Labor Stage, ThirdNCT02656108
Omission of Controlled Cord Traction During Active Management of Third Stage of Labor
A study of Labor Stage, Third, run by Ain Shams University at 1 site in Egypt.
Trial summary
This is a comparative study which will be conducted in Ain Shams University Maternity hospital to assess the individual and specfic role of controlled cord traction as a part of active management of third stage of labor Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Stage, Third
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2018to 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- singleton pregnancy
- term pregnancy
Who cannot join
- episiotomy
- operative vaginal delivery
- known coagulation defect
- Acute complication during labor e.g. eclampsia
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine, Ain Shams University
Cairo, Cairo Governorate
ahmed kotb, MD, 2001008681999, ahmedmkotp@hotmail.com
ahmed kotb, ahmedmkotp@hotmail.com
About this study
Official title: Omission of Controlled Cord Traction During Active Management of Third Stage of Labor. A Single Blinded Randomized Controlled Trial
This is a comparative study which will be conducted in Ain Shams University Maternity hospital to assess the individual and specfic role of controlled cord traction as a part of active management of third stage of labor
Read the detailed description
300 patients will be randomized into two groups with controlled cord traction and withoout. The primary outcome will be sever postpartum haemorrhage
- Conditions
- Labor Stage, Third
- Being tested
- Ommited controlled cord traction, controlled cord traction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ommited controlled cord tractionProcedure or surgery
No controlled cord traction and no fundal pressure. placenta will be allowed to deliver physiologically
controlled cord tractionProcedure or surgery
active management of third stage of labor in the form of uterine massage with controlled cord traction
| Study group | Role | What they receive |
|---|---|---|
| omiited controlled cord traction | Experimental | neither controlled cord traction nor fundal pressure will be applied. The placenta will be delivered physiologically and signs of placental separation will be awaited Receives: Procedure: Ommited controlled cord traction |
| controlled cord traction | Active comparator | the cord will be held in one hand and the other hand will be placed just above the woman's pubic boneto stabilize the uterus during cord traction Receives: Procedure: controlled cord traction |
What is being measured
The primary outcome is the main question the study is designed to answer.
sever post partum haemorrhage
blood loss more than 500 cc
Measured: 24 hours
Secondary outcomes (1)
duration of third stage of labor
from delivery of the baby to delivery of the placenta
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2016 (estimated)
- Study start1 Jan 2018
- Primary completionNov 2018 (estimated)
- Study completionNov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor Stage, ThirdStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed El Kotb Abdel Fattah, Ain Shams University
- Investigators
- Ahmed M kotb, MD, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02656108
- Sponsor's protocol ID
- CCO
- Status last verified
- Oct 2018
- First submitted
- 12 Jan 2016
- Last updated
- 17 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omission of Controlled Cord Traction During Active Management of Third Stage of Labor. A Single Blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02656108
- Acronym / sponsor ID
- CCO
- Conditions
- Labor Stage, Third
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 14 Jan 2016 (estimated)
- 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 is a comparative study which will be conducted in Ain Shams University Maternity hospital to assess the individual and specfic role of controlled cord traction as a part of active management of third stage of labor
Detailed description
300 patients will be randomized into two groups with controlled cord traction and withoout. The primary outcome will be sever postpartum haemorrhage
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| omiited controlled cord traction | Experimental | Procedure: Ommited controlled cord tractionneither controlled cord traction nor fundal pressure will be applied. The placenta will be delivered physiologically and signs of placental separation will be awaited |
| controlled cord traction | Active comparator | Procedure: controlled cord tractionthe cord will be held in one hand and the other hand will be placed just above the woman's pubic boneto stabilize the uterus during cord traction |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- singleton pregnancy
- term pregnancy
Key exclusion criteria (4 listed)
- episiotomy
- operative vaginal delivery
- known coagulation defect
- Acute complication during labor e.g. eclampsia
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 |
|---|---|---|
| Ommited controlled cord tractionNo controlled cord traction and no fundal pressure. placenta will be allowed to deliver physiologically | Procedure or surgery | omiited controlled cord traction |
| controlled cord tractionactive management of third stage of labor in the form of uterine massage with controlled cord traction | Procedure or surgery | controlled cord traction |
Primary outcome
sever post partum haemorrhage
Time frame: 24 hours
blood loss more than 500 cc
1 secondary outcome
duration of third stage of labor
Time frame: 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 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.
Ahmed M kotb, MD principal investigator
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 of Labor Stage, Third, 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 2 inclusion and 4 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 17 Oct 2018. 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 M Kotb, MD (010086819990 ext. 0020, ahmedmkotp@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sever post partum haemorrhage (time frame: 24 hours). 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 17 Oct 2018.