Contraction stress test before planned cesarean section to reduce the risk of neonatal respiratory distress syndrome.
Zusammenfassung der Studie
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)
Untersuchte Intervention
Contraction stress test before performing a planned cesarean section
(BASEC)
Untersuchte Krankheit(en)
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)
Ausschlusskriterien
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)
Studienstandort
Basel, St Gallen, Winterthur, Zürich, Andere
(BASEC)
Baden
(BASEC)
Sponsor
nicht verfügbar
Kontakt für weitere Auskünfte zur Studie
Allgemeine Auskünfte
Dept. of Obstetrics, University Hospital Zurich,
+41 44 255 5192
tilo.burkhardt@clutterusz.ch(ICTRP)
Wissenschaftliche Auskünfte
Dept. of Obstetrics, University Hospital Zurich,
+41 44 255 5192
tilo.burkhardt@clutterusz.ch(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Zürich
(BASEC)
Datum der Bewilligung durch die Ethikkommission
15.02.2019
(BASEC)
ICTRP Studien-ID
NCT03693885 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
nicht verfügbar
Wissenschaftlicher Titel
Mild Induced Labour Prior to Planned Caesarean Delivery to Improve Neonatal and Maternal Outcome - a Randomized Trial (ICTRP)
Öffentlicher Titel
Oxytocin Administration Prior Planned Caesarean Section (ICTRP)
Untersuchte Krankheit(en)
Respiratory Insufficiency Syndrome of Newborn;Breastfeeding Status (ICTRP)
Untersuchte Intervention
Other: Oxytocin challenge test (OCT) (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label). (ICTRP)
Ein-/Ausschlusskriterien
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)
nicht verfügbar
Primäre und sekundäre Endpunkte
Incidence of neonatal respiratory morbidity (ICTRP)
Umbilical cord blood copeptin levels;Postnatal neonatal weight change;Breastfeeding status (ICTRP)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
University of Basel (ICTRP)
Weitere Kontakte
Tilo Burkhardt, MD;Tilo Burkhardt, MD, tilo.burkhardt@usz.ch, +41 44 255 5192, Dept. of Obstetrics, University Hospital Zurich, (ICTRP)
Sekundäre IDs
Lacarus (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
No (ICTRP)
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT03693885 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar