Blood LossNCT03487341
Placental Cord Drainage After Vaginal Delivery
A study testing Cord drainage and Cord clamping in people with Blood Loss, run by Ain Shams University at 1 site in Egypt.
Trial summary
Placental Cord Drainage after Vaginal Delivery A randomized clinical trial Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Blood Loss
- What is being tested?
- Cord drainage and Cord clamping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2018to 10 Nov 2018
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Singleton pregnancy.
- Pregnancy with vertex presentation.
- Gestational age37 up to 42 weeks
- Patient expected to have spontaneous vaginal delivery.
- Maternal age 18 years old or more.
Who cannot join
- Previous history of Postpartum hemorrhage.
- Antepartum hemorrhage
- Multiple pregnancies
- Instrumental deliveries
- Coagulation disorders
- Over distended uterus (hydramnios, large fetus).
Show all 11Show fewer
- Patient with extensive extended vaginal or cervical tear.
- Rupture uterus.
- Secondary arrest of cervical dilatation.
- Persistent occipito-posterior.
- Deep transverse arrest of fetal head.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Placental Cord Drainage After Vaginal Delivery: A Randomized Clinical Trial
Placental Cord Drainage after Vaginal Delivery A randomized clinical trial
- Conditions
- Blood Loss
- Being tested
- Cord drainage, Cord clamping
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cord drainageOther
Cord drainage
Cord clampingOther
Cord clamping
| Study group | Role | What they receive |
|---|---|---|
| Cord drainage | Active comparator | Not described Receives: Other: Cord drainage |
| Cord clamping | Active comparator | Not described Receives: Other: Cord clamping |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood loss
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2018
- Study start1 Apr 2018
- Primary completion10 Nov 2018
- Study completion10 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood LossStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed S Sweed, MD, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03487341
- Sponsor's protocol ID
- AS1751
- Status last verified
- Jan 2019
- First submitted
- 24 Mar 2018
- Last updated
- 29 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placental Cord Drainage After Vaginal Delivery: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03487341
- Acronym / sponsor ID
- AS1751
- Conditions
- Blood Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 10 Nov 2018 (actual)
- Study completion
- 10 Nov 2018 (actual)
- First posted
- 4 Apr 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.
Placental Cord Drainage after Vaginal Delivery A randomized clinical trial
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cord drainage | Active comparator | Other: Cord drainage |
| Cord clamping | Active comparator | Other: Cord clamping |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Singleton pregnancy.
- Pregnancy with vertex presentation.
- Gestational age37 up to 42 weeks
- Patient expected to have spontaneous vaginal delivery.
- Maternal age 18 years old or more.
Key exclusion criteria (11 listed)
- Previous history of Postpartum hemorrhage.
- Antepartum hemorrhage
- Multiple pregnancies
- Instrumental deliveries
- 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 |
|---|---|---|
| Cord drainageCord drainage | Other | Cord drainage |
| Cord clampingCord clamping | Other | Cord clamping |
Primary outcome
blood loss
Time frame: 1 hour
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 29 Jan 2019.
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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 Cord drainage and Cord clamping in people with Blood Loss, run by Ain Shams University at 1 site in Egypt.
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 5 inclusion and 11 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 29 Jan 2019. 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 Egypt. 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?
blood loss (time frame: 1 hour). 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 29 Jan 2019.