Postpartum HemorrhageNCT05610345
The Effect of Placental Cord Drainage on Postpartum Blood Loss
A study testing Placental Blood Drainage and Placenta Blood Not Drained in people with Postpartum Hemorrhage, run by University of Tennessee at 1 site in United States.
Trial summary
To determine if placental cord drainage decreases the blood loss after spontaneous vaginal delivery Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Hemorrhage
- What is being tested?
- Placental Blood Drainage and Placenta Blood Not Drained
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Nov 2022to 1 Jun 2023
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Singleton Gestation
- Ages 18-45
- English Speaking
- Third Trimester Gestation
Who cannot join
- Operative Vaginal Delivery
- Multiple Gestation
- Cesarean Delivery
- Episiotomy
- 3rd or 4th degree laceration
- Less than the Third Trimester of Pregnancy
Show all 9Show fewer
- Chorioamnionitis
- History of Postpartum Hemorrhage
- Macrosomic Infant
Trial locations and contacts
1 site in 1 country.
About this study
To determine if placental cord drainage decreases the blood loss after spontaneous vaginal delivery
Read the detailed description
Postpartum hemorrhage complicates 3% of pregnancies in the United States and is a leading cause of maternal morbidity and mortality. ACOG defines PPH as cumulative blood loss greater than 1000cc; however a blood loss >500cc should be considered abnormal. Primary PPH occurs in the first 24 hours and is largely secondary to uterine agony. ACOG as well as the WHO recommend active management of the third stage of labor to prevent PPH. This includes oxytocin administration, uterine massage, and gentle cord traction. Placental cord drainage (PCD) is the unclamping of the umbilical cord to allow for drainage of the blood from the placenta. It is another technique used to shorten the third stage of labor; however, it has not been well studied
- Conditions
- Postpartum Hemorrhage
- Being tested
- Placental Blood Drainage, Placenta Blood Not Drained
- 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 Blood DrainageProcedure or surgery
Immediately after vaginal delivery following delayed cord clamping and cutting of the cord, the cord will be unclamped and blood will be drained from the placenta until cessation of flow.
Placenta Blood Not DrainedProcedure or surgery
Placenta Blood Not Drained
| Study group | Role | What they receive |
|---|---|---|
| Placenta Blood Drained | Experimental | Immediately after delayed cord clamping and cutting of the umbilical cord, the cord will be unclamped and blood with be drained until cessation of flow. Receives: Procedure: Placental Blood Drainage |
| Placenta Blood Not Drained | Active comparator | This is the control group. The cord will not be unclamped. Receives: Procedure: Placenta Blood Not Drained |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative Blood Loss
Total Volume in Underbuttocks Drape - Initial Volume in Drape (amniotic fluid etc) + blood in laparotomy sponges
Measured: Through delivery completion, on average 30 minutes
Secondary outcomes (8)
Duration of Third Stage of Labor
After neonatal delivery to delivery of the placenta
Measured: On average 30 minutes
Retained Placenta
Placenta not delivered > 30 minutes
Measured: 30 minutes after delivery
Postpartum Hemorrhage
Blood Loss Greater than 1000cc
Measured: 30 minutes to 1 hour after delivery
Blood Loss > 500 cc
Greater than average postpartum blood loss
Measured: 30 minutes to 1 hour after delivery
Need for Blood Transfusion
In event of HgB <7 or active bleeding
Measured: Up to 24 hours postpartum
Percent Drop in HgB and Hct
Lab draw following delivery
Measured: Up to 48 hours following delivery
Additional Uterotonic Administration
Medications administered to stop postpartum bleeding
Measured: 30 minutes to 1 hour following delivery
Endometritis
Infection of myometrium of uterus
Measured: Up to 12 weeks following delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2022
- Study start12 Nov 2022
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Postpartum HemorrhageStudies 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
- Model description
- Placenta Blood Drained Placenta Blood Not Drained
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tennessee
- Sponsor type
- University, hospital or other
- Collaborators
- Sponsor GmbH
- Responsible party
- Sponsor
- Investigators
- John Schorge, MD, FACS, Study chair, Regional One Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05610345
- Sponsor's protocol ID
- 21-08299-XP
- Status last verified
- Feb 2024
- First submitted
- 26 Oct 2022
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Committee on Practice Bulletins-Obstetrics. Practice Bulletin No. 183: Postpartum Hemorrhage. Obstet Gynecol. 2017 Oct;130(4):e168-e186. doi: 10.1097/AOG.0000000000002351.
