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

Improving Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02878187
• Other study ID #: PP
• Status: Completed
• Start date: January 15, 2017
• Est. completion date: May 2020

Study information

• Verified date: May 2020
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Description:

No previous studies performed for evaluation of the effect of those procedures on the uterine cavity or uterine blood flow. Most of the studies in the literature evaluated the menstrual and fertility outcome after conservative measures for intraoperative hemorrhage due to placenta previa/accreta were retrospective and depend on the resumption of menses and pregnancy rate

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Women Age 18-40 years

2. Gestational age of pregnancy 28-40 weeks

3. Diagnosed antenatally as placenta previa/accreta

4. Patients who will be managed by conservative surgical techniques for intraoperative hemorrhage

5. Women who will accept to participate in the study and are reliable for follow-up

Exclusion Criteria:

• 1- 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

Related Conditions & MeSH terms

• Improving Quality of Life
• Placenta Previa

Intervention

Device:
• Doppler
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

Locations

Country	Name	City	State
Egypt	Ahmed Abbas	Assiut	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The mean difference in the uterine arteries diameters in both groups		3 months