Postpartum BleedingNCT01954186
When and How to Administer Oxytocin for Active Management of Third Stage of Labour
A study testing intravenous & intramuscular oxytocin and after delivery of the fetus & when anterior shoulder seen in people with Postpartum Bleeding, run by Etlik Zubeyde Hanim Womens' Health and Teaching Hospital at 1 site in Turkey (Türkiye).
Trial summary
To compare the efficacy of the route and timing of oxytocin administration for Active management of third stage of labour (AMTSL). Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Postpartum Bleeding
- What is being tested?
- intravenous & intramuscular oxytocin and after delivery of the fetus & when anterior shoulder seen
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2010to Dec 2010
- 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
- having a singleton pregnancy above 37th gestational week
- normal live vaginal delivery with cephalic presentation
- being in active labor
Who cannot join
- Fetal demise
- multiple pregnancy
- known coagulation disorder
- presentation anomalies
- placental pathology
- liver disease
Show all 11Show fewer
- thrombocytopenia
- hypertension or being currently on anticoagulants
- having a cesarean section, operative delivery or deep vaginal tear
- chorioamnionitis
- developing HELLP syndrome (hemolysis, elevated liver enzymes, and low platelet count) or DIC (disseminated intravascular coagulation) before delivery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Etlik Zübeyde Hanım Women's Health Teaching and Research Hospital
Ankara
About this study
To compare the efficacy of the route and timing of oxytocin administration for Active management of third stage of labour (AMTSL).
Read the detailed description
Our objective is to determine the most efficient route and timing of oxytocin administration by measuring the duration of third stage of labour, quantitative blood during the first hour after delivery and comparing haemoglobin and haematocrit changes and the need for additional interventions in patients who had either a spontaneous labour or received labour augmentation with oxytocin.
- Conditions
- Postpartum Bleeding
- Being tested
- intravenous & intramuscular oxytocin, after delivery of the fetus & when anterior shoulder seen
- Keywords
- Oxytocin, Active Management of Third Stage of Labour
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravenous & intramuscular oxytocinDrug
Also called Postuitrin
intravenous or intramuscular 10 iu oxytocin
after delivery of the fetus & when anterior shoulder seenProcedure or surgery
oxytocin 10 iu after the delivery of the fetus or when the anterior shoulder was seen after the fetal head was delivered
| Study group | Role | What they receive |
|---|---|---|
| intravenous & intramuscular oxytocin | Experimental | intravenous or intramuscular 10 iu oxytocin Receives: Procedure: after delivery of the fetus & when anterior shoulder seen |
| after delivery & when anterior shoulder seen | Active comparator | oxytocin 10 iu after the delivery of the fetus or when the anterior shoulder was seen after the fetal head was delivered Receives: Drug: intravenous & intramuscular oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
postpartum bleeding in the third stage of labour
Measured: participants will be followed for the duration of hospital stay, an expected average of 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2013 (estimated)
- Study startJan 2010
- Primary completionOct 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postpartum BleedingStudies 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
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Etlik Zubeyde Hanim Womens' Health and Teaching Hospital
- Responsible party
- Principal investigator, SEZİN ERTURK AKSAKAL, Etlik Zubeyde Hanim Womens' Health and Teaching Hospital
- Investigators
- Berna DILBAZ, Assoc. Prof., Study director, Etlik Zübeyde Hanım Women's Health Teaching and Research Hospital, Obstetrics and Gynecology, Ankara, Turkey ,Emire OGUZ ORHAN, MD, Study chair, Sivas State HospitalSezin ERTURK AKSAKAL, MD, Principal investigator, Etlik Zübeyde Hanım Women's Health Teaching and Research Hospital, Obstetrics and Gynecology, Ankara, TurkeySibel ALTINBAS, Assist. Prof., Study chair, Hacettepe University Kastamonu Medical Faculty, Obstetrics and Gynecology, Ankara, Turkey,Salim ERKAYA, Assoc. Prof., Study chair, Zekai Tahir Burak Maternity and Teaching Hospital, Obstetrics and Gynecology, Ankara, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01954186
- Sponsor's protocol ID
- EtlikWHTH
- Status last verified
- Sep 2013
- First submitted
- 22 Sep 2013
- Last updated
- 1 Oct 2013
- 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 33169839Oguz Orhan E, Dilbaz B, Aksakal SE, Altinbas S, Erkaya S. Prospective randomized trial of oxytocin administration for active management of the third stage of labor. Int J Gynaecol Obstet. 2014 Nov;127(2):175-9. doi: 10.1016/j.ijgo.2014.05.022. Epub 2014 Jul 17.
