NCT02255903

Brief Summary

The aim of this study is to assess the values of MCA PI / UA PI and MCA RI / UA RI ratios and amniotic fluid volume in predicting the adverse perinatal fetal outcome in uncomplicated postdate pregnancy

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 3, 2014

Completed
7.3 years until next milestone

Study Start

First participant enrolled

February 1, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

February 14, 2022

Status Verified

January 1, 2022

Enrollment Period

1.2 years

First QC Date

September 26, 2014

Last Update Submit

January 30, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Adverse pregnancy outcome

    at time of delivery

Study Arms (2)

Group 1(Control Group):

ultrasound and Doppler examination: of 100 pregnant females with gestational age 37-40 weeks.

Other: ultrasound and Doppler examination

Group 2 (post date Group)

ultrasound and Doppler examination:will be done for 100 pregnant females with gestational age 41 weeks or more

Other: ultrasound and Doppler examination

Interventions

ultrasound and Doppler examination: Trans-abdominal ultrasound examination will be peformed to all patienst while women in a slightly tilted position with the head of the bed raised 30 degrees and with a small pillow under the right lion

Group 1(Control Group):Group 2 (post date Group)

Eligibility Criteria

Age19 Years - 48 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Two hundred pregnant women will be recruited from outpatient clinic. Starting from February 2022. An informed consent will be obtained from the patients . The patients will be subdivided into two groups: Group 1(Control Group):consist of 100 pregnant females with gestational age 37-40 weeks. Group 2 (post date Group):consist of 100 pregnant females with gestational age 41 weeks or more.

You may qualify if:

  • Singleton, viable fetus in the vertex presentation
  • History of regular menstrual cycles
  • Gestational age calculated from the first day of last menstryal period or by first-trimester or second-trimester (before 20 weeks) ultrasound examination
  • No obstetric or medical complications of pregnancy apart from post-date pregnancy

You may not qualify if:

  • Patients unsure of their dates
  • Medical disorders with pregnancy as (hypertension, diabetes mellitus or Rh isoimmunization)
  • Prelabor rupture of membranes
  • Polyhydramnios
  • Women with multiple pregnancy
  • Congenital fetal anomalies
  • Antepartum hemorrhage
  • Previus cesarean section
  • Fetal malpresentation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AFHSR

Khamis Mushait, Afhsa, 10018, Saudi Arabia

RECRUITING

MeSH Terms

Conditions

Pregnancy, Prolonged

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • khalid ibrahim, MD

    Armed Forces Hospitals, Southern Region, Saudi Arabia

    STUDY CHAIR
  • KHALID IBRAHIM, MD

    Armed Forces Hospitals, Southern Region, Saudi Arabia

    STUDY DIRECTOR

Central Study Contacts

KHALID IBRAHIM, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer and consultant of oblgyne

Study Record Dates

First Submitted

September 26, 2014

First Posted

October 3, 2014

Study Start

February 1, 2022

Primary Completion

May 1, 2023

Study Completion

August 1, 2023

Last Updated

February 14, 2022

Record last verified: 2022-01

Locations