun üçüncü Evresinin yönetiminde Vajinal doğum sonrası Plasental Drenaja karşı Plasenta drenajı: Randomize Bir çalışma
In this randomized controlled study, 222 pregnant women who admitted to Zeynep Kamil Women and Children's Health Training and Research Hospital from December 2016 and July 2017 were included. They were randomized into study(111) or control(111) group when they delivered vaginally. In study group; umbilical cord was clamped from fetal side but unclamped from maternal side. After that unclamped side of umblical cord was left open to drain the blood until the flow ceased. In control group the umblical cord was clamped both sides.
Read the detailed description
This was a randomized controlled trial on 222 pregnant women who admitted to our hospital from December 2016 and July 2017. After approval of the ethics committee and written consent of the patients were taken, 222 pregnant women were included in this study. They were randomized into study(111) or control(111) group when they delivered vaginally. Randomization was performed by means of a computer-generated randomization table.
In study group; umbilical cord was clamped from fetal side but unclamped from maternal side. After that unclamped side of umblical cord was left open to drain the blood until the flow ceased. The blood was collected in the metal bowl and measured using a measuring jar. Care was taken not to mix the drained blood from the cord with the blood lost during the third stage. In control group the umblical cord was clamped both sides.
The inclusion criteria were>37 weeks of gestation, singleton, alive pregnancy, with vertex presentation expected to have spontaneous vaginal delivery. The exclusion criteria were fetal malpresentation, history of postpartum hemorrhage, preterm delivery, multiple pregnancy, fetal anomaly, uterine malformation, fetal demise, women with immediate delivery indications, unable to give written informed consent, a clinically estimated fetal weight >4500, preeclampsia, antepartum hemorrhage, previous cesarean section, instrumental delivery and known coagulation disorders. Patients were recruited regardless of using cervical ripening agents.
General physical and obstetric examination were performed after a detailed history taking. A sample of venous blood was obtained for hemoglobin concentration on admission. Labour was conducted according to the hospital protocol. Labour was augmented with oxytocin in active phase of labour. All patients were monitored with cardiotocography (CTG) before induction of labor and CTG was used continuously during labor. Oxytocin infusion was continued until delivery of both child and placenta, unless complications occurred. For all patients, blood lost in the third stage of labour was measured by collecting the blood in a disposable conical measuring bag. The time of delivery of the neonate was recorded and after then prophylactic uterotonic agents (Synpitan Fort, 5 IU) was given to all patients. Placenta was delivered by controlled cord traction andthe time of placental delivery was noted in both groups. If the placenta had not been delivered spontaneously by 30 minutes after birth, it was removed manually. The vital signs(blood pressure, pulse rate, temperature) uterine tone of the patients were monitored after delivery of neonate and placenta. The hemoglobin concentration was estimated 24 hours after delivery.
The outcome measures were the duration of the third stage of labour, defined as interval from birth of the infant to delivery of the placenta, haemoglobin difference between admission and 24 hours after delivery, visual analog scale (VAS) scores, weight of placenta, need for blood transfusion, blood loss from umbilical cord and blood loss in the third stage of labour. PPH was defined as a loss of more than 500 mL of blood within the first 24 hours following childbirth.
- Conditions
- Placental Bleeding
- Being tested
- placental drainage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placental drainageDiagnostic test
| Study group | Role | What they receive |
|---|---|---|
| placental drainage group | Experimental | In study group; umbilical cord was clamped from fetal side but unclamped from maternal side. After that unclamped side of umblical cord was left open to drain the blood until the flow ceased. The blood was collected in the metal bowl and measured using a measuring jar. Care was taken not to mix the drained blood from the cord with the blood lost during the third stage. Receives: Diagnostic Test: placental drainage |
| no placental drainage group | Active comparator | In control group the umblical cord was clamped both sides. Receives: Diagnostic Test: placental drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
the duration of the third stage of labour
interval from birth of the infant to delivery of the placenta
Measured: minutes from baby delivery to delivery of the placenta
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2018
- Study startDec 2016
- Primary completionJun 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Placental BleedingStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zeynep Kamil Maternity and Pediatric Research and Training Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Evrim Bostancı, Zeynep Kamil Maternity and Pediatric Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03542292
- Sponsor's protocol ID
- EY.FR.22
- Status last verified
- May 2018
- First submitted
- 18 May 2018
- Last updated
- 1 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Asicioglu O, Unal C, Asicioglu BB, Temizkan O, Yildirim G, Arici B, Gulova S. Influence of placental cord drainage in management of the third stage of labor: a multicenter randomized controlled study. Am J Perinatol. 2015 Mar;32(4):343-50. doi: 10.1055/s-0034-1384639. Epub 2014 Aug 11.
PubMed 25111038Soltani 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 21901693Roy 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 27651611
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Doğumun üçüncü Evresinin yönetiminde Vajinal doğum sonrası Plasental Drenaja karşı Plasenta drenajı: Randomize Bir çalışma
- ClinicalTrials.gov ID
- NCT03542292
- Acronym / sponsor ID
- EY.FR.22
- Conditions
- Placental Bleeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- Zeynep Kamil Maternity and Pediatric Research and Training HospitalUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 31 May 2018 (actual)
- 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.
