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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2021-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Misoprostol Before Elective Caesarean Section for Decreasing the Neonatal Respiratory Morbidity

NCT03031353

Transient Tachypnea Newborn Cesarean Delivery Affecting Fetus

UNKNOWN NA

Vaginal Misoprostol to Improve the Neonatal Respiratory Outcome

NCT03239327

Neonatal Respiratory Distress

UNKNOWN NA

Misoprostol Before Caesarean Section

NCT06946914

Misoprostol Respiratory Distress Syndrome (RDS) of Neonate Caesarean Section

RECRUITING PHASE4

Could Pre-operative Rectal Misoprostol Reduce Intra-operative Blood Loss During Ceserean Section?

NCT02509351

Postpartum Haemorrhage

COMPLETED PHASE2/PHASE3

Sublingual Misoprostol & Isoflurane During Caesarean Section

NCT01466530

Pregnancy Cesarean Delivery

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Transient Tachypnea of the Newborn Neonatal Respiratory Distress

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Misoprostol Group

Group Type ACTIVE_COMPARATOR

Misoprostol

Intervention Type DRUG

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

Placebo Group

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Misoprostol

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

prostaglandin E1

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes