Attempted Vaginal Delivery After a Cesarean SectionNCT03298594
A Specific Cervicograph for Women Attempting at Vaginal Delivery After Cesarean Section
A study testing specific cervicograph in people with Attempted Vaginal Delivery After a Cesarean Section, run by University Hospital, Geneva.
Trial summary
The main objective is to evaluate a specific cervicograph (the graph describing the cervical dilation, included in the partograph) for pregnant women with an history of cesarean section, to improve the management of labor for women attempting at a vaginal delivery (VBAC). Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Attempted Vaginal Delivery After a Cesarean Section
- What is being tested?
- specific cervicograph
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- No sites listed yet
- Study dates
- 26 Feb 2013to 11 Oct 2016
- 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 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women in labor, admitted for a VBAC at a gestational age of 37 weeks or more
- Single pregnancy
- Cephalic presentation
Who cannot join
- More than 1 previous cesarean section
- Multiple pregnancies
- Presentations other than cephalic
- History of low vertical uterotomy, classical or inverted T-shaped
- Past history of myomectomy
- Fetal death
- Fetal anomalies
- Placental anomalies
About this study
Official title: A Specific Cervicograph for Women Attempting at Vaginal Delivery After Cesarean Section: is the Management of Labor Improved?
The main objective is to evaluate a specific cervicograph (the graph describing the cervical dilation, included in the partograph) for pregnant women with an history of cesarean section, to improve the management of labor for women attempting at a vaginal delivery (VBAC). Women will be randomly assigned to this specific cervicograph (including an action line 2 hours after the alert line), or to the normal cervicograph (no lines). The primary outcome is appropriate detection of dystocia.
Read the detailed description
Appropriate management of labor is essential to minimize the risk of uterine rupture in case of attempt at vaginal delivery after a cesarean section (VBAC). Dystocia is a known risk factor for uterine rupture during labor in women with previous cesarean section. Some studies have shown that this risk increases after 2 hours at the same cervical dilation during labor. The cervicograph is an important tool to detect dystocia during labor. There is currently no specific cervicograph for pregnant women with a history of cesarean section, and no study evaluated the cervicograph in the monitoring of labor for women with a scarred uterus.
The main objective is to evaluate a specific cervicograph (the graph describing the cervical dilation, included in the partograph) for pregnant women with an history of cesarean section, to improve the management of labor for women attempting at a vaginal delivery (VBAC). Women will be randomly assigned to a specific cervicograph (including an action line 2 hours after the alert line), or to the normal cervicograph (no lines).
The outcomes of this randomized trial are: appropriate detection and management of dystocia; uterine rupture; and success of VBAC.
- Being tested
- specific cervicograph
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
specific cervicographDiagnostic test
Also called usual cervicograph
| Study group | Role | What they receive |
|---|---|---|
| specific cervicograph | Experimental | Specific cervicograph, including an alert line (normal progression of cervical dilation, i.e. 1 cm per hour) and an action line 2 hours after the alert line. This should be completed after the diagnose of active labor Receives: Diagnostic Test: specific cervicograph |
| Usual cervicograph | No intervention | The usual cervicograph in our unit is not having lines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of dystocia during labor in women with past history of cesarean section
Appropriate detection and management of dystocia by identifying women with: no progression of cervical dilation for more than 2 hours during labor; or slow progress, defined as a cervical dilation of less than 2 cm in 4 hours; and immediate decision of cesarean section, to be performed within 30 minutes.
Measured: From inclusion in the study (randomization usually from 2cm) until full cervical dilation.
