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NCT01198691 · ClinicalTrials.gov registry record · Phase 2

A Comparison of Metallic Staples Versus Absorbable Staples After a Cesarean Section (C-Section)

A Phase 2 study of Cesarean Section, sponsored by TriHealth.

Completed
Registry status
Phase 2
Development phase
100
Enrollment target
1
Study location

NCT01198691: Completed Phase 2 study of Cesarean Section, sponsored by TriHealth.

NCT01198691 is a Phase 2 study of Cesarean Section that has completed, run by TriHealth. The registered enrollment target is 100 participants, below the 163-participant average among 14 other Cesarean Section trials with a reported enrollment target (39% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01198691, a Phase 2 study of Cesarean Section, has completed, sponsored by TriHealth.

COMPLETED
Registry status
Phase 2
Development phase
100 participants
Enrollment target
1
Study location

Study Summary

The purpose of the study is to compare post operative pain, cost effectiveness, speed of closure and patient satisfaction of Pfannenstiel incisions closed with metallic staples versus absorbable staples (Insorb) after Cesarean Delivery.

Primary Outcome

Post operative pain at post operative day #1 will be measured using the Visual Analogue Scale (VAS). The scale has a minimum score of 0 representing no pain and a maximum score of 10 representing the worst possible pain.

Conditions Studied

Interventions

  • DEVICE Insorb absorbable staples
  • DEVICE Insorb

Study Locations (1)

Ohio

  • Good Samaritan Hospital - Cincinnati

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2010-07
Est. Completion 2011-05
Phase Phase 2
TriHealth

81 total trials

What the finished NCT01198691 record still lists

NCT01198691 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 163-participant average among 14 other Cesarean Section trials with a reported enrollment target (39% lower).

The record links to 1 condition, with Cesarean Section appearing as the primary indexed condition, and to 2 interventions - of which Insorb absorbable staples is the first listed.

NCT01198691 reports a single indexed study location in Ohio.

Frequently Asked Questions

What is clinical trial NCT01198691 about?

NCT01198691 is a clinical study titled "A Comparison of Metallic Staples Versus Absorbable Staples After a Cesarean Section (C-Section)". The purpose of the study is to compare post operative pain, cost effectiveness, speed of closure and patient satisfaction of Pfannenstiel incisions closed with metallic staples versus absorbable staples (Insorb) after Cesarean Delivery.

What is the current status of trial NCT01198691?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2010-07. Estimated completion is 2011-05.

What conditions does trial NCT01198691 study?

This clinical trial studies the following conditions: Cesarean Section.

What interventions are being tested in trial NCT01198691?

The interventions under investigation include: Insorb absorbable staples (DEVICE), Insorb (DEVICE).

Who is sponsoring clinical trial NCT01198691?

This trial is sponsored by TriHealth, which has 81 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01198691 being conducted?

This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Cesarean Section

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01198691's enrollment target sits among peer trials

100 8th of 14 higher than 6 of 14 other Cesarean Section trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Cesarean Section trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01198691, the US trial registry maintained by the National Library of Medicine. NCT01198691 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.