Cesarean Section ComplicationsNCT04046510
Comparaison of 3 Protocols of Ocytocin Administration in C Section
A study testing Ocytocin in people with Cesarean Section Complications and Oxytocin Adverse Reaction, run by Mongi Slim Hospital at 1 site in Tunisia.
Trial summary
This study aimed to compare 3 doses of ocytocin in bolus injection and contnious perfusion during C section. these doses determined by: high, intermediate and low doses, were administred to parturients during elective or urgent C section under spinal anesthesia Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cesarean Section Complications, Oxytocin Adverse Reaction
- What is being tested?
- Ocytocin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Sep 2018to 31 Jul 2019
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adult patients scheduled for C section under spinal anesthesia, monofoetal pregnancy, full term
Who cannot join
- necessity of general anesthesia
- non conscent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparaison of 3 Protocols of Ocytocin Administration in Cesarean Section
This study aimed to compare 3 doses of ocytocin in bolus injection and contnious perfusion during C section. these doses determined by: high, intermediate and low doses, were administred to parturients during elective or urgent C section under spinal anesthesia
Read the detailed description
This study aimed to compare 3 doses of ocytocin in bolus injection and contnious perfusion during C section. these doses determined by: high, intermediate and low doses, were administred to parturients during elective or urgent C section under spinal anesthesia.
The aim was to determine the lowest efficient dose to prevent post partum hemorrage and with the lowest incidence of maternal side effects.
- Being tested
- Ocytocin
- Keywords
- Cesarean section, ocytocin, uterine tone, side effects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OcytocinDrug
Administration of lower doses of Ocytocin in bolus and continuous infusion
| Study group | Role | What they receive |
|---|---|---|
| High doses | Active comparator | the patients of this group recieved conventionnal doses of ocytocin after foetal extraction in C section: 5IU in bolus followed by 15IU in continuous infusion Receives: Drug: Ocytocin |
| Intermediate doses | Experimental | the patients of this group recieved after foetal extraction in C section: 2IU in bolus followed by 10IU in continuous infusion Receives: Drug: Ocytocin |
| Low doses | Experimental | the patients of this group recieved after foetal extraction in C section: 2IU in bolus followed by 5 IU in continuous infusion Receives: Drug: Ocytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
uterine tone
uterine tone juged by the obstetrician
Measured: 10 minutes
Secondary outcomes (3)
hemoglobin rate
delta hemoglobin: preoperative HB- Post operative HB
Measured: 30 minutes after C section
Additive boluses of Ocytocin
necessity of Additive boluses of Ocytocin
Measured: 30 minutes after C section
side effects of Ocytocin
Tachycardia, hypotension, nausea vomiting, headache, chest pain
Measured: up to 30 minutes after C section
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2019
- Study start1 Sep 2018
- Primary completion31 Mar 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Section ComplicationsStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mongi Slim Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mhamed Sami Mebazaa, Mongi Slim Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04046510
- Sponsor's protocol ID
- Ocytocin in c section
- Status last verified
- Jul 2019
- First submitted
- 31 Jul 2019
- Last updated
- 6 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparaison of 3 Protocols of Ocytocin Administration in Cesarean Section
- ClinicalTrials.gov ID
- NCT04046510
- Acronym / sponsor ID
- Ocytocin in c section
- Keywords
- Cesarean section, ocytocin, uterine tone, side effects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Mongi Slim HospitalUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 6 Aug 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.
This study aimed to compare 3 doses of ocytocin in bolus injection and contnious perfusion during C section. these doses determined by: high, intermediate and low doses, were administred to parturients during elective or urgent C section under spinal anesthesia
Detailed description
This study aimed to compare 3 doses of ocytocin in bolus injection and contnious perfusion during C section. these doses determined by: high, intermediate and low doses, were administred to parturients during elective or urgent C section under spinal anesthesia.
The aim was to determine the lowest efficient dose to prevent post partum hemorrage and with the lowest incidence of maternal side effects.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High doses | Active comparator | Drug: Ocytocinthe patients of this group recieved conventionnal doses of ocytocin after foetal extraction in C section: 5IU in bolus followed by 15IU in continuous infusion |
| Intermediate doses | Experimental | Drug: Ocytocinthe patients of this group recieved after foetal extraction in C section: 2IU in bolus followed by 10IU in continuous infusion |
| Low doses | Experimental | Drug: Ocytocinthe patients of this group recieved after foetal extraction in C section: 2IU in bolus followed by 5 IU in continuous infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adult patients scheduled for C section under spinal anesthesia, monofoetal pregnancy, full term
Key exclusion criteria (2 listed)
- necessity of general anesthesia
- non conscent
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 |
|---|---|---|
| OcytocinAdministration of lower doses of Ocytocin in bolus and continuous infusion | Drug | High doses, Intermediate doses, Low doses |
Primary outcome
uterine tone
Time frame: 10 minutes
uterine tone juged by the obstetrician
3 secondary outcomes
hemoglobin rate
Time frame: 30 minutes after C section
Additive boluses of Ocytocin
Time frame: 30 minutes after C section
side effects of Ocytocin
Time frame: up to 30 minutes after C section
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 6 Aug 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Cesarean Section Complications
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Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
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Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
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Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Pain, Postpartum Depression
Recruiting
Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
Not yet recruiting
The Mepilex Cesarean Delivery Trial / MEPIDEL
Surgical Site Infection
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 Ocytocin in people with Cesarean Section Complications and Oxytocin Adverse Reaction, run by Mongi Slim Hospital at 1 site in Tunisia.
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 2 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 6 Aug 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 Tunisia. 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?
uterine tone (time frame: 10 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 6 Aug 2019.