Antenatal Management of the Fetal Gastrointestinal AtresiaDANATRESIANCT05362604
Prenatal Diagnosis of the Fetal Esophageal or Intestinal Atresia
An observational study of Antenatal Management of the Fetal Gastrointestinal Atresia, run by Poitiers University Hospital at 1 site in France.
Trial summary
Aim- to investigate how prenatal diagnosis of fetal esophageal or intestinal atresia impacts obstetric and neonatal outcomes. Methods- This was a retrospective cohort study at a single center. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Antenatal Management of the Fetal Gastrointestinal Atresia
- What is being tested?
- scheduled delivery at a tertiary center
- Type of treatment
- Surgery or procedure
- How many people
- 51 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2021to 7 Feb 2022
- 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: 51 mother-baby pairs
Who may be able to join
- all pregnancies affected by fetal esophageal, duodenal or intestinal atresia referred to our prenatal diagnosis unit
- all newborns managed for such atresia in our unit of pediatric surgery
Who cannot join
- termination of pregnancy,
- stillbirth,
- the false positive cases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Top Benefits of the Prenatal Diagnosis of the Fetal Esophageal or Intestinal Atresia
Aim- to investigate how prenatal diagnosis of fetal esophageal or intestinal atresia impacts obstetric and neonatal outcomes.
Methods- This was a retrospective cohort study at a single center. The study population comprised 51 consecutive pregnancies, including 29 mothers (57%) and their fetuses affected by prenatally diagnosed fetal esophageal or intestinal atresia, and 22 mothers (43%) and their babies with postnatally diagnosed fetal esophageal or intestinal atresia.
Read the detailed description
Aim- to investigate how prenatal diagnosis of fetal esophageal or intestinal atresia impacts obstetric and neonatal outcomes.
Methods- This was a retrospective cohort study at a single center. The study population comprised 51 consecutive participants, including 29 mothers (57%) and their fetuses affected by prenatally diagnosed fetal esophageal or intestinal atresia, and 22 mothers (43%) and their babies with postnatally diagnosed fetal esophageal or intestinal atresia.
- Being tested
- scheduled delivery at a tertiary center
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
scheduled delivery at a tertiary centerProcedure or surgery
Neonatal units in French hospitals are classified in three levels. The intention is for infants requiring high level care to receive it in a tertiary neonatal unit within the same network when appropriate. In case of known fetal gastro-intestinal artesia, the prenatal care includes obstetric consultation and level 3 ultrasound scheduled every four weeks at our unit until the end of the pregnancy, antenatal consultations with a specialized multidisciplinary team, and an antenatal visit of the birth center to reduce the parental anxiety.
| Study group | Role | What they receive |
|---|---|---|
| prenatal | patients affected by confirmed fetal esophageal, duodenal or intestinal atresia and followed in our high-risk pregnancy unit, and scheduled for delivery between 38 and 39 weeks in our tertiary center, regardless of the patient's place of residence Receives: Procedure: scheduled delivery at a tertiary center | |
| postnatal | patients with unsuspected fetal atresia who delivered in their local hospitals: their newborns were transferred to our tertiary hospital within 24 hours and the mother had the option to be also transferred in order to follow her baby. |
What is being measured
The primary outcome is the main question the study is designed to answer.
gestational age of delivery
weeks
Measured: 1 year
mode of delivery
Vaginal, Operative vaginal, Elective cesarean section, Cesarean section for fetal indication
Measured: 1 year
Secondary outcomes (2)
neonatal morbidity
Age at surgery, Cutaneous stoma, Anastomotic leakage, Mechanical ventilation, Phototherapy, Infection
Measured: 1 year
length of hospital stay
Length of neonatal intensive care unit stay, Length of neonatal reanimation stay (days)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2022
- Study start1 Apr 2021
- Primary completion7 Feb 2022
- Study completion7 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antenatal Management of the Fetal Gastrointestinal AtresiaStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe 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
- Retrospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05362604
- Sponsor's protocol ID
- DANATRESIA
- Acronym
- DANATRESIA
- Status last verified
- Feb 2022
- First submitted
- 8 Feb 2022
- Last updated
- 5 May 2022
- Results posted
- No
- 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 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Top Benefits of the Prenatal Diagnosis of the Fetal Esophageal or Intestinal Atresia
- ClinicalTrials.gov ID
- NCT05362604
- Acronym / sponsor ID
- DANATRESIA / DANATRESIA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 7 Feb 2022 (actual)
- Study completion
- 7 Feb 2022 (actual)
- First posted
- 5 May 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.
Aim- to investigate how prenatal diagnosis of fetal esophageal or intestinal atresia impacts obstetric and neonatal outcomes.
Methods- This was a retrospective cohort study at a single center. The study population comprised 51 consecutive pregnancies, including 29 mothers (57%) and their fetuses affected by prenatally diagnosed fetal esophageal or intestinal atresia, and 22 mothers (43%) and their babies with postnatally diagnosed fetal esophageal or intestinal atresia.
Detailed description
Aim- to investigate how prenatal diagnosis of fetal esophageal or intestinal atresia impacts obstetric and neonatal outcomes.
Methods- This was a retrospective cohort study at a single center. The study population comprised 51 consecutive participants, including 29 mothers (57%) and their fetuses affected by prenatally diagnosed fetal esophageal or intestinal atresia, and 22 mothers (43%) and their babies with postnatally diagnosed fetal esophageal or intestinal atresia.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| prenatal | – | Procedure: scheduled delivery at a tertiary centerpatients affected by confirmed fetal esophageal, duodenal or intestinal atresia and followed in our high-risk pregnancy unit, and scheduled for delivery between 38 and 39 weeks in our tertiary center, regardless of the patient's place of residence |
| postnatal | – | –patients with unsuspected fetal atresia who delivered in their local hospitals: their newborns were transferred to our tertiary hospital within 24 hours and the mother had the option to be also transferred in order to follow her baby. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 51 mother-baby pairs
Key inclusion criteria (2 listed)
- all pregnancies affected by fetal esophageal, duodenal or intestinal atresia referred to our prenatal diagnosis unit
- all newborns managed for such atresia in our unit of pediatric surgery
Key exclusion criteria (3 listed)
- termination of pregnancy,
- stillbirth,
- the false positive cases
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 |
|---|---|---|
| scheduled delivery at a tertiary centerNeonatal units in French hospitals are classified in three levels. The intention is for infants requiring high level care to receive it in a tertiary neonatal unit within the same network when appropriate. In case of known fetal gastro-intestinal artesia, the prenatal care includes obstetric consultation and level 3 ultrasound scheduled every four weeks at our unit until the end of the pregnancy, antenatal consultations with a specialized multidisciplinary team, and an antenatal visit of the birth center to reduce the parental anxiety. | Procedure or surgery | prenatal |
Primary outcome
gestational age of delivery
Time frame: 1 year
weeks
mode of delivery
Time frame: 1 year
Vaginal, Operative vaginal, Elective cesarean section, Cesarean section for fetal indication
2 secondary outcomes
neonatal morbidity
Time frame: 1 year
length of hospital stay
Time frame: 1 year
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 5 May 2022.
- 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.
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 Antenatal Management of the Fetal Gastrointestinal Atresia, run by Poitiers University Hospital 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 2 inclusion and 3 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 5 May 2022. 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?
gestational age of delivery (time frame: 1 year). The study lists 2 primary outcomes in all. 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 5 May 2022.