Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06030479
Other study ID # MS-469-2023
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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 …. )

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT04579172 - Conservative Management of Morbidly Adherent Anterior Situated Placenta N/A
Completed NCT04593303 - Internal Iliac Artery Ligation During Management of Placenta Accreta Spectrum N/A
Recruiting NCT03638024 - Cell-free Fetal DNA Concentration in Cases of Abnormal Placental Invasion .
Not yet recruiting NCT06100640 - Paracervical Pouch in Placenta Accreta Spectrum
Completed NCT05979181 - Peripartum Cesarean Hysterectomy for Placenta Percreta
Recruiting NCT04609527 - Management of Placenta Accreta Spectrum Phase 2/Phase 3
Recruiting NCT06185894 - Single-step Placenta Accreta Resective Technique Tourniqueted vs Absence, Conservative Uterine Surgery N/A
Completed NCT04573452 - Galectin-3 and Placenta Accreta
Not yet recruiting NCT03273569 - PDIUC Protocol for Placental Accreta N/A
Completed NCT03707132 - Tourniquet Reduces Blood Loss in Postpartum Hemorrhage During Hysterectomy for Placenta Accreta
Not yet recruiting NCT05104177 - Effectivness of Conservative Techniques in Management of PAS
Completed NCT02806024 - Perioperative Administration of Tranexamic Acid for Placenta Previa and Accreta Study Phase 4
Active, not recruiting NCT02784886 - Cell-free Fetal DNA Circulating in the Maternal Plasma as a Marker for Morbidly Adherent Placenta N/A
Recruiting NCT05070689 - Placenta Accreta Spectrum Disorders: A. Chohan Continuous Squeezing Suture (ACCSS) N/A
Completed NCT05813743 - Detection of Urinary Bladder Wall Involvement in Abnormally Invasive Placenta (AIP) by 3D Ultrasonography N/A
Withdrawn NCT04003428 - Feasibility of HIFU for Management of Placenta Accreta (HIFU-ACCRETA) N/A
Completed NCT04161521 - Conservative Surgical Novel Technique of Placenta Accreta in Menoufia University Hospital N/A
Recruiting NCT05139498 - Conservative Management for PAS Pilot N/A
Not yet recruiting NCT03530475 - Diagnostic Accuracy of Doppler Ultrasound and Role of Uterine Artery Doppler N/A
Recruiting NCT05922397 - Placenta Accreta Spectrum Topographic Classification