Ultrasound Study of the Uterine Healing Process After Ces... | NCT00224250

Studies
Ultrasound Study of the Uterine Healing Process After Cesarean Delivery

NCT00224250

Sponsor

Yale University

Status

Completed

Last Update Posted

Mar 13, 2018Actual

Enrollment

Phase

Not Applicable

Conditions

Myometrial Remodeling

Interventions

One- versus two-layer hysterotomy closure

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2005

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 22, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 9, 2018

Last Update Posted Date

Mar 13, 2018Actual

Description Module

Brief Summary

Our hypothesis is that there is no difference in the healing process in those women who have a one- or two-layer uterine closure at the time of cesarean delivery.

Detailed Description

We are recruiting women who are presenting for their first (primary) cesarean delivery. They will be randomized to one- or two-layer myometrial closure at the time of their cesarean delivery. Ultrasound will be used to serially assess the myometrial thickness and myometrial remodeling process.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
One- versus two-layer hysterotomy closure	Procedure

Measure	Description	Time Frame
myometrial thickness

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

singleton gestation
term pregnancy
Kerr uterine incision employed
age > 18

Exclusion Criteria:

Pain score > 4
Current cesarean delivery for non-reassuring fetal status or other emergent situation (eg. maternal bleeding, etc.)
Prior cesarean section
Prior uterine surgery
Hysterotomy other than Kerr (low transverse) incision in current cesarean
Extension of the uterine incision in current cesarean
Multifetal pregnancy
Maternal diabetes mellitus
Maternal connective tissue disorder
Uterine malformation
Uterine myomas (fibroids) in the anterior lower uterine segment
Chorioamnionitis
Non-English speaking

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Benjamin Hamar, MD	Yale University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Yale-New Haven Hospital		New Haven	Connecticut	06511	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17906013	Derived	Hamar BD, Saber SB, Cackovic M, Magloire LK, Pettker CM, Abdel-Razeq SS, Rosenberg VA, Buhimschi IA, Buhimschi CS. Ultrasound evaluation of the uterine scar after cesarean delivery: a randomized controlled trial of one- and two-layer closure. Obstet Gynecol. 2007 Oct;110(4):808-13. doi: 10.1097/01.AOG.0000284628.29796.80.