Antenatal Corticosteroid in Elective Cesarean Section

Role of Antenatal Corticosteroid Use in Elective Term 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.

Study Overview

• Status: Completed
• Conditions: Cesarean Section Complications
• Intervention / Treatment: Drug: Dexamethasone; Drug: Placebo

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 498
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt
    • Assiut University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dexamethasone; Dexamethasone 6mg, IM, 48 hours before cesarean section	Drug: Dexamethasone; Dexamethasone 6mg, IM, 48 hours before cesarean section
Placebo Comparator: Placebo; Placebo 6mg, IM, 48 hours before cesarean section	Drug: Placebo; Placebo 6mg, IM, 48 hours before cesarean section; Other Names: Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of respiratory complications after cesarean section	To determine respiratory distress in infants born by elective cesarean section	30 min

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Chair: Ahmed Fayek, Professor, Assiut University

Publications and helpful links

General Publications

• Barber EL, Lundsberg LS, Belanger K, Pettker CM, Funai EF, Illuzzi JL. Indications contributing to the increasing cesarean delivery rate. Obstet Gynecol. 2011 Jul;118(1):29-38. doi: 10.1097/AOG.0b013e31821e5f65.

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2018
• Primary Completion (Actual): November 25, 2019
• Study Completion (Actual): May 24, 2020

Study Registration Dates

• First Submitted: January 5, 2018
• First Submitted That Met QC Criteria: January 5, 2018
• First Posted (Actual): January 10, 2018

Study Record Updates

• Last Update Posted (Actual): June 21, 2021
• Last Update Submitted That Met QC Criteria: June 18, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone
• Other Study ID Numbers: ACESC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No