Prenatal Diagnosis of the Fetal Esophageal or Intestinal Atresia

Completed

• Conditions: Antenatal Management of the Fetal Gastrointestinal Atresia
• Interventions: Procedure: scheduled delivery at a tertiary center

• Registration Number: NCT05362604
• Lead Sponsor: Poitiers University Hospital

Brief 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. 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 Timeline

• Study Start: 2021-04-01
• Status Verified: 2022-02
• Primary Completion: 2022-02-07
• Study Completion: 2022-02-07
• Study First Submitted: 2022-02-08
• Study First Submitted QC: 2022-04-30
• Last Update Submitted: 2022-04-30
• Study First Posted: 2022-05-05
• Last Update Posted: 2022-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
prenatal	scheduled delivery at a tertiary center	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

Primary Outcome Measures

Name	Time	Method
gestational age of delivery	1 year	weeks
mode of delivery	1 year	Vaginal, Operative vaginal, Elective cesarean section, Cesarean section for fetal indication

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Centre Hospitalier Universitaire de Poitiers; 🇫🇷 Poitiers, France