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Antenatal Corticosteroid in Elective Cesarean Section

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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

Tracking Information
First Submitted Date  ICMJE January 5, 2018
First Posted Date  ICMJE January 10, 2018
Last Update Posted Date January 10, 2018
Estimated Study Start Date  ICMJE February 2018
Estimated Primary Completion Date February 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 5, 2018)
Incidence of respiratory complications after cesarean section [ Time Frame: 30 min ]
To determine respiratory distress in infants born by elective cesarean section
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Antenatal Corticosteroid in Elective Cesarean Section
Official Title  ICMJE Role of Antenatal Corticosteroid Use in Elective Term Cesarean Section
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Cesarean Section Complications
Intervention  ICMJE
  • Drug: Dexamethasone
    Dexamethasone 6mg, IM, 48 hours before cesarean section
  • Drug: Placebo
    Placebo 6mg, IM, 48 hours before cesarean section
Study Arms  ICMJE
  • Active Comparator: Dexamethasone
    Dexamethasone 6mg, IM, 48 hours before cesarean section
    Intervention: Drug: Dexamethasone
  • Placebo Comparator: Placebo
    Placebo 6mg, IM, 48 hours before cesarean section
    Intervention: Drug: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 5, 2018)
2000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2019
Estimated Primary Completion Date February 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03396107
Other Study ID Numbers  ICMJE ACESC
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Mohammed Mostafa Haroun, Assiut University
Study Sponsor  ICMJE Assiut University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Ahmed Fayek, Professor Assiut University
PRS Account Assiut University
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP