Postpartum HemorrhageEarly Phase 1NCT04089176
Carbetocin Versus Oxytocin for Prevention of Postcesarean Hemorrhage in Pregnancy With High Risk for PPH
A Early Phase 1 study testing Carbetocin and oxytocin in people with Postpartum Hemorrhage and Cesarean Section, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.
Trial summary
Objective: study efficacy of carbtocin versus oxytocin for prevention postpartum hemorrhage in high risk pregnancy who undergo cesarean section Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Hemorrhage, Cesarean Section, High Risk Pregnancy
- 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
- 120 participants
- Where
- 1 siteThailand
- Study dates
- 1 Feb 2019to 31 May 2019
- Phase
- Early Phase 1
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- previous history of postpartum hemorrhage
- polyhydramnios
- fetal macrosomia
- previous cesarean section
- grand multiparity
- intramural myoma
Show all 9Show fewer
- chorioamnionitis
- prolonged premature rupture of membrane
- augmentation of labour
Who cannot join
- pregnancy induce hypertension
- on anticoagulant
- placenta previa or placenta percreta
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Carbetocin Versus Oxytocin for Prevention of Postcesarean Hemorrhage in Pregnant Women With High Risk Postpartum Hemorrhage: a Randomized Controlled Trial
Objective: study efficacy of carbtocin versus oxytocin for prevention postpartum hemorrhage in high risk pregnancy who undergo cesarean section
Read the detailed description
Randomized controlled clinical trial. Defined patient in two group. Primary outcome is evaluate additional drug use Secondary outcome is evaluated estimated blood loss, hemoglobin level
- Conditions
- Postpartum Hemorrhage, Cesarean Section, High Risk Pregnancy
- Being tested
- Carbetocin, oxytocin
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarbetocinDrug
carbetocin 100 mcg + RLS solution 10 ml injected directly into the vein over 2 min
oxytocinDrug
oxytocin 20 IU diluted in 1000 ml of RLS solution administered intravenously at rate 120 ml/hr x 8 hr
| Study group | Role | What they receive |
|---|---|---|
| protocal A | Active comparator | Carbetocin versus placebo Receives: Drug: Carbetocin; Drug: oxytocin |
| protocal B | Active comparator | Oxytocin versus placebo Receives: Drug: Carbetocin; Drug: oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Additional drug use
Number of additional drug use after intervention drug
Measured: during intra-operation
Secondary outcomes (3)
Estimate blood loss
amount of blood loss
Measured: During intra-opeartion and acute post operation period as 24 hours post operation
Side effect
type of side effect
Measured: During intra-opeartion and acute post operation period as 24 hours post operation
Hemoglobin level
differentiation of hemoglobin
Measured: Pre-operation and 24 hours post operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2019
- Study start1 Feb 2019
- Primary completion30 Apr 2019
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Department of Medical Services Ministry of Public Health of Thailand
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04089176
- Sponsor's protocol ID
- T.Sopida
- Status last verified
- Sep 2019
- First submitted
- 28 Apr 2019
- Last updated
- 13 Sep 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 13 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carbetocin Versus Oxytocin for Prevention of Postcesarean Hemorrhage in Pregnant Women With High Risk Postpartum Hemorrhage: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04089176
- Acronym / sponsor ID
- T.Sopida
- Conditions
- Postpartum Hemorrhage, Cesarean Section, High Risk Pregnancy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Department of Medical Services Ministry of Public Health of ThailandOther government
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 13 Sep 2019 (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.
Objective: study efficacy of carbtocin versus oxytocin for prevention postpartum hemorrhage in high risk pregnancy who undergo cesarean section
Detailed description
Randomized controlled clinical trial. Defined patient in two group. Primary outcome is evaluate additional drug use Secondary outcome is evaluated estimated blood loss, hemoglobin level
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| protocal A | Active comparator | Drug: Carbetocin, Drug: oxytocinCarbetocin versus placebo |
| protocal B | Active comparator | Drug: Carbetocin, Drug: oxytocinOxytocin versus placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- previous history of postpartum hemorrhage
- polyhydramnios
- fetal macrosomia
- previous cesarean section
- grand multiparity
Key exclusion criteria (3 listed)
- pregnancy induce hypertension
- on anticoagulant
- placenta previa or placenta percreta
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 |
|---|---|---|
| Carbetocincarbetocin 100 mcg + RLS solution 10 ml injected directly into the vein over 2 min | Drug | protocal A, protocal B |
| oxytocinoxytocin 20 IU diluted in 1000 ml of RLS solution administered intravenously at rate 120 ml/hr x 8 hr | Drug | protocal A, protocal B |
Primary outcome
Additional drug use
Time frame: during intra-operation
Number of additional drug use after intervention drug
3 secondary outcomes
Estimate blood loss
Time frame: During intra-opeartion and acute post operation period as 24 hours post operation
Side effect
Time frame: During intra-opeartion and acute post operation period as 24 hours post operation
Hemoglobin level
Time frame: Pre-operation and 24 hours post operation
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 13 Sep 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 Early Phase 1 study testing Carbetocin and oxytocin in people with Postpartum Hemorrhage and Cesarean Section, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.
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 9 inclusion and 3 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 13 Sep 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 Thailand. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Additional drug use (time frame: during intra-operation). 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 13 Sep 2019.