PubMed 25108586
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- When and How to Administer Oxytocin for Active Management of Third Stage of Labour
- ClinicalTrials.gov ID
- NCT01954186
- Acronym / sponsor ID
- EtlikWHTH
- Conditions
- Postpartum Bleeding
- Keywords
- Oxytocin, Active Management of Third Stage of Labour
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Etlik Zubeyde Hanim Womens' Health and Teaching Hospital
- Study start
- Jan 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 1 Oct 2013 (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.
To compare the efficacy of the route and timing of oxytocin administration for Active management of third stage of labour (AMTSL).
Detailed description
Our objective is to determine the most efficient route and timing of oxytocin administration by measuring the duration of third stage of labour, quantitative blood during the first hour after delivery and comparing haemoglobin and haematocrit changes and the need for additional interventions in patients who had either a spontaneous labour or received labour augmentation with oxytocin.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intravenous & intramuscular oxytocin | Experimental | Procedure: after delivery of the fetus & when anterior shoulder seenintravenous or intramuscular 10 iu oxytocin |
| after delivery & when anterior shoulder seen | Active comparator | Drug: intravenous & intramuscular oxytocinoxytocin 10 iu after the delivery of the fetus or when the anterior shoulder was seen after the fetal head was delivered |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- having a singleton pregnancy above 37th gestational week
- normal live vaginal delivery with cephalic presentation
- being in active labor
Key exclusion criteria (11 listed)
- Fetal demise
- multiple pregnancy
- known coagulation disorder
- presentation anomalies
- placental pathology
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 |
|---|---|---|
| intravenous & intramuscular oxytocinAlso: Postuitrinintravenous or intramuscular 10 iu oxytocin | Drug | after delivery & when anterior shoulder seen |
| after delivery of the fetus & when anterior shoulder seenoxytocin 10 iu after the delivery of the fetus or when the anterior shoulder was seen after the fetal head was delivered | Procedure or surgery | intravenous & intramuscular oxytocin |
Primary outcome
postpartum bleeding in the third stage of labour
Time frame: participants will be followed for the duration of hospital stay, an expected average of 48 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 1 Oct 2013.
- 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.
- Derived from this study: PubMed 25108586Oguz Orhan E, Dilbaz B, Aksakal SE, Altinbas S, Erkaya S. Prospective randomized trial of oxytocin administration for active management of the third stage of labor. Int J Gynaecol Obstet. 2014 Nov;127(2):175-9. doi: 10.1016/j.ijgo.2014.05.022. Epub 2014 Jul 17.
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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.
Berna DILBAZ, Assoc. Prof. study director
Etlik Zübeyde Hanım Women's Health Teaching and Research Hospital, Obstetrics and Gynecology, Ankara, Turkey ,
Emire OGUZ ORHAN, MD study chair
Sivas State Hospital
Sezin ERTURK AKSAKAL, MD principal investigator
Etlik Zübeyde Hanım Women's Health Teaching and Research Hospital, Obstetrics and Gynecology, Ankara, Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intravenous & intramuscular oxytocin and after delivery of the fetus & when anterior shoulder seen in people with Postpartum Bleeding, run by Etlik Zubeyde Hanim Womens' Health and Teaching Hospital 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 3 inclusion and 11 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 1 Oct 2013. 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?
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?
postpartum bleeding in the third stage of labour (time frame: participants will be followed for the duration of hospital stay, an expected average of 48 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 NCT01954186, which also lists 2 linked publications.
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 1 Oct 2013.