Centre Hospitalier Universitaire de Poitiers
Poitiers, 86000, France
Completed
NCT Number: NCT05362604
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.
Completed
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Notify MeKey information
Age range
18 year–50 year
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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
Exclusion criteria
- termination of pregnancy,
- stillbirth,
- the false positive cases
Treatment and study plan
scheduled delivery at a tertiary center
ProcedureNeonatal 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.
Primary outcomes
-
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
Secondary outcomes
-
neonatal morbidity
Time frame: 1 year
Age at surgery, Cutaneous stoma, Anastomotic leakage, Mechanical ventilation, Phototherapy, Infection
-
length of hospital stay
Time frame: 1 year
Length of neonatal intensive care unit stay, Length of neonatal reanimation stay (days)
Sponsors and collaborators
Lead sponsor
Poitiers University Hospital
Other
Registry information
Official study title
Top Benefits of the Prenatal Diagnosis of the Fetal Esophageal or Intestinal Atresia
Acronym: DANATRESIA
Important dates
- Study start
- 2021
- Primary completion
- 2022
- Study completion
- 2022
- First posted
- May 5, 2022
- Registry last updated
- May 5, 2022
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.