Atonic PPHNCT05099575
Protocols for Prevention of PPH During CS in High Risk Group
An observational study of Atonic PPH, run by Assiut University.
Trial summary
PPH is one of the most leading causes of maternal mortality,. It means loss of 500 ml blood after vaginal delivery and 1000 ml blood after cesarean delivery. Although it's preventable it represents about 27%of maternal deaths. Atony is the main cause of PPH. 70%of PPH corresponds to uterine atony. Read more about this study
- Who is it for?
- Ages 19 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Atonic PPH
- What is being tested?
- Syntocinon, papal, misotac
- How many people
- 448 participants
- Where
- No sites listed yet
- Study dates
- 30 Oct 2021to 30 Oct 2022
- Phase
- Observational
- 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 19 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Prevention of atonic PPH during CD in high risk group
Who may be able to join
- 1. Pregnant full term>37 w 2. Maternal age 19- 40 3.physical state 1\&2 4.patient willing to enter the study
Who cannot join
- 1.who refuse to participate in study 2.immunocomprmized and patients who had contraindicated from any of drugs used 3.patients with hypersensitivity to any drug
About this study
Official title: Different Protocols for Prevention of Atonic Postpartum Hemorrhage During Cesarean Delivery in High Risk Group
PPH is one of the most leading causes of maternal mortality,. It means loss of 500 ml blood after vaginal delivery and 1000 ml blood after cesarean delivery. Although it's preventable it represents about 27%of maternal deaths. Atony is the main cause of PPH. 70%of PPH corresponds to uterine atony. Uterotonics like oxytocin, misoprostol, ergometrine, carbetocin and combinations of these drugs can be used but until now there is no agreement on medication that can be the most effective.
- Conditions
- Atonic PPH
- Being tested
- Syntocinon, papal, misotac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Syntocinon, papal, misotacDrug
Using different drugs to prevent atonic PPH during CD in high risk group
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women who receive oxytocin | Not described Receives: Drug: Syntocinon, papal, misotac | |
| Pregnant Women who receive carbetocin | Not described Receives: Drug: Syntocinon, papal, misotac | |
| Pregnant women who receive misoprostol | Not described Receives: Drug: Syntocinon, papal, misotac | |
| Pregnant women who receive ergometrine | Not described Receives: Drug: Syntocinon, papal, misotac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of blood loss
Decrease amount of blood loss
Measured: 1 year
Secondary outcomes (1)
Finding the drug most effective with least adverse effects
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study start30 Oct 2021 (estimated)
- Primary completion30 Oct 2022 (estimated)
- Study completion30 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atonic PPHStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 448 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Randa Wanees Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05099575
- Sponsor's protocol ID
- Atonic PPH in high risk group
- Status last verified
- Oct 2021
- First submitted
- 19 Oct 2021
- Last updated
- 29 Oct 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Protocols for Prevention of Atonic Postpartum Hemorrhage During Cesarean Delivery in High Risk Group
- ClinicalTrials.gov ID
- NCT05099575
- Acronym / sponsor ID
- Atonic PPH in high risk group
- Conditions
- Atonic PPH
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 448 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Oct 2021 (estimated)
- Primary completion
- 30 Oct 2022 (estimated)
- Study completion
- 30 Oct 2022 (estimated)
- First posted
- 29 Oct 2021 (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.
PPH is one of the most leading causes of maternal mortality,. It means loss of 500 ml blood after vaginal delivery and 1000 ml blood after cesarean delivery. Although it's preventable it represents about 27%of maternal deaths. Atony is the main cause of PPH. 70%of PPH corresponds to uterine atony. Uterotonics like oxytocin, misoprostol, ergometrine, carbetocin and combinations of these drugs can be used but until now there is no agreement on medication that can be the most effective.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pregnant women who receive oxytocin | – | Drug: Syntocinon, papal, misotac |
| Pregnant Women who receive carbetocin | – | Drug: Syntocinon, papal, misotac |
| Pregnant women who receive misoprostol | – | Drug: Syntocinon, papal, misotac |
| Pregnant women who receive ergometrine | – | Drug: Syntocinon, papal, misotac |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Prevention of atonic PPH during CD in high risk group
Key inclusion criteria (1 listed)
- 1. Pregnant full term>37 w 2. Maternal age 19- 40 3.physical state 1\&2 4.patient willing to enter the study
Key exclusion criteria (1 listed)
- 1.who refuse to participate in study 2.immunocomprmized and patients who had contraindicated from any of drugs used 3.patients with hypersensitivity to any drug
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 |
|---|---|---|
| Syntocinon, papal, misotacUsing different drugs to prevent atonic PPH during CD in high risk group | Drug | Pregnant Women who receive carbetocin, Pregnant women who receive ergometrine, Pregnant women who receive misoprostol, Pregnant women who receive oxytocin |
Primary outcome
Amount of blood loss
Time frame: 1 year
Decrease amount of blood loss
1 secondary outcome
Finding the drug most effective with least adverse effects
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2021.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Atonic PPH, run by Assiut University.
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 1 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: status not confirmed, as of the sponsor's last update on 29 Oct 2021. 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. 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?
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?
Amount of blood loss (time frame: 1 year). 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 Oct 2021; AzTrials last refreshed its copy on 6 Nov 2026.