Postpartum HemorrhageCORD-PPHNCT07401160
Umbilical Cord Drainage to Prevent Postpartum Hemorrhage
A study testing Umbilical Cord Drainage and Standard Active Management of Third Stage (No Cord Drainage) in people with Postpartum Hemorrhage, run by Universidad Nacional Autonoma de Honduras at 2 sites in Honduras.
Trial summary
This study aims to analyze whether there is a significant difference in the occurrence of postpartum hemorrhage between women who underwent umbilical cord drainage and those who did not. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Hemorrhage
- What is being tested?
- Umbilical Cord Drainage and Standard Active Management of Third Stage (No Cord Drainage)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 2 sitesHonduras
- Study dates
- 15 Feb 2026to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women aged 18-49 years.
- Singleton pregnancy.
- Gestational age ≥37 weeks.
- active labor with cephalic presentation.
- Planned for vaginal delivery.
- Capable of providing informed consent.
Who cannot join
- Planned or emergent cesarean section.
- Instrumental delivery (e.g., forceps, vacuum).
- Antepartum hemorrhage.
- Severe anemia (Hemoglobin <8 g/dL) or specific hematological disorders (e.g., sickle cell disease, thalassemia, hemophilia, thrombocytopenia <100,000/µL).
- Use of anticoagulant medication.
- Non-cephalic fetal presentation (e.g., breech, transverse).
- Refusal to participate or inability to provide informed consent.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Honduras2 sites, 2 recruiting
- Recruiting
Hospital Escuela
Tegucigalpa, Francisco Morazán Department, 11101
Ricardo A Gutierrez Ramirez, MD, MSc., 50497546940, ricardo.gutierrez@unah.edu.hn
Alma I Zuniga Briceño, MD, alma.zuniga@unah.edu.hn
- Recruiting
Instituto Hondureño de Seguridad Social
Tegucigalpa, Francisco Morazán Department, 11101
Benjamin Fortin Rivera, MD, 99706155, bfortinr@yahoo.com
Clardy Martinez, MD
About this study
Official title: Relationship Between Umbilical Cord Drainage and Postpartum Hemorrhage: A Randomized Single-Blind Clinical Trial.
This study aims to analyze whether there is a significant difference in the occurrence of postpartum hemorrhage between women who underwent umbilical cord drainage and those who did not. Variables such as estimated blood loss volume, drop in hemoglobin levels, and the need for additional maneuvers or treatments to control hemorrhage will be examined. The research will be conducted under a parallel-group clinical trial design at the Hospital Escuela Universitario. Post-birth umbilical cord drainage may contribute to a lower frequency of postpartum hemorrhage compared to not performing it.
Read the detailed description
This is a single-blind, parallel-group, superiority efficacy clinical trial. The intervention involves passive drainage of blood from the umbilical cord immediately after cord clamping and cutting, allowing it to flow into a calibrated drape. The control group receives standard active management of the third stage of labor without cord drainage. The primary objective is to compare postpartum blood loss between the groups. Secondary objectives include comparing pre- and postpartum hemoglobin levels, the need for additional therapeutic interventions (uterotonics, uterine revision, transfusion), incidence of adverse events related to cord management, and maternal satisfaction using the Birth Satisfaction Scale. The study plans to enroll 400 participants (200 per group) over approximately 6 months at a single center.
- Conditions
- Postpartum Hemorrhage
- Being tested
- Umbilical Cord Drainage, Standard Active Management of Third Stage (No Cord Drainage)
- Keywords
- Cord Drainage, Third Stage of Labor, Obstetric Hemorrhage, Labor Stage
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Umbilical Cord DrainageProcedure or surgery
Following delivery of the newborn and immediate clamping/cutting of the umbilical cord, the maternal end of the cord is unclamped and allowed to drain passively. The cord is held over a sterile, graduated collection drape (Brass-V Drape) to facilitate the complete, gravity-dependent emptying of the residual placental blood (approximately 50-100 mL) prior to placental delivery. The procedure is completed within 1-3 minutes, after which standard controlled cord traction is applied to assist placental expulsion. This is a non-invasive adjunct to active management of the third stage of labor.
