Role of Uterotonics in Reducing Intraoperative Blood Loss in Patients With PASD Undergoing Cesarean Hysterectomy

NCT06493968 | Recruiting

• 1 other identifier: Uterotonics in PASD
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives: To evaluate the effect of oxytocin in reducing intraoperative blood loss in patients with PAS disorders planned for cesarean hysterectomy.

Conditions

Placenta Accreta Spectrum

Outcome Measures

Primary Outcomes (1)

• Intraoperative blood loss

  amount of intraoperative blood loss in patients with PAS disorders undergoing cesarean hysterectomy

  during operation

Secondary Outcomes (1)

• operative time

  during operation

Study Arms (2)

Group (A)

EXPERIMENTAL

Patients will be given uterotonics

Drug: oxytocin

Group (B)

PLACEBO COMPARATOR

Patients will not be given uterotonics

Other: placebo

Interventions

oxytocin DRUG

Uterotonics will be given in the form of an IV bolus of 10 units of oxytocin immediately with the uterine incision

Group (A)

placebo OTHER

IV bolus of normal saline immediately with the uterine incision

Group (B)

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnancy of singleton living fetus
• Previous one or more cesarean sections
• Gestational age: \> 32 weeks
• The following ultrasound markers such as "loss of clear retroplacental translucency", "myometrial thinning", "abnormal lacunae", "irregular bladder wall", "utero-vesicalhypervascularity".
• Preoperative hemoglobin more than 10 gm/dl
• Cases with PAS that will undergoing CS Hysterectomy

You may not qualify if:

• Maternal medical disorders e.g.: coagulation defects, cardiac diseases etc.….
• Any known or reported hypersensitivity to the used medication.
• All cases with spontaneous placental separation at laparotomy.
• All patients undergoing conservative management of PAS.
• All cases which necessitate emergency termination.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Placenta Accreta

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Placenta Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Central Study Contacts

Abdalla Mousa

CONTACT

+201277664430; Dr_abdallamousa@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of obgyn Cairo university

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: July 10, 2024
• Study Start: July 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: July 10, 2024

Record last verified: 2024-07

Locations

EG (1)