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Antenatal Corticosteroid in Elective Cesarean Section

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03396107
Recruitment Status : Unknown
Verified January 2018 by Mohammed Mostafa Haroun, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : January 10, 2018
Last Update Posted : January 10, 2018
Sponsor:
Information provided by (Responsible Party):
Mohammed Mostafa Haroun, Assiut University

Brief 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.

Condition or disease Intervention/treatment Phase
Cesarean Section Complications Drug: Dexamethasone Drug: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Role of Antenatal Corticosteroid Use in Elective Term Cesarean Section
Estimated Study Start Date : February 2018
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

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




Primary Outcome Measures :
  1. Incidence of respiratory complications after cesarean section [ Time Frame: 30 min ]
    To determine respiratory distress in infants born by elective cesarean section



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03396107


Contacts
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Contact: Ahmed Fayek, Professor 01005211819 ahmedamen1@yahoo.com
Contact: Hisham Abo Taleb, Lecturer 01003332139 hishamaboutaleb1@yahoo.com

Sponsors and Collaborators
Assiut University
Investigators
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Study Chair: Ahmed Fayek, Professor Assiut University

Publications:
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Responsible Party: Mohammed Mostafa Haroun, Dr, Assiut University
ClinicalTrials.gov Identifier: NCT03396107    
Other Study ID Numbers: ACESC
First Posted: January 10, 2018    Key Record Dates
Last Update Posted: January 10, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dexamethasone
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents