Cesarean SectionPhase 2/3CSNCT02786992
Misoprostol+Oxytocin vs. Carbetocin in CS
A Phase 2/3 study testing Misoprostol, Oxytocin and Carbetocin in people with Cesarean Section, run by Ain Shams University at 1 site in Egypt.
Trial summary
This prospective randomized double-blind clinical trial will be conducted at Ain-Shams University Maternity Hospital, Cairo, Egypt. Patients eligible for elective lower segment cesarean section will be randomized to 2 groups. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Cesarean Section
- What is being tested?
- Misoprostol, Oxytocin and Carbetocin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- 1 siteEgypt
- Study dates
- May 2016to Jan 2020
- Phase
- Phase 2/3
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Women with singleton pregnancy Women scheduled for elective CS full term (gestational age ≥37 weeks).
Who cannot join
- hypersensitivity to oxytocin, carbetocin or prostaglandins
- contraindication to prostaglandins (e.g. glaucoma)
- history of significant heart disease
- severe asthma
- epilepsy
- history or evidence of liver
Show all 13Show fewer
- renal or vascular disease
- history of coagulopathy
- thrombocytopenia or anticoagulant therapy
- women with HELLP syndrome
- eclampsia
- women presenting by placental abruption
- contraindication to spinal anesthesia as carbetocin is licensed for use with regional anesthesia only.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adjuvant Use of Misoprostol and Oxytocin vs. Carbetocin for the Prevention of Post-partum Hemorrhage in Elective Cesarian Section
This prospective randomized double-blind clinical trial will be conducted at Ain-Shams University Maternity Hospital, Cairo, Egypt. Patients eligible for elective lower segment cesarean section will be randomized to 2 groups. Group 1: will receive 400 ug misoprostol following + 10 IU oxytocin intravenous slowly after cord clamping. Group 2: will receive 100 ug carbetocin intravenous after cord clamping.
- Conditions
- Cesarean Section
- Being tested
- Misoprostol, Oxytocin, Carbetocin, Placebo
- Keywords
- Misoprostol, Oxytocin, Carbetocin, Prevention, Post-partum hemorrhage
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
Also called Mesotec, Mesotac
OxytocinDrug
Also called Syntocinon
CarbetocinDrug
Also called Pabal
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Misoprostol + Oxytocin | Active comparator | 400 ug sublingual misoprostol + 10 IU Oxytocin IVI Receives: Drug: Misoprostol; Drug: Oxytocin; Drug: Placebo |
| Carbetocin | Active comparator | 100 ug Carbetocin IV Receives: Drug: Carbetocin; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of post-partum hemorrhage
Measured: 24 hours
amount of blood loss
Measured: 24 hours
Secondary outcomes (8)
Number of participants needing extra uterotonic drug (10 IU oxytocin IVI)
An experienced attendant (principal investigator) will assess the need of extra uterotonic drug (10 IU oxytocin IVI) if the uterus is atonic or if blood loss is more than 1000 ml.
Measured: 24 hours
Number of participants needing hemostatic surgical interventions
Measured: intra-operative
Hemoglobin deficit in gm/dl
difference between pre-operative and 24 hours post-operative hemoglobin in gm/dl
Measured: 24 hours
APGAR score at 1 minute and 5 minutes
Measured: 1 minute and 5 minutes
Number of participants with NICU admission
Measured: 24 hours
Drug side effects
Measured: 24 hours
Time till resuming bowel habits
Time of passing gas will be recorded how many hours post-operative
Measured: 24 hours
hematocrit deficit in %
difference between pre-operative and 24 hours post-operative hematocrit in %
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2016 (estimated)
- Study startMay 2016
- Primary completionJan 2020
- Study completionJan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed S Sweed, MD, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02786992
- Sponsor's protocol ID
- AS1301
- Acronym
- CS
- Status last verified
- Jul 2020
- First submitted
- 24 May 2016
- Last updated
- 8 Jul 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Use of Misoprostol and Oxytocin vs. Carbetocin for the Prevention of Post-partum Hemorrhage in Elective Cesarian Section
- ClinicalTrials.gov ID
- NCT02786992
- Acronym / sponsor ID
- CS / AS1301
- Conditions
- Cesarean Section
- Keywords
- Misoprostol, Oxytocin, Carbetocin, Prevention, Post-partum hemorrhage
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Jan 2020 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 1 Jun 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 prospective randomized double-blind clinical trial will be conducted at Ain-Shams University Maternity Hospital, Cairo, Egypt. Patients eligible for elective lower segment cesarean section will be randomized to 2 groups. Group 1: will receive 400 ug misoprostol following + 10 IU oxytocin intravenous slowly after cord clamping. Group 2: will receive 100 ug carbetocin intravenous after cord clamping.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Misoprostol + Oxytocin | Active comparator | Drug: Misoprostol, Drug: Oxytocin, Drug: Placebo400 ug sublingual misoprostol + 10 IU Oxytocin IVI |
| Carbetocin | Active comparator | Drug: Carbetocin, Drug: Placebo100 ug Carbetocin IV |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women with singleton pregnancy Women scheduled for elective CS full term (gestational age ≥37 weeks).
Key exclusion criteria (13 listed)
- hypersensitivity to oxytocin, carbetocin or prostaglandins
- contraindication to prostaglandins (e.g. glaucoma)
- history of significant heart disease
- severe asthma
- epilepsy
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 |
|---|---|---|
| MisoprostolAlso: Mesotec, Mesotac | Drug | Misoprostol + Oxytocin |
| OxytocinAlso: Syntocinon | Drug | Misoprostol + Oxytocin |
| CarbetocinAlso: Pabal | Drug | Carbetocin |
| Placebo | Drug | Carbetocin, Misoprostol + Oxytocin |
Primary outcome
incidence of post-partum hemorrhage
Time frame: 24 hours
amount of blood loss
Time frame: 24 hours
8 secondary outcomes
Number of participants needing extra uterotonic drug (10 IU oxytocin IVI)
Time frame: 24 hours
Number of participants needing hemostatic surgical interventions
Time frame: intra-operative
Hemoglobin deficit in gm/dl
Time frame: 24 hours
APGAR score at 1 minute and 5 minutes
Time frame: 1 minute and 5 minutes
Number of participants with NICU admission
Time frame: 24 hours
Drug side effects
Time frame: 24 hours
Time till resuming bowel habits
Time frame: 24 hours
hematocrit deficit in %
Time frame: 24 hours
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 8 Jul 2020.
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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 Phase 2/3 study testing Misoprostol, Oxytocin and Carbetocin in people with Cesarean Section, 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 13 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 8 Jul 2020. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
incidence of post-partum hemorrhage (time frame: 24 hours). The study lists 2 primary outcomes in all. 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 Jul 2020.