Uterine Atony With HemorrhageNCT06353074
Uterine Preservation With Acar's Atony Suture for Postpartum Uterine Hemorrhage
An observational study of Uterine Atony With Hemorrhage and Postpartum Hemorrhage, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
Trial summary
This study is aimed to show effectiveness of a new suture technique to stop postpartum uterine bleeding due to uterine atony. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Uterine Atony With Hemorrhage, Postpartum Hemorrhage
- How many people
- 16 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2021to 30 Nov 2023
- 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 45 years
- Women only
- Adult
Study population: Women admitted to the university hospital for delivery and women referred to the university hospital with uterine atony diagnosis
Who may be able to join
- women without systemic disease
Who cannot join
- cardiac disease
- rheumatological disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Uterine Preservation With Acar's Atony Suture for Postpartum Uterine Atony
This study is aimed to show effectiveness of a new suture technique to stop postpartum uterine bleeding due to uterine atony.
Read the detailed description
A retrospective study of all women received Acar's uterine compressive atony suture between January 2021-November 2023 at a single tertiary hospital with approximately 4000 deliveries per year, was performed. The local protocol for PPH due to uterine atony is uterine manual compression, 20 IU of intravenous oxytocin in 500 cc of normal saline at 500 cc/h; 800 µg of misoprostol inserted per rectal. If additional treatment is needed, carbetocin 100mcg in 100 cc of normal saline or tranexamic acid in different posologies are used.
If uterine atony persists, intrauterine balloon tamponade or uterine compressive sutures were applied at the discretion of the physician and according to mode of delivery. When uterine compressive suture was performed, original Acar's atony suture was applied.
- Keywords
- Cesarean section, compression suture, 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.
| Study group | Role | What they receive |
|---|---|---|
| study group | The patients who had uterine atony during delivery and to whom Acar's atony suture were performed consisted study group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postpartum hysterectomy and/or intensive care unit need ratio
The need for hysterectomy or massive transfusion because of unstoppable and mortal bleeding
Measured: Since first operation to discharge from hospital assessed up to 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start1 Jan 2021
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Uterine Atony With HemorrhageStudies of the same condition, open and under way.
- More trials run by Necmettin Erbakan UniversityThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cemre Alan, Necmettin Erbakan University
- Investigators
- Ali Acar, Clinic Prof., Principal investigator, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06353074
- Sponsor's protocol ID
- 1335cemre.
- Status last verified
- Apr 2024
- First submitted
- 26 Dec 2023
- Last updated
- 8 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not yet known if there will be a plan to make IPD available. Because the investigators want to see long term results first and larger sample sizes.
Publications
Say L, Chou D, Gemmill A, Tuncalp O, Moller AB, Daniels J, Gulmezoglu AM, Temmerman M, Alkema L. Global causes of maternal death: a WHO systematic analysis. Lancet Glob Health. 2014 Jun;2(6):e323-33. doi: 10.1016/S2214-109X(14)70227-X. Epub 2014 May 5.
PubMed 25103301Santos RR, Martins I, Clode N, Santo S. Uterine preservation with Alcides-Pereira's compressive sutures for postpartum uterine atony. Eur J Obstet Gynecol Reprod Biol. 2022 Oct;277:27-31. doi: 10.1016/j.ejogrb.2022.08.008. Epub 2022 Aug 12.
PubMed 35987075Balki M, Wong CA. Refractory uterine atony: still a problem after all these years. Int J Obstet Anesth. 2021 Nov;48:103207. doi: 10.1016/j.ijoa.2021.103207. Epub 2021 Jul 21.
PubMed 34391025Bateman BT, Berman MF, Riley LE, Leffert LR. The epidemiology of postpartum hemorrhage in a large, nationwide sample of deliveries. Anesth Analg. 2010 May 1;110(5):1368-73. doi: 10.1213/ANE.0b013e3181d74898. Epub 2010 Mar 17.
PubMed 20237047Al-Zirqi I, Vangen S, Forsen L, Stray-Pedersen B. Prevalence and risk factors of severe obstetric haemorrhage. BJOG. 2008 Sep;115(10):1265-72. doi: 10.1111/j.1471-0528.2008.01859.x.
PubMed 18715412Ramler PI, van den Akker T, Henriquez DDCA, Zwart JJ, van Roosmalen J, van Lith JMM, van der Bom JG; TeMpOH-1 study group. Women receiving massive transfusion due to postpartum hemorrhage: A comparison over time between two nationwide cohort studies. Acta Obstet Gynecol Scand. 2019 Jun;98(6):795-804. doi: 10.1111/aogs.13542. Epub 2019 Feb 11.
