Postpartum BleedingNCT02495272
Postpartum Uterotonic Administration
A study testing Oxytocin in people with Postpartum Bleeding, run by Bagcilar Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The investigators are planning to determine the effect of the timing of oxytocin administration on the amount of blood loss, necessity for additional medical or surgical interventions. 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
- Postpartum Bleeding
- What is being tested?
- Oxytocin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jun 2014to Jan 2016
- 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
- Cephalic presentation
- Singleton pregnancy
- Gestational age >35 weeks,
- In active labour.
- Expected fetal birth weight 2500-4500 grams.
Who cannot join
- Acute Fetal Distress
- Conversion to abdominal delivery
- Persistent high blood pressure (>140/90mmHg)
- Placenta Previa
- Ablatio placenta
- Previous C-Section
Show all 14Show fewer
- Uterine scar
- Postpartum hemorrhage in previous pregnancies.
- Hydramnios
- Maternal infection
- Forceps/Vacuum Assisted deliveries
- Abnormal placentation ( Placenta accreta, increta or percreta)
- Coagulation Defects
- Hemoglobin < 8g/dl
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kanuni Sultan Suleyman Teaching and Research Hospital
Istanbul, 34303
Dogukan Yıldırım, MD, +905063284383, dogukanyildirim@yahoo.com
About this study
Official title: The Effect of the Timing of Uterotonic Administration in the Third Stage of Labour on Postpartum Hemorrhage
The investigators are planning to determine the effect of the timing of oxytocin administration on the amount of blood loss, necessity for additional medical or surgical interventions.
Read the detailed description
The investigators are studying the effects of the timing of intramuscular oxytocin administration in the third stage of labour. The investigators are measuring the postpartum blood loss: quantitatively in the postpartum 1st hour and indirectly by the decrease in the hemoglobin-haematocrit levels in the postpartum 24th hour. The investigators are monitoring the length of the third stage of labour, and the need for extra uterotonics and/or surgical interventions.
- Conditions
- Postpartum Bleeding
- Being tested
- Oxytocin
- Keywords
- Postpartum hemorrhage, Third stage of labour, Oxytocin, Uterotonics, 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.
OxytocinDrug
Also called PostuitrinFort Amp I.E.Ulagay
Oxytocin 10IU Administered intramuscularly.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Oxytocin 10IU im was administered after placental delivery Receives: Drug: Oxytocin |
| Study Group | Experimental | Oxytocin 10IU im was administered after the anterior shoulder could be seen. Receives: Drug: Oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postpartum blood loss
Quantitative collection of blood loss.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 24 hour
Postpartum blood loss >500cc
Number of participants whose blood loss is higher than 500cc.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 24 hour
Secondary outcomes (5)
Need for additional uterotonics
Additional uterotonics (Oxytocin 10IU; Cytotec tb Rectal and/or vaginal) were administered if postpartum blood loss >500ml OR uterine atony was observed OR sudden excessive hemorrhage was encountered.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 24 hour
Postpartum transfusion
Measured: Participants will be followed for the duration of hospital stay, an expected average of 24 hour.
Manual removal of the placenta.
Measured: At first hour after delivery of the fetus
Duration of the third stage of labour.
Measured: Participants will be followed for the duration of labor unit stay, an expected average of one hour
Drop in the hemoglobin and hematocrit levels
Measured: At the 24th hour,postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2015 (estimated)
- Study startJun 2014
- Primary completionDec 2015 (estimated)
- Study completionJan 2016 (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 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bagcilar Training and Research Hospital
- Sponsor type
- Other government
- Collaborators
- Kanuni Sultan Suleyman Training and Research Hospital
- Responsible party
- Principal investigator, Eser Sefik Ozyurek, Bagcilar Training and Research Hospital
- Investigators
- Burak Ozkose, MD, Study chair, Kanuni Sultan Suleyman Teaching and Research Hospital, IstanbulDogukan Yildirim, MD, Principal investigator, Kanuni Sultan Suleyman Teaching and Research Hospital, IstanbulEser S Ozyurek, MD, Study chair, Bagcilar Training and Research HospitalBatuhan Ustun, MD, Study chair, Kanuni Sultan Suleyman Teaching and Research Hospital, Istanbul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02495272
- Sponsor's protocol ID
- Kanuni-Bagcilar
- Status last verified
- Jul 2015
- First submitted
- 9 Apr 2015
- Last updated
- 13 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Oguz 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 13 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Timing of Uterotonic Administration in the Third Stage of Labour on Postpartum Hemorrhage
- ClinicalTrials.gov ID
- NCT02495272
- Acronym / sponsor ID
- Kanuni-Bagcilar
- Conditions
- Postpartum Bleeding
- Keywords
- Postpartum hemorrhage, Third stage of labour, Oxytocin, Uterotonics, Active management of third stage of labour
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Bagcilar Training and Research HospitalOther government
- Collaborators
- Kanuni Sultan Suleyman Training and Research Hospital
- Study start
- Jun 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 13 Jul 2015 (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 investigators are planning to determine the effect of the timing of oxytocin administration on the amount of blood loss, necessity for additional medical or surgical interventions.
Detailed description
The investigators are studying the effects of the timing of intramuscular oxytocin administration in the third stage of labour. The investigators are measuring the postpartum blood loss: quantitatively in the postpartum 1st hour and indirectly by the decrease in the hemoglobin-haematocrit levels in the postpartum 24th hour. The investigators are monitoring the length of the third stage of labour, and the need for extra uterotonics and/or surgical interventions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Drug: OxytocinOxytocin 10IU im was administered after placental delivery |
| Study Group | Experimental | Drug: OxytocinOxytocin 10IU im was administered after the anterior shoulder could be seen. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Cephalic presentation
- Singleton pregnancy
- Gestational age >35 weeks,
- In active labour.
- Expected fetal birth weight 2500-4500 grams.
Key exclusion criteria (14 listed)
- Acute Fetal Distress
- Conversion to abdominal delivery
- Persistent high blood pressure (>140/90mmHg)
- Placenta Previa
- Ablatio placenta
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 |
|---|---|---|
| OxytocinAlso: PostuitrinFort Amp I.E.UlagayOxytocin 10IU Administered intramuscularly. | Drug | Control Group, Study Group |
Primary outcome
Postpartum blood loss
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 24 hour
Quantitative collection of blood loss.
Postpartum blood loss >500cc
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 24 hour
Number of participants whose blood loss is higher than 500cc.
5 secondary outcomes
Need for additional uterotonics
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 24 hour
Postpartum transfusion
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 24 hour.
Manual removal of the placenta.
Time frame: At first hour after delivery of the fetus
Duration of the third stage of labour.
Time frame: Participants will be followed for the duration of labor unit stay, an expected average of one hour
Drop in the hemoglobin and hematocrit levels
Time frame: At the 24th hour,postpartum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2015.
- Background: 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.
Burak Ozkose, MD study chair
Kanuni Sultan Suleyman Teaching and Research Hospital, Istanbul
Dogukan Yildirim, MD principal investigator
Kanuni Sultan Suleyman Teaching and Research Hospital, Istanbul
Eser S Ozyurek, MD study chair
Bagcilar Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxytocin in people with Postpartum Bleeding, run by Bagcilar Training and Research 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 5 inclusion and 14 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 13 Jul 2015. 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 Dogukan Yildirim, MD (+905063284383, dogukanyildirim@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postpartum blood loss (time frame: Participants will be followed for the duration of hospital stay, an expected average of 24 hour). 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?
On the ClinicalTrials.gov record for NCT02495272, 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 13 Jul 2015.