Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03396107 |
| Other study ID # |
ACESC |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 3
|
| First received |
|
| Last updated |
|
| Start date |
May 17, 2018 |
| Est. completion date |
May 24, 2020 |
Study information
| Verified date |
June 2021 |
| Source |
Assiut University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Caesarean section is a risk factor for the development of neonatal respiratory complications,
mostly respiratory distress syndrome (RDS) and transient tachypnoea of the new-born, both in
term and preterm infants.
Description:
Infants born at term by caesarean delivery are more likely to develop respiratory morbidity
than infants born vaginally, and this risk increases furthermore for the subgroup of children
born by elective caesarean section, i.e. before onset of labour, with potentially severe
implications. The risk is decreasing with advancing gestational age, and infants born between
37+0 and 37+6 weeks are at 1.7 times more risk for respiratory complications than those born
between 38+0 and 38+6 weeks, which in turn are at 2.4 times more risk than the infants born
between 39+0 and 39+6 weeks. If women were given two intramuscular injections of 12 mg of
dexamethasone, two doses for 48 hrs,the rates of admissions were 5.2% at 37 weeks, 2.8% at 38
weeks, and 0.6% at 39 weeks. Although none of the babies in the control group died, admission
will increase parental anxiety, the cost to nursery unit and invasive procedures including
artificial ventilation giving mothers dexamethasone, two doses before elective section halved
neonatal morbidity. Five studies lasting between three and 20 years with more than 1500
patients have shown no adverse effect of single course of antenatal corticosteroid, neither
through infection of the fetus or mother nor in long term neurological or cognitive effect In
view of this evidence, it is currently recommended that elective caesarean section should be
deferred to 39 weeks. However approximately 10%-15% of woman planed for c/s may deliver
before 38 weeks, and there may be concern on waiting in the presence of speci c indications
or previous history. Respiratory morbidity in cases of term elective caesarean birth appears
to have a different pathophysiology than in preterm birth, and retention in the lungs being
the most likely cause.
Interestingly, recent evidence indicates that apart from the traditional mechanical concept
of vaginal squeeze, molecular mechanisms (predominantly lung epithelial sodium channels
promote alveolar uid drainage, and these channels are under active in fetuses unexposed to
the process of labor. Glucocorticoid appears to increase the number and the function of
thyroid hormones, providing a rational for their exogenous administration in cases of
elective caesarean delivery.
