Cesarean SectionPhase 1NCT03390010
Misoprostol Versus Active Management of Labour in CS
A Phase 1 study testing Misoprostol + syntocinon and using extra uterotonic drugs when needed ; methergine and Syntocinon and using extra uterotonic drugs when needed ; methergine carboprost in people with Cesarean Section, run by Aljazeera Hospital at 1 site in Egypt.
Trial summary
Several treatment strategies are emplemented to prevent post delivery hemorage and decreasing maternal morbidity and mortality . Read more about this study
- Who is it for?
- Ages 18 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section
- What is being tested?
- Misoprostol + syntocinon and using extra uterotonic drugs when needed ; methergine and Syntocinon and using extra uterotonic drugs when needed ; methergine carboprost
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Dec 2017to 6 Mar 2018
- Phase
- Phase 1
- 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 42 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- • All patients included in this research were aged 18-42 years, pregnant 37 weeks till 42 weeks
- no medical disorders with pregnancy e.g DM, HTN. All patients were subjected to full history taking, examination.
Who cannot join
- The following patients were excluded , GA before 37 weeks or after 42 weeks , medical disorders with pregnancy eg. DM with pregnancy, HTN with pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intrauterine Misoprostol With Active Management of Labour Versus Active Management of Labour for Prevebtion of Postpartum Hemorage in Cesarean Section ,Randomized Controlled Trial
Several treatment strategies are emplemented to prevent post delivery hemorage and decreasing maternal morbidity and mortality .
Read the detailed description
Many approved drugs are used in prophylaxis against postpartum hemorage from these medications are the (syntocinon combined with methergine ) that are known as active management of labour drugs .
Moreover there is misotac , that also guards against postpartum hemorage .
All these medications act in a different way to cause uterine contraction post delivery to prevent uterine atony .
-Here we are comparing the additive value of misotac intrauterine to syntocinon and methergine in comparison to the usually used syntocinon plus methergine .
- Conditions
- Cesarean Section
- Being tested
- Misoprostol + syntocinon and using extra uterotonic drugs when needed ; methergine, Syntocinon and using extra uterotonic drugs when needed ; methergine carboprost
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Misoprostol + syntocinon and using extra uterotonic drugs when needed ; methergineDrug
Also called DrugsMisoprostol plus syntocinon and using extra uterotonic drugs when needed ; methergine , carboprost
medical prophylaxis against postpartum atony and postpartum hemorage by giving misoprostol plus syntocinon and using extra uterotonic drugs when needed ; methergine, carboprost
Syntocinon and using extra uterotonic drugs when needed ; methergine carboprostDrug
Also called drugs ( syntocinon and using extra uterotonic drugs when needed ; methergine, carboprost
medical prophylaxis against postpartum atony and postpartum hemorage by giving syntocinon and using extra uterotonic drugs when needed ; methergine, carboprost
| Study group | Role | What they receive |
|---|---|---|
| Extra medication group | Active comparator | -Procedure : Giving misoprostol plus syntocinon during CS
this group in which prevention of uterine atony is made by intrauterine misoprostol plus the usual syntocinon and using extra uterotonic drugs when needed ; methergine , carboprost Receives: Drug: Misoprostol + syntocinon and using extra uterotonic drugs when needed ; methergine |
| Active management of labour group | Active comparator | * Procedure: Giving syntocinon during cesarean section
* this group in which prevention of uterine atony is made by the usual active management of labour syntocinon and using extra uterotonic drugs when needed ; methergine , carboprost Receives: Drug: Syntocinon and using extra uterotonic drugs when needed ; methergine carboprost |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of participants who passed cesarean section without postpartum hemorage
Measured: within 2 days post CS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2018
- Study start28 Dec 2017
- Primary completion28 Feb 2018
- Study completion6 Mar 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.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aljazeera Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Sponsor
- Investigators
- Mahmoud Alalfy, M.s.c, Study chair, Algazeerah hospital -Location (Giza -Egypt )yossra Lasheen, M.D, Principal investigator, kasraliny hospital- Aljazeerah hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03390010
- Sponsor's protocol ID
- Active management of labour
- Status last verified
- Nov 2022
- First submitted
- 28 Dec 2017
- Last updated
- 16 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrauterine Misoprostol With Active Management of Labour Versus Active Management of Labour for Prevebtion of Postpartum Hemorage in Cesarean Section ,Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03390010
- Acronym / sponsor ID
- Active management of labour
- Conditions
- Cesarean Section
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Aljazeera HospitalUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 28 Dec 2017 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 6 Mar 2018 (actual)
- First posted
- 4 Jan 2018 (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.
Several treatment strategies are emplemented to prevent post delivery hemorage and decreasing maternal morbidity and mortality .
Detailed description
Many approved drugs are used in prophylaxis against postpartum hemorage from these medications are the (syntocinon combined with methergine ) that are known as active management of labour drugs .
Moreover there is misotac , that also guards against postpartum hemorage .
All these medications act in a different way to cause uterine contraction post delivery to prevent uterine atony .
-Here we are comparing the additive value of misotac intrauterine to syntocinon and methergine in comparison to the usually used syntocinon plus methergine .
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extra medication group | Active comparator | Drug: Misoprostol + syntocinon and using extra uterotonic drugs when needed ; methergine-Procedure : Giving misoprostol plus syntocinon during CS this group in which prevention of uterine atony is made by intrauterine misoprostol plus the usual syntocinon and using extra uterotonic drugs when needed ; methergine , carboprost |
| Active management of labour group | Active comparator | Drug: Syntocinon and using extra uterotonic drugs when needed ; methergine carboprost* Procedure: Giving syntocinon during cesarean section * this group in which prevention of uterine atony is made by the usual active management of labour syntocinon and using extra uterotonic drugs when needed ; methergine , carboprost |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- • All patients included in this research were aged 18-42 years, pregnant 37 weeks till 42 weeks
Key exclusion criteria (1 listed)
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 + syntocinon and using extra uterotonic drugs when needed ; methergineAlso: DrugsMisoprostol plus syntocinon and using extra uterotonic drugs when needed ; methergine , carboprostmedical prophylaxis against postpartum atony and postpartum hemorage by giving misoprostol plus syntocinon and using extra uterotonic drugs when needed ; methergine, carboprost | Drug | Extra medication group |
| Syntocinon and using extra uterotonic drugs when needed ; methergine carboprostAlso: drugs ( syntocinon and using extra uterotonic drugs when needed ; methergine, carboprostmedical prophylaxis against postpartum atony and postpartum hemorage by giving syntocinon and using extra uterotonic drugs when needed ; methergine, carboprost | Drug | Active management of labour group |
Primary outcome
The number of participants who passed cesarean section without postpartum hemorage
Time frame: within 2 days post CS
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 16 Nov 2022.
- Individual participant dataSharing planned: No
Related trials for Cesarean Section
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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.
Mahmoud Alalfy, M.s.c study chair
Algazeerah hospital -Location (Giza -Egypt )
yossra Lasheen, M.D principal investigator
kasraliny hospital- Aljazeerah hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Misoprostol + syntocinon and using extra uterotonic drugs when needed ; methergine and Syntocinon and using extra uterotonic drugs when needed ; methergine carboprost in people with Cesarean Section, run by Aljazeera Hospital 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 2 inclusion and 1 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 16 Nov 2022. 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 phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The number of participants who passed cesarean section without postpartum hemorage (time frame: within 2 days post CS). 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 16 Nov 2022.