ıntrapartum HaemorrhagePhase 4NCT01931410
The Effect of Rectal and Sublingual Misoprostol Administration in Postpartum or Intrapartum Haemorrhage at Elective Caesarean Delivery: a Randomized Controlled Trial
A Phase 4 study testing Misoprostol in people with ıntrapartum Haemorrhage and Postpartum Haemorrhage, run by Istanbul Bakirkoy Maternity and Children Diseases Hospital.
Trial summary
The investigators hypothesis in this study is that administration of rectal and sublingual misoprostol decreases intrapartum and postpartum haemorrhage. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- ıntrapartum Haemorrhage, Postpartum Haemorrhage
- What is being tested?
- Misoprostol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 618 participants
- Where
- No sites listed yet
- Study dates
- Jun 2013to Feb 2014
- Phase
- Phase 4
- 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 44 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- live and singleton pregnancy
- Elective caesarean
- Gestational week greater than 37 weeks
- patient between 18-44 year old
Who cannot join
- -multiple pregnancy
- Preeclampsia
- Gestational diabetes
- Macrosomia
- Oligohidraamnıos
- Polihidraamnıos
Show all 9Show fewer
- Myoma
- Morbid obesity
- Coagulatıon defect (such as HELLP syndrome)
About this study
The investigators hypothesis in this study is that administration of rectal and sublingual misoprostol decreases intrapartum and postpartum haemorrhage.
- Conditions
- ıntrapartum Haemorrhage, Postpartum Haemorrhage
- Being tested
- Misoprostol
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
| Study group | Role | What they receive |
|---|---|---|
| sublingual | Placebo comparator | 400 microgram mısoprostol will be administered sublıngually before elective caesarean Receives: Drug: Misoprostol |
| rectal | Placebo comparator | rectal 600 mgr misoprostol will be administered Receives: Drug: Misoprostol |
| synpitan | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postpartum Haemorrhage
Measured: postpartum 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2013 (estimated)
- Study startJun 2013
- Primary completionJan 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ıntrapartum HaemorrhageStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 618 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Bakirkoy Maternity and Children Diseases Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Osman Aşıcıoğlu, Istanbul Bakirkoy Maternity and Children Diseases Hospital
- Investigators
- Berhan AŞICIOĞLU, M.D., Principal investigator, T.C.S.B. Kanuni Sultan Süleyman Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01931410
- Sponsor's protocol ID
- Aşıcıoğlu-05
- Status last verified
- Feb 2014
- First submitted
- 26 Aug 2013
- Last updated
- 25 Feb 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Rectal and Sublingual Misoprostol Administration in Postpartum or Intrapartum Haemorrhage at Elective Caesarean Delivery: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01931410
- Acronym / sponsor ID
- Aşıcıoğlu-05
- Conditions
- ıntrapartum Haemorrhage, Postpartum Haemorrhage
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 618 participants (actual)
- Lead sponsor
- Istanbul Bakirkoy Maternity and Children Diseases HospitalOther government
- Study start
- Jun 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 29 Aug 2013 (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.
The investigators hypothesis in this study is that administration of rectal and sublingual misoprostol decreases intrapartum and postpartum haemorrhage.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| sublingual | Placebo comparator | Drug: Misoprostol400 microgram mısoprostol will be administered sublıngually before elective caesarean |
| rectal | Placebo comparator | Drug: Misoprostolrectal 600 mgr misoprostol will be administered |
| synpitan | No intervention | – |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- live and singleton pregnancy
- Elective caesarean
- Gestational week greater than 37 weeks
- patient between 18-44 year old
Key exclusion criteria (9 listed)
- -multiple pregnancy
- Preeclampsia
- Gestational diabetes
- Macrosomia
- Oligohidraamnıos
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 |
|---|---|---|
| Misoprostol | Drug | rectal, sublingual |
Primary outcome
Postpartum Haemorrhage
Time frame: postpartum 24 hour
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 25 Feb 2014.
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.
Berhan AŞICIOĞLU, M.D. principal investigator
T.C.S.B. Kanuni Sultan Süleyman Research Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Misoprostol in people with ıntrapartum Haemorrhage and Postpartum Haemorrhage, run by Istanbul Bakirkoy Maternity and Children Diseases Hospital.
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 9 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 25 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Postpartum Haemorrhage (time frame: postpartum 24 hour). 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 25 Feb 2014.