MiscarriagePhase 2/3NCT03479879
Estradiol Pretreatment With Misoprostol in Second Trimester Miscarriage
A Phase 2/3 study testing Estradiol and Misoprostol in people with Miscarriage, run by Ain Shams University at 1 site in Egypt.
Trial summary
To compare the effectiveness of estradiol pretreatment with misoprostol and vaginal misoprostol alone in induction of second trimestr miscarriage. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Miscarriage
- What is being tested?
- Estradiol and Misoprostol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Mar 2018to 20 Dec 2018
- Phase
- Phase 2/3
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Maternal age more than 18 years old (age of legal consent).
- Gestational age between 12-26 weeks.
- Hb level > 10 g/dL.
- BMI between 25 kg/m2 and 35 kg/m2.
- Missed abortion.
- Living fetus with multiple congenital malformations incompatible with life.
- PPROMS with drained liquor and parents are consenting for termination of pregnancy.
Who cannot join
- Maternal age less than 18 years old.
- Gestational age less than 12 weeks or more than 26 weeks.
- Hb level < 10 g/dL.
- Scared uterus (previous myomectomy - cesarean section - hysterectomy and ruptured uterus).
- Polyhydramnios.
- Anencephaly.
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- Fibroid uterus.
- BMI less than 25 kg/m2 and more than 35 kg/m2.
- Coagulopathy.
- Previous attempts for induction of abortion in the current pregnancy.
- Allergy to misoprostol or estradiol.
- Placenta previa.
- Medical disorder that contraindicate induction of abortion (e.g. heart failure).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Estradiol Pretreatment With Misoprostol in Second Trimester Miscarriage: A Prospective, Double-blind, Randomized Clinical Trial
To compare the effectiveness of estradiol pretreatment with misoprostol and vaginal misoprostol alone in induction of second trimestr miscarriage.
- Conditions
- Miscarriage
- Being tested
- Estradiol, Placebo Oral Tablet, Misoprostol
- Medical subject headings
- Abortion, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EstradiolDrug
Estradiol
Placebo Oral TabletDrug
Placebo
MisoprostolDrug
Misoprostol
| Study group | Role | What they receive |
|---|---|---|
| Estradiol + Misoprostol | Experimental | Not described Receives: Drug: Estradiol; Drug: Misoprostol |
| Placebo + Misoprostol | Placebo comparator | Not described Receives: Drug: Placebo Oral Tablet; Drug: Misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of induction of abortion
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 posted27 Mar 2018
- Study start21 Mar 2018
- Primary completion20 Dec 2018
- Study completion20 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MiscarriageStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed S Sweed, MD, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03479879
- Sponsor's protocol ID
- AS1731
- Status last verified
- Jan 2019
- First submitted
- 21 Mar 2018
- Last updated
- 29 Jan 2019
- 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 29 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estradiol Pretreatment With Misoprostol in Second Trimester Miscarriage: A Prospective, Double-blind, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03479879
- Acronym / sponsor ID
- AS1731
- Conditions
- Miscarriage
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 21 Mar 2018 (actual)
- Primary completion
- 20 Dec 2018 (actual)
- Study completion
- 20 Dec 2018 (actual)
- First posted
- 27 Mar 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.
To compare the effectiveness of estradiol pretreatment with misoprostol and vaginal misoprostol alone in induction of second trimestr miscarriage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Estradiol + Misoprostol | Experimental | Drug: Estradiol, Drug: Misoprostol |
| Placebo + Misoprostol | Placebo comparator | Drug: Placebo Oral Tablet, Drug: Misoprostol |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Maternal age more than 18 years old (age of legal consent).
- Gestational age between 12-26 weeks.
- Hb level > 10 g/dL.
- BMI between 25 kg/m2 and 35 kg/m2.
- Missed abortion.
Key exclusion criteria (13 listed)
- Maternal age less than 18 years old.
- Gestational age less than 12 weeks or more than 26 weeks.
- Hb level < 10 g/dL.
- Scared uterus (previous myomectomy - cesarean section - hysterectomy and ruptured uterus).
- Polyhydramnios.
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 |
|---|---|---|
| EstradiolEstradiol | Drug | Estradiol + Misoprostol |
| Placebo Oral TabletPlacebo | Drug | Placebo + Misoprostol |
| MisoprostolMisoprostol | Drug | Estradiol + Misoprostol, Placebo + Misoprostol |
Primary outcome
Duration of induction of abortion
Time frame: 24 hours
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 29 Jan 2019.
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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 2/3 study testing Estradiol and Misoprostol in people with Miscarriage, 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 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 29 Jan 2019. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
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?
Duration of induction of abortion (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 29 Jan 2019.