PubMed 28937571WHO recommendations on maternal health: guidelines approved by the WHO Guidelines Review Committee [Internet]. Geneva: World Health Organization; 2017. Available from http://www.ncbi.nlm.nih.gov/books/NBK615100/
PubMed 40455892Roy 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 27651611Wu HL, Chen XW, Wang P, Wang QM. Effects of placental cord drainage in the third stage of labour: A meta-analysis. Sci Rep. 2017 Aug 1;7(1):7067. doi: 10.1038/s41598-017-07722-7.
PubMed 28765609Vasconcelos 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 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Placental Cord Drainage on Postpartum Blood Loss
- ClinicalTrials.gov ID
- NCT05610345
- Acronym / sponsor ID
- 21-08299-XP
- Conditions
- Postpartum Hemorrhage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- University of TennesseeUniversity, hospital or other
- Collaborators
- Sponsor GmbH
- Study start
- 12 Nov 2022 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 9 Nov 2022 (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.
To determine if placental cord drainage decreases the blood loss after spontaneous vaginal delivery
Detailed description
Postpartum hemorrhage complicates 3% of pregnancies in the United States and is a leading cause of maternal morbidity and mortality. ACOG defines PPH as cumulative blood loss greater than 1000cc; however a blood loss >500cc should be considered abnormal. Primary PPH occurs in the first 24 hours and is largely secondary to uterine agony. ACOG as well as the WHO recommend active management of the third stage of labor to prevent PPH. This includes oxytocin administration, uterine massage, and gentle cord traction. Placental cord drainage (PCD) is the unclamping of the umbilical cord to allow for drainage of the blood from the placenta. It is another technique used to shorten the third stage of labor; however, it has not been well studied
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Placenta Blood Drained Placenta Blood Not Drained
| Arm | Type | Receives |
|---|---|---|
| Placenta Blood Drained | Experimental | Procedure: Placental Blood DrainageImmediately after delayed cord clamping and cutting of the umbilical cord, the cord will be unclamped and blood with be drained until cessation of flow. |
| Placenta Blood Not Drained | Active comparator | Procedure: Placenta Blood Not DrainedThis is the control group. The cord will not be unclamped. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Singleton Gestation
- Ages 18-45
- English Speaking
- Third Trimester Gestation
Key exclusion criteria (9 listed)
- Operative Vaginal Delivery
- Multiple Gestation
- Cesarean Delivery
- Episiotomy
- 3rd or 4th degree laceration
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 following delayed cord clamping and cutting of the cord, the cord will be unclamped and blood will be drained from the placenta until cessation of flow. | Procedure or surgery | Placenta Blood Drained |
| Placenta Blood Not DrainedPlacenta Blood Not Drained | Procedure or surgery | Placenta Blood Not Drained |
Primary outcome
Qualitative Blood Loss
Time frame: Through delivery completion, on average 30 minutes
Total Volume in Underbuttocks Drape - Initial Volume in Drape (amniotic fluid etc) + blood in laparotomy sponges
8 secondary outcomes
Duration of Third Stage of Labor
Time frame: On average 30 minutes
Retained Placenta
Time frame: 30 minutes after delivery
Postpartum Hemorrhage
Time frame: 30 minutes to 1 hour after delivery
Blood Loss > 500 cc
Time frame: 30 minutes to 1 hour after delivery
Need for Blood Transfusion
Time frame: Up to 24 hours postpartum
Percent Drop in HgB and Hct
Time frame: Up to 48 hours following delivery
Additional Uterotonic Administration
Time frame: 30 minutes to 1 hour following delivery
Endometritis
Time frame: Up to 12 weeks following delivery
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 13 Feb 2024.
- Background: PubMed 28937571Committee on Practice Bulletins-Obstetrics. Practice Bulletin No. 183: Postpartum Hemorrhage. Obstet Gynecol. 2017 Oct;130(4):e168-e186. doi: 10.1097/AOG.0000000000002351.
- Background: PubMed 40455892WHO recommendations on maternal health: guidelines approved by the WHO Guidelines Review Committee [Internet]. Geneva: World Health Organization; 2017. Available from http://www.ncbi.nlm.nih.gov/books/NBK615100/
- 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 28765609Wu HL, Chen XW, Wang P, Wang QM. Effects of placental cord drainage in the third stage of labour: A meta-analysis. Sci Rep. 2017 Aug 1;7(1):7067. doi: 10.1038/s41598-017-07722-7.
- Results publication: 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.
- 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.
John Schorge, MD, FACS study chair
Regional One Health
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 Blood Drainage and Placenta Blood Not Drained in people with Postpartum Hemorrhage, run by University of Tennessee at 1 site in United States.
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 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: finished, as of the sponsor's last update on 13 Feb 2024. 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 United States. 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?
Qualitative Blood Loss (time frame: Through delivery completion, on average 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 NCT05610345, which also lists 5 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 Feb 2024.