Myometrial RemodelingNCT00224250
Ultrasound Study of the Uterine Healing Process After Cesarean Delivery
A study testing One- versus two-layer hysterotomy closure in people with Myometrial Remodeling, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Myometrial Remodeling
- What is being tested?
- One- versus two-layer hysterotomy closure
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- singleton gestation
- term pregnancy
- Kerr uterine incision employed
- age > 18
Who cannot join
- 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
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- Multifetal pregnancy
- Maternal diabetes mellitus
- Maternal connective tissue disorder
- Uterine malformation
- Uterine myomas (fibroids) in the anterior lower uterine segment
- Chorioamnionitis
- Non-English speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale-New Haven Hospital
New Haven, Connecticut, 06511
About this study
Official title: Ultrasonographic Assessment of the Uterine Scarring Process Following Closure of the Uterus in One Versus Two Layer Technique.
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.
Read the 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.
- Conditions
- Myometrial Remodeling
- Being tested
- One- versus two-layer hysterotomy closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One- versus two-layer hysterotomy closureProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
myometrial thickness
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myometrial RemodelingStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Investigators
- Benjamin Hamar, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00224250
- Sponsor's protocol ID
- 27269
- Status last verified
- Mar 2018
- First submitted
- 13 Sep 2005
- Last updated
- 13 Mar 2018
- Results posted
- No
Publications
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.
PubMed 17906013
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonographic Assessment of the Uterine Scarring Process Following Closure of the Uterus in One Versus Two Layer Technique.
- ClinicalTrials.gov ID
- NCT00224250
- Acronym / sponsor ID
- 27269
- Conditions
- Myometrial Remodeling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Jan 2005
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- singleton gestation
- term pregnancy
- Kerr uterine incision employed
- age > 18
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| One- versus two-layer hysterotomy closure | Procedure or surgery | – |
Primary outcome
myometrial thickness
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2018.
- Derived from this study: PubMed 17906013Hamar 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin Hamar, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing One- versus two-layer hysterotomy closure in people with Myometrial Remodeling, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
myometrial thickness. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00224250, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2018.