Standard Active Management of Third Stage (No Cord Drainage)Other
This arm receives the standard, evidence-based active management of the third stage of labor, as per institutional protocol, without the specific addition of umbilical cord drainage. The procedure includes immediate administration of a prophylactic uterotonic agent (e.g., oxytocin), delayed cord clamping (as per routine practice), controlled cord traction with counter-pressure on the uterus (Brandt-Andrews maneuver) to assist placental delivery, and uterine massage after placental expulsion. All blood loss is collected and measured in a standard graduated drape. This represents the current standard of care against which the experimental intervention is compared.
| Study group | Role | What they receive |
|---|---|---|
| Umbilical Cord Drainage Group | Experimental | Procedure: Umbilical Cord Drainage. Passive drainage of blood from the cut maternal end of the umbilical cord into a calibrated collection drape after birth. Receives: Procedure: Umbilical Cord Drainage |
| Standard Care (Control) Group | Sham comparator | Other: Standard Active Management of Third Stage. Includes administration of uterotonics, controlled cord traction, and monitoring, but no specific cord drainage. Receives: Other: Standard Active Management of Third Stage (No Cord Drainage) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Postpartum Blood Loss Volume
Difference between estimated blood loss volume in the first 24 hours postpartum and an immediate postpartum baseline. Measured using a calibrated drape (Brass-V Drape)
Measured: From delivery until 24 hours postpartum.
Secondary outcomes (4)
Change in Hemoglobin Levels
Difference between pre-delivery and postpartum (6-24 hours) hemoglobin levels (g/dL).
Measured: Pre-delivery and at 6-24 hours postpartum.
Need for Additional Therapeutic Interventions
Requirement for additional uterotonics, uterine revision, blood transfusion, or surgical procedures to control hemorrhage.
Measured: First 24 hours postpartum.
Incidence of Cord Management-Related Adverse Events
Occurrence of events such as retained placenta, hypovolemic shock.
Measured: First 24 hours postpartum
Maternal Satisfaction Score
Maternal satisfaction with the intrapartum experience is measured using the validated Birth Satisfaction Scale-Revised (BSS-R). This is a 10-item self-report questionnaire with three subscales: Quality of Care, Women's Personal Attributes, and Stress Experienced During Labor. Items are scored on a 4-point Likert scale (0-3). The total score ranges from 0 to 30, with a higher total score indicating greater birth satisfaction.
Measured: At 2 hours postpartum.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start15 Feb 2026 (estimated)
- Primary completion31 Aug 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
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 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a parallel-group, two-arm, randomized, single-blind trial. Participants are randomly assigned 1:1 to receive either umbilical cord drainage (intervention) or standard active management without drainage (control). Randomization is performed via RedCap. Group assignment is concealed from the outcomes assessors (e.g., personnel measuring blood loss, analyzing lab results, scoring satisfaction scales) to maintain single-blinding and minimize measurement bias, while participants and care providers remain unblinded due to the nature of the procedure.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Nacional Autonoma de Honduras
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ricardo A Gutierrez Ramirez, MD, MSc, FACOG, Universidad Nacional Autonoma de Honduras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07401160
- Sponsor's protocol ID
- PGO-UNAH-49-8-2026
- Acronym
- CORD-PPH
- Status last verified
- Feb 2026
- First submitted
- 3 Feb 2026
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not yet known if there will be a plan to make individual participant data (IPD) available. The final decision will depend on the specific requirements of the target publication journal, further consultation with the local ethics committee regarding data sharing agreements, and a thorough assessment of our capacity to properly anonymize the data while preserving its scientific value for secondary analysis.
Publications
Koshkin ES. A review of the genus Dodia Dyar, 1901 (Lepidoptera: Erebidae, Arctiinae) with description of a new remarkable species from the Russian Far East. Zootaxa. 2024 May 27;5458(1):53-72. doi: 10.11646/zootaxa.5458.1.2.
PubMed 39646951
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Umbilical Cord Drainage and Postpartum Hemorrhage: A Randomized Single-Blind Clinical Trial.
- ClinicalTrials.gov ID
- NCT07401160
- Acronym / sponsor ID
- CORD-PPH / PGO-UNAH-49-8-2026
- Conditions
- Postpartum Hemorrhage
- Keywords
- Cord Drainage, Third Stage of Labor, Obstetric Hemorrhage, Labor Stage
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Universidad Nacional Autonoma de HondurasUniversity, hospital or other
- Study start
- 15 Feb 2026 (estimated)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 10 Feb 2026 (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.
This study aims to analyze whether there is a significant difference in the occurrence of postpartum hemorrhage between women who underwent umbilical cord drainage and those who did not. Variables such as estimated blood loss volume, drop in hemoglobin levels, and the need for additional maneuvers or treatments to control hemorrhage will be examined. The research will be conducted under a parallel-group clinical trial design at the Hospital Escuela Universitario. Post-birth umbilical cord drainage may contribute to a lower frequency of postpartum hemorrhage compared to not performing it.
