Intra Uterine Fetal DeathPhase 2MISNCT02669420
Misoprostol for Second Trimester Pregnancy Termination
A Phase 2 study testing termination of second trimester pregnancy in people with Intra Uterine Fetal Death, run by Assiut University.
Trial summary
The majority of second-trimester pregnancy termination performed in the United States are performed surgically by dilation and evacuation. The frequency of induction of abortion increases as gestational age advances. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Intra Uterine Fetal Death
- What is being tested?
- termination of second trimester pregnancy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Jan 2016
- Phase
- Phase 2
- 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
- Pregnancy 13-24 weeks.
- Women with indication for termination of the pregnancy due to intra uterine fetal death
Who cannot join
- Pregnancy beyond 24 weeks.
- Women with scared uterus.
- Known hypersensitivity for misoprostol.
- Refusal of the woman to participate.
About this study
Official title: Intra Uterine Extra Amniotic (200 μg ) Versus Vaginal (200 μg) Misoprostol for Second Trimester Pregnancy Termination: Randomized Controlled Trial
The majority of second-trimester pregnancy termination performed in the United States are performed surgically by dilation and evacuation. The frequency of induction of abortion increases as gestational age advances. In the late second trimester and early third trimester, induction is the primary method of termination in cases of fetal abnormalities. In many other countries, however, induction is the primary method of abortion throughout the second trimester
- Conditions
- Intra Uterine Fetal Death
- Being tested
- termination of second trimester pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
termination of second trimester pregnancyProcedure or surgery
Intra uterine extra amniotic (200 μg ) versus Vaginal (200 μg) Misoprostol for Second Trimester Pregnancy Termination. Randomized controlled trial
| Study group | Role | What they receive |
|---|---|---|
| extra amniotic misoprostol | Experimental | misoprostol dissolved in warm saline , become dissolute misoprostol saline solution(200 microgram every 4 hours) Receives: Procedure: termination of second trimester pregnancy |
| vaginal misoprostol | Experimental | misoprostol tablet soaked with distilled water and inserted in the posterior fornix of the vagina( 200 microgram every 4 hours) Receives: Procedure: termination of second trimester pregnancy |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean duration from the initial misoprostol dose until complete fetal expulsion
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 posted1 Feb 2016 (estimated)
- Study startJan 2015
- Primary completionDec 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intra Uterine Fetal DeathStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, abo bakr mitwally, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02669420
- Sponsor's protocol ID
- 220
- Acronym
- MIS
- Status last verified
- Jan 2016
- First submitted
- 23 Jan 2016
- Last updated
- 1 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Ghosh J, Papadopoulou A, Devall AJ, Jeffery HC, Beeson LE, Do V, Price MJ, Tobias A, Tuncalp O, Lavelanet A, Gulmezoglu AM, Coomarasamy A, Gallos ID. Methods for managing miscarriage: a network meta-analysis. Cochrane Database Syst Rev. 2021 Jun 1;6(6):CD012602. doi: 10.1002/14651858.CD012602.pub2.
PubMed 34061352
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra Uterine Extra Amniotic (200 μg ) Versus Vaginal (200 μg) Misoprostol for Second Trimester Pregnancy Termination: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02669420
- Acronym / sponsor ID
- MIS / 220
- Conditions
- Intra Uterine Fetal Death
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 1 Feb 2016 (estimated)
- 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.
The majority of second-trimester pregnancy termination performed in the United States are performed surgically by dilation and evacuation. The frequency of induction of abortion increases as gestational age advances. In the late second trimester and early third trimester, induction is the primary method of termination in cases of fetal abnormalities. In many other countries, however, induction is the primary method of abortion throughout the second trimester
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| extra amniotic misoprostol | Experimental | Procedure: termination of second trimester pregnancymisoprostol dissolved in warm saline , become dissolute misoprostol saline solution(200 microgram every 4 hours) |
| vaginal misoprostol | Experimental | Procedure: termination of second trimester pregnancymisoprostol tablet soaked with distilled water and inserted in the posterior fornix of the vagina( 200 microgram every 4 hours) |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Pregnancy 13-24 weeks.
- Women with indication for termination of the pregnancy due to intra uterine fetal death
Key exclusion criteria (4 listed)
- Pregnancy beyond 24 weeks.
- Women with scared uterus.
- Known hypersensitivity for misoprostol.
- Refusal of the woman to participate.
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 |
|---|---|---|
| termination of second trimester pregnancyIntra uterine extra amniotic (200 μg ) versus Vaginal (200 μg) Misoprostol for Second Trimester Pregnancy Termination. Randomized controlled trial | Procedure or surgery | extra amniotic misoprostol, vaginal misoprostol |
Primary outcome
mean duration from the initial misoprostol dose until complete fetal expulsion
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 1 Feb 2016.
- Derived from this study: PubMed 34061352Ghosh J, Papadopoulou A, Devall AJ, Jeffery HC, Beeson LE, Do V, Price MJ, Tobias A, Tuncalp O, Lavelanet A, Gulmezoglu AM, Coomarasamy A, Gallos ID. Methods for managing miscarriage: a network meta-analysis. Cochrane Database Syst Rev. 2021 Jun 1;6(6):CD012602. doi: 10.1002/14651858.CD012602.pub2.
- Individual participant dataSharing planned: Yes
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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing termination of second trimester pregnancy in people with Intra Uterine Fetal Death, 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 2 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: finished, as of the sponsor's last update on 1 Feb 2016. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
mean duration from the initial misoprostol dose until complete fetal expulsion (time frame: 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 NCT02669420, which also lists 1 linked publication.
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 1 Feb 2016; AzTrials last refreshed its copy on 29 Oct 2026.