Scarred UterusCICAMODANCT05439733
Planned Mode of Delivery After Caesarean: a Comparative Prospective National Population-based Cohort Study
An observational study of Scarred Uterus, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
In women with one previous caesarean, the choice of mode of delivery is determined by a shared decision-making process between the women and the obstetrician, with the two options being a trial of labour after caesarean (TOLAC) or an elective repeat caesarean delivery (ERCD). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Scarred Uterus
- What is being tested?
- Questionnaire completion
- How many people
- 16,764 participants
- Where
- 1 siteFrance
- Study dates
- 22 Jun 2023to 13 Jan 2026
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant women age of 18 years or older
Who may be able to join
- Pregnant women age of 18 years or older
- Women admitted to the labour ward at gestational age ≥ 34 weeks
- Women with a singleton pregnancy
- Women with one previous caesarean delivery
- Computer savvy-women Exclusion Criteria:
Who cannot join
- Women who oppose to participation in the study
- Age < 18 years
- Women admitted to the labour ward at gestational age < 34 weeks
- Women with multiple pregnancy
- Women with more than one previous caesarean or more than one uterine scar
- Women who do not understand the French language
- Women under judicial protection
Trial locations and contacts
1 site in 1 country.
France1 site
Assistance Publique Hôpitaux Marseille
Marseille, Bouches-du-rhône, 13354
About this study
In women with one previous caesarean, the choice of mode of delivery is determined by a shared decision-making process between the women and the obstetrician, with the two options being a trial of labour after caesarean (TOLAC) or an elective repeat caesarean delivery (ERCD).
To date, the scientific literature has reported of higher perinatal morbidity-mortality with TOLAC, although with low absolute risks and discordant results about maternal morbidity-mortality. These studies suffer from limitations, as they include women with more than one previous caesarean or with high rates of failed TOLAC, which are two risk factors for uterine rupture, and the definition of planned versus effective mode of delivery is not precise in most studies.
Read more
However, scientific societies recommend that most women with one previous caesarean should be offered TOLAC because of the low absolute perinatal risk of this option and the high maternal and perinatal risk associated with an ERCD in the short- and long-term.
Conversely, the investigators hypothesise that TOLAC would be not inferior to ERCD in women with one previous caesarean in terms of perinatal morbidity-mortality.
Read the detailed description
Primary and secondary objectives :
The primary objective is to evaluate the non-inferiority of TOLAC compared to ERCD on the perinatal morbidity-mortality rate. The secondary objectives are to compare between the TOLAC and ECRD groups: the maternal morbidity-mortality rate, care trajectories of women and child one year after delivery, the uterine rupture rate, pain experienced during delivery, the breastfeeding rates at the time of hospital discharge and at 6-weeks postpartum, the satisfaction, the quality of life, and the bonding of women at 6-weeks postpartum, the risk of postnatal depression, and the post-traumatic stress disorder at 6-weeks postpartum, the medical resource costs and perform a cost-effectiveness analysis or a cost-minimization analysis depending on the result on the primary endpoint, the risk perception of women and of the obstetrician about the course of delivery: at the time of the shared decision-making process with the obstetrician of their planned mode of delivery, two days after delivery, and at 6-weeks postpartum (ancillary study CICAMODA Risk), and the risk of urinary incontinence at 12 months postpartum (ancillary study CICAMODA PP).
Methods :
- Design : the investigators plan a national multicentre prospective observational cohort study.
- General procedure : after admission of the women in the labour ward and within the 72 hours after birth, obstetricians will inform women about the study and determine whether or not they object to participate, in accordance with French law. The investigators will collect data about characteristics of the women, the previous caesarean delivery, the planned mode of delivery, the pregnancy, the course of labour, and postpartum data.
- Schedule : the investigators plan a 12-month inclusion period to obtain a complete view of French practices in planned mode of delivery after one previous caesarean delivery thanks to this observational study. The duration of the follow-up period will be 12-months for each included woman.
- Sample size : thanks to data of 2016 National Perinatal Survey, the investigators assume that TOLAC will be planned in 68.9% of French women with one previous caesarean and ERCD in the remaining 31.1%.
