Routine Bilateral Uterine Artery Ligation During the Cesarean Delivery of Multiple Gestation

NCT05670886 | Unknown DMC

• 1 other identifier: 23BM73
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

Multiple pregnancy is well defined to be associated with a greater risk of postpartum blood loss . Interventions to control PPH generally stepped from less to more invasive and including compression maneuvers , drugs , and further radical surgeries. Conservative management plans such as medications which cause the uterus to contract, external massage to the uterine body , and bimanual compression are overall used as 1st line interventions. PPH was defined as a cumulative blood loss of 1,000 mL or more, or blood loss that occurred within 24 hours of childbirth and was accompanied by indications or symptoms of hypervolemia. The most frequent cause of PPH, which accounted for roughly 80% of cases, is uterine atony (3). PPH is brought on by hyperexpansion, which impaired uterine myometrial contractility and caused uterine contraction fatigue , PPH were twice as high when pregnant with twins (4).The only effective surgical treatment for blood loss is a hysterectomy, but this is a risky procedure, especially for young women.(5) Due to this, a number of fertility-preserving surgical procedures have been developed, including the B-Lynch technique, internal iliac artery ligation, and uterine artery ligation (UAL) One of the most widely used surgical methods for preserving fertility is UAL. It is simple to carry out and works well to control PPH. Additionally, it permits patients to have more children in the future and is generally safe. Additionally, it has a success rate of above 90%. Concerns have been raised about its effect on women who want to become pregnant in the future regarding their ovarian reserve. The accepted practice of medicine worldwide is the prophylactic use of uterotonics. A synthetic oxytocin analogue with a lengthy half-life, carbetocin also stimulates uterine contractions . One benefit of carbetocin over oxytocin is that it is more heat-stable, which is of greater importance to low resource settings . Studies compare the effectiveness of carbetocin and oxytocin in preventing PPH and find that carbetocin is equally effective or even more effective.

Conditions

Postpartum Hemorrhage

Keywords

PPH - uterine artery ligation - carbetocin - multiple gesation

Outcome Measures

Primary Outcomes (1)

• mean Blood loss after placental separation

  by using weight of soaked towels (weight of soaked towel - weight of dry towel) and amount of blood in suction set

  30 minutes

Secondary Outcomes (2)

• Number of Participants with postpartum hemorrhage

  12 hours

• The number of participant needed for blood transfusion

  24 hours

Study Arms (2)

uterine artery ligation + carbetocin

EXPERIMENTAL

Group (A) , study group (N=55) : patients with multiple pregnancy undergoing cesarean section underwent bilateral uterine artery ligation and received carbetocin.

Procedure: uterine artery ligation

carbetocin only

ACTIVE COMPARATOR

Group (B ) , control group (N=55) : patients with twin pregnancy undergoing cesarean section received carbetocin only.

Procedure: uterine artery ligation

Interventions

uterine artery ligation PROCEDURE

The peritoneum over the vesico-uterine pouch already being incised horizontally, the peritoneum over the uterine isthmus and cervix was dissected downwards, and this dissection was then extended laterally Lower uterine incision was done followed by fetal extraction and placental delivery . bilateral uterine artery ligation were done 2cm below the uterine incision.

Also known as: carbetocin

carbetocin only; uterine artery ligation + carbetocin

Eligibility Criteria

• Age: 18 Years - 42 Years
• Gender Eligibility Details: pregnant females with multiple gestations
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• women undergoing cesarean section
• multiple pregnancy

You may not qualify if:

• Placenta previa.
• Ante-partum hemorrhage.
• patient refuse to participate

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Alainy outpatient infertility clinic

Cairo, Egypt

RECRUITING

Related Publications (4)

• Committee on Practice Bulletins-Obstetrics. Practice Bulletin No. 183: Postpartum Hemorrhage. Obstet Gynecol. 2017 Oct;130(4):e168-e186. doi: 10.1097/AOG.0000000000002351.

  PMID: 28937571 BACKGROUND

• Santana DS, Cecatti JG, Surita FG, Silveira C, Costa ML, Souza JP, Mazhar SB, Jayaratne K, Qureshi Z, Sousa MH, Vogel JP; WHO Multicountry Survey on Maternal and Newborn Health Research Network. Twin Pregnancy and Severe Maternal Outcomes: The World Health Organization Multicountry Survey on Maternal and Newborn Health. Obstet Gynecol. 2016 Apr;127(4):631-641. doi: 10.1097/AOG.0000000000001338.

  PMID: 26959199 BACKGROUND

• Gallos ID, Williams HM, Price MJ, Merriel A, Gee H, Lissauer D, Moorthy V, Tobias A, Deeks JJ, Widmer M, Tuncalp O, Gulmezoglu AM, Hofmeyr GJ, Coomarasamy A. Uterotonic agents for preventing postpartum haemorrhage: a network meta-analysis. Cochrane Database Syst Rev. 2018 Apr 25;4(4):CD011689. doi: 10.1002/14651858.CD011689.pub2.

  PMID: 29693726 BACKGROUND

• Tulandi T, Sammour A, Valenti D, Child TJ, Seti L, Tan SL. Ovarian reserve after uterine artery embolization for leiomyomata. Fertil Steril. 2002 Jul;78(1):197-8. doi: 10.1016/s0015-0282(02)03164-3. No abstract available.

  PMID: 12095516 BACKGROUND

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

carbetocin

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

bassiony dabian, MD

CONTACT

1095195513; bassiony.dabian@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of obstetrics and gynecology

Study Record Dates

• First Submitted: January 2, 2023
• First Posted: January 4, 2023
• Study Start: June 1, 2022
• Primary Completion: January 5, 2023
• Study Completion: January 30, 2023
• Last Updated: January 4, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

EG (1)