Skip to main content
OpenTrials
Completed

NCT Number: NCT03396107

Antenatal Corticosteroid in Elective Cesarean Section

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Assiut university

Asyut, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Maternal age (18-35 years)
  • Singleton pregnancy
  • Gestational age (38-40 years)

Exclusion criteria

  • Major maternal morbidities as DM and pre-eclampsia
  • Sever oligohydramnios
  • Premature rupture of membranes
  • Women who receive steroids during pregnancy

Treatment and study plan

Dexamethasone

Drug

Dexamethasone 6mg, IM, 48 hours before cesarean section

Placebo

Drug

Placebo 6mg, IM, 48 hours before cesarean section

Other names: Saline

Primary outcomes

  1. Incidence of respiratory complications after cesarean section

    Time frame: 30 min

    To determine respiratory distress in infants born by elective cesarean section

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Role of Antenatal Corticosteroid Use in Elective Term Cesarean Section

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jan 10, 2018
Registry last updated
Jun 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.