the Efficacy and Safety of the 3-steps Conservative Approach in the Management of Placenta Accreta Spectrum (a Novel Technique)

NCT05191316 | Unknown

• 1 other identifier: MEMAbdullah
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Placenta accrete spectrum (PAS) is an heterogeneous condition associated with a high maternal morbidity and mortality rate, presenting unique challenges in its diagnosis and management (Morlandoi et al., 2020). PAS describes a clinical situation where the placenta does not detach spontaneously after delivery and cannot be forcibly removed without causing massive and potentially life-threatening bleeding (Jauniaux et al., 2018), in this study we study a novel 3-step technique for surgical conservative management of PAS, in terms of efficacy and safety.

Conditions

Placenta Accreta, Third Trimester

Keywords

surgical conservative management

Outcome Measures

Primary Outcomes (1)

• The efficacy of the 3-steps conservative approach as a novel technique in the management of PAS (measured using the percentage of successful surgical procedure among study population).

  immediate and short term success of the 3-step conservative management technique

  6 weeks

Secondary Outcomes (3)

• estimated blood loss (EBL)

  pre and post operative

• evaluate the rate of complication

  first 24 hrs post operative

• To evaluate the impact of the studied approach on the integrity of uterine cavity

  6 weeks post-operative

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

28 pregnant females diagnosed with focal or partial PAS (placenta accreta/increta/percreta) undergoing 3rd trimester cesarean delivery.

You may qualify if:

• Patients aged 20-40 years old.
• Pregnant females with previous CS deliveries (at least 1) diagnosed with focal or partial PAS (placenta accreta/increta/percreta) candidate for 3rd trimester cesarean delivery.
• Patients wishing uterine conservation to preserve fertility.
• Gestational age: \> 28 weeks confirmed by the 1st day of the LMP or 1st trimesteric ultrasound scan.
• Singleton pregnancies.
• CS under general anesthesia.

You may not qualify if:

• Maternal Anemia (hemoglobin \< 10 g %).
• Chronic or pregnancy induced medical disorders (e.g., cardiac, renal, DM and hepatic diseases).
• Patients presented with severe antepartum hemorrhage.
• Patients requested radical management (caesarean hysterectomy).
• Fetal death (IUFD).
• Fetal anomalies or IUGR (estimated fetal weight below the 5th centile).
• Women attending for emergency CS.
• Patients found to be suffering from placenta previa or total placenta accreta

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr al Ainy university, obstetrics and gynecology department

Cairo, Greater-cairo, 11562, Egypt

Location

MeSH Terms

Conditions

Placenta Accreta

Condition Hierarchy (Ancestors)

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

Study Officials

• Hassan M Gaafar, M.D

  prof. of obstetrics and gynecology (Faculty of medicine -Cairo university)

  PRINCIPAL INVESTIGATOR

• Moataz M El-sherbini, M.D

  prof. of obstetrics and gynecology (Faculty of medicine -Cairo university)

  PRINCIPAL INVESTIGATOR

• Abdalla m Mousa, M.D

  lecturer of obstetrics and gynecology (Faculty of medicine -Cairo university)

  PRINCIPAL INVESTIGATOR

• mostafa E Abdalla, MRCOG

  Senior specialist clinical fellow, gynecology Guy's and St. Thomas's NHS TRUST

  PRINCIPAL INVESTIGATOR

• Mazen m Abdel-rasheed, PhD

  reproductive health research department, national research centre

  PRINCIPAL INVESTIGATOR

• sondos m salem, PhD

  reproductive health research department, national research centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

mohamed E abdullah, M.B.B.S.

CONTACT

0020-100-311-3995; demk.93@gmail.com

Abdalla M Mousa, M.D

CONTACT

0020-127-766-4430; dr_abdallamousa@yahoo.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DR.

Study Record Dates

• First Submitted: December 12, 2021
• First Posted: January 13, 2022
• Study Start: February 15, 2022
• Primary Completion: April 15, 2022
• Study Completion: May 15, 2022
• Last Updated: January 13, 2022

Record last verified: 2021-12

Locations

EG (1)