Induction of LaborEarly Phase 1NCT06539975
Effectiveness of Evening Primrose Oil for Induction of Labor
A Early Phase 1 study testing Evening Primrose Oil 1000 MG in people with Induction of Labor, run by Assiut University.
Trial summary
Effectivness of primrose oil in induction of labour . Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Induction of Labor
- What is being tested?
- Evening Primrose Oil 1000 MG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 10 Dec 2024to 12 Oct 2025
- Phase
- Early 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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- pregenent of 38 weeks and longer
- singleton pregenency
- vertex presentation
- indication of labor induction
- bishop score <6 and cervical dilation<2 cm
Who cannot join
- women who delivered by classical cs or had a history of myomectomy , hysterscopic uterine surgery , or cervical surgery like conisation
- women with multiple gestation
- women with evidence of low implanted placenta by ultrasound
- women with contraindication to misoprostol or vaginal delivery
Trial locations and contacts
No sites are listed yet.
About this study
Effectivness of primrose oil in induction of labour .
Read the detailed description
Using primrose oil in addition to misoprostol for induction of labor in one group of pregnant women and compare the result with those of another group in which we are using misoprstol only.
- Conditions
- Induction of Labor
- Being tested
- Evening Primrose Oil 1000 MG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evening Primrose Oil 1000 MGDrug
Evening primrose oil 1000mg vaginally plus misoprostal for induction of labor
| Study group | Role | What they receive |
|---|---|---|
| Evening primrose oil + misoprostol | Active comparator | combination of both drugs for induction of labor adminstrated vaginally. Receives: Drug: Evening Primrose Oil 1000 MG |
| misoprostol only | Other | misoprostol alone for induction of labor adminstrated vaginally. Receives: Drug: Evening Primrose Oil 1000 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
The interval between induction of labor and delivery
comparing between the interval between induction of labor and delivery in two groups one is using evening primrose oil + misoprostol and the other using misoprostol only.
Measured: induction of labor may take more than 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start10 Dec 2024 (estimated)
- Primary completion10 Sep 2025 (estimated)
- Study completion12 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Induction of LaborStudies 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will be a douple-centered, serially-numbered closed opaque envelope, randomised clinical trial.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, sayed mohamed sayed mostafa, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06539975
- Sponsor's protocol ID
- primrose oil in labor
- Status last verified
- Aug 2024
- First submitted
- 2 Aug 2024
- Last updated
- 6 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hemmatzadeh S, Mohammad Alizadeh Charandabi S, Veisy A, Mirghafourvand M. Evening primrose oil for cervical ripening in term pregnancies: a systematic review and meta-analysis. J Complement Integr Med. 2021 Jul 14;20(2):328-337. doi: 10.1515/jcim-2020-0314. eCollection 2023 Jun 1.
PubMed 34261202Moradi M, Niazi A, Heydarian Miri H, Lopez V. The effect of evening primrose oil on labor induction and cervical ripening: A systematic review and meta-analysis. Phytother Res. 2021 Oct;35(10):5374-5383. doi: 10.1002/ptr.7147. Epub 2021 Apr 29.
PubMed 33913585
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Evening Primrose Oil for Induction of Labor
- ClinicalTrials.gov ID
- NCT06539975
- Acronym / sponsor ID
- primrose oil in labor
- Conditions
- Induction of Labor
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Dec 2024 (estimated)
- Primary completion
- 10 Sep 2025 (estimated)
- Study completion
- 12 Oct 2025 (estimated)
- First posted
- 6 Aug 2024 (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.
Effectivness of primrose oil in induction of labour .
Detailed description
Using primrose oil in addition to misoprostol for induction of labor in one group of pregnant women and compare the result with those of another group in which we are using misoprstol only.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- The study will be a douple-centered, serially-numbered closed opaque envelope, randomised clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Evening primrose oil + misoprostol | Active comparator | Drug: Evening Primrose Oil 1000 MGcombination of both drugs for induction of labor adminstrated vaginally. |
| misoprostol only | Other | Drug: Evening Primrose Oil 1000 MGmisoprostol alone for induction of labor adminstrated vaginally. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- pregenent of 38 weeks and longer
- singleton pregenency
- vertex presentation
- indication of labor induction
- bishop score <6 and cervical dilation<2 cm
Key exclusion criteria (4 listed)
- women who delivered by classical cs or had a history of myomectomy , hysterscopic uterine surgery , or cervical surgery like conisation
- women with multiple gestation
- women with evidence of low implanted placenta by ultrasound
- women with contraindication to misoprostol or vaginal delivery
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 |
|---|---|---|
| Evening Primrose Oil 1000 MGEvening primrose oil 1000mg vaginally plus misoprostal for induction of labor | Drug | Evening primrose oil + misoprostol, misoprostol only |
Primary outcome
The interval between induction of labor and delivery
Time frame: induction of labor may take more than 24 hours
comparing between the interval between induction of labor and delivery in two groups one is using evening primrose oil + misoprostol and the other using misoprostol only.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Background: PubMed 34261202Hemmatzadeh S, Mohammad Alizadeh Charandabi S, Veisy A, Mirghafourvand M. Evening primrose oil for cervical ripening in term pregnancies: a systematic review and meta-analysis. J Complement Integr Med. 2021 Jul 14;20(2):328-337. doi: 10.1515/jcim-2020-0314. eCollection 2023 Jun 1.
- Results publication: PubMed 33913585Moradi M, Niazi A, Heydarian Miri H, Lopez V. The effect of evening primrose oil on labor induction and cervical ripening: A systematic review and meta-analysis. Phytother Res. 2021 Oct;35(10):5374-5383. doi: 10.1002/ptr.7147. Epub 2021 Apr 29.
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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.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Evening Primrose Oil 1000 MG in people with Induction of Labor, 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 5 inclusion and 4 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 6 Aug 2024. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact sayed mohamed, resident (01093622038, sayedmohmed19@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The interval between induction of labor and delivery (time frame: induction of labor may take more than 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06539975, which also lists 2 linked publications.
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 6 Aug 2024.