PubMed 30667050Huque S, Roberts I, Fawole B, Chaudhri R, Arulkumaran S, Shakur-Still H. Risk factors for peripartum hysterectomy among women with postpartum haemorrhage: analysis of data from the WOMAN trial. BMC Pregnancy Childbirth. 2018 May 29;18(1):186. doi: 10.1186/s12884-018-1829-7.
PubMed 29843627B-Lynch C, Coker A, Lawal AH, Abu J, Cowen MJ. The B-Lynch surgical technique for the control of massive postpartum haemorrhage: an alternative to hysterectomy? Five cases reported. Br J Obstet Gynaecol. 1997 Mar;104(3):372-5. doi: 10.1111/j.1471-0528.1997.tb11471.x.
PubMed 9091019Nelson WL, O'Brien JM. The uterine sandwich for persistent uterine atony: combining the B-Lynch compression suture and an intrauterine Bakri balloon. Am J Obstet Gynecol. 2007 May;196(5):e9-10. doi: 10.1016/j.ajog.2006.10.887.
PubMed 17466689Baskett TF. Uterine compression sutures for postpartum hemorrhage: efficacy, morbidity, and subsequent pregnancy. Obstet Gynecol. 2007 Jul;110(1):68-71. doi: 10.1097/01.AOG.0000267499.40531.a4.
PubMed 17601898Acar A, Ercan F, Pekin A, Elci Atilgan A, Sayal HB, Balci O, Gorkemli H. Conservative management of placental invasion anomalies with an intracavitary suture technique. Int J Gynaecol Obstet. 2018 Nov;143(2):184-190. doi: 10.1002/ijgo.12593. Epub 2018 Aug 13.
PubMed 29989156Pereira A, Nunes F, Pedroso S, Saraiva J, Retto H, Meirinho M. Compressive uterine sutures to treat postpartum bleeding secondary to uterine atony. Obstet Gynecol. 2005 Sep;106(3):569-72. doi: 10.1097/01.AOG.0000168434.28222.d3.
PubMed 16135589Moleiro ML, Braga J, Machado MJ, Guedes-Martins L. Uterine Compression Sutures in Controlling Postpartum Haemorrhage: A Narrative Review. Acta Med Port. 2022 Jan 3;35(1):51-58. doi: 10.20344/amp.11987. Epub 2019 Oct 7.
PubMed 32208130Acar A, Alan C, Dogru S. A new technique: Acar's atony suture for postpartum uterine hemorrhage. Z Geburtshilfe Neonatol. 2025 Jun;229(3):195-200. doi: 10.1055/a-2441-6846. Epub 2024 Nov 11.
PubMed 39529317
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uterine Preservation With Acar's Atony Suture for Postpartum Uterine Atony
- ClinicalTrials.gov ID
- NCT06353074
- Acronym / sponsor ID
- 1335cemre.
- Keywords
- Cesarean section, compression suture, postpartum hemorrhage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 8 Apr 2024 (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.
This study is aimed to show effectiveness of a new suture technique to stop postpartum uterine bleeding due to uterine atony.
Detailed description
A retrospective study of all women received Acar's uterine compressive atony suture between January 2021-November 2023 at a single tertiary hospital with approximately 4000 deliveries per year, was performed. The local protocol for PPH due to uterine atony is uterine manual compression, 20 IU of intravenous oxytocin in 500 cc of normal saline at 500 cc/h; 800 µg of misoprostol inserted per rectal. If additional treatment is needed, carbetocin 100mcg in 100 cc of normal saline or tranexamic acid in different posologies are used.
If uterine atony persists, intrauterine balloon tamponade or uterine compressive sutures were applied at the discretion of the physician and according to mode of delivery. When uterine compressive suture was performed, original Acar's atony suture was applied.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | – | –The patients who had uterine atony during delivery and to whom Acar's atony suture were performed consisted study group. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Women admitted to the university hospital for delivery and women referred to the university hospital with uterine atony diagnosis
Key inclusion criteria (1 listed)
- women without systemic disease
Key exclusion criteria (2 listed)
- cardiac disease
- rheumatological disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postpartum hysterectomy and/or intensive care unit need ratio
Time frame: Since first operation to discharge from hospital assessed up to 5 days
The need for hysterectomy or massive transfusion because of unstoppable and mortal bleeding
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 8 Apr 2024.