From an analysis of the literature, the investigators estimate that the perinatal morbidity-mortality rate is 0.9% in the ERCD group. The noninferiority boundary based on clinical evidence and an expert committee has validated an estimated rate of perinatal morbidity-mortality of 1.4% in the TOLAC group. According to these assumptions and with a power of 80% and a one-sided alpha risk of 2.5%, the number of women to be included is 4343 in the ERCD group and 9669 in the TOLAC group, i.e. a total of 14,012 women. With anticipation that 5% of women will provide incomplete data to define the primary outcome, 14750 women will be needed.
During the inclusion period, the investigators except to include 16800 women, which will provide enough power to investigate the non-inferiority of TOLAC in terms of perinatal morbidity-mortality.
- Conditions
- Scarred Uterus
- Being tested
- Questionnaire completion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire completionOther
Women will be asked to complete questionnaires 6 weeks after delivery
| Study group | Role | What they receive |
|---|---|---|
| Exposed group | Women with a history of cesarean section and with a base-line attempt after planned cesarean section (TVBAC). Receives: Other: Questionnaire completion | |
| Non-exposed group | Women with a history of cesarean section and scheduled cesarean section after cesarean section (CPAC). Receives: Other: Questionnaire completion |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint will be the perinatal morbidity-mortality rate
Composite measure of:
- Perinatal death (any foetal death or death of a liveborn infant before hospital discharge [excluding lethal congenital anomalies])
- Birth trauma
- SARNAT Stage 2 or 3 hypoxic ischemic encephalopathy
- Perinatal asphyxia, which is fulfilment of at least one of the following criteria:
- Severe biological signs: pH < 7,0 or Lactate ≥ 11 mmol/L
- Or 7.0 < pH ≤ 7.15, or 8 ≤ lactates < 11 mmol/l, or not available but with:
- Perinatal event (severe non reassuring fetal hearth rate, cord prolapse, uterine rupture, maternal trauma or cardio-respiratory arrest
- Or sudden change of fetal hearth rate
- Or 10 minutes Apgar score of 5 or less or assisted ventilation initiated at birth and continued for at least 10 minutes
- Admission to intensive care with intratracheal intubation or need for ventilation
- Length of stay in Neonatal Intensive > 4 days
- Neonatal respiratory distress syndrome
- Proven early neonatal sepsis bacterial infection
Measured: From admission and maximum 28 days after delivery
Secondary outcomes (8)
Maternal morbidity-mortality rate
Maternal death
- Severe postpartum haemorrhage (blood loss ≥ 1000 mL)
- Blood transfusion
- Obstetrical anal sphincter injury (stages 3 or 4 of the Royal College of Obstetricians and Gynaecologists classification of perineal tears)
- Intensive care unit admission
- Damage to the bladder, ureter or bowel requiring repair
- Wound infection or wound dehiscence (requiring prolongation of hospital stay)
- Readmission to the operating room
- Hysterectomy
- Deep vein thrombosis, thrombophlebitis, or pulmonary embolus requiring anticoagulant therapy
- Proven endometritis (positive vaginal bacteriology) or proven postpartum sepsis (positive blood cultures)
- Prolongation of hospital stay > 15 days
Measured: From admissionand maximum 15 days after delivery
Uterine rupture rate
Defined as a clinically significant rupture involving the full thickness of the uterine wall and requiring surgical repair
Measured: During the surgery and confirmed by an adjudication committee.
Breastfeeding rate at the time of hospital discharge
Breastfeeeding rate
Measured: Between day 3 and day 5
Felt pain during delivery
The felt pain during delivery will be evaluated thanks to numeric scale (0 to 10) and how was dealt the pain by the team of care. A low score means that the patient's postpartum pain is low. On the contrary, the higher the score, the greater the pain.
Measured: 6-weeks postpartum
Breastfeeding rate
The breastfeeding will be evaluated by the following questions:
Do you breastfeed your baby at the present time? Do you give bottles to your baby at the present time? The maternal satisfaction will be evaluated as previously reported in this specific clinical situation.
Measured: 6-weeks postpartum
Evaluate the satisfaction
Thanks to Likert scales, we will evaluate the satisfaction about the previous caesarean delivery, about the most recent delivery, about the recovery after the previous caesarean delivery and after the most recent delivery, and about the most recent delivery in comparison with the previous caesarean delivery.
Measured: 6-weeks postpartum
Evaluate the quality of life
The quality of life will be evaluated thanks to the Short-Form 12 (SF-12) as recommended. The choice of the 12 items version is justified by the feasibility (acceptability by the postpartum women).
A low score means that the patient's quality of life is low. The higher the score, the higher the quality of life.
Measured: 6-weeks postpartum
Risk of postnatal depression, and post-traumatic stress disorder
(French version Edinburgh Postpartum Depression Scale EPDS)81. The score per question varies from 0 to 3. The higher the score, the greater the risk of postnatal depression and post-traumatic stress disorder.
Measured: 6-weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start22 Jun 2023
- Primary completion13 Jan 2026
- Study completion13 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scarred UterusStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16,764 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François CREMIEUX, Study director, ASSITANCE PUBLIQUE HOPITAUX MARSEILLEJulie BLANC, Principal investigator, ASSITANCE PUBLIQUE HOPITAUX MARSEILLE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05439733
- Sponsor's protocol ID
- 2022-A00514-39
- Acronym
- CICAMODA
- Status last verified
- Jul 2026
- First submitted
- 2 Jun 2022
- Last updated
- 3 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Planned Mode of Delivery After Caesarean: a Comparative Prospective National Population-based Cohort Study
- ClinicalTrials.gov ID
- NCT05439733
- Acronym / sponsor ID
- CICAMODA / 2022-A00514-39
- Conditions
- Scarred Uterus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16,764 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 22 Jun 2023 (actual)
- Primary completion
- 13 Jan 2026 (actual)
- Study completion
- 13 Jan 2026 (actual)
- First posted
- 30 Jun 2022 (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.
In women with one previous caesarean, the choice of mode of delivery is determined by a shared decision-making process between the women and the obstetrician, with the two options being a trial of labour after caesarean (TOLAC) or an elective repeat caesarean delivery (ERCD).
To date, the scientific literature has reported of higher perinatal morbidity-mortality with TOLAC, although with low absolute risks and discordant results about maternal morbidity-mortality. These studies suffer from limitations, as they include women with more than one previous caesarean or with high rates of failed TOLAC, which are two risk factors for uterine rupture, and the definition of planned versus effective mode of delivery is not precise in most studies.
However, scientific societies recommend that most women with one previous caesarean should be offered TOLAC because of the low absolute perinatal risk of this option and the high maternal and perinatal risk associated with an ERCD in the short- and long-term.
Conversely, the investigators hypothesise that TOLAC would be not inferior to ERCD in women with one previous caesarean in terms of perinatal morbidity-mortality.
Detailed description
Primary and secondary objectives :
The primary objective is to evaluate the non-inferiority of TOLAC compared to ERCD on the perinatal morbidity-mortality rate. The secondary objectives are to compare between the TOLAC and ECRD groups: the maternal morbidity-mortality rate, care trajectories of women and child one year after delivery, the uterine rupture rate, pain experienced during delivery, the breastfeeding rates at the time of hospital discharge and at 6-weeks postpartum, the satisfaction, the quality of life, and the bonding of women at 6-weeks postpartum, the risk of postnatal depression, and the post-traumatic stress disorder at 6-weeks postpartum, the medical resource costs and perform a cost-effectiveness analysis or a cost-minimization analysis depending on the result on the primary endpoint, the risk perception of women and of the obstetrician about the course of delivery: at the time of the shared decision-making process with the obstetrician of their planned mode of delivery, two days after delivery, and at 6-weeks postpartum (ancillary study CICAMODA Risk), and the risk of urinary incontinence at 12 months postpartum (ancillary study CICAMODA PP).
Methods :
- Design : the investigators plan a national multicentre prospective observational cohort study.
- General procedure : after admission of the women in the labour ward and within the 72 hours after birth, obstetricians will inform women about the study and determine whether or not they object to participate, in accordance with French law. The investigators will collect data about characteristics of the women, the previous caesarean delivery, the planned mode of delivery, the pregnancy, the course of labour, and postpartum data.
- Schedule : the investigators plan a 12-month inclusion period to obtain a complete view of French practices in planned mode of delivery after one previous caesarean delivery thanks to this observational study. The duration of the follow-up period will be 12-months for each included woman.
