NCT03494582

Brief Summary

This study will compare the vaginal versus the abdominal approach for the management of uterine prolapse

Trial Health

87
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

April 1, 2017

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 11, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

December 3, 2018

Status Verified

November 1, 2018

Enrollment Period

1.5 years

First QC Date

March 29, 2018

Last Update Submit

November 30, 2018

Conditions

Uterine Prolapse

Outcome Measures

Primary Outcomes (1)

  • Pelvic organ prolapse quantification system

    compare Pelvic organ prolapse quantification system between groups

    3 month

Secondary Outcomes (2)

  • Perioperative data

    1 day

  • operative details

    1 day

Study Arms (2)

Sacral Hysteropexy

EXPERIMENTAL

Abdominal approach for uterine suspension

Procedure: Sacral Hysteropexy

sacrospinous Hysteropexy

EXPERIMENTAL

Transvaginal approach for uterine suspension

Procedure: sacrospinous Hysteropexy

Interventions

Sacral HysteropexyPROCEDURE

Abdominal approach for uterine suspension

Sacral Hysteropexy
sacrospinous HysteropexyPROCEDURE

Transvaginal approach for uterine suspension

sacrospinous Hysteropexy

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Uterine Prolapse

You may not qualify if:

  • Previous prolapse surgery Hereditary Connective tissue disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urogynecology Unit

Cairo, Egypt

Location

MeSH Terms

Conditions

Uterine Prolapse

Condition Hierarchy (Ancestors)

Uterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesPelvic Organ ProlapseProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Hamdy HA Ahmed, MD

    Ain Shams University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Fellow of OBS/GYN

Study Record Dates

First Submitted

March 29, 2018

First Posted

April 11, 2018

Study Start

April 1, 2017

Primary Completion

October 1, 2018

Study Completion

December 1, 2018

Last Updated

December 3, 2018

Record last verified: 2018-11

Locations

EG(1)