Transient Tachypnea of the NewbornPhase 3NCT04780412
Efficacy of Misoprostol in Prevention of Neonatal Respiratory Morbidity in Parturient at Early Term Elective Caesarian Section
A Phase 3 study testing Misoprostol in people with Transient Tachypnea of the Newborn and Neonatal Respiratory Distress, run by Ain Shams University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Transient Tachypnea of the Newborn, Neonatal Respiratory Distress
- What is being tested?
- Misoprostol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2020to Mar 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Misoprostol, Placebo
- Medical subject headings
- Transient Tachypnea of the Newborn, Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
Also called prostaglandin E1
Vaginal Misoprostol tablets in a dose of 50 microgram given 90-120 minutes before an elective caesarian section.
PlaceboDrug
Vaginal placebo pills given 90-120 minutes before an elective caesarian section.
| Study group | Role | What they receive |
|---|---|---|
| Misoprostol Group | Active comparator | Not described Receives: Drug: Misoprostol |
| Placebo Group | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 24 hours after birth
Secondary outcomes (1)
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.
Measured: up to 24 hours after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start1 Sep 2020
- Primary completionMar 2021 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transient Tachypnea of the NewbornStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samar Ali, Ain Shams University
- Investigators
- Samar A. Kandeel, Principal investigator, Ain Shams University - Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04780412
- Sponsor's protocol ID
- Misoprostol
- Status last verified
- Mar 2021
- First submitted
- 24 Feb 2021
- Last updated
- 3 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Misoprostol in Prevention of Neonatal Respiratory Morbidity in Parturient at Early Term Elective Caesarian Section
- ClinicalTrials.gov ID
- NCT04780412
- Acronym / sponsor ID
- Misoprostol
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 3 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Misoprostol Group | Active comparator | Drug: Misoprostol |
| Placebo Group | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MisoprostolAlso: prostaglandin E1Vaginal Misoprostol tablets in a dose of 50 microgram given 90-120 minutes before an elective caesarian section. | Drug | Misoprostol Group |
| PlaceboVaginal placebo pills given 90-120 minutes before an elective caesarian section. | Drug | Placebo Group |
Primary outcome
incidence of neonatal respiratory morbidity (NRM)
Time frame: 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.
1 secondary outcome
Neonatal intensive care unit (NICU) admission
Time frame: up to 24 hours after birth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
Related trials for Transient Tachypnea of the Newborn
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Active, not recruitingObservational study
Assessment of Diastolic Function During the Transitional Period and Infancy Using Serial Echocardiography
Diastolic Dysfunction, Neonatal Encephalopathy
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Pulmonary Function Using Non-invasive Forced Oscillometry
Infant, Premature, Diseases, Infant, Newborn, Diseases
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The Effectiveness of Inhaled Salbutamol in the Management of Transient Tachypnea of the Newborn(TTN)
TTN
Active, not recruitingPhase 3
the Inhaled β2-adrenergic Receptor Agonist for Transient Tachypnoea of the Newborn (the REFSAL Trial)
TTN, Respiratory Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samar A. Kandeel principal investigator
Ain Shams University - Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Misoprostol in people with Transient Tachypnea of the Newborn and Neonatal Respiratory Distress, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of neonatal respiratory morbidity (NRM) (time frame: up to 24 hours after birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2021.