Postpartum HemorrhageoxytocinNCT02080104
Intramuscular Versus Intravenous Prophylactic Oxytocin for Hemorrhage After Vaginal Delivery
A study testing intarvenous and intramusculer 10 IU oxytocin in people with Postpartum Hemorrhage, run by Hediye Dagdeviren at 1 site in Turkey (Türkiye).
Trial summary
Intramuscular versus intravenous prophylactic oxytocin for the third stage of labour following vaginal delivery: A randomised controlled trial Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Postpartum Hemorrhage
- What is being tested?
- intarvenous and intramusculer 10 IU oxytocin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Feb 2014to Feb 2015
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Research volunteers, the undersigned, pregnant women
- Only with vaginal delivery (episiotomy and perineal tears can)
- > 34 weeks or more will be
- Cephalic presentation will be
- At low risk of postpartum hemorrhage
Who cannot join
- <18 years
- Multiple pregnancies
- The presence of uterine myoma
- Having postpartum hemorrhage in previous pregnancies
- Placenta previa, polyhydramnios
- More than four parity
Show all 13Show fewer
- Fetal macrosomia
- Hb <9mg/dl
- preeclampsia
- Uterine anomalies
- Receiving anticoagulant therapy, suspected coagulopathy
- > 42 weeks of pregnancy
- Oxytocin allergy -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bakırkoy Dr Sadi Konuk Teaching and Research Hospital
Istanbul, 34140
hediye dağdeviren, md, 2124147171 ext. 7372, hediyedagdeviren@gmail.com
hüseyin cengiz, md
About this study
Official title: Intramuscular Versus Intravenous Prophylactic Oxytocin for the Third Stage of Labour Following Vaginal Delivery: A Randomised Controlled Trial
Intramuscular versus intravenous prophylactic oxytocin for the third stage of labour following vaginal delivery: A randomised controlled trial
Read the detailed description
Prevention of postpartum haemorrhage is essential in the pursuit of improved health care for women. In this study investigators aimed to compare intramuscular oxytocin with intravenous oxytocin for the routine prevention of postpartum haemorrhage in women who deliver vaginally.In some countries, intravenous access can not be provided easily . Intramuscular application is faster , easier and tougher enforcement requires less skill and equipment . For this reason, less educated , which can be applied by those offering health services .
- Conditions
- Postpartum Hemorrhage
- Being tested
- intarvenous and intramusculer 10 IU oxytocin
- Keywords
- postpartum hemorrhage, oxytocin, vaginal delivery, prophylactic
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intarvenous and intramusculer 10 IU oxytocinDrug
intarvenous and intramusculer 10 IU oxytocin
| Study group | Role | What they receive |
|---|---|---|
| intravenous 10 ıu oxytocin | Active comparator | group which 2 ampul prophylactic oxytocin given for third stage of labour intravenously after vaginal delivery Receives: Drug: intarvenous and intramusculer 10 IU oxytocin |
| intramusculer 10 ıu oxytocin | Experimental | group which oxytocin administered intramusculary after vaginal delivery Receives: Drug: intarvenous and intramusculer 10 IU oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
early postpartum hemorrhage
Blood loss during the birth and postpartum hemorrhage asset (within 24 hours> 500 cc blood loss)
Measured: postpartum 24 hours
Secondary outcomes (1)
Blood transfusion requirement
- Blood transfusion requirement
- duration of phase 3 (> 30 min)
- necessity of additional treatments for postpartum hemorrhage
- the necessity of manual removal of placenta
- side effects of the
Measured: postpartum 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2014 (estimated)
- Study startFeb 2014
- Primary completionFeb 2015 (estimated)
- Study completionFeb 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hediye Dagdeviren
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Hediye Dagdeviren, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02080104
- Sponsor's protocol ID
- 27-01.14-02-02
- Acronym
- oxytocin
- Status last verified
- Mar 2014
- First submitted
- 1 Mar 2014
- Last updated
- 6 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Oladapo OT, Okusanya BO, Abalos E, Gallos ID, Papadopoulou A. Intravenous versus intramuscular prophylactic oxytocin for the third stage of labour. Cochrane Database Syst Rev. 2020 Nov 9;11(11):CD009332. doi: 10.1002/14651858.CD009332.pub4.
