Topical Adrenaline Versus Warm Saline Solution for Minimizing Intraperitoneal Bleeding During Caesarian Delivery for Placenta Previa / Accreta Spectrum ( PAS)

Placenta Accreta Clinical Trial

Official title:

Topical Adrenaline Versus Warm Saline Solution for Minimizing Intraperitoneal Bleeding During Caesarian Delivery for Placenta Previa / Accreta Spectrum ( PAS): A Randomized Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06030479
• Other study ID #: MS-469-2023
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: October 25, 2023

Study information

• Verified date: September 2023
• Source: Cairo University
• Contact: bassiony dabian, MD
• Phone: 1095195513
• Email: bassiony.dabian[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Placenta accreta spectrum (PAS), encompassing the terms placenta accreta, increta, and percreta; abnormally invasive placenta; morbidly adherent placenta; and invasive placentation, is a leading cause of life-threatening obstetric haemorrage . Currently, more than 90% of women diagnosed with PAS also have a placenta praevia , and the combination of both conditions leads to high maternal morbidity and mortality due to massive haemorrhage at the time of birth . Maternal mortality of placenta praevia with percreta has been reported to be as high as 7% of cases .

Adrenaline has also been demonstrated to be a reasonable hemostatic agent because of its low cost, low risk, powerful vasoconstrictor, and platelet aggregation. Topical use of adrenaline is an effective and reasonable hemostatic agent in tonsillectomy.

Description:

• Population of study: A total of 84 pregnant patients with placenta previa / Accreta spectrum.

• Study location: Obstetrics and Gynecology Kasr Al-Ainy Hospital , Faculty of Medicine , Cairo University.

This is a randomized controlled trial including a total number of 84 patients representing study group , randomized in 2 equal groups , using computer generated randomization sheet on (Medcalc ®) .

Group A : Topical adrenaline group (n=42)

Group B : Warm saline Group (control) (n=42)

The aim of the study is to evaluate the efficacy of topical adrenaline for decreasing intraperitoneal bleeding during caesarian section for placenta previa/ Accreta spectrum (PAS).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: October 25, 2023
• Est. primary completion date: October 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Age from 18 to 40 years.

• BMI < 35.

• Pregnant patients with placenta previa .

• Placenta accrete spectrum.

• Vitally stable .

Exclusion Criteria:

• Vitally unstable .

• Massive pre- or intra-operative bleeding.

• Medical disorders ( e.g. : hypertension , cardiac …. )

Related Conditions & MeSH terms

• Placenta Accreta
• Placenta Previa

Intervention

Drug:
• Topical adrenaline
Skin is incised midline sub-umbilical incision , bladder dissection will be done , uterus will be incised by vertical upper segment incision , followed by delivery of the baby. Surgical assessment and decision for either conservative management or CS hysterectomy will be done. After completion of surgical procedure , surgical field is observed for major bleeding and patients are subjected to intervention Packing the pelvic surgical field with towels fully saturated with adrenaline 1:10000 solution.
• Warm saline
Skin is incised midline sub-umbilical incision , bladder dissection will be done , uterus will be incised by vertical upper segment incision , followed by delivery of the baby. Surgical assessment and decision for either conservative management or CS hysterectomy will be done. After completion of surgical procedure , surgical field is observed for major bleeding and patients are subjected to intervention Packing the surgical field with towels fully saturated with warm saline solution ( 50 degrees).

Locations

Country	Name	City	State
Egypt	Kasr Alainy outpatient clinic	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

Hatton RC. Bismuth subgallate-epinephrine paste in adenotonsillectomies. Ann Pharmacother. 2000 Apr;34(4):522-5. doi: 10.1345/aph.19216. — View Citation

Jauniaux E, Bhide A, Kennedy A, Woodward P, Hubinont C, Collins S; FIGO Placenta Accreta Diagnosis and Management Expert Consensus Panel. FIGO consensus guidelines on placenta accreta spectrum disorders: Prenatal diagnosis and screening. Int J Gynaecol Obstet. 2018 Mar;140(3):274-280. doi: 10.1002/ijgo.12408. No abstract available. — View Citation

Solheim KN, Esakoff TF, Little SE, Cheng YW, Sparks TN, Caughey AB. The effect of cesarean delivery rates on the future incidence of placenta previa, placenta accreta, and maternal mortality. J Matern Fetal Neonatal Med. 2011 Nov;24(11):1341-6. doi: 10.3109/14767058.2011.553695. Epub 2011 Mar 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	control of intra-operative bleeding from surgical field.	control of intra-operative bleeding from surgical field if bleeding stopped , or minimal oozing , towel are not soaked with blood and improvement of general condition with no hemoglobin drop.	30 minutes after application of topical drug
Secondary	Need for hemostatic sutures , uterine artery ligation , internal iliac artery ligation , hysterectomy	Need for hemostatic sutures , uterine artery ligation , internal iliac artery ligation , hysterectomy	if bleeding continued 30 minutes after topical drugs
Secondary	immediate maternal complications ( postpartum haemorrage , DIC , hysterectomy , maternal mortality , ICU admission , …)	immediate maternal complications ( postpartum haemorrage , DIC , hysterectomy , maternal mortality , ICU admission , …)	24 hours after delivery