Uterine Preservation With Acar's Atony Suture for Postpartum Uterine Hemorrhage

Postpartum Hemorrhage Clinical Trial

Official title:

Uterine Preservation With Acar's Atony Suture for Postpartum Uterine Atony

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06353074
• Other study ID #: 1335cemre.
• Status: Completed
• Start date: January 1, 2021
• Est. completion date: November 30, 2023

Study information

• Verified date: April 2024
• Source: Necmettin Erbakan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: November 30, 2023
• Est. primary completion date: November 30, 2023
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• women without systemic disease

Exclusion Criteria:

• cardiac disease
• rheumatological disease

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Hemorrhage
• Uterine Atony With Hemorrhage
• Uterine Inertia

Locations

Country	Name	City	State
Turkey	Cemre Alan	Konya

Sponsors (1)

Lead Sponsor	Collaborator
Necmettin Erbakan University

Country where clinical trial is conducted

Turkey, 

References & Publications (13)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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