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

NCT04780412 — Phase 3, Unknown, 210 participants, Ain Shams University

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Registry	NCT04780412
Status	Unknown
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: single, prevention
Enrollment	210 (Actual)
Sponsor	Ain Shams University (Other)
Conditions	Transient Tachypnea of the Newborn, Neonatal Respiratory Distress
Interventions	Misoprostol, Placebo (Drug)
Dates	start 2020-09-01, primary completion 2021-03-01 (estimated), completion 2021-03-01 (estimated), first posted 2021-03-03, last updated 2021-03-03
Locations	1 site in Egypt

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Misoprostol Group	Active comparator	Drug: Misoprostol
Placebo Group	Placebo comparator	Drug: Placebo

Misoprostol (Drug), also known as prostaglandin E1: Vaginal Misoprostol tablets in a dose of 50 microgram given 90-120 minutes before an elective caesarian section.
Placebo (Drug): Vaginal placebo pills given 90-120 minutes before an elective caesarian section.

+Outcome measures

Primary outcomes

incidence of neonatal respiratory morbidity (NRM) [up to 24 hours after birth]: The incidence of neonatal respiratory morbidity, especially transient tachypnea of newborn, in early term neonates born to elective caesarian section.

Secondary outcomes

Neonatal intensive care unit (NICU) admission [up to 24 hours after birth]: 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.

+Eligibility

Sex: Female, ages: 18 Years to any, 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.

+Locations (1)

Facility	City	Country	Status
Ain Shams University - Faculty of Medicine	Cairo	Egypt

+Investigators

Samar A. Kandeel, Principal investigator, Ain Shams University - Faculty of Medicine

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