CompletedNCT03494582Updated Dec 3, 2018

Abdominal Versus Vaginal Hysteropexy

An interventional study of Sacral Hysteropexy and sacrospinous Hysteropexy in Uterine Prolapse, sponsored by Ain Shams Maternity Hospital. Completed at 1 site in Egypt. Open to female participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2018-12-03.

Sponsored by Ain Shams Maternity Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

Registered 11 months after the study started (first participant enrolled Apr 2017, registered Mar 2018).

Phase: Not applicable
Study type: Interventional
Enrollment: 53
Allocation: Randomized
Ages: 20 Years to 40 Years
Sex: Female

Study summary

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

Read the detailed description

this study compares The unilateral sacrospinous hysteropexy with prolene sutures versus the abdominal sacral hysteropexy using Mersilene suture for the management of uterine prolapse

Conditions studied

Uterine Prolapse

Browse trials for

Uterine Prolapse 111

In context

Uterine Prolapse

111 studies on the registry are indexed under Uterine Prolapse; 18 are open to participants now.

This study's enrollment of 53 is below the median of 70 across 76 interventional studies indexed under Uterine Prolapse.

Browse Uterine Prolapse studies →

Lead sponsor

Ain Shams Maternity Hospital is the lead sponsor of 139 studies on the registry; 8 are open to participants now.

Browse Ain Shams Maternity Hospital studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 20 Years to 40 Years
Sexes eligible: Female
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Uterine Prolapse

Exclusion criteria

Exclusion Criteria:

Previous prolapse surgery Hereditary Connective tissue disorders

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 53 participants (actual)

Study arms

Experimental
Sacral Hysteropexy
Abdominal approach for uterine suspension
Procedure: Sacral Hysteropexy
Experimental
sacrospinous Hysteropexy
Transvaginal approach for uterine suspension
Procedure: sacrospinous Hysteropexy

Interventions

ProcedureSacral Hysteropexy
Abdominal approach for uterine suspension
Proceduresacrospinous Hysteropexy
Transvaginal approach for uterine suspension

What researchers measure

Primary outcomes

Pelvic organ prolapse quantification system
compare Pelvic organ prolapse quantification system between groups
Time frame: 3 month

Secondary outcomes

Perioperative data
operative time
Time frame: 1 day
operative details
blood loss
Time frame: 1 day

Study locations

1 site

Urogynecology Unit
Cairo, Egypt

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2017 to primary completion in Oct 2018, 18 months.

Of 37 interventional studies with no phase under Uterine Prolapse, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 68. This study's 18 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered: Mar 29, 2018
First posted: Apr 11, 2018
StartActual: Apr 1, 2017
Primary completionActual: Oct 1, 2018
CompletionActual: Dec 1, 2018
Last update: Dec 3, 2018

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Dec 3, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03494582
Lead sponsor: Ain Shams Maternity Hospital
Responsible party: Hamdy Ahmed Saaid (Fellow of OBS/GYN, Ain Shams Maternity Hospital) — Principal investigator
First posted: Apr 11, 2018
Start date: Apr 1, 2017
Primary completion: Oct 1, 2018
Completion: Dec 1, 2018
Last update: Dec 3, 2018

Study contacts

Hamdy HA Ahmed, MD

principal investigator · Ain Shams University

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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