NCT06324331

Brief Summary

Assessing the impact of endometrial sparing at double-layer uterine closure as a specific surgical technique in CS to reduce the rate of post-cessarian delivery niche develoment

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
184

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2024

Status
not yet recruiting

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

March 15, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 21, 2024

Completed
11 days until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

March 21, 2024

Status Verified

March 1, 2024

Enrollment Period

1.4 years

First QC Date

March 15, 2024

Last Update Submit

March 15, 2024

Conditions

Cesarean Section ComplicationsCesarean Section Niche

Keywords

Decidual sparing

Outcome Measures

Primary Outcomes (1)

  • Impact of decidual sparing on niche formation

    Assessing incidence of niche formation in EFCT vs routine uterine closure of CS by TVUS

    3-6 months post CS

Secondary Outcomes (1)

  • Impact of uterine closure technique on post CS niche criteria

    3-6 months post CS

Study Arms (2)

Non decidual sparing

EXPERIMENTAL

uterine incision repair including suturing of the endometrium

Procedure: Non decidual sparing

Decidual sparing

EXPERIMENTAL

uterine incision repair without including the endometrium.

Procedure: Decidual sparing

Interventions

Decidual sparingPROCEDURE

Endometrial free uterine closure technique

Decidual sparing
Non decidual sparingPROCEDURE

Routine uterine closure technique including endometrium

Non decidual sparing

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • pregnancy of gestational age ≥ 32wks

You may not qualify if:

  • previous uterine scar

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SCREENING
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

March 15, 2024

First Posted

March 21, 2024

Study Start

April 1, 2024

Primary Completion

September 1, 2025

Study Completion

December 1, 2025

Last Updated

March 21, 2024

Record last verified: 2024-03