CARBETOCIN FOR PREVENTION OF PLACENTAL RETAINEDPhase 4NCT01827124
Randomized Clinical Trial for Comparison Of Intravenous Carbeitocin Versus Oxytocin In Management Of Placental Delivery In Second Trimester Interruption
A Phase 4 study testing Carbetocin and oxytocin in people with CARBETOCIN FOR PREVENTION OF PLACENTAL RETAINED, run by Wafaa Uthman Ahmed at 1 site in Egypt.
Trial summary
Intravenous Carbetocin is more efficient than intravenous infusion oxytocin in management of placental delivery in 2nd trimester interruption. Read more about this study
- Who is it for?
- Ages 16 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- CARBETOCIN FOR PREVENTION OF PLACENTAL RETAINED
- What is being tested?
- Carbetocin and oxytocin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2013to Dec 2013
- Phase
- Phase 4
- 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 16 to 50 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age:16-50 years
- Pregnancy duration: 14-24weeks
- Spontaneous abortion or medical induced abortion at 14-24weeks
Who cannot join
- Age less than 16years and more than 50 years
- Surgical termination
- Placenta previa
- Uterine fibroid
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams university maternity hospital department of obstetrics and gynacology
Cairo, Tertiary
Ahmed M Ibrahim, ass. prof, 01223416828 ext. 002, abugooda@hotmail.com
Mohamed SE El-safty 002, lecturer, 01003922211 ext. 002, melsafty76@hotmail.com
About this study
Intravenous Carbetocin is more efficient than intravenous infusion oxytocin in management of placental delivery in 2nd trimester interruption.
- Being tested
- Carbetocin, oxytocin
- Keywords
- CARBETOCIN AND OXYTOCIN AND SECOND TRIMESTER INTERRUPTION
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarbetocinDrug
Also called pabal
oxytocinDrug
Also called syntocinon
| Study group | Role | What they receive |
|---|---|---|
| carbetocin and placebo | Experimental | 100microgram carbetocin IV and 1cc normal saline(placebo)infusion Receives: Drug: Carbetocin; Drug: oxytocin |
| oxytocin and placebo | Experimental | 20Interntional unit oxytocin infusion and 1cc normal saline IV Receives: Drug: Carbetocin; Drug: oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Record duration of spontaneous placental expulsion after delivery of fetus in second trimester interruption
Measured: at the time of delivery
Secondary outcomes (1)
Estimation of blood loss in each group by weighing all pads put under the patient after delivery of fetus tell expulsion of placenta( before and after using of pads).
Measured: at time of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionNov 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CARBETOCIN FOR PREVENTION OF PLACENTAL RETAINEDStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wafaa Uthman Ahmed
- Sponsor type
- University, hospital or other
- Collaborators
- Ain Shams Maternity Hospital
- Responsible party
- Sponsor-investigator, Wafaa Uthman Ahmed, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01827124
- Sponsor's protocol ID
- Ain Shams U
- Status last verified
- Apr 2013
- First submitted
- 5 Apr 2013
- Last updated
- 8 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial for Comparison Of Intravenous Carbeitocin Versus Oxytocin In Management Of Placental Delivery In Second Trimester Interruption
- ClinicalTrials.gov ID
- NCT01827124
- Acronym / sponsor ID
- Ain Shams U
- Keywords
- CARBETOCIN AND OXYTOCIN AND SECOND TRIMESTER INTERRUPTION
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Wafaa Uthman AhmedUniversity, hospital or other
- Collaborators
- Ain Shams Maternity Hospital
- Study start
- Apr 2013
- Primary completion
- Nov 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 9 Apr 2013 (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.
Intravenous Carbetocin is more efficient than intravenous infusion oxytocin in management of placental delivery in 2nd trimester interruption.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| carbetocin and placebo | Experimental | Drug: Carbetocin, Drug: oxytocin100microgram carbetocin IV and 1cc normal saline(placebo)infusion |
| oxytocin and placebo | Experimental | Drug: Carbetocin, Drug: oxytocin20Interntional unit oxytocin infusion and 1cc normal saline IV |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Age:16-50 years
- Pregnancy duration: 14-24weeks
- Spontaneous abortion or medical induced abortion at 14-24weeks
Key exclusion criteria (4 listed)
- Age less than 16years and more than 50 years
- Surgical termination
- Placenta previa
- Uterine fibroid
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 |
|---|---|---|
| CarbetocinAlso: pabal | Drug | carbetocin and placebo, oxytocin and placebo |
| oxytocinAlso: syntocinon | Drug | carbetocin and placebo, oxytocin and placebo |
Primary outcome
Record duration of spontaneous placental expulsion after delivery of fetus in second trimester interruption
Time frame: at the time of delivery
1 secondary outcome
Estimation of blood loss in each group by weighing all pads put under the patient after delivery of fetus tell expulsion of placenta( before and after using of pads).
Time frame: at time of delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2013.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Carbetocin and oxytocin in people with CARBETOCIN FOR PREVENTION OF PLACENTAL RETAINED, run by Wafaa Uthman Ahmed 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 3 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 8 Oct 2013. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 WAFAA UTHMAN AHMED, M.B.CH.B (00201119760754, WAFAA.UTHMAN@YAHOO.COM), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Record duration of spontaneous placental expulsion after delivery of fetus in second trimester interruption (time frame: at the time of delivery). 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 8 Oct 2013.