Secondary outcomes (1)
Uterine rupture during labor in women with past history of cesarean section
Uterine rupture will be defined as a complete separation of the uterine scar that resulted in protrusion of fetal or placental parts in the peritoneal cavity
Measured: From inclusion in the study (randomization usually from 2cm) until delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2017
- Study start26 Feb 2013
- Primary completion11 Oct 2016
- Study completion11 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attempted Vaginal Delivery After a Cesarean SectionStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michel Boulvain, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03298594
- Sponsor's protocol ID
- 12-173 MATPED 12-036
- Status last verified
- Sep 2017
- First submitted
- 26 Sep 2017
- Last updated
- 2 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Specific Cervicograph for Women Attempting at Vaginal Delivery After Cesarean Section: is the Management of Labor Improved?
- ClinicalTrials.gov ID
- NCT03298594
- Acronym / sponsor ID
- 12-173 MATPED 12-036
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- 26 Feb 2013 (actual)
- Primary completion
- 11 Oct 2016 (actual)
- Study completion
- 11 Oct 2016 (actual)
- First posted
- 2 Oct 2017 (actual)
- 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.
The main objective is to evaluate a specific cervicograph (the graph describing the cervical dilation, included in the partograph) for pregnant women with an history of cesarean section, to improve the management of labor for women attempting at a vaginal delivery (VBAC). Women will be randomly assigned to this specific cervicograph (including an action line 2 hours after the alert line), or to the normal cervicograph (no lines). The primary outcome is appropriate detection of dystocia.
Detailed description
Appropriate management of labor is essential to minimize the risk of uterine rupture in case of attempt at vaginal delivery after a cesarean section (VBAC). Dystocia is a known risk factor for uterine rupture during labor in women with previous cesarean section. Some studies have shown that this risk increases after 2 hours at the same cervical dilation during labor. The cervicograph is an important tool to detect dystocia during labor. There is currently no specific cervicograph for pregnant women with a history of cesarean section, and no study evaluated the cervicograph in the monitoring of labor for women with a scarred uterus.
The main objective is to evaluate a specific cervicograph (the graph describing the cervical dilation, included in the partograph) for pregnant women with an history of cesarean section, to improve the management of labor for women attempting at a vaginal delivery (VBAC). Women will be randomly assigned to a specific cervicograph (including an action line 2 hours after the alert line), or to the normal cervicograph (no lines).
The outcomes of this randomized trial are: appropriate detection and management of dystocia; uterine rupture; and success of VBAC.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| specific cervicograph | Experimental | Diagnostic Test: specific cervicographSpecific cervicograph, including an alert line (normal progression of cervical dilation, i.e. 1 cm per hour) and an action line 2 hours after the alert line. This should be completed after the diagnose of active labor |
| Usual cervicograph | No intervention | –The usual cervicograph in our unit is not having lines |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women in labor, admitted for a VBAC at a gestational age of 37 weeks or more
- Single pregnancy
- Cephalic presentation
Key exclusion criteria (8 listed)
- More than 1 previous cesarean section
- Multiple pregnancies
- Presentations other than cephalic
- History of low vertical uterotomy, classical or inverted T-shaped
- Past history of myomectomy
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 |
|---|---|---|
| specific cervicographAlso: usual cervicograph | Diagnostic test | specific cervicograph |
Primary outcome
Detection of dystocia during labor in women with past history of cesarean section
Time frame: From inclusion in the study (randomization usually from 2cm) until full cervical dilation.
Appropriate detection and management of dystocia by identifying women with: no progression of cervical dilation for more than 2 hours during labor; or slow progress, defined as a cervical dilation of less than 2 cm in 4 hours; and immediate decision of cesarean section, to be performed within 30 minutes.
1 secondary outcome
Uterine rupture during labor in women with past history of cesarean section
Time frame: From inclusion in the study (randomization usually from 2cm) until delivery
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 2 Oct 2017.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing specific cervicograph in people with Attempted Vaginal Delivery After a Cesarean Section, run by University Hospital, Geneva.
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 3 inclusion and 8 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 2 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Detection of dystocia during labor in women with past history of cesarean section (time frame: From inclusion in the study (randomization usually from 2cm) until full cervical dilation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Oct 2017.