PubMed 33169839
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intramuscular Versus Intravenous Prophylactic Oxytocin for the Third Stage of Labour Following Vaginal Delivery: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02080104
- Acronym / sponsor ID
- oxytocin / 27-01.14-02-02
- Conditions
- Postpartum Hemorrhage
- Keywords
- postpartum hemorrhage, oxytocin, vaginal delivery, prophylactic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Hediye DagdevirenOther government
- Study start
- Feb 2014
- Primary completion
- Feb 2015 (estimated)
- Study completion
- Feb 2015 (estimated)
- First posted
- 6 Mar 2014 (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.
Intramuscular versus intravenous prophylactic oxytocin for the third stage of labour following vaginal delivery: A randomised controlled trial
Detailed description
Prevention of postpartum haemorrhage is essential in the pursuit of improved health care for women. In this study investigators aimed to compare intramuscular oxytocin with intravenous oxytocin for the routine prevention of postpartum haemorrhage in women who deliver vaginally.In some countries, intravenous access can not be provided easily . Intramuscular application is faster , easier and tougher enforcement requires less skill and equipment . For this reason, less educated , which can be applied by those offering health services .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intravenous 10 ıu oxytocin | Active comparator | Drug: intarvenous and intramusculer 10 IU oxytocingroup which 2 ampul prophylactic oxytocin given for third stage of labour intravenously after vaginal delivery |
| intramusculer 10 ıu oxytocin | Experimental | Drug: intarvenous and intramusculer 10 IU oxytocingroup which oxytocin administered intramusculary after vaginal delivery |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Research volunteers, the undersigned, pregnant women
- Only with vaginal delivery (episiotomy and perineal tears can)
- > 34 weeks or more will be
- Cephalic presentation will be
- At low risk of postpartum hemorrhage
Key exclusion criteria (13 listed)
- <18 years
- Multiple pregnancies
- The presence of uterine myoma
- Having postpartum hemorrhage in previous pregnancies
- Placenta previa, polyhydramnios
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 |
|---|---|---|
| intarvenous and intramusculer 10 IU oxytocinintarvenous and intramusculer 10 IU oxytocin | Drug | intramusculer 10 ıu oxytocin, intravenous 10 ıu oxytocin |
Primary outcome
early postpartum hemorrhage
Time frame: postpartum 24 hours
Blood loss during the birth and postpartum hemorrhage asset (within 24 hours> 500 cc blood loss)
1 secondary outcome
Blood transfusion requirement
Time frame: postpartum 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2014.
- Derived from this study: PubMed 33169839Oladapo OT, Okusanya BO, Abalos E, Gallos ID, Papadopoulou A. Intravenous versus intramuscular prophylactic oxytocin for the third stage of labour. Cochrane Database Syst Rev. 2020 Nov 9;11(11):CD009332. doi: 10.1002/14651858.CD009332.pub4.
Related trials for Postpartum Hemorrhage
Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
Postpartum Hemorrhage, Uterine Atony
RecruitingPhase 3
Tranexamic Acid to Prevent Heavy Bleeding After Childbirth in Women at Higher Risk
Postpartum Hemorrhage
Not yet recruitingObservational study
Measured Versus Hemoglobin-Calculated Postpartum Blood Loss in Waterbirth
Postpartum Hemorrhage, Waterbirth
RecruitingObservational study
Long Term Outcome After Use of Vacuum-induced Tamponade for Postpartum Hemorrhage
Postpartum Hemorrhage, Treatment Outcome
RecruitingPhase 2
Prevention of Postpartum Hemorrhage With Tranexamic Acid
Post Partum Hemorrhage
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intarvenous and intramusculer 10 IU oxytocin in people with Postpartum Hemorrhage, run by Hediye Dagdeviren at 1 site in Turkey (Türkiye).
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 5 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: status not confirmed, as of the sponsor's last update on 6 Mar 2014. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact nurten kayacan aydemir (2124147171 ext. 7372, nurten.aydemir@beah.gov.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
early postpartum hemorrhage (time frame: postpartum 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02080104, which also lists 1 linked publication.
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 Mar 2014.