NCT06353074

Brief Summary

This study is aimed to show effectiveness of a new suture technique to stop postpartum uterine bleeding due to uterine atony.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

December 26, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 8, 2024

Completed
Last Updated

April 8, 2024

Status Verified

April 1, 2024

Enrollment Period

2.9 years

First QC Date

December 26, 2023

Last Update Submit

April 3, 2024

Conditions

Keywords

Cesarean sectioncompression suturepostpartum hemorrhage

Outcome Measures

Primary Outcomes (1)

  • Postpartum hysterectomy and/or intensive care unit need ratio

    The need for hysterectomy or massive transfusion because of unstoppable and mortal bleeding

    Since first operation to discharge from hospital assessed up to 5 days

Study Arms (1)

study group

The patients who had uterine atony during delivery and to whom Acar's atony suture were performed consisted study group.

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Women admitted to the university hospital for delivery and women referred to the university hospital with uterine atony diagnosis

You may qualify if:

  • women without systemic disease

You may not qualify if:

  • cardiac disease
  • rheumatological disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cemre Alan

Konya, Turkey (Türkiye)

Location

Related Publications (14)

  • 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.

    PMID: 25103301BACKGROUND
  • Santos 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.

    PMID: 35987075BACKGROUND
  • Balki 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.

    PMID: 34391025BACKGROUND
  • Bateman 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.

    PMID: 20237047BACKGROUND
  • Al-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.

    PMID: 18715412BACKGROUND
  • Ramler 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.

    PMID: 30667050BACKGROUND
  • Huque 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.

    PMID: 29843627BACKGROUND
  • B-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.

    PMID: 9091019BACKGROUND
  • Nelson 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.

    PMID: 17466689BACKGROUND
  • Baskett 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.

    PMID: 17601898BACKGROUND
  • Acar 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.

    PMID: 29989156BACKGROUND
  • Pereira 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.

    PMID: 16135589BACKGROUND
  • Moleiro 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.

    PMID: 32208130BACKGROUND
  • Acar 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.

MeSH Terms

Conditions

Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersUterine HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ali Acar, Clinic Prof.

    Necmettin Erbakan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Fellow of Gynecologic Oncology

Study Record Dates

First Submitted

December 26, 2023

First Posted

April 8, 2024

Study Start

January 1, 2021

Primary Completion

November 30, 2023

Study Completion

November 30, 2023

Last Updated

April 8, 2024

Record last verified: 2024-04

Locations