Clinical trial NCT06353074: Uterine Preservation With Acar's Atony Suture for Postpartum Uterine Hemorrhage
Official title: Uterine Preservation With Acar's Atony Suture for Postpartum Uterine Atony
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Uterine Atony With Hemorrhage
Postpartum Hemorrhage
Keywords: Cesarean section
compression suture
postpartum hemorrhage
Lead sponsor: Necmettin Erbakan University
Sponsor class: OTHER
First posted: 2024-04-08
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women admitted to the university hospital for delivery and women referred to the university hospital with uterine atony diagnosis

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* women without systemic disease

Exclusion Criteria:

* cardiac disease
* rheumatological disease

Primary outcomes:
measure: Postpartum hysterectomy and/or intensive care unit need ratio
timeFrame: Since first operation to discharge from hospital assessed up to 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Cemre Alan
Study officials:
affiliation: Necmettin Erbakan University
name: Ali Acar, Clinic Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.