Missed AbortionPhase 4NCT03584698
Evening Primrose Oil to Misoprostol During Induction of Second-trimester Missed Miscarriage
A Phase 4 study testing Misoprostol 100Mcg Tab and Evening Primrose Oil 1000 MG in people with Missed Abortion, run by Assiut University at 1 site in Egypt.
Trial summary
Termination of pregnancy is an important subject that has complex and emotional controversies. The most common time of termination of pregnancy is the mid-trimester which has two-thirds of all serious abortion-related complications. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Missed Abortion
- What is being tested?
- Misoprostol 100Mcg Tab and Evening Primrose Oil 1000 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2019to 31 Mar 2021
- Phase
- Phase 4
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Nullipara or previous vaginal delivery only
- Bishop score was ≤ 5
- Women who will accept to participate in the study
Who cannot join
- Multiple gestations
- Rupture of fetal membranes
- Previous cesarean sections
- Women with heavy bleeding
- Evidence of low implanted placenta by US
- Evidence of intra-uterine infection (either clinical or laboratory)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Adding Vaginal Evening Primrose Oil to Misoprostol During Induction of Second-trimester Missed Miscarriage; a Randomized Controlled Trial
Termination of pregnancy is an important subject that has complex and emotional controversies. The most common time of termination of pregnancy is the mid-trimester which has two-thirds of all serious abortion-related complications. There are many indications for mid trimester termination of pregnancy such as missed abortion, serious fetal abnormalities and lastly some women do not wish to continue a pregnancy and will often request termination of pregnancy
- Conditions
- Missed Abortion
- Being tested
- Misoprostol 100Mcg Tab, Evening Primrose Oil 1000 MG
- Medical subject headings
- Abortion, Missed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Misoprostol 100Mcg TabDrug
women will receive misoprostol 100 mcg (Misotac, Sigma Pharmaceuticals, Egypt) vaginally applied every 6 hours till cervical dilatation.
Evening Primrose Oil 1000 MGDrug
women will receive 4 capsules evening primrose oil 1000 mg (Primrose plus, Ema Pharm, Egypt) vaginally applied every 6 hours till cervical dilatation.
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | Misoprostol + Evening primrose oil group Receives: Drug: Misoprostol 100Mcg Tab; Drug: Evening Primrose Oil 1000 MG |
| control group | Active comparator | Misoprostol only group Receives: Drug: Misoprostol 100Mcg Tab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The induction to fetal expulsion time.
Duration of delivery of fetus
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2018
- Study start1 Sep 2019
- Primary completion15 Jan 2021
- Study completion31 Mar 2021
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.
- 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
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Abbas, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03584698
- Sponsor's protocol ID
- EPOM
- Status last verified
- Apr 2021
- First submitted
- 30 Jun 2018
- Last updated
- 26 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Adding Vaginal Evening Primrose Oil to Misoprostol During Induction of Second-trimester Missed Miscarriage; a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03584698
- Acronym / sponsor ID
- EPOM
- Conditions
- Missed Abortion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 15 Jan 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 12 Jul 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.
Termination of pregnancy is an important subject that has complex and emotional controversies. The most common time of termination of pregnancy is the mid-trimester which has two-thirds of all serious abortion-related complications. There are many indications for mid trimester termination of pregnancy such as missed abortion, serious fetal abnormalities and lastly some women do not wish to continue a pregnancy and will often request termination of pregnancy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Drug: Misoprostol 100Mcg Tab, Drug: Evening Primrose Oil 1000 MGMisoprostol + Evening primrose oil group |
| control group | Active comparator | Drug: Misoprostol 100Mcg TabMisoprostol only group |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Nullipara or previous vaginal delivery only
- Bishop score was ≤ 5
- Women who will accept to participate in the study
Key exclusion criteria (6 listed)
- Multiple gestations
- Rupture of fetal membranes
- Previous cesarean sections
- Women with heavy bleeding
- Evidence of low implanted placenta by US
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 100Mcg Tabwomen will receive misoprostol 100 mcg (Misotac, Sigma Pharmaceuticals, Egypt) vaginally applied every 6 hours till cervical dilatation. | Drug | control group, study group |
| Evening Primrose Oil 1000 MGwomen will receive 4 capsules evening primrose oil 1000 mg (Primrose plus, Ema Pharm, Egypt) vaginally applied every 6 hours till cervical dilatation. | Drug | study group |
Primary outcome
The induction to fetal expulsion time.
Time frame: 24 hours
Duration of delivery of fetus
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 26 Apr 2021.
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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 Phase 4 study testing Misoprostol 100Mcg Tab and Evening Primrose Oil 1000 MG in people with Missed Abortion, run by Assiut 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 3 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: finished, as of the sponsor's last update on 26 Apr 2021. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 induction to fetal expulsion time. (time frame: 24 hours). 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 26 Apr 2021.