- Background: PubMed 25103301Say L, Chou D, Gemmill A, Tuncalp O, Moller AB, Daniels J, Gulmezoglu AM, Temmerman M, Alkema L. Global causes of maternal death: a WHO systematic analysis. Lancet Glob Health. 2014 Jun;2(6):e323-33. doi: 10.1016/S2214-109X(14)70227-X. Epub 2014 May 5.
- Background: PubMed 35987075Santos RR, Martins I, Clode N, Santo S. Uterine preservation with Alcides-Pereira's compressive sutures for postpartum uterine atony. Eur J Obstet Gynecol Reprod Biol. 2022 Oct;277:27-31. doi: 10.1016/j.ejogrb.2022.08.008. Epub 2022 Aug 12.
- Background: PubMed 34391025Balki M, Wong CA. Refractory uterine atony: still a problem after all these years. Int J Obstet Anesth. 2021 Nov;48:103207. doi: 10.1016/j.ijoa.2021.103207. Epub 2021 Jul 21.
- Background: PubMed 20237047Bateman BT, Berman MF, Riley LE, Leffert LR. The epidemiology of postpartum hemorrhage in a large, nationwide sample of deliveries. Anesth Analg. 2010 May 1;110(5):1368-73. doi: 10.1213/ANE.0b013e3181d74898. Epub 2010 Mar 17.
- Background: PubMed 18715412Al-Zirqi I, Vangen S, Forsen L, Stray-Pedersen B. Prevalence and risk factors of severe obstetric haemorrhage. BJOG. 2008 Sep;115(10):1265-72. doi: 10.1111/j.1471-0528.2008.01859.x.
- Background: PubMed 30667050Ramler PI, van den Akker T, Henriquez DDCA, Zwart JJ, van Roosmalen J, van Lith JMM, van der Bom JG; TeMpOH-1 study group. Women receiving massive transfusion due to postpartum hemorrhage: A comparison over time between two nationwide cohort studies. Acta Obstet Gynecol Scand. 2019 Jun;98(6):795-804. doi: 10.1111/aogs.13542. Epub 2019 Feb 11.
- Background: PubMed 29843627Huque S, Roberts I, Fawole B, Chaudhri R, Arulkumaran S, Shakur-Still H. Risk factors for peripartum hysterectomy among women with postpartum haemorrhage: analysis of data from the WOMAN trial. BMC Pregnancy Childbirth. 2018 May 29;18(1):186. doi: 10.1186/s12884-018-1829-7.
- Background: PubMed 9091019B-Lynch C, Coker A, Lawal AH, Abu J, Cowen MJ. The B-Lynch surgical technique for the control of massive postpartum haemorrhage: an alternative to hysterectomy? Five cases reported. Br J Obstet Gynaecol. 1997 Mar;104(3):372-5. doi: 10.1111/j.1471-0528.1997.tb11471.x.
- Background: PubMed 17466689Nelson WL, O'Brien JM. The uterine sandwich for persistent uterine atony: combining the B-Lynch compression suture and an intrauterine Bakri balloon. Am J Obstet Gynecol. 2007 May;196(5):e9-10. doi: 10.1016/j.ajog.2006.10.887.
- Background: PubMed 17601898Baskett TF. Uterine compression sutures for postpartum hemorrhage: efficacy, morbidity, and subsequent pregnancy. Obstet Gynecol. 2007 Jul;110(1):68-71. doi: 10.1097/01.AOG.0000267499.40531.a4.
- Background: PubMed 29989156Acar A, Ercan F, Pekin A, Elci Atilgan A, Sayal HB, Balci O, Gorkemli H. Conservative management of placental invasion anomalies with an intracavitary suture technique. Int J Gynaecol Obstet. 2018 Nov;143(2):184-190. doi: 10.1002/ijgo.12593. Epub 2018 Aug 13.
- Background: PubMed 16135589Pereira A, Nunes F, Pedroso S, Saraiva J, Retto H, Meirinho M. Compressive uterine sutures to treat postpartum bleeding secondary to uterine atony. Obstet Gynecol. 2005 Sep;106(3):569-72. doi: 10.1097/01.AOG.0000168434.28222.d3.
- Individual participant dataSharing planned: Undecided. It is not yet known if there will be a plan to make IPD available. Because the investigators want to see long term results first and larger sample sizes.
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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.
Ali Acar, Clinic Prof. principal investigator
Necmettin Erbakan University
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 Uterine Atony With Hemorrhage and Postpartum Hemorrhage, run by Necmettin Erbakan University 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 2 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 8 Apr 2024. 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 hysterectomy and/or intensive care unit need ratio (time frame: Since first operation to discharge from hospital assessed up to 5 days). 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 NCT06353074, which also lists 14 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 8 Apr 2024.