Detailed description
This is a single-blind, parallel-group, superiority efficacy clinical trial. The intervention involves passive drainage of blood from the umbilical cord immediately after cord clamping and cutting, allowing it to flow into a calibrated drape. The control group receives standard active management of the third stage of labor without cord drainage. The primary objective is to compare postpartum blood loss between the groups. Secondary objectives include comparing pre- and postpartum hemoglobin levels, the need for additional therapeutic interventions (uterotonics, uterine revision, transfusion), incidence of adverse events related to cord management, and maternal satisfaction using the Birth Satisfaction Scale. The study plans to enroll 400 participants (200 per group) over approximately 6 months at a single center.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a parallel-group, two-arm, randomized, single-blind trial. Participants are randomly assigned 1:1 to receive either umbilical cord drainage (intervention) or standard active management without drainage (control). Randomization is performed via RedCap. Group assignment is concealed from the outcomes assessors (e.g., personnel measuring blood loss, analyzing lab results, scoring satisfaction scales) to maintain single-blinding and minimize measurement bias, while participants and care providers remain unblinded due to the nature of the procedure.
| Arm | Type | Receives |
|---|---|---|
| Umbilical Cord Drainage Group | Experimental | Procedure: Umbilical Cord DrainageProcedure: Umbilical Cord Drainage. Passive drainage of blood from the cut maternal end of the umbilical cord into a calibrated collection drape after birth. |
| Standard Care (Control) Group | Sham comparator | Other: Standard Active Management of Third Stage (No Cord Drainage)Other: Standard Active Management of Third Stage. Includes administration of uterotonics, controlled cord traction, and monitoring, but no specific cord drainage. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Pregnant women aged 18-49 years.
- Singleton pregnancy.
- Gestational age ≥37 weeks.
- active labor with cephalic presentation.
- Planned for vaginal delivery.
Key exclusion criteria (7 listed)
- Planned or emergent cesarean section.
- Instrumental delivery (e.g., forceps, vacuum).
- Antepartum hemorrhage.
- Severe anemia (Hemoglobin <8 g/dL) or specific hematological disorders (e.g., sickle cell disease, thalassemia, hemophilia, thrombocytopenia <100,000/µL).
- Use of anticoagulant medication.
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 |
|---|---|---|
| Umbilical Cord DrainageFollowing delivery of the newborn and immediate clamping/cutting of the umbilical cord, the maternal end of the cord is unclamped and allowed to drain passively. The cord is held over a sterile, graduated collection drape (Brass-V Drape) to facilitate the complete, gravity-dependent emptying of the residual placental blood (approximately 50-100 mL) prior to placental delivery. The procedure is completed within 1-3 minutes, after which standard controlled cord traction is applied to assist placental expulsion. This is a non-invasive adjunct to active management of the third stage of labor. | Procedure or surgery | Umbilical Cord Drainage Group |
| Standard Active Management of Third Stage (No Cord Drainage)This arm receives the standard, evidence-based active management of the third stage of labor, as per institutional protocol, without the specific addition of umbilical cord drainage. The procedure includes immediate administration of a prophylactic uterotonic agent (e.g., oxytocin), delayed cord clamping (as per routine practice), controlled cord traction with counter-pressure on the uterus (Brandt-Andrews maneuver) to assist placental delivery, and uterine massage after placental expulsion. All blood loss is collected and measured in a standard graduated drape. This represents the current standard of care against which the experimental intervention is compared. | Other | Standard Care (Control) Group |
Primary outcome
Change in Postpartum Blood Loss Volume
Time frame: From delivery until 24 hours postpartum.
Difference between estimated blood loss volume in the first 24 hours postpartum and an immediate postpartum baseline. Measured using a calibrated drape (Brass-V Drape)
4 secondary outcomes
Change in Hemoglobin Levels
Time frame: Pre-delivery and at 6-24 hours postpartum.
Need for Additional Therapeutic Interventions
Time frame: First 24 hours postpartum.
Incidence of Cord Management-Related Adverse Events
Time frame: First 24 hours postpartum
Maternal Satisfaction Score
Time frame: At 2 hours postpartum.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Background: PubMed 39646951Koshkin ES. A review of the genus Dodia Dyar, 1901 (Lepidoptera: Erebidae, Arctiinae) with description of a new remarkable species from the Russian Far East. Zootaxa. 2024 May 27;5458(1):53-72. doi: 10.11646/zootaxa.5458.1.2.
- Individual participant dataSharing planned: Undecided. It is not yet known if there will be a plan to make individual participant data (IPD) available. The final decision will depend on the specific requirements of the target publication journal, further consultation with the local ethics committee regarding data sharing agreements, and a thorough assessment of our capacity to properly anonymize the data while preserving its scientific value for secondary analysis.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Umbilical Cord Drainage and Standard Active Management of Third Stage (No Cord Drainage) in people with Postpartum Hemorrhage, run by Universidad Nacional Autonoma de Honduras at 2 sites in Honduras.
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 6 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Honduras. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ricardo A Gutierrez Ramirez, MD, MSc (+50497546940, ricardo.gutierrez@unah.edu.hn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Postpartum Blood Loss Volume (time frame: From delivery until 24 hours postpartum.). 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 NCT07401160, 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 13 Feb 2026.