Contraction stress test before planned cesarean section to reduce the risk of neonatal respiratory distress syndrome.
Descrizione riassuntiva dello studio
Children born by cesarean section without prior contractions have an increased risk of adaptation disorders with respiratory problems. The reason for this is that without contractions, no stress hormones are released in the child and its mother at the time of birth, which improves adaptation to postnatal conditions. Accordingly, children with a normal vaginal birth have much less frequently adaptation problems and their mothers have fewer issues with the initiation and success of breastfeeding. A contraction stress test before a planned cesarean section leads to an increase in stress hormones similar to that of children after a normal vaginal birth. For measuring stress hormone levels, the stable cleavage product of the stress hormone vasopressin, copeptin, is particularly suitable. This study will include pregnant women with more than 34 weeks of gestation and a planned primary cesarean section, meaning that neither the amniotic sac has ruptured nor have spontaneous contractions started. Exclusion criteria are set as follows: pregnancies before 35+0 weeks of gestation, multiple pregnancies, fetal growth retardation, fetal malformations, suspicious CTG, contraindications for the induction of contractions such as placenta previa, internal diseases of the pregnant woman which are contraindications for the administration of oxytocin. The study intervention is the performance of a contraction stress test a few hours before the planned cesarean section. This means that oxytocin will be administered until regular contractions are recorded every 3 minutes with the contraction monitor or are palpable through the abdominal wall. After birth, 5 ml of umbilical cord blood will be collected from the placenta to measure stress hormones and precursor cells, as well as stool samples from the children and maternal milk samples from the mother, to examine possible effects of contraction stress on the infant and maternal microbiome.
(BASEC)
Intervento studiato
Contraction stress test before performing a planned cesarean section
(BASEC)
Malattie studiate
Neonatal respiratory distress syndrome after a cesarean section without prior contractions. Influence of contractions on breastfeeding rates.
(BASEC)
Singleton pregnancies ≥ 35 completed weeks of gestation Planned cesarean section (BASEC)
Criteri di esclusione
More than one cesarean section in the medical history, Multiple pregnancies (twins, triplets, etc.), Any contraindications for contractions, e.g. transverse position, placenta previa, history of myomectomy with uterine cavity opening, history of longitudinal cesarean, Severe fetal malformations: syndromic diseases, heart defects, arrhythmias, gastrointestinal malformations, Oligohydramnios or hydramnios, Intrauterine growth restriction (<5th percentile), Suspicious or pathological CTG, Signs of peripartum infection, clinically or laboratory-wise (CRP or leukocyte increase in the pregnant woman), Internal diseases of the pregnant woman that are contraindications for the administration of oxytocin (heart defects, arrhythmias) (BASEC)
Luogo dello studio
Basilea, San Gallo, Winterthur, Zurigo, Altro
(BASEC)
Baden
(BASEC)
Sponsor
non disponibile
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Tilo Burkhardt
+41 44 255 51 92
tilo.burkhardt@clutterusz.ch(BASEC)
Informazioni generali
Dept. of Obstetrics, University Hospital Zurich,
+41 44 255 5192
tilo.burkhardt@clutterusz.ch(ICTRP)
Informazioni scientifiche
Dept. of Obstetrics, University Hospital Zurich,
+41 44 255 5192
tilo.burkhardt@clutterusz.ch(ICTRP)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione etica Zurigo
(BASEC)
Data di approvazione del comitato etico
15.02.2019
(BASEC)
ID di studio ICTRP
NCT03693885 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
non disponibile
Titolo accademico
Mild Induced Labour Prior to Planned Caesarean Delivery to Improve Neonatal and Maternal Outcome - a Randomized Trial (ICTRP)
Titolo pubblico
Oxytocin Administration Prior Planned Caesarean Section (ICTRP)
Malattie studiate
Respiratory Insufficiency Syndrome of Newborn;Breastfeeding Status (ICTRP)
Intervento studiato
Other: Oxytocin challenge test (OCT) (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label). (ICTRP)
Criteri di inclusione/esclusione
Gender: Female
Maximum age: N/A
Minimum age: 18 Years
Inclusion Criteria:
- Singleton pregnancy >34 weeks
- primary caesarean section, that is without preceding contractions or rupture of the
membranes,
- absence of a contraindication to oxytocin
Exclusion Criteria:
- Chromosomal aberration
- malformation,
- IUGR,
- Nonreassuring fetal heart rate pattern,
- Placenta praevia,
- maternal substance abuse,
- infections,
- hypertension,
- preeclampsia,
- diabetes type I or II,
- autoimmune disease (antiphospholipid syndrome, lupus erythematosus, etc.),
- renal disease,
- history of more than one previous caesarean section.
(ICTRP)
non disponibile
Endpoint primari e secondari
Incidence of neonatal respiratory morbidity (ICTRP)
Umbilical cord blood copeptin levels;Postnatal neonatal weight change;Breastfeeding status (ICTRP)
Data di registrazione
non disponibile
Inclusione del primo partecipante
non disponibile
Sponsor secondari
University of Basel (ICTRP)
Contatti aggiuntivi
Tilo Burkhardt, MD;Tilo Burkhardt, MD, tilo.burkhardt@usz.ch, +41 44 255 5192, Dept. of Obstetrics, University Hospital Zurich, (ICTRP)
ID secondari
Lacarus (ICTRP)
Risultati-Dati individuali dei partecipanti
No (ICTRP)
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT03693885 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile