Clinical trial NCT06030479: Topical Adrenaline Versus Warm Saline Solution for Minimizing Intraperitoneal Bleeding During Caesarian Delivery for Placenta Previa / Accreta Spectrum ( PAS)
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Placenta Accreta
Placenta Previa
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-09-11
Enrollment: 84
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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).

Eligibility criteria: 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 .... )

Primary outcomes:
measure: control of intra-operative bleeding from surgical field.
timeFrame: 30 minutes after application of topical drug
Secondary outcomes:
measure: Need for hemostatic sutures , uterine artery ligation , internal iliac artery ligation , hysterectomy
timeFrame: if bleeding continued 30 minutes after topical drugs
measure: immediate maternal complications ( postpartum haemorrage , DIC , hysterectomy , maternal mortality , ICU admission , …)
timeFrame: 24 hours after delivery
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Alainy outpatient clinic
Study officials:
References:
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.
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.
citation: Hatton RC. Bismuth subgallate-epinephrine paste in adenotonsillectomies. Ann Pharmacother. 2000 Apr;34(4):522-5. doi: 10.1345/aph.19216.