Misoprostol Before Elective Caesarean Section for Decreasing the Neonatal Respiratory Morbidity
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|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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||170 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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
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
placebos tablet will be given before elective Cesarean sections
- 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
- 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
- neonatal mortality [ Time Frame: first month after delivery ]number of neonates died from respiratory morbidity with one month of delivery
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03031353
|Contact: Ahmed M kotb, MD||01008681999 ext email@example.com|
|Contact: ahmed DR kotb, MD||1008681999 ext firstname.lastname@example.org|