- Sample size : thanks to data of 2016 National Perinatal Survey, the investigators assume that TOLAC will be planned in 68.9% of French women with one previous caesarean and ERCD in the remaining 31.1%.
From an analysis of the literature, the investigators estimate that the perinatal morbidity-mortality rate is 0.9% in the ERCD group. The noninferiority boundary based on clinical evidence and an expert committee has validated an estimated rate of perinatal morbidity-mortality of 1.4% in the TOLAC group. According to these assumptions and with a power of 80% and a one-sided alpha risk of 2.5%, the number of women to be included is 4343 in the ERCD group and 9669 in the TOLAC group, i.e. a total of 14,012 women. With anticipation that 5% of women will provide incomplete data to define the primary outcome, 14750 women will be needed.
During the inclusion period, the investigators except to include 16800 women, which will provide enough power to investigate the non-inferiority of TOLAC in terms of perinatal morbidity-mortality.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed group | – | Other: Questionnaire completionWomen with a history of cesarean section and with a base-line attempt after planned cesarean section (TVBAC). |
| Non-exposed group | – | Other: Questionnaire completionWomen with a history of cesarean section and scheduled cesarean section after cesarean section (CPAC). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women age of 18 years or older
Key inclusion criteria (5 listed)
- Pregnant women age of 18 years or older
- Women admitted to the labour ward at gestational age ≥ 34 weeks
- Women with a singleton pregnancy
- Women with one previous caesarean delivery
- Computer savvy-women Exclusion Criteria:
Key exclusion criteria (7 listed)
- Women who oppose to participation in the study
- Age < 18 years
- Women admitted to the labour ward at gestational age < 34 weeks
- Women with multiple pregnancy
- Women with more than one previous caesarean or more than one uterine scar
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 |
|---|---|---|
| Questionnaire completionWomen will be asked to complete questionnaires 6 weeks after delivery | Other | Exposed group, Non-exposed group |
Primary outcome
The primary endpoint will be the perinatal morbidity-mortality rate
Time frame: From admission and maximum 28 days after delivery
Composite measure of: * Perinatal death (any foetal death or death of a liveborn infant before hospital discharge [excluding lethal congenital anomalies]) * Birth trauma * SARNAT Stage 2 or 3 hypoxic ischemic encephalopathy * Perinatal asphyxia, which is fulfilment of at least one of the following criteria: * Severe biological signs: pH < 7,0 or Lactate ≥ 11 mmol/L * Or 7.0 < pH ≤ 7.15, or 8 ≤ lactates < 11 mmol/l, or not available but with: * Perinatal event (severe non reassuring fetal hearth rate, cord prolapse, uterine rupture, maternal trauma or cardio-respiratory arrest * Or sudden change of fetal hearth rate * Or 10 minutes Apgar score of 5 or less or assisted ventilation initiated at birth and continued for at least 10 minutes * Admission to intensive care with intratracheal intubation or need for ventilation * Length of stay in Neonatal Intensive > 4 days * Neonatal respiratory distress syndrome * Proven early neonatal sepsis bacterial infection
8 secondary outcomes
Maternal morbidity-mortality rate
Time frame: From admissionand maximum 15 days after delivery
Uterine rupture rate
Time frame: During the surgery and confirmed by an adjudication committee.
Breastfeeding rate at the time of hospital discharge
Time frame: Between day 3 and day 5
Felt pain during delivery
Time frame: 6-weeks postpartum
Breastfeeding rate
Time frame: 6-weeks postpartum
Evaluate the satisfaction
Time frame: 6-weeks postpartum
Evaluate the quality of life
Time frame: 6-weeks postpartum
Risk of postnatal depression, and post-traumatic stress disorder
Time frame: 6-weeks postpartum
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 3 Aug 2026.
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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.
François CREMIEUX study director
ASSITANCE PUBLIQUE HOPITAUX MARSEILLE
Julie BLANC principal investigator
ASSITANCE PUBLIQUE HOPITAUX MARSEILLE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Scarred Uterus, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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 5 inclusion and 7 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 3 Aug 2026. 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 France. 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?
The primary endpoint will be the perinatal morbidity-mortality rate (time frame: From admission and maximum 28 days after delivery). 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 3 Aug 2026.