Planned Mode of Delivery After Caesarean: a Comparative Prospective National Population-based Cohort Study (CICAMODA)

June 13, 2023 updated by: Assistance Publique Hopitaux De Marseille

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
    • Bouches-du-rhône
      • Marseille, Bouches-du-rhône, France, 13354

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Pregnant women age of 18 years or older

Description

Inclusion Criteria:

  • 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:

Exclusion criteria :

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Exposed group
Women with a history of cesarean section and with a base-line attempt after planned cesarean section (TVBAC).
Other: Questionnaire completion
Women will be asked to complete questionnaires 6 weeks after delivery
Non-exposed group
Women with a history of cesarean section and scheduled cesarean section after cesarean section (CPAC).
Other: Questionnaire completion
Women will be asked to complete questionnaires 6 weeks after delivery

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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: Arterial or venous cord blood pH < 7,0 or Base deficit ≥ 16 mmol/L or Lactate ≥ 11 mmol/L
    • Or 7.0 < pH ≤ 7.15, or 10 ≤ base deficit < 16 mmol/L, ou 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
From admission and maximum 28 days after delivery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Maternal morbidity-mortality rate
Time Frame: From admissionand maximum 15 days after delivery

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
From admissionand maximum 15 days after delivery
Uterine rupture rate
Time Frame: During the surgery and confirmed by an adjudication committee.
Defined as a clinically significant rupture involving the full thickness of the uterine wall and requiring surgical repair
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
Breastfeeeding rate
Between day 3 and day 5
Felt pain during delivery
Time Frame: 6-weeks postpartum
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.
6-weeks postpartum
Breastfeeding rate
Time Frame: 6-weeks postpartum

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.
6-weeks postpartum
Evaluate the satisfaction
Time Frame: 6-weeks postpartum
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.
6-weeks postpartum
Evaluate the quality of life
Time Frame: 6-weeks postpartum

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.
6-weeks postpartum
Risk of postnatal depression, and post-traumatic stress disorder
Time Frame: 6-weeks postpartum
(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.
6-weeks postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assistance Publique Hopitaux De Marseille

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: François CREMIEUX, ASSITANCE PUBLIQUE HOPITAUX MARSEILLE
  • Principal Investigator: Julie BLANC, ASSITANCE PUBLIQUE HOPITAUX MARSEILLE

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 2, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 2, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 28, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 30, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 15, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 13, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2022-A00514-39

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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