Vitamin KNCT04984083
Maternal and Neonatal Benefits of Prophylactic Administration of Vitamin K Before Elective Cesarean Section
A study testing vitamin k in people with Vitamin K, run by National Research Centre, Egypt at 1 site in Egypt.
Trial summary
Vitamin K deficiency can cause serious risks to pregnant women and their babies that may lead to hemorrhage, especially in newborns. We aim to evaluate the efficacy of vitamin k in decreasing blood loss during and after elective cesarean section (CS), and to assess the neonatal beneficial effects of prophylactic… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vitamin K
- What is being tested?
- vitamin k
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jul 2021to 31 Dec 2021
- Phase
- Interventional
- 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age from 20-40 years.
- Gestational age between 36-39 weeks.
- Patients who will undergo an elective cesarean section.
- Full-term alive baby.
- Non-scarred uterus.
- No obstetric or medical complications.
- No bleeding tendency.
Who cannot join
- Patients at less than 36 gestational weeks.
- Patient refusal.
- Patients who have thrombo-embolic complications.
- Patients with obstetric and medical complications.
- Patients with anomalous fetuses.
- Patients on anti-coagulant drugs, long-term antibiotics, and anti-epileptic drugs.
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- Patients with obstetric cholestasis.
- Patients with a previous history of preterm labor.
- Patients with multiple pregnancies.
- Gestational hypertension or preeclampsia.
- Blood clotting disorders.
- Placental abnormalities such as, Placenta accreta, Placenta increta, and Placenta percreta.
- Placental abruption and Placenta previa.
Trial locations and contacts
1 site in 1 country.
About this study
Vitamin K deficiency can cause serious risks to pregnant women and their babies that may lead to hemorrhage, especially in newborns. We aim to evaluate the efficacy of vitamin k in decreasing blood loss during and after elective cesarean section (CS), and to assess the neonatal beneficial effects of prophylactic maternal vitamin k administration.
- Conditions
- Vitamin K
- Being tested
- vitamin k
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin kDietary supplement
patients will take vitamin k 10 mg/ml once daily orally or IM between four and 96 hours before elective cesarean section
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | patients will take vitamin k 10 mg/ml once daily orally or IM between four and 96 hours before elective cesarean section Receives: Dietary Supplement: vitamin k |
| Group II | No intervention | patients will not take vitamin k before cesarean section |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood loss (measured in cc)
Measured: During Cesarean Section
Prothrombin time of the mother (measured in seconds)
Measured: 6 hour postmartum
Activated Partial Thromboplastin Time (APTT) of the mother (measured in seconds)
Measured: 6 hour postmartum
Prothrombin Concentration (PC) of the mother (measured in %)
Measured: 6 hour postmartum
Prothrombin time of the newborn (measured in seconds)
Measured: immediately after birth
Prothrombin Concentration (PC) of the newborn (measured in %)
Measured: immediately after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2021
- Study start30 Jul 2021
- Primary completion1 Oct 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin KStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Research Centre, Egypt
- Sponsor type
- University, hospital or other
- Collaborators
- Minia University
- Responsible party
- Principal investigator, Mazen Abdel Rasheed, National Research Centre, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04984083
- Sponsor's protocol ID
- Prophylactic Vitamin K
- Status last verified
- Feb 2022
- First submitted
- 16 Jul 2021
- Last updated
- 15 Feb 2022
- 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 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal and Neonatal Benefits of Prophylactic Administration of Vitamin K Before Elective Cesarean Section
- ClinicalTrials.gov ID
- NCT04984083
- Acronym / sponsor ID
- Prophylactic Vitamin K
- Conditions
- Vitamin K
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- National Research Centre, EgyptUniversity, hospital or other
- Collaborators
- Minia University
- Study start
- 30 Jul 2021 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 30 Jul 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.
Vitamin K deficiency can cause serious risks to pregnant women and their babies that may lead to hemorrhage, especially in newborns. We aim to evaluate the efficacy of vitamin k in decreasing blood loss during and after elective cesarean section (CS), and to assess the neonatal beneficial effects of prophylactic maternal vitamin k administration.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Dietary Supplement: vitamin kpatients will take vitamin k 10 mg/ml once daily orally or IM between four and 96 hours before elective cesarean section |
| Group II | No intervention | –patients will not take vitamin k before cesarean section |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age from 20-40 years.
- Gestational age between 36-39 weeks.
- Patients who will undergo an elective cesarean section.
- Full-term alive baby.
- Non-scarred uterus.
Key exclusion criteria (13 listed)
- Patients at less than 36 gestational weeks.
- Patient refusal.
- Patients who have thrombo-embolic complications.
- Patients with obstetric and medical complications.
- Patients with anomalous fetuses.
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 |
|---|---|---|
| vitamin kpatients will take vitamin k 10 mg/ml once daily orally or IM between four and 96 hours before elective cesarean section | Dietary supplement | Group I |
Primary outcome
Blood loss (measured in cc)
Time frame: During Cesarean Section
Prothrombin time of the mother (measured in seconds)
Time frame: 6 hour postmartum
Activated Partial Thromboplastin Time (APTT) of the mother (measured in seconds)
Time frame: 6 hour postmartum
Prothrombin Concentration (PC) of the mother (measured in %)
Time frame: 6 hour postmartum
Prothrombin time of the newborn (measured in seconds)
Time frame: immediately after birth
Prothrombin Concentration (PC) of the newborn (measured in %)
Time frame: immediately after birth
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 15 Feb 2022.
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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 study testing vitamin k in people with Vitamin K, run by National Research Centre, Egypt 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 7 inclusion and 13 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 15 Feb 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.
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?
Blood loss (measured in cc) (time frame: During Cesarean Section). The study lists 6 primary outcomes in all. 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 15 Feb 2022.