Postpartum HemorrhageNCT03229304
Prediction of Postpartum Hemorrhage With Uterine Artery Doppler Measurement
An observational study of Postpartum Hemorrhage, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to evaluate the uterine artery doppler just before labour in term low risk pregnancies. And to investigate with this measurement if investigators could foreseen the amount of postpartum hemorrhage looking at decreased in the hematocrit values. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Postpartum Hemorrhage
- How many people
- 800 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2016to 1 Jun 2017
- How long will I take part?
- 9 Months
- Phase
- Observational
- 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
- No healthy volunteers
- Adult
Study population: The pregnant women that is term and have no risk factors for postpartum hemorrhage
Who may be able to join
- singleton term pregnancies
Who cannot join
- polyhydramnios
- Large for gestational age fetuses
- multiple pregnancies
- preterm labour
- chorioamnionitis
- history of atonia or postpartum hemorrhage
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Uterine Artery Doppler Measurement to Predict the Amount of Postpartum Hemorrhage in Low Risk Term Pregnancy
The aim of the study is to evaluate the uterine artery doppler just before labour in term low risk pregnancies. And to investigate with this measurement if investigators could foreseen the amount of postpartum hemorrhage looking at decreased in the hematocrit values.
- Conditions
- Postpartum Hemorrhage
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the uterine artery Pulsatility index in term pregnant women
With ultrasonography uterine artery doppler Pulsatility index (cm/s) will be measure
Measured: 6-8 hour before the delivery
To measure the uterine artery Resistant index (cm/s) in term pregnant women
With ultrasonography uterine artery doppler Resistant index will be measure
Measured: 6-8 hour before the delivery
To measure the uterine artery mean systolic/diastolic volume (cm/s) in term pregnant women
With ultrasonography Uterine artery doppler Mean systolic/diastolic volume (cm/s) ) will be measure
Measured: 6-8 hour before the delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2017
- Study start1 May 2016
- Primary completion1 May 2017
- Study completion1 Jun 2017
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 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (actual)
- Target duration
- 9 Months
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kerem Doga Seckin, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03229304
- Sponsor's protocol ID
- 12341
- Status last verified
- Apr 2017
- First submitted
- 14 Jul 2017
- Last updated
- 25 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kaplanoglu M, Karateke A, Un B, Gunsoy L, Baloglu A. Evaluation of uterine artery recanalization and doppler parameters after bilateral uterine artery ligation in women with postpartum hemorrhage. Int J Clin Exp Med. 2015 May 15;8(5):7823-9. eCollection 2015.
PubMed 26221335Yildirim D, Ozyurek SE, Ekiz A, Eren EC, Hendem DU, Bafali O, Seckin KD. Comparison of active vs. expectant management of the third stage of labor in women with low risk of postpartum hemorrhage: a randomized controlled trial. Ginekol Pol. 2016;87(5):399-404. doi: 10.5603/GP.2016.0015.
PubMed 27304659
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Uterine Artery Doppler Measurement to Predict the Amount of Postpartum Hemorrhage in Low Risk Term Pregnancy
- ClinicalTrials.gov ID
- NCT03229304
- Acronym / sponsor ID
- 12341
- Conditions
- Postpartum Hemorrhage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 1 May 2016 (actual)
- Primary completion
- 1 May 2017 (actual)
- Study completion
- 1 Jun 2017 (actual)
- First posted
- 25 Jul 2017 (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.
The aim of the study is to evaluate the uterine artery doppler just before labour in term low risk pregnancies. And to investigate with this measurement if investigators could foreseen the amount of postpartum hemorrhage looking at decreased in the hematocrit values.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 9 Months
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The pregnant women that is term and have no risk factors for postpartum hemorrhage
Key inclusion criteria (1 listed)
- singleton term pregnancies
Key exclusion criteria (6 listed)
- polyhydramnios
- Large for gestational age fetuses
- multiple pregnancies
- preterm labour
- chorioamnionitis
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 |
|---|---|---|
| Other | – |
Primary outcome
To measure the uterine artery Pulsatility index in term pregnant women
Time frame: 6-8 hour before the delivery
With ultrasonography uterine artery doppler Pulsatility index (cm/s) will be measure
To measure the uterine artery Resistant index (cm/s) in term pregnant women
Time frame: 6-8 hour before the delivery
With ultrasonography uterine artery doppler Resistant index will be measure
To measure the uterine artery mean systolic/diastolic volume (cm/s) in term pregnant women
Time frame: 6-8 hour before the delivery
With ultrasonography Uterine artery doppler Mean systolic/diastolic volume (cm/s) ) will be measure
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 25 Jul 2017.
- Background: PubMed 26221335Kaplanoglu M, Karateke A, Un B, Gunsoy L, Baloglu A. Evaluation of uterine artery recanalization and doppler parameters after bilateral uterine artery ligation in women with postpartum hemorrhage. Int J Clin Exp Med. 2015 May 15;8(5):7823-9. eCollection 2015.
- Background: PubMed 27304659Yildirim D, Ozyurek SE, Ekiz A, Eren EC, Hendem DU, Bafali O, Seckin KD. Comparison of active vs. expectant management of the third stage of labor in women with low risk of postpartum hemorrhage: a randomized controlled trial. Ginekol Pol. 2016;87(5):399-404. doi: 10.5603/GP.2016.0015.
- Individual participant dataSharing planned: No
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.
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?
An observational study of Postpartum Hemorrhage, run by Kanuni Sultan Suleyman 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 1 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 25 Jul 2017. 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?
To measure the uterine artery Pulsatility index in term pregnant women (time frame: 6-8 hour before the delivery). The study lists 3 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 NCT03229304, 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 25 Jul 2017.