Obstetric DeliveryPLCDNCT03137810
Placental Cord Drainage Versus no Placental Drainage in the Management of Third Stage of Labour
A study testing placental cord drainage and non placemtal cord drainage in people with Obstetric Delivery, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of this work is to compare the effectiveness of placental cord drainage with no drainage in reducing the duration and blood loss in 3rd stage of labour. Read more about this study
- Who is it for?
- Ages 18 to 38 years, women only
- Conditions the study is for
- Obstetric Delivery
- What is being tested?
- placental cord drainage and non placemtal cord drainage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2017to 30 Nov 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 to 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Full term Uncomplicated singleton pregnancy Pregnancy with vertex presentation Patients expected to have spontaneous vaginal delivery
Who cannot join
- Over distended uterus(hydramnios.large fetus) Previous history of postpartum haemorrhage Known coagulation disorder Haemoglobin less than 8 g/dl Ante partum haemorrhage Multiple pregnancies Instrumental delivery
Trial locations and contacts
1 site in 1 country.
Hassan A Bayoumy, MD contact
Egypt1 site, 1 recruiting
- Recruiting
Ain shams university maternity hospital
Cairo, 25187
Ahmed A Elshahawy, MD, +201223266380, ahmedshafy@hotmail.com
About this study
Official title: Placental Cord Drainage Versus no Placental Drainage in the Management of Third Stage of Labour: Randomized Controlled Trial
The aim of this work is to compare the effectiveness of placental cord drainage with no drainage in reducing the duration and blood loss in 3rd stage of labour.
- Conditions
- Obstetric Delivery
- Being tested
- placental cord drainage, non placemtal cord drainage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placental cord drainageProcedure or surgery
In the study group a of total number of 90 women placental end of the cut umbilical cord 1st will be clamped for few seconds and then unclamped and left open to drain blood in a vessel until flow stoped. This will prevent the drained blood from getting mixed with blood lost in the 3rd stage.
Blood loss in the third stage will be measured using a Kelly's pad which will be used during delivery and the blood lost will be collected in a clean metal bowl which will be kept at the tail end of Kelley's pad.
non placemtal cord drainageProcedure or surgery
In 90 women after vaginal delivery of the baby placental end of the cut umbilical cord will be kept clamped.
| Study group | Role | What they receive |
|---|---|---|
| placental cord drainage | Experimental | In 90 women after vaginal delivery of the baby, the placental end of the cut umbilical cord 1st will be clamped for few seconds and then unclamped and left open to drain blood in a vessel until flow stoped. This will prevent the drained blood from getting mixed with blood lost in the 3rd stage. Receives: Procedure: placental cord drainage |
| Non placental cord drainage | Active comparator | In 90 women after vaginal delivery of the baby placental end of the cut umbilical cord will be kept clamped. Receives: Procedure: non placemtal cord drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of the third stage of labour
Measured: within 15 min of delivery of baby
Secondary outcomes (5)
Amount of blood loss
Measured: FIRST 24 HOURS
retained placenta
Measured: 1ST HOUR OF DELIVERY
Manual removal of placenta
Measured: 1HOUR OF DELIVERY
Changes in maternal haematocrit (Hct) after birth
Measured: 1ST 24 HOURS
blood transfusion
Measured: 1ST 24 HOURS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2017
- Study start1 Jan 2017
- Primary completion1 Nov 2017 (estimated)
- Study completion30 Nov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstetric DeliveryStudies 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
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdel Shafy El Shahawy, Ain Shams University
- Investigators
- Hassan A Bayoumy, MD, Study chair, Ain Shams UniversityAmgad E Abou-Gamrah, MD, Study director, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03137810
- Sponsor's protocol ID
- Placental Cord Drainage versus
- Acronym
- PLCD
- Status last verified
- Aug 2017
- First submitted
- 4 Apr 2017
- Last updated
- 16 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placental Cord Drainage Versus no Placental Drainage in the Management of Third Stage of Labour: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03137810
- Acronym / sponsor ID
- PLCD / Placental Cord Drainage versus
- Conditions
- Obstetric Delivery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Nov 2017 (estimated)
- Study completion
- 30 Nov 2017 (estimated)
- First posted
- 3 May 2017 (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.
The aim of this work is to compare the effectiveness of placental cord drainage with no drainage in reducing the duration and blood loss in 3rd stage of labour.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placental cord drainage | Experimental | Procedure: placental cord drainageIn 90 women after vaginal delivery of the baby, the placental end of the cut umbilical cord 1st will be clamped for few seconds and then unclamped and left open to drain blood in a vessel until flow stoped. This will prevent the drained blood from getting mixed with blood lost in the 3rd stage. |
| Non placental cord drainage | Active comparator | Procedure: non placemtal cord drainageIn 90 women after vaginal delivery of the baby placental end of the cut umbilical cord will be kept clamped. |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Full term Uncomplicated singleton pregnancy Pregnancy with vertex presentation Patients expected to have spontaneous vaginal delivery
Key exclusion criteria (1 listed)
- Over distended uterus(hydramnios.large fetus) Previous history of postpartum haemorrhage Known coagulation disorder Haemoglobin less than 8 g/dl Ante partum haemorrhage Multiple pregnancies Instrumental delivery
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 drainageIn the study group a of total number of 90 women placental end of the cut umbilical cord 1st will be clamped for few seconds and then unclamped and left open to drain blood in a vessel until flow stoped. This will prevent the drained blood from getting mixed with blood lost in the 3rd stage. Blood loss in the third stage will be measured using a Kelly's pad which will be used during delivery and the blood lost will be collected in a clean metal bowl which will be kept at the tail end of Kelley's pad. | Procedure or surgery | placental cord drainage |
| non placemtal cord drainageIn 90 women after vaginal delivery of the baby placental end of the cut umbilical cord will be kept clamped. | Procedure or surgery | Non placental cord drainage |
Primary outcome
Duration of the third stage of labour
Time frame: within 15 min of delivery of baby
5 secondary outcomes
Amount of blood loss
Time frame: FIRST 24 HOURS
retained placenta
Time frame: 1ST HOUR OF DELIVERY
Manual removal of placenta
Time frame: 1HOUR OF DELIVERY
Changes in maternal haematocrit (Hct) after birth
Time frame: 1ST 24 HOURS
blood transfusion
Time frame: 1ST 24 HOURS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2017.
- Individual participant dataSharing planned: Undecided
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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.
Hassan A Bayoumy, MD contact
Hassan A Bayoumy, MD study chair
Ain Shams University
Amgad E Abou-Gamrah, MD study director
Ain Shams University
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 and non placemtal cord drainage in people with Obstetric Delivery, 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 16 Aug 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed A ElShahawy, MD (+2 01223266380, ahmedshafy@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of the third stage of labour (time frame: within 15 min of delivery of baby). 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 16 Aug 2017.