Uterine Cavity and Blood Flow After Conservative Management of Placenta Previa/Accreta

NCT02878187 | Completed DMC

• 1 other identifier: PP
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Bleeding is the most significant cause of maternal death worldwide with more than half of those occurring within the first day of delivery. About 10.5% (some estimate as high at 12-17%) of live births world-wide, or about 14 million births, are complicated by postpartum hemorrhage; a woman dies every 4 minutes from postpartum hemorrhage. Uterine atony and placenta accreta are the two leading causes of postpartum hysterectomies with up to 64% of Cesarean hysterectomies done for abnormally adherent placentation

Conditions

Improving Quality of Life

Outcome Measures

Primary Outcomes (1)

• The mean difference in the uterine arteries diameters in both groups

  3 months

Study Arms (2)

placenta previa

all women managed by conservative surgical techniques during cesarean section after intraoperative hemorrhage due to placenta previa/accreta

Device: Doppler

healthy controls

women delivered by Cesarean for any other indication with no intraoperative hemorrhage or any additional surgical techniques performed during Cesarean

Device: Doppler

Interventions

Doppler DEVICE

Color Doppler ultrasound will be used to demonstrate the main ascending branches of left and right uterine arteries as they cross over the hypogastric vessels just before they enter the uterus at the uterine-cervical junction. The high pass filter was set at 125 Hz and the uterine artery will be obtained immediately after the crossing of the hypogastric artery. The sample volume will be placed on the artery with an angle of about 0°. After detection of blood flow and visu¬alization of the waveform of the uterine artery, five blood flow indices will be automatically cal¬culated: The pulsatility index The resistance index The peak systolic velocity ; The end-diastolic velocity The time-averaged maximum

healthy controls; placenta previa

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All women delivered by elective/emergency cesarean section due to placenta previa/accreta during the study period will be included in the study.

You may qualify if:

• Women Age 18-40 years
• Gestational age of pregnancy 28-40 weeks
• Diagnosed antenatally as placenta previa/accreta
• Patients who will be managed by conservative surgical techniques for intraoperative hemorrhage
• Women who will accept to participate in the study and are reliable for follow-up

You may not qualify if:

• Patients who will be managed by hysterectomy 2- Patients who will be managed by conservative leaving the placenta in-situ 3- Diabetic or hypertensive women 4- Women who will refuse to participate in the study

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Ahmed Abbas

Assiut, Cairo Governorate, 002, Egypt

Location

MeSH Terms

Interventions

Echocardiography, Doppler

Intervention Hierarchy (Ancestors)

Echocardiography; Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Ultrasonography, Doppler; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• Ahmed Abbas, MD

  Assiut University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: August 22, 2016
• First Posted: August 25, 2016
• Study Start: January 15, 2017
• Primary Completion: December 1, 2019
• Study Completion: May 1, 2020
• Last Updated: May 13, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)