Misoprostol Before Elective Caesarean Section for Decreasing the Neonatal Respiratory Morbidity

Cesarean Delivery Affecting Fetus Clinical Trial

Official title:

Misoprostol Before Elective Caesarean Section for Decreasing the Neonatal Respiratory Morbidity: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03031353
• Other study ID #: AinShamsU103
• Status: Recruiting
• Phase: N/A
• Start date: January 2017
• Est. completion date: June 2018

Study information

• Verified date: May 2018
• Source: Ain Shams University
• Contact: Ahmed M kotb, MD
• Phone: 01008681999
• Email: ahmedmkotp[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 170
• Est. completion date: June 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cesarean Delivery Affecting Fetus
• Tachypnea
• Transient Tachypnea Newborn
• Transient Tachypnea of the Newborn

Intervention

Drug:
• Misoprostol
Misoprostol is given before elective cesarean section as prophylaxis against post partum hemorrhage
• Placebos
placebos tablet will be given before elective Cesarean sections

Locations

Country	Name	City	State
Egypt	Faculty of Medicine, Ain Shams University	Cairo	Al Qahirah

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	neonatal mortality	number of neonates died from respiratory morbidity with one month of delivery	first month after delivery
Primary	The need for admission to neonatal intensive care unit (NICU)	Number of newborns admitted to NICU for respiratory morbidity	first 24 hours after delivery
Secondary	APGAR score below 6 at 5 minute	number of newborns delivered with APGAR score below 6 at 5 minutes	5 minutes after delivery