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

Sponsor

Ain Shams University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04780412

Collaborator

(none)

210

Enrollment

Location

Arms

5.9

Anticipated Duration (Months)

35.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Transient Tachypnea of the Newborn Neonatal Respiratory Distress	Drug: Misoprostol Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

210 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Sep 1, 2020

Anticipated Primary Completion Date :

Mar 1, 2021

Anticipated Study Completion Date :

Mar 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Misoprostol Group	Drug: Misoprostol Vaginal Misoprostol tablets in a dose of 50 microgram given 90-120 minutes before an elective caesarian section. Other Names: prostaglandin E1
Placebo Comparator: Placebo Group	Drug: Placebo Vaginal placebo pills given 90-120 minutes before an elective caesarian section.

Arm

Intervention/Treatment

Active Comparator: Misoprostol Group

Drug: Misoprostol

Vaginal Misoprostol tablets in a dose of 50 microgram given 90-120 minutes before an elective caesarian section.

Other Names:

prostaglandin E1

Placebo Comparator: Placebo Group

Drug: Placebo

Vaginal placebo pills given 90-120 minutes before an elective caesarian section.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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 Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.