Adverse Effect of Oxytocic DrugsNCT01726478
Uterotonic Efficacy of Oxytocin 2.5 Versus 10 Units During Caesarean Section at Mulago Hospital
A study testing 2.5 units Oxytocin and 10 units Oxytocin in people with Adverse Effect of Oxytocic Drugs and Uterine Hemorrhage, run by Faculty of Medicine at 1 site in Uganda.
Trial summary
The purpose of the study was to determine whether 2.5 international units of oxytocin gives adequate uterine tone and is safe as compared to 10 international units of oxytocin following caesarean section delivery at Mulago hospital. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Adverse Effect of Oxytocic Drugs, Uterine Hemorrhage, Inappropriate Dose of Drug Administered
- What is being tested?
- 2.5 units Oxytocin and 10 units Oxytocin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 386 participants
- Where
- 1 siteUganda
- Study dates
- Feb 2011to Apr 2011
- 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 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- ASA I (Healthy patient with no systemic disease) or II ( mild to moderate systemic disease)
- Age between 18 to 40 years
- Singleton pregnancies
Who cannot join
- • Allergy to oxytocin
- Ruptured uterus
- Significant obstetric disease (including Pregnancy induced Hypertension, Eclampsia,)
- Known risk factors for postpartum haemorrhage or uterine atony
- Inherited or acquired coagulation disorder
- History of post partum haemorrhage
Trial locations and contacts
1 site in 1 country.
Uganda1 site
Mulago Hospital Labour Suite Operating Theatres
Kampala, East Africa, +256
About this study
Official title: Uterotonic Efficacy of Oxytocin 2.5 Versus 10 Units During Caesarean Section at Mulago Hospital; Adouble Blinded Clinical Trial.
The purpose of the study was to determine whether 2.5 international units of oxytocin gives adequate uterine tone and is safe as compared to 10 international units of oxytocin following caesarean section delivery at Mulago hospital.
- Conditions
- Adverse Effect of Oxytocic Drugs, Uterine Hemorrhage, Inappropriate Dose of Drug Administered
- Being tested
- 2.5 units Oxytocin, 10 units Oxytocin
- Keywords
- Oxytocin, Uterine tone, Mulago Hospital, Dose, Side effects
- Medical subject headings
- Uterine Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2.5 units OxytocinDrug
Also called pitocin
Administration of 2.5 units of oxytocin after clamping of umbilical cord
10 units OxytocinDrug
Also called pitocin
Administration of 10 units of oxytocin after clamping of umbilical cord
| Study group | Role | What they receive |
|---|---|---|
| 2.5 units oxytocin | Active comparator | Administration of 2.5 units of oxytocin intravenously after clamping of umbilical cord Receives: Drug: 2.5 units Oxytocin |
| 10 units oxytocin | Placebo comparator | Administration of 10 units of oxytocin after clamping of umbilical cord Receives: Drug: 10 units Oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uterine tone adequacy
The primary outcome was the assessment of either adequate or inadequate Uterine tone at various times after administration of initial oxytocin dose
Measured: 2 minutes
Secondary outcomes (1)
Intraoperative blood loss
Blood loss was estimated by measuring the amount in the suction bottles and weighing of the mops. The patients were followed up for any occurrence of postpartum haemorrhage for the next 24 hours after surgery.
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 posted15 Nov 2012 (estimated)
- Study startFeb 2011
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adverse Effect of Oxytocic DrugsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 386 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculty of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Faculty of Medicine, Makerere University
- Investigators
- Andrew Kintu, MBChB, Principal investigator, Makerere University College of Health Sciences Department of Anaesthesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01726478
- Sponsor's protocol ID
- OXY168
- Status last verified
- Nov 2012
- First submitted
- 3 Nov 2012
- Last updated
- 15 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uterotonic Efficacy of Oxytocin 2.5 Versus 10 Units During Caesarean Section at Mulago Hospital; Adouble Blinded Clinical Trial.
- ClinicalTrials.gov ID
- NCT01726478
- Acronym / sponsor ID
- OXY168
- Conditions
- Adverse Effect of Oxytocic Drugs, Uterine Hemorrhage, Inappropriate Dose of Drug Administered
- Keywords
- Oxytocin, Uterine tone, Mulago Hospital, Dose, Side effects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 386 participants (actual)
- Lead sponsor
- Faculty of MedicineUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 15 Nov 2012 (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.
The purpose of the study was to determine whether 2.5 international units of oxytocin gives adequate uterine tone and is safe as compared to 10 international units of oxytocin following caesarean section delivery at Mulago hospital.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2.5 units oxytocin | Active comparator | Drug: 2.5 units OxytocinAdministration of 2.5 units of oxytocin intravenously after clamping of umbilical cord |
| 10 units oxytocin | Placebo comparator | Drug: 10 units OxytocinAdministration of 10 units of oxytocin after clamping of umbilical cord |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ASA I (Healthy patient with no systemic disease) or II ( mild to moderate systemic disease)
- Age between 18 to 40 years
- Singleton pregnancies
Key exclusion criteria (6 listed)
- • Allergy to oxytocin
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 |
|---|---|---|
| 2.5 units OxytocinAlso: pitocinAdministration of 2.5 units of oxytocin after clamping of umbilical cord | Drug | 2.5 units oxytocin |
| 10 units OxytocinAlso: pitocinAdministration of 10 units of oxytocin after clamping of umbilical cord | Drug | 10 units oxytocin |
Primary outcome
Uterine tone adequacy
Time frame: 2 minutes
The primary outcome was the assessment of either adequate or inadequate Uterine tone at various times after administration of initial oxytocin dose
1 secondary outcome
Intraoperative blood loss
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 15 Nov 2012.
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.
Andrew Kintu, MBChB principal investigator
Makerere University College of Health Sciences Department of Anaesthesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2.5 units Oxytocin and 10 units Oxytocin in people with Adverse Effect of Oxytocic Drugs and Uterine Hemorrhage, run by Faculty of Medicine at 1 site in Uganda.
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 6 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 15 Nov 2012. 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 Uganda. 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. Some participants in this study may receive a placebo. 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 adequacy (time frame: 2 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 15 Nov 2012; AzTrials last refreshed its copy on 8 Nov 2026.