Missed AbortionPhase 3NCT03698734
Evening Primrose Oil Efficacy in Second Trimester Abortion
A Phase 3 study testing Evening primrose oil(EPO) in people with Missed Abortion, run by Ain Shams University at 1 site in Egypt.
Trial summary
efficacy of evening primrose oil in shortening the duration of induction in 2nd trimesteric missed abortion Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Missed Abortion
- What is being tested?
- Evening primrose oil(EPO)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2018to 1 Nov 2019
- Phase
- Phase 3
- 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
- Primiparous women
Who cannot join
- Previous uterine incision( Cs, myomectomy,)
- Contraindications to medical or surgical uterine evacuations (eg, hemodynamically unstable, coagulopathy)
- Evidence of intra-uterine infection
- Rupture of fetal membranes.
- Intrauterine device in place.
- Allergy to prostaglandins or EPO
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
AinShams university maternity hospital
Cairo, Abbassya, 11566
Ahmed K Maklad, MD
About this study
Official title: Effect of Adding Evening Primrose Oil to Misoprostol in Second Trimester Abortion
efficacy of evening primrose oil in shortening the duration of induction in 2nd trimesteric missed abortion
- Conditions
- Missed Abortion
- Being tested
- Evening primrose oil(EPO), Placebo - Cap
- Medical subject headings
- Abortion, Missed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evening primrose oil(EPO)Drug
primiparous women with missed abortion between(13 to 24 weeks) will receive 1 capsule of EPO( 1000mg) in addition to misopristol
Placebo - CapDrug
primiparous women with missed abortion between(13 to 24 weeks) will receive 1 capsule of placebo in addition to misopristol
| Study group | Role | What they receive |
|---|---|---|
| Evening primrose oil | Active comparator | Not described Receives: Drug: Evening primrose oil(EPO) |
| placebo | Placebo comparator | Not described Receives: Drug: Placebo - Cap |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of medical induction of abortion
time needed for complete expulsion of fetus and placenta
Measured: up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start1 Nov 2018 (estimated)
- Primary completion1 Nov 2019 (estimated)
- Study completion1 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Missed AbortionStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Radwa Rasheedy Ali, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03698734
- Sponsor's protocol ID
- ASU obstetrics hosp
- Status last verified
- Oct 2018
- First submitted
- 4 Oct 2018
- Last updated
- 9 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Adding Evening Primrose Oil to Misoprostol in Second Trimester Abortion
- ClinicalTrials.gov ID
- NCT03698734
- Acronym / sponsor ID
- ASU obstetrics hosp
- Conditions
- Missed Abortion
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Nov 2018 (estimated)
- Primary completion
- 1 Nov 2019 (estimated)
- Study completion
- 1 Nov 2019 (estimated)
- First posted
- 9 Oct 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.
efficacy of evening primrose oil in shortening the duration of induction in 2nd trimesteric missed abortion
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Evening primrose oil | Active comparator | Drug: Evening primrose oil(EPO) |
| placebo | Placebo comparator | Drug: Placebo - Cap |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Primiparous women
Key exclusion criteria (6 listed)
- Previous uterine incision( Cs, myomectomy,)
- Contraindications to medical or surgical uterine evacuations (eg, hemodynamically unstable, coagulopathy)
- Evidence of intra-uterine infection
- Rupture of fetal membranes.
- Intrauterine device in place.
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(EPO)primiparous women with missed abortion between(13 to 24 weeks) will receive 1 capsule of EPO( 1000mg) in addition to misopristol | Drug | Evening primrose oil |
| Placebo - Capprimiparous women with missed abortion between(13 to 24 weeks) will receive 1 capsule of placebo in addition to misopristol | Drug | placebo |
Primary outcome
duration of medical induction of abortion
Time frame: up to 1 week
time needed for complete expulsion of fetus and placenta
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Evening primrose oil(EPO) in people with Missed Abortion, run by Ain Shams University 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 1 inclusion and 6 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 9 Oct 2018. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Radwa R Ali, MD (01283492979 ext. 02002, radwaebed@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
duration of medical induction of abortion (time frame: up to 1 week). 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 9 Oct 2018.