Prenatal Diagnosis of the Fetal Esophageal or Intestinal Atresia (DANATRESIA)

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.

Study Overview

• Status: Completed
• Conditions: Antenatal Management of the Fetal Gastrointestinal Atresia
• Intervention / Treatment: Procedure: scheduled delivery at a tertiary center

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 Type: Observational
• Enrollment (Actual): 51

Contacts and Locations

Study Locations

• France
  • Poitiers, France, 86000
    • Centre Hospitalier Universitaire de Poitiers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

51 mother-baby pairs

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Procedure: scheduled delivery at a tertiary center; 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.
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
gestational age of delivery	weeks	1 year
mode of delivery	Vaginal, Operative vaginal, Elective cesarean section, Cesarean section for fetal indication	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
neonatal morbidity	Age at surgery, Cutaneous stoma, Anastomotic leakage, Mechanical ventilation, Phototherapy, Infection	1 year
length of hospital stay	Length of neonatal intensive care unit stay, Length of neonatal reanimation stay (days)	1 year

Collaborators and Investigators

• Sponsor: Poitiers University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Actual): February 7, 2022
• Study Completion (Actual): February 7, 2022

Study Registration Dates

• First Submitted: February 8, 2022
• First Submitted That Met QC Criteria: April 30, 2022
• First Posted (Actual): May 5, 2022

Study Record Updates

• Last Update Posted (Actual): May 5, 2022
• Last Update Submitted That Met QC Criteria: April 30, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Congenital Abnormalities; Gastrointestinal Diseases; Intestinal Diseases; Digestive System Abnormalities; Intestinal Atresia
• Other Study ID Numbers: DANATRESIA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No