Transient Tachypnea NewbornNCT03031353
Misoprostol Before Elective Caesarean Section for Decreasing the Neonatal Respiratory Morbidity
A study testing Misoprostol in people with Transient Tachypnea Newborn and Cesarean Delivery Affecting Fetus, run by Ain Shams University at 1 site in Egypt.
Trial summary
Neonatal respiratory distress may occur in either term or preterm newborns with a higher relative risk in preterm, and whether born vaginally or through caesarean section, but in a higher percentage after elective caesarean section whose rate is rising. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Transient Tachypnea Newborn, Cesarean Delivery Affecting Fetus
- 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
- 170 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2017to Jun 2018
- Phase
- Interventional
- 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 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age: 18 years or more.
- Term singleton pregnancy (38 - 38+6 weeks gestation).
- Planned for elective transverse lower segment caesarean section with an indication.
Who cannot join
- Women with history of significant cardiac disease, eclampsia, pre eclampsia, epilepsy, severe asthma, severe allergic condition, vascular disease, renal or hepatic disease.
- Women with contraindication to prostaglandins as Glucoma or known hypersensitivity to prostaglandins or specifically for misoprostol.
- Psychological problem or mental disease that renders the patient not able to understand the nature, scope, and sequences of the study.
- Pregnancies with known foetal malformation/s or chromosomal aberration.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine, Ain Shams University
Cairo, Cairo Governorate
ahmed kotb, MD, 2001008681999, ahmedmkotp@hotmail.com
ebtihal dr eltaieb, MD, 1004711414 ext. 0020, ahmedmkotp@hotmail.com
About this study
Official title: Misoprostol Before Elective Caesarean Section for Decreasing the Neonatal Respiratory Morbidity: A Randomized Controlled Trial
Neonatal respiratory distress may occur in either term or preterm newborns with a higher relative risk in preterm, and whether born vaginally or through caesarean section, but in a higher percentage after elective caesarean section whose rate is rising.
Prostaglandins may be given about one hour before an elective caesarean section after excluding the presence of contraindication to their use to decrease the neonatal respiratory diseases and thus, the number of children who suffered from bronchopulmonary dysplasia that occurs frequently in children who had previously TTN will diminish.
- Being tested
- Misoprostol, Placebos
- Medical subject headings
- Transient Tachypnea of the Newborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
Also called Mesotac
Misoprostol is given before elective cesarean section as prophylaxis against post partum hemorrhage
PlacebosDrug
placebos tablet will be given before elective Cesarean sections
| Study group | Role | What they receive |
|---|---|---|
| Misoprostol | Experimental | After preparing for elective caesarean section, the pessary will be given containing the misoprostol medication 1 hour before , women in the operating room, and the anaesthetic and surgical techniques will be standardized Receives: Drug: Misoprostol |
| Placebo | Active comparator | After preparing for elective caesarean section, the pessary will be given containing placebo 1 hour before , women in the operating room, and the anaesthetic and surgical techniques will be standardized Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
The need for admission to neonatal intensive care unit (NICU)
Number of newborns admitted to NICU for respiratory morbidity
Measured: first 24 hours after delivery
Secondary outcomes (1)
APGAR score below 6 at 5 minute
number of newborns delivered with APGAR score below 6 at 5 minutes
Measured: 5 minutes after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionMay 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transient Tachypnea 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed El Kotb Abdel Fattah, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03031353
- Sponsor's protocol ID
- AinShamsU103
- Status last verified
- May 2018
- First submitted
- 27 Nov 2016
- Last updated
- 29 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Misoprostol Before Elective Caesarean Section for Decreasing the Neonatal Respiratory Morbidity: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03031353
- Acronym / sponsor ID
- AinShamsU103
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- May 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 25 Jan 2017 (estimated)
- 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 distress may occur in either term or preterm newborns with a higher relative risk in preterm, and whether born vaginally or through caesarean section, but in a higher percentage after elective caesarean section whose rate is rising.
Prostaglandins may be given about one hour before an elective caesarean section after excluding the presence of contraindication to their use to decrease the neonatal respiratory diseases and thus, the number of children who suffered from bronchopulmonary dysplasia that occurs frequently in children who had previously TTN will diminish.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Misoprostol | Experimental | Drug: MisoprostolAfter preparing for elective caesarean section, the pessary will be given containing the misoprostol medication 1 hour before , women in the operating room, and the anaesthetic and surgical techniques will be standardized |
| Placebo | Active comparator | Drug: PlacebosAfter preparing for elective caesarean section, the pessary will be given containing placebo 1 hour before , women in the operating room, and the anaesthetic and surgical techniques will be standardized |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age: 18 years or more.
- Term singleton pregnancy (38 - 38+6 weeks gestation).
- Planned for elective transverse lower segment caesarean section with an indication.
Key exclusion criteria (4 listed)
- Women with history of significant cardiac disease, eclampsia, pre eclampsia, epilepsy, severe asthma, severe allergic condition, vascular disease, renal or hepatic disease.
- Women with contraindication to prostaglandins as Glucoma or known hypersensitivity to prostaglandins or specifically for misoprostol.
- Psychological problem or mental disease that renders the patient not able to understand the nature, scope, and sequences of the study.
- Pregnancies with known foetal malformation/s or chromosomal aberration.
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: MesotacMisoprostol is given before elective cesarean section as prophylaxis against post partum hemorrhage | Drug | Misoprostol |
| Placebosplacebos tablet will be given before elective Cesarean sections | Drug | Placebo |
Primary outcome
The need for admission to neonatal intensive care unit (NICU)
Time frame: first 24 hours after delivery
Number of newborns admitted to NICU for respiratory morbidity
1 secondary outcome
APGAR score below 6 at 5 minute
Time frame: 5 minutes after delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2018.
- Individual participant dataSharing planned: No
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The Effectiveness of Inhaled Salbutamol in the Management of Transient Tachypnea of the Newborn(TTN)
TTN
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the Inhaled β2-adrenergic Receptor Agonist for Transient Tachypnoea of the Newborn (the REFSAL Trial)
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Misoprostol in people with Transient Tachypnea Newborn and Cesarean Delivery Affecting Fetus, 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 3 inclusion and 4 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 29 May 2018. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Contact Ahmed M kotb, MD (01008681999 ext. 0020, ahmedmkotp@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The need for admission to neonatal intensive care unit (NICU) (time frame: first 24 hours after delivery). 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 29 May 2018.