Efficacy of Misoprostol in Prevention of Neonatal Respiratory Morbidity in Parturient at Early Term Elective Caesarian Section

Neonatal Respiratory Distress Clinical Trial

Official title:

Efficacy of Misoprostol in Prevention of Neonatal Respiratory Morbidity in Parturient at Early Term Elective Caesarian Section

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04780412
• Other study ID #: Misoprostol
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: September 1, 2020
• Est. completion date: March 2021

Study information

• Verified date: March 2021
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Neonatal respiratory morbidities represent a common group of post natal complications including respiratory distress syndrome, transient tachypnea of newborn, and persistent pulmonary hypertension of newborn.

It is thought that preoperative vaginal misoprostol administration may decrease the incidence of neonatal respiratory morbidity especially transient tachypnea of newborn. And therefore, it may decrease the incidence of admission to neonatal intensive care units for respiratory causes.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 210
• Est. completion date: March 2021
• Est. primary completion date: March 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age: 18 years or more.

• Early term singleton pregnancy.

• Elective caesarian section at (37 - 38+6) weeks of gestation.

• Any indication for lower uterine segment caesarian section other than labor (as malpresentations, severe preeclampsia, placenta previa with no previous bleeding attacks, Diabetes Mellitus, macrosomic fetus, non reassuring cardiotocogram (CTG), and fetal growth restriction).

• Informed written consent signed by the participating pregnant woman.

Exclusion Criteria:

• Women having any contraindication to Prostaglandin E1 as hypersensitivity, respiratory disease (especially bronchial asthma), or glaucoma.

• Any mental problems that block understanding of the nature and all the possible consequences of the procedure and the study.

• Pregnancies of known fetal diseases or chromosomal abnormalities.

• Non-singleton pregnancies.

• Emergency caesarian section as in ruptured membrane and women in labor pain.

Related Conditions & MeSH terms

• Neonatal Respiratory Distress
• Respiratory Distress Syndrome, Newborn
• Tachypnea
• Transient Tachypnea of the Newborn

Intervention

Drug:
• Misoprostol
Vaginal Misoprostol tablets in a dose of 50 microgram given 90-120 minutes before an elective caesarian section.
• Placebo
Vaginal placebo pills given 90-120 minutes before an elective caesarian section.

Locations

Country	Name	City	State
Egypt	Ain Shams University - Faculty of Medicine	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of neonatal respiratory morbidity (NRM)	The incidence of neonatal respiratory morbidity, especially transient tachypnea of newborn, in early term neonates born to elective caesarian section.	up to 24 hours after birth
Secondary	Neonatal intensive care unit (NICU) admission	The incidence of the need for neonatal intensive care unit admission during the first ten days after delivery in early term neonates born to elective caesarian section.	up to 24 hours after birth