Cesarean SectionPhase 2/3NCT03144401
Preoperative vs. Postoperative Misoprostol in Elective Cesarean Section
A Phase 2/3 study testing Misoprostol in people with Cesarean Section, 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 October 2017. 120 women candidate foe elective cesarean section will receive preoperative sublingual 400 microgram of misoprostol, and another 120 women will… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Cesarean Section
- 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
- 240 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Apr 2017to 1 Feb 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 booked for elective cesarean section.
- Singleton pregnancies.
- 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.
- Multiple pregnancies.
- Overdistended uterus eg. Hydramnios.
- Pre-eclampsia.
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- Marked maternal anemia (Preoperative hemoglobin < 9 gm/dl).
- Previous history of PPH.
- Contraindications to prostaglandin therapy (e.g. history of severe bronchial asthma or allergy to misoprostol.
- Placenta previa.
- Previous myomectomy.
- 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 Misoprostol in Elective Cesarean Section: A Double-blind Randomized Clinical Trial
This prospective double-blind placebo-controlled randomized clinical trial will be conducted at Ain-Shams University Maternity Hospital from April 2017 till October 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
- Cesarean Section
- Being tested
- Misoprostol, Placebo
- Keywords
- cesarean section, Misoprostol, sublingual, uterotonics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
mesotac
PlaceboOther
Placebo tablet identical to the misoprostol tablet but without the active ingredient
| Study group | Role | What they receive |
|---|---|---|
| Preoperative | Active comparator | • Group no.1 will receive preoperative sublingual 400 microgram of misoprostol (Sigma) "2 tablets" and postoperative sublingual placebo"2 tablets". Receives: Drug: Misoprostol; Other: Placebo |
| Postoperative | Active comparator | • Group no.2 will receive preoperative sublingual placebo "2 tablets" and postoperative sublingual 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.
Need for extra uterotonics
Measured: 24 hours
Secondary outcomes (3)
intraoperative blood loss
Measured: intraoperative
postpartum hemorrhage
Measured: 24 hours
neonatal outcome
measured by APGAR score at 1 and 5 minutes
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2017
- Study start10 Apr 2017
- Primary completion12 Jan 2018
- Study completion1 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionStudies 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
- 240 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
- NCT03144401
- Sponsor's protocol ID
- AS1374
- 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 Misoprostol in Elective Cesarean Section: A Double-blind Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03144401
- Acronym / sponsor ID
- AS1374
- Conditions
- Cesarean Section
- Keywords
- cesarean section, Misoprostol, sublingual, uterotonics
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 10 Apr 2017 (actual)
- Primary completion
- 12 Jan 2018 (actual)
- Study completion
- 1 Feb 2018 (actual)
- First posted
- 8 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 October 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: Placebo• Group no.1 will receive preoperative sublingual 400 microgram of misoprostol (Sigma) "2 tablets" and postoperative sublingual placebo"2 tablets". |
| Postoperative | Active comparator | Drug: Misoprostol, Other: Placebo• Group no.2 will receive preoperative sublingual placebo "2 tablets" and postoperative sublingual 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 (5 listed)
- Patients booked for elective cesarean section.
- Singleton pregnancies.
- Full term pregnancies (GA 37- 42 Wks).
- Age (18-40 yrs).
- body mass index (BMI) (20-30(Kg/m2 .
Key exclusion criteria (12 listed)
- Contraindication to spinal anesthesia.
- Blood dyscrasias.
- Large fibroids.
- Multiple pregnancies.
- Overdistended uterus eg. Hydramnios.
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 |
|---|---|---|
| Misoprostolmesotac | Drug | Postoperative, Preoperative |
| PlaceboPlacebo tablet identical to the misoprostol tablet but without the active ingredient | Other | Postoperative, Preoperative |
Primary outcome
Need for extra uterotonics
Time frame: 24 hours
3 secondary outcomes
intraoperative blood loss
Time frame: intraoperative
postpartum hemorrhage
Time frame: 24 hours
neonatal outcome
Time frame: 5 minutes
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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Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
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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 Cesarean Section, 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 12 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?
Need for extra uterotonics (time frame: 24 hours). 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.