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Misoprostol Before Elective Caesarean Section for Decreasing the Neonatal Respiratory Morbidity

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: NCT03031353
Recruitment Status : Unknown
Verified May 2018 by Ahmed Mohamed El Kotb Abdel Fattah, Ain Shams University.
Recruitment status was:  Recruiting
First Posted : January 25, 2017
Last Update Posted : May 29, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmed Mohamed El Kotb Abdel Fattah, Ain Shams University

Brief Summary:

Neonatal respiratory distress may occur in either term or preterm newborns with a higher relative risk in preterm, and whether born vaginally or through caesarean section, but in a higher percentage after elective caesarean section whose rate is rising.

Prostaglandins may be given about one hour before an elective caesarean section after excluding the presence of contraindication to their use to decrease the neonatal respiratory diseases and thus, the number of children who suffered from bronchopulmonary dysplasia that occurs frequently in children who had previously TTN will diminish.


Condition or disease Intervention/treatment Phase
Transient Tachypnea Newborn Cesarean Delivery Affecting Fetus Drug: Misoprostol Drug: Placebos Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Misoprostol Before Elective Caesarean Section for Decreasing the Neonatal Respiratory Morbidity: A Randomized Controlled Trial
Actual Study Start Date : January 2017
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : June 2018


Arm Intervention/treatment
Experimental: Misoprostol
After preparing for elective caesarean section, the pessary will be given containing the misoprostol medication 1 hour before , women in the operating room, and the anaesthetic and surgical techniques will be standardized
Drug: Misoprostol
Misoprostol is given before elective cesarean section as prophylaxis against post partum hemorrhage
Other Name: Mesotac

Active Comparator: Placebo
After preparing for elective caesarean section, the pessary will be given containing placebo 1 hour before , women in the operating room, and the anaesthetic and surgical techniques will be standardized
Drug: Placebos
placebos tablet will be given before elective Cesarean sections




Primary Outcome Measures :
  1. The need for admission to neonatal intensive care unit (NICU) [ Time Frame: first 24 hours after delivery ]
    Number of newborns admitted to NICU for respiratory morbidity


Secondary Outcome Measures :
  1. APGAR score below 6 at 5 minute [ Time Frame: 5 minutes after delivery ]
    number of newborns delivered with APGAR score below 6 at 5 minutes


Other Outcome Measures:
  1. neonatal mortality [ Time Frame: first month after delivery ]
    number of neonates died from respiratory morbidity with one month of delivery



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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:

  • Age: 18 years or more.
  • Term singleton pregnancy (38 - 38+6 weeks gestation).
  • Planned for elective transverse lower segment caesarean section with an indication.

Exclusion Criteria:

  • Women with history of significant cardiac disease, eclampsia, pre eclampsia, epilepsy, severe asthma, severe allergic condition, vascular disease, renal or hepatic disease.
  • Women with contraindication to prostaglandins as Glucoma or known hypersensitivity to prostaglandins or specifically for misoprostol.
  • Psychological problem or mental disease that renders the patient not able to understand the nature, scope, and sequences of the study.
  • Pregnancies with known foetal malformation/s or chromosomal aberration.

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): NCT03031353


Contacts
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Contact: Ahmed M kotb, MD 01008681999 ext 0020 ahmedmkotp@hotmail.com
Contact: ahmed DR kotb, MD 1008681999 ext 0020 ahmedmkotp@hotmail.com

Locations
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Egypt
Faculty of Medicine, Ain Shams University Recruiting
Cairo, Al Qahirah, Egypt
Contact: ahmed kotb, MD    2001008681999    ahmedmkotp@hotmail.com   
Contact: ebtihal dr eltaieb, MD    1004711414 ext 0020    ahmedmkotp@hotmail.com   
Sponsors and Collaborators
Ain Shams University
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Responsible Party: Ahmed Mohamed El Kotb Abdel Fattah, Dr., Lecturer in obstertics and gynecology, Ain Shams University Hospital, Ain Shams University
ClinicalTrials.gov Identifier: NCT03031353    
Other Study ID Numbers: AinShamsU103
First Posted: January 25, 2017    Key Record Dates
Last Update Posted: May 29, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Tachypnea
Transient Tachypnea of the Newborn
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Respiratory Distress Syndrome, Newborn
Lung Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases
Misoprostol
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics