Preeclampsia SevereNCT04756661
Uterotonics for Severe Preeclampsia
A study testing Carbetocin, Oxytocin and Misoprostol in people with Preeclampsia Severe, run by Assiut University at 1 site in Egypt.
Trial summary
The study compares the effect of Intravenous carbetocin versus combined use of intravenous oxytocin and rectal misoprostol for prevention of postpartum hemorrhage during delivery of women with severe preeclampsia Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Preeclampsia Severe
- What is being tested?
- Carbetocin, Oxytocin and Misoprostol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2020to 10 Feb 2021
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pregnant women which diagnosed with severe pre-eclampsia.
- Singleton pregnancy.
- Termination of pregnancy by Cesarean section after 28 weeks of gestation.
Who cannot join
- Suspected or proven placental abruption.
- Known placenta Previa or acreata.
- Multiple pregnancies.
- Obesity (BMI >35).
- Anemia (<9 g/dl).
- Retained placental tissues.
Show all 12Show fewer
- Big baby (> 4 kg).
- Presence of coagulopathy.
- Polyhydramnios.
- Presence of Uterine fibroids.
- Medical diseases as; cardiac, liver, renal or endocrine diseases.
- General anesthesia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Carbetocin Versus Combined Oxytocin and Misoprostol for Prevention of Postpartum Hemorrhage in Women With Severe Preeclampsia
The study compares the effect of Intravenous carbetocin versus combined use of intravenous oxytocin and rectal misoprostol for prevention of postpartum hemorrhage during delivery of women with severe preeclampsia
- Conditions
- Preeclampsia Severe
- Being tested
- Carbetocin, Oxytocin, Misoprostol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarbetocinDrug
100 mcg of Carbetocin intravenous injection
OxytocinDrug
10 IU oxytocin IV drip
MisoprostolDrug
400 mcg rectal
| Study group | Role | What they receive |
|---|---|---|
| Carbetocin | Experimental | Patient received 100 mcg of carbetocin intravenous over one minute immediately after delivery of the baby. Receives: Drug: Carbetocin |
| Oxytocin plus misoprostol | Active comparator | Patient received 10 units of oxytocin IV drip and 400 mcg of misoprostol rectally after anesthesia. Receives: Drug: Oxytocin; Drug: Misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of postpartum hemorrhage more than 1000 ml
the amount of bleeding during and after CS
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 posted16 Feb 2021
- Study start1 Jan 2020
- Primary completion31 Dec 2020
- Study completion10 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preeclampsia SevereStudies of the same condition, open and under way.
- More trials run by Assiut 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
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Abbas, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04756661
- Sponsor's protocol ID
- CARBOXMISO
- Status last verified
- Feb 2021
- First submitted
- 12 Feb 2021
- Last updated
- 16 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carbetocin Versus Combined Oxytocin and Misoprostol for Prevention of Postpartum Hemorrhage in Women With Severe Preeclampsia
- ClinicalTrials.gov ID
- NCT04756661
- Acronym / sponsor ID
- CARBOXMISO
- Conditions
- Preeclampsia Severe
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 10 Feb 2021 (actual)
- First posted
- 16 Feb 2021 (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 study compares the effect of Intravenous carbetocin versus combined use of intravenous oxytocin and rectal misoprostol for prevention of postpartum hemorrhage during delivery of women with severe preeclampsia
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carbetocin | Experimental | Drug: CarbetocinPatient received 100 mcg of carbetocin intravenous over one minute immediately after delivery of the baby. |
| Oxytocin plus misoprostol | Active comparator | Drug: Oxytocin, Drug: MisoprostolPatient received 10 units of oxytocin IV drip and 400 mcg of misoprostol rectally after anesthesia. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Pregnant women which diagnosed with severe pre-eclampsia.
- Singleton pregnancy.
- Termination of pregnancy by Cesarean section after 28 weeks of gestation.
Key exclusion criteria (12 listed)
- Suspected or proven placental abruption.
- Known placenta Previa or acreata.
- Multiple pregnancies.
- Obesity (BMI >35).
- Anemia (<9 g/dl).
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 |
|---|---|---|
| Carbetocin100 mcg of Carbetocin intravenous injection | Drug | Carbetocin |
| Oxytocin10 IU oxytocin IV drip | Drug | Oxytocin plus misoprostol |
| Misoprostol400 mcg rectal | Drug | Oxytocin plus misoprostol |
Primary outcome
The rate of postpartum hemorrhage more than 1000 ml
Time frame: 30 minutes
the amount of bleeding during and after CS
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 16 Feb 2021.
- 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.
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 Carbetocin, Oxytocin and Misoprostol in people with Preeclampsia Severe, run by Assiut 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 3 inclusion and 12 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 16 Feb 2021. 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?
The rate of postpartum hemorrhage more than 1000 ml (time frame: 30 minutes). 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 Feb 2021.