Neonatal OutcomePhase 2/3NCT03148717
Preoperative vs. Postoperative Rectal Misoprostol in Cesarean Section
A Phase 2/3 study testing Misoprostol in people with Neonatal Outcome, run by Ain Shams University at 1 site in Egypt.
Trial summary
This prospective double-blind placebo-controlled randomized clinical trial will be conducted at Ain-Shams University Maternity Hospital from April 2017 till December 2017. Group 1 women, candidates for cesarean section, will receive preoperative rectal 400 microgram of misoprostol, and Group 2 women will receive… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Neonatal Outcome
- 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
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 10 May 2017to 20 Mar 2018
- Phase
- Phase 2/3
- 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 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients candidate for cesarean section.
- Full term pregnancies (GA 37- 42 Wks).
- Age (18-40 yrs).
- body mass index (BMI) (20-30(Kg/m2 .
Who cannot join
- Contraindication to spinal anesthesia.
- Blood dyscrasias.
- Large fibroids.
- Contraindications to prostaglandin therapy (e.g. history of severe bronchial asthma or allergy to misoprostol.
- Emergency CS such as fetal distress
- Extreme of BMI (<20 or >30 Kg/m2 ).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preoperative vs. Postoperative Rectal Misoprostol in Cesarean Section: A Randomized, Double Blind Clinical Trial
This prospective double-blind placebo-controlled randomized clinical trial will be conducted at Ain-Shams University Maternity Hospital from April 2017 till December 2017. Group 1 women, candidates for cesarean section, will receive preoperative rectal 400 microgram of misoprostol, and Group 2 women will receive postoperative rectal 400 microgram of misoprostol.
2017. 120 women candidate foe elective cesarean section will receive preoperative sublingual 400 microgram of misoprostol, and another 120 women will receive postoperative sublingual 400 microgram of misoprostol.
- Conditions
- Neonatal Outcome
- Being tested
- Misoprostol, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
Also called Mesotac
Cytotec
PlaceboOther
Placebo tablet similar in shape, odour and consistency to misoprostol tablet.
| Study group | Role | What they receive |
|---|---|---|
| Preoperative | Active comparator | Group no.1 will receive preoperative rectal 400 microgram of misoprostol (Sigma) "2 tablets" and postoperative rectal placebo"2 tablets". Receives: Drug: Misoprostol; Other: Placebo |
| Postoperative | Active comparator | Group no.2 will receive preoperative rectal placebo "2 tablets" and postoperative rectal 400 microgram of misoprostol (Sigma) " 2 tablets" . Receives: Drug: Misoprostol; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal outcome
measured by APGAR score at 5 minutes
Measured: 5 minutes
Secondary outcomes (4)
NICU admission
Number of neonates admitted to NICU within 24 hours.
Measured: 24 hours
amount of blood loss
Measured: 24 hours
Postpartum hemorrhage
Measured: 24 hours
Need for extra uterotonics
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2017
- Study start10 May 2017
- Primary completion2 Mar 2018
- Study completion20 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal OutcomeStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed S Sweed, MD, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03148717
- Sponsor's protocol ID
- AS1380
- Status last verified
- Mar 2018
- First submitted
- 29 Apr 2017
- Last updated
- 22 Mar 2018
- 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 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative vs. Postoperative Rectal Misoprostol in Cesarean Section: A Randomized, Double Blind Clinical Trial
- ClinicalTrials.gov ID
- NCT03148717
- Acronym / sponsor ID
- AS1380
- Conditions
- Neonatal Outcome
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 10 May 2017 (actual)
- Primary completion
- 2 Mar 2018 (actual)
- Study completion
- 20 Mar 2018 (actual)
- First posted
- 11 May 2017 (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.
This prospective double-blind placebo-controlled randomized clinical trial will be conducted at Ain-Shams University Maternity Hospital from April 2017 till December 2017. Group 1 women, candidates for cesarean section, will receive preoperative rectal 400 microgram of misoprostol, and Group 2 women will receive postoperative rectal 400 microgram of misoprostol.
2017. 120 women candidate foe elective cesarean section will receive preoperative sublingual 400 microgram of misoprostol, and another 120 women will receive postoperative sublingual 400 microgram of misoprostol.
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 |
|---|---|---|
| Preoperative | Active comparator | Drug: Misoprostol, Other: PlaceboGroup no.1 will receive preoperative rectal 400 microgram of misoprostol (Sigma) "2 tablets" and postoperative rectal placebo"2 tablets". |
| Postoperative | Active comparator | Drug: Misoprostol, Other: PlaceboGroup no.2 will receive preoperative rectal placebo "2 tablets" and postoperative rectal 400 microgram of misoprostol (Sigma) " 2 tablets" . |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients candidate for cesarean section.
- Full term pregnancies (GA 37- 42 Wks).
- Age (18-40 yrs).
- body mass index (BMI) (20-30(Kg/m2 .
Key exclusion criteria (6 listed)
- Contraindication to spinal anesthesia.
- Blood dyscrasias.
- Large fibroids.
- Contraindications to prostaglandin therapy (e.g. history of severe bronchial asthma or allergy to misoprostol.
- Emergency CS such as fetal distress
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: MesotacCytotec | Drug | Postoperative, Preoperative |
| PlaceboPlacebo tablet similar in shape, odour and consistency to misoprostol tablet. | Other | Postoperative, Preoperative |
Primary outcome
Neonatal outcome
Time frame: 5 minutes
measured by APGAR score at 5 minutes
4 secondary outcomes
NICU admission
Time frame: 24 hours
amount of blood loss
Time frame: 24 hours
Postpartum hemorrhage
Time frame: 24 hours
Need for extra uterotonics
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Misoprostol in people with Neonatal Outcome, 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 22 Mar 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Neonatal outcome (time frame: 5 minutes). 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 22 Mar 2018.