In this randomized controlled study, 222 pregnant women who admitted to Zeynep Kamil Women and Children's Health Training and Research Hospital from December 2016 and July 2017 were included. They were randomized into study(111) or control(111) group when they delivered vaginally. In study group; umbilical cord was clamped from fetal side but unclamped from maternal side. After that unclamped side of umblical cord was left open to drain the blood until the flow ceased. In control group the umblical cord was clamped both sides.
Detailed description
This was a randomized controlled trial on 222 pregnant women who admitted to our hospital from December 2016 and July 2017. After approval of the ethics committee and written consent of the patients were taken, 222 pregnant women were included in this study. They were randomized into study(111) or control(111) group when they delivered vaginally. Randomization was performed by means of a computer-generated randomization table.
In study group; umbilical cord was clamped from fetal side but unclamped from maternal side. After that unclamped side of umblical cord was left open to drain the blood until the flow ceased. The blood was collected in the metal bowl and measured using a measuring jar. Care was taken not to mix the drained blood from the cord with the blood lost during the third stage. In control group the umblical cord was clamped both sides.
The inclusion criteria were>37 weeks of gestation, singleton, alive pregnancy, with vertex presentation expected to have spontaneous vaginal delivery. The exclusion criteria were fetal malpresentation, history of postpartum hemorrhage, preterm delivery, multiple pregnancy, fetal anomaly, uterine malformation, fetal demise, women with immediate delivery indications, unable to give written informed consent, a clinically estimated fetal weight >4500, preeclampsia, antepartum hemorrhage, previous cesarean section, instrumental delivery and known coagulation disorders. Patients were recruited regardless of using cervical ripening agents.
General physical and obstetric examination were performed after a detailed history taking. A sample of venous blood was obtained for hemoglobin concentration on admission. Labour was conducted according to the hospital protocol. Labour was augmented with oxytocin in active phase of labour. All patients were monitored with cardiotocography (CTG) before induction of labor and CTG was used continuously during labor. Oxytocin infusion was continued until delivery of both child and placenta, unless complications occurred. For all patients, blood lost in the third stage of labour was measured by collecting the blood in a disposable conical measuring bag. The time of delivery of the neonate was recorded and after then prophylactic uterotonic agents (Synpitan Fort, 5 IU) was given to all patients. Placenta was delivered by controlled cord traction andthe time of placental delivery was noted in both groups. If the placenta had not been delivered spontaneously by 30 minutes after birth, it was removed manually. The vital signs(blood pressure, pulse rate, temperature) uterine tone of the patients were monitored after delivery of neonate and placenta. The hemoglobin concentration was estimated 24 hours after delivery.
The outcome measures were the duration of the third stage of labour, defined as interval from birth of the infant to delivery of the placenta, haemoglobin difference between admission and 24 hours after delivery, visual analog scale (VAS) scores, weight of placenta, need for blood transfusion, blood loss from umbilical cord and blood loss in the third stage of labour. PPH was defined as a loss of more than 500 mL of blood within the first 24 hours following childbirth.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placental drainage group | Experimental | Diagnostic Test: placental drainageIn study group; umbilical cord was clamped from fetal side but unclamped from maternal side. After that unclamped side of umblical cord was left open to drain the blood until the flow ceased. The blood was collected in the metal bowl and measured using a measuring jar. Care was taken not to mix the drained blood from the cord with the blood lost during the third stage. |
| no placental drainage group | Active comparator | Diagnostic Test: placental drainageIn control group the umblical cord was clamped both sides. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- >37 weeks of gestation, singleton, alive pregnancy, with vertex presentation expected to have spontaneous vaginal delivery -
Key exclusion criteria (2 listed)
- fetal malpresentation, history of postpartum hemorrhage, preterm delivery, multiple pregnancy, fetal anomaly, uterine malformation, fetal demise, women with immediate delivery indications, unable to give written informed consent, a clinically estimated fetal weight >4500, preeclampsia, antepartum hemorrhage, previous cesarean section, instrumental delivery known coagulation disorders.
- -
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 drainage | Diagnostic test | no placental drainage group, placental drainage group |
Primary outcome
the duration of the third stage of labour
Time frame: minutes from baby delivery to delivery of the placenta
interval from birth of the infant to delivery of the placenta
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 1 Jun 2018.
- Results publication: PubMed 25111038Asicioglu O, Unal C, Asicioglu BB, Temizkan O, Yildirim G, Arici B, Gulova S. Influence of placental cord drainage in management of the third stage of labor: a multicenter randomized controlled study. Am J Perinatol. 2015 Mar;32(4):343-50. doi: 10.1055/s-0034-1384639. Epub 2014 Aug 11.
- 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.
- 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.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing placental drainage in people with Placental Bleeding, 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 1 inclusion and 2 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 1 Jun 2018. 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?
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 duration of the third stage of labour (time frame: minutes from baby delivery to delivery of the placenta). 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 NCT03542292, which also lists 3 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 1 Jun 2018.