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

Ain Shams University

Status and phase

Unknown

Phase 3

Conditions

Neonatal Respiratory Distress

Transient Tachypnea of the Newborn

Treatments

Drug: Misoprostol

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT04780412

Misoprostol

Details and patient eligibility

About

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.

